Od 2044 1 - Ed.1

IECEE OD-2044-1
Edition 1.0 2023-06-28
IECEE
OPERATIONAL DOCUMENT
IEC System of Conformity Assessment Schemes for Electrotechnical Equipment

and Components (IECEE System)
Committee of Testing Laboratories (CTL)
Evaluation of Risk Management in medical electrical equipment according to the

IEC 60601-1:2005 + A1:2012 + A2:2020 & related ISO/IEC 80601-1 Series of
Standards
IECEE OD-2044:2023(EN)
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–2– IECEE OD-2044-1:2023© IEC 2023
Contents
Contents ................................................................................................................................................................................ 2
FOREWORD ......................................................................................................................................................................... 3
1 Scope .......................................................................................................................................................... 4
2 Reference documents ................................................................................................................................. 4
3 Terms and definitions .................................................................................................................................. 4
4 Application of Risk Management Principle for IEC 60601 series CB Scheme investigations .................... 5
5 Assessment of Risk Management principles in the IEC 60601 series CB Scheme investigations ............ 5
6 Clause mapping guide IEC 60601 / ISO 14971 ........................................................................................ 22
Annex A - ISO 14971:2019 Checklist (Informative) ............................................................................................................. 65
Disclaimer: This document is controlled and has been released electronically.

Only the version on the IECEE Website is the current document version
IECEE OD-2044-1:2023© IEC 2023 –3–
FOREWORD
Document Owner
CTL ETF-3 “MEAS, MED”
History of changes
Date Brief summary of changes
New document to update previous document OD 2044 to IEC60601-

2022-11-01
1:2005 + AMD 1:2012 + AMD 2:2020 and new TRF
Effective date Next maintenance due date

2023-06-30 2026-06-30

–4– IECEE OD-2044-1:2023© IEC 2023
1 Scope
The scope of this procedure is to provide a uniform approach to the CBTL and Manufacturer on how to assess and
document compliance with the relevant clauses of IEC 60601 standard series related to the standard ISO 14971:2019.
2 Reference documents
IEC 60601-1:2005 incl. AMD 1:2012 and AMD 2: 2020, Medical equipment – Part 1: General requirements for basic
safety and essential performance (Also known as IEC 60601-1 ed 3.2)
IEC 60601-1:2005/AMD 1:2012/ISH1:2021
IEC 60601-1-2:2014 incl. AMD 1:2020, Medical electrical equipment - Collateral standard: Electromagnetic compatibility -
Requirements and tests
IEC 60601-1-3:2008 incl. AMD 1:2013, Medical electrical equipment - Collateral Standard: Radiation protection in
diagnostic X-ray equipment
IEC 60601-1-6:2010 incl. AMD 1:2013 and AMD 2:2020, Medical electrical equipment - Collateral Standard: Usability
IEC 60601-1-8:2006 incl. AMD 1:2012 and AMD 2:2020, Medical electrical equipment - Collateral Standard: General
requirements, tests and guidance for alarm systems in medical electrical equipment and medical electrical systems
IEC 60601-1-10:2007 incl. AMD 1:2013 and AMD 2:2020, Medical electrical equipment - Collateral Standard:
Requirements for the development of physiologic closed-loop controllers
IEC 60601-1-11:2015 incl. AMD 1:2020, Medical electrical equipment - Collateral Standard: Requirements for medical
electrical equipment and medical electrical systems used in the home healthcare environment
IEC 62366-1:2015 incl. AMD 1:2020, Medical devices – Application of usability engineering to medical devices
IEC 62304:2006 incl. AMD 1:2015, Medical device software – Software life cycle processes
ISO 14971:2019, Medical devices – Application of risk management to medical devices
IEC60601_1T, IECEE Test Report form - IEC 60601-1: 2005 + AMD 1 (2012) + AMD 2(2020)
3 Terms and definitions

For the purposes of this Operational Document, the terms and definitions of ISO 14971:2019 standard and IEC 60601
standard series apply.
For the purpose of this document, the Risk Management Process is a management system intended to address all
activities related to ISO 14971.
For the purpose of this document, unless otherwise specified, the following conventions are used:
• IEC 60601-1:2005 + AMD 1:2012 + AMD 2: 2020 designates "the general standard" alone;
• IEC 60601-1 designates reference to IEC 60601-1:2005 + AMD 1:2012 + AMD 2: 2020
• IEC 60601-1-nn designates a specific collateral standard (this applies for all the collateral standards stated in this
document where “nn” is the number of the collateral)
IECEE OD-2044-1:2023© IEC 2023 –5–
• IEC 60601 series designates the combination of the general standard IEC 60601-1:2005 + AMD 1:2012 + AMD
2:2020 and the collateral standards IEC 60601-1-nn.
• ISO 14971 designates reference to ISO 14971:2019
4 Application of Risk Management Principle for IEC 60601 series CB Scheme

investigations
4.1 General
The third edition of IEC 60601-1:2005 +AMD 1:2012 + AMD 2:2020 is the primary standard in a series of standards that
covers safety and essential performance of medical electrical equipment. It is the first IEC standard in the scope of the
CB Scheme that incorporates risk management principles according to ISO 14971:2019. The introduction of Risk
Management is the reason for this Operational Document.
The existence of a CB Test Certificate does not solely establish legal market entry. However, it could be used to help
substantiate a request for legal market access.
This Operational Document is related solely to the IECEE CB Scheme and is intended for use by those individuals with a
working knowledge of risk management for medical electrical equipment and the provisions of the IEC 60601 series.
5 Assessment of Risk Management principles in the IEC 60601 series CB

Scheme investigations
5.1 General principles

There is a general requirement to perform the risk management process as specified in ISO 14971:2019 (IEC 60601-
1:2005 + AMD 1:2012 + AMD 2: 2020, Clause 4.2.2)
The registration to ISO 13485 is not sufficient to demonstrate that a risk management process compliant with ISO 14971
requirements is performed. There can be no investigation to IEC 60601 series without the manufacturer’s Risk
Management File being available, unless specifically permitted by the rules of the CB Scheme.
The CB Test Report and Certificate confirms that there is a Risk Management Process performed which complies with
the risk management requirements of IEC 60601 series and the applicable requirements of ISO 14971. This does not
mean that a complete Risk Management System in compliance with ISO 14971 is in place. The CB Test Report is only a
snapshot in time and does not necessarily assess all top management responsibilities.
Several clauses of ISO 14971 define the requirements for the application of the Risk Management Process to “the
particular medical device being considered”. When those clauses of ISO 14971 are used to address Risk Management
requirements in IEC 60601-1, the verification shall confirm whether the Risk Management Process is correctly applied to
the particular Device Under Evaluation/Test.
A separate certification of registration to ISO 14971 indicates that a risk management system conforming to ISO 14971 is
in place, but does not necessarily provide the risk management device specific documentation to meet the requirements
of IEC 60601 series. IEC 60601 series requires specific Risk Management activities to be done and the CB Test Report
requires objective evidence that these activities have been performed for the Device Under Test.
A CB Scheme Test Certificate does not imply that an audit of the manufacturer’s Risk Management System was
conducted.

–6– IECEE OD-2044-1:2023© IEC 2023
In view of the above and similar to the second edition, the CB Test Report according to IEC 60601-1 is not necessarily a
guarantee of certification by an accepting NCB.
A certificate of registration may be requested for local or regional certification to IEC 60601 series as it relates to follow-
up services. There may be differences in requirements that are the subject of local legal market entry requirements.
5.2 Implementation of ISO 14971 into the IEC 60601 series

In the clauses of IEC 60601-1 series there are three types of references to ISO 14971 Risk Management requirements:
a) Direct reference to Risk Management Process as specified by ISO 14971 (for example clause 4.2.2).
b) Test related references to give appropriate alternative to the application of laboratory testing with specific pass/fail
criteria or to select appropriate tests to be performed on the specific product (for example clause 5.7).
c) Indirect reference to offer additional elements to be considered in the implementation of the Risk Management
Process specified by ISO 14971 for the specific product. (for example clause 14.1)
The manufacturer can also identify alternative means to provide an equivalent safety level to IEC 60601 series. The
manufacturer may implement new and original approaches to developing effective means of protection against
unacceptable risks. The manufacturer must verify that the residual risks that result from applying the alternative means
are equal to or less than the residual risks that result from applying the requirements of IEC 60601 series. All these
activities must be performed in accordance with the requirements of ISO 14971.
Clause 4.2.2 of IEC 60601-1:2005 +AMD 1:2012 + AMD 2:2020 does not require post market monitoring (e.g. clause 10
of ISO 14971:2019) of the effectiveness of the risk control measures
Tables appended in Clause 6 of this Operational Document provide mapping with all the clauses of IEC 60601-1 and the
IEC collaterals standards which require risk management, and the applicable clauses in ISO 14971:2019. These tables
provide guidance and considerations for application and assessment of RM criteria.
5.3 ISO 14971:2019 (3rd edition)

The process of standards development progresses over a significant length of time. The IEC 60601 series of standards
to which this Operational Document refers were published between 2005 and 2020. When IEC 60601-1:2005 was
published and consequentially its collateral standards published, the risk management standard used as reference was
ISO 14971:2000.
5.4 Description of ISO 14971:2019 clauses application in regards to IEC 60601-1

standard
The following Table is a guidance document. Refer to standard ISO 14971 for more detailed requirements and
supporting rationales. This table explains what action or evidence is required for each clause of ISO 14971:2019.
IEC 60601-1 TRF – RM RESULTS TABLE 4.2 – Risk Management Process
4.2 RM RESULTS TABLE: Risk Management Process for ME Equipment or ME P

Systems

IECEE OD-2044-1:2023© IEC 2023 –7–
Clause of Document Ref. in RMF Result – Remarks Verdict

ISO 14971 (Document No. and - What type of objective evidence would be
paragraph) required in the Document Ref.
– Main topic of clause
4.2 Management Requires that the manufacturer define and document the P
responsibilities policy for determining criteria for risk acceptability; this
policy ensures that criteria are based upon applicable
national or regional regulations and relevant International
Standards, and takes into account available information
such as the generally accepted state of the art and known
stakeholder concerns. The CBTL must review the
manufacturer’s policy and verify that it meets these
requirements. This review is done once, as is
recommended to be completed early in the risk
management review process.
ISO 14971:2019 additionally requires an assessment to
ensure the manufacturer will allocate sufficient
resources and assign trained personnel to the risk
management process
4.3 Qualification of Requires the personnel performing risk management tasks P

personnel to have the appropriate knowledge and experience for the
tasks assigned to them. This includes knowledge and
experience related to the medical device(s), their use,
technologies involved and risk management techniques.
The manufacturer is required to maintain qualification
records
4.4 Risk management plan The criteria for risk acceptability are based on the P
manufacturer’s policy for determining acceptable risk,
including criteria for accepting risks when the probability of
occurrence of harm cannot be estimated. The
manufacturer’s risk management process must include the
risk acceptability criteria. The CBTL must review the
manufacturer’s risk acceptability criteria and verify that it
meets established requirements. This review is done once,
as is recommended to be completed early in the risk
management review process
4.5 Risk management file Requires the manufacturer to estabilish and maintain a file P
containing the results of the risk management activities
including all documentation requirements specified in ISO
14971 and traceability for each identified hazard to: the risk
analysis, the risk evaluation, risk control measures and
acceptance of residual risks

–8– IECEE OD-2044-1:2023© IEC 2023

5.1 Risk analysis process Risk analysis shall be performed for the particular medical P
device as described in 4.2 to 4.4. The implementation of
the planned risk analysis activities and the results of the
risk analysis shall be recorded in the risk management file.
In addition to the records required in 4.2 to 4.4, the
documentation of the conduct and results of the risk
analysis shall include at least the following:
a) a description and identification of the medical device that
was analyzed;
b) identification of the person(s) and organization who
carried out the risk analysis;
c) scope and date of the risk analysis
5.2 Intended use and For the particular medical device being considered, the P
reasonably foreseeable manufacturer documents the intended use and reasonably
misuse foreseeable misuse. This documentation shall be
maintained in the risk management file. The CBTL must
review the risk management file and verify that based on
the device, the manufacturer has complied with these
requirements. Note that the identification of characteristics
that could affect safety, needs to include those hazard
based requirements from the IEC 60601 series of
standards where clause 4.2 of ISO 14971 is a required
element. This review repeats for each IEC 60601 series
hazard based risk management requirement.
5.3 Identification of The manufacturer identifies and documents those

characteristics related to qualitative and quantitative characteristics that could affect
safety the safety of the medical device and, where appropriate,
their defined limits. This documentation shall be maintained
in the risk management file
5.4 Identification of hazards The manufacturer compiles documentation on known and P

and hazardous situations foreseeable hazards associated with the medical device in
both normal and fault conditions. The manufacturer
processes identified risks through hazard
identification→event(s) or circumstance(s) leading to a
hazardous situation→hazardous situation→event(s) or
circumstance(s) leading to harm→harm→who or what is
harmed. For those hazard based requirements that are
applicable to the medical device, the CBTL uses this
information for completing clause 4.3 and 4.4 of the IECEE
Risk Management Results Tables. The CBTL reviews and
verifies compliance for all of the applicable hazard based
risk management requirements.

IECEE OD-2044-1:2023© IEC 2023 –9–

5.5 Risk estimation The manufacturer determines and documents rreasonably P
foreseeable sequences or combinations of events that can
result in a hazardous situation and records the resulting
hazardous situation(s).
For each identified hazardous situation, the manufacturer
estimates the associated risk(s) using available information
or data. For hazardous situations for which the probability
of the occurrence of harm cannot be estimated, the
possible consequences shall be listed for use in risk
evaluation and risk control. The results of these activities
shall be recorded in the risk management file.
Any system used for qualitative or quantitative
categorization of probability of occurrence of harm or
severity of harm shall be recorded in the risk management
file.
The CBTL reviews the risk analysis and risk estimation and
enters verification of each of the hazards based risk
management analysis and risk estimation in the test results
table.
6 Risk evaluation For each identified hazardous situation, the manufacturer P

shall decide, using the criteria defined in the risk
management plan, if risk reduction is required. If risk
reduction is not required, the requirements given in 6.2 to
6.6 do not apply for this hazardous situation. The results of
this risk evaluation shall be recorded in the risk
management file.
The CBTL reviews the manufacturer’s risk evaluation for
each hazard based risk required by the IEC 60601 series
of standards and enters a verdict in the Risk Management
Results Table. The CBTL uses this information for test
plans and conducting tests (e.g. unacceptable performance
becomes essential performance).

– 10 – IECEE OD-2044-1:2023© IEC 2023

7.1 Risk control option The manufacturer identifies risk control measure(s) that are P
analysis appropriate for reducing the risk(s) to an acceptable level.
The manufacturer uses one or more of the following risk
control options in the priority order listed:
a) inherent safety by design;
b) protective measures in the medical device itself or in the
manufacturing process;
c) information for safety
The manufacturer records the risk control measure(s) in
the risk management file.
If, during risk control option analysis, the manufacturer
determines that required risk reduction is not practicable,
the manufacturer shall conduct a risk/benefit analysis of the
residual risk (proceed to 6.5).
The CBTL reviews the manufacturer’s chosen risk control
measure(s) for each hazard based requirement from IEC
60601 series of standards and documents their findings in
the Risk Management Results Tables in the TRF.
7.2 Implementation of risk The manufacturer implements the identified risk control P
control measure(s) measure(s). The manufacturer verifies the implementation
of each hazard based risk control measure. The
effectiveness of the risk control measure(s) shall be verified
and the results shall be recorded in the risk management
file.
The CBTL reviews manufacturer’s implementation,
verification and effectiveness of risk control measure(s) for
each hazard based requirement from IEC 60601 series of
standards and documents their findings in the Risk
Management Results Tables in the TRF.

IECEE OD-2044-1:2023© IEC 2023 – 11 –

7.3 Residual risk evaluation After the risk control measures are applied, the P
manufacturer evaluates any residual risk using the criteria
defined in the risk management plan. The results of this
evaluation are recorded in the risk management file.
If the residual risk is not judged acceptable using these
criteria, then the manufacturer applies further risk control
measures.
For residual risks that are judged acceptable, the
manufacturer decides which residual risks to disclose and
what information is necessary to include in the
accompanying documents in order to disclose those
residual risks.
The CBTL reviews the manufacturer’s residual risk
analysis, risk control looping where necessary, and their
determination of information to be included in the
accompanying documents. The CBTL verifies compliance
with these requirements and records their findings in the
Risk Management Results Tables of the TRF for each
hazard based risk management from the IEC 60601 series
of standards.
7.4 Benefit-risk analysis If the residual risk is not judged acceptable using the P
criteria established in the risk management plan and further
risk control is not practicable, the manufacturer may gather
and review data and literature to determine if the medical
benefits of the intended use outweigh the residual risk. If
this evidence does not support the conclusion that the
medical benefits outweigh the residual risk, then the risk
remains unacceptable. If the medical benefits outweigh the
residual risk, then proceed to 6.6.
For risks that are demonstrated to be outweighed by the
benefits, the manufacturer shall decide which information
for safety is necessary to disclose the residual risk.
The CBTL is responsible for carefully reviewing the
manufacturers’ risk management file and entering their
findings in the Risk Management Results table.

– 12 – IECEE OD-2044-1:2023© IEC 2023

7.5 Risks arising from risk The manufacturer reviews the effects of the risk control P
control measures measures with regard to:
a) the introduction of new hazards or hazardous situations;
b) whether the estimated risks for previously identified
hazardous situations are affected by the introduction of the
risk control measures.
The manufacturer processes newly identified hazards or
hazardous situations through their risk management
process and reprocesses risks that are affected by the
introduction of risk control measures through initial risk
estimation, risk evaluation and if necessary, risk control.
The CBTL reviews the manufacturers’ risk management file
and records their findings in the TRF Risk Management
Results Table.
7.6 Completeness of risk The manufacturer ensures that the risk(s) from all identified P
control hazardous situations have been considered. The results of
this activity are recorded in the risk management file.
and records their findings in the Risk Management Results
Table
8 Evaluation of overall After all risk control measures have been implemented and P
residual risk verified, the manufacturer decides if the overall residual
risk posed by the medical device is acceptable using the
criteria defined in the risk management plan.
If the overall residual risk is not judged acceptable using
the criteria established in the risk management plan, the
manufacturer may gather and review data and literature to
determine if the medical benefits of the intended use
outweigh the overall residual risk. If this evidence supports
the conclusion that the medical benefits outweigh the
overall residual risk, then the overall residual risk can be
judged acceptable. Otherwise, the overall residual risk
remains unacceptable.
For an overall residual risk that is judged acceptable, the
manufacturer shall decide which information is necessary
to include in the accompanying documents in order to
disclose the overall residual risk.
regarding their overall residual risk and records a verdict in
the TRF Risk Management Results Table.

IECEE OD-2044-1:2023© IEC 2023 – 13 –

9 Risk management review Requires the manufacturer to prepare a report prior to P
commercial release documenting a review of the risk
management process (specific to activities on specific
devices). The report is intended to ensure that the risk
management plan was properly implemented, the overall
residual risk is acceptable and there are appropriate
methods in place to collect and analyze production and
post-production information.
The portion of the requirement related to production and
post-production information is outside the scope of
assessment under the IECEE CB Scheme
5.5 Evaluating RISK – HAZARDS identified in the IEC 60601-series

The requirements of this standard shall be applied in the following way when evaluating RISK:
a) Where this standard or its collateral or particular standards specify requirements addressing particular
HAZARDS, together with specific acceptance criteria, compliance with these requirements is presumed to
establish that the RESIDUAL RISKS have been reduced to acceptable levels unless there is OBJECTIVE
EVIDENCE to the contrary.
EXAMPLE 1: Sub-clause 8.5.1.2, MEANS OF PATIENT PROTECTION (MOPP)
EXAMPLE 2: Sub-clause 9.4.2.1, Instability in transport position

Compliance is checked by satisfying the relevant requirements of this standard and its collateral and particular
standards.
b) Where this standard or its collateral or particular standards specify requirements addressing particular HAZARDS
but do not provide specific acceptance criteria, the MANUFACTURER shall provide the acceptance criteria for
which the RESIDUAL RISK shall be acceptable according to the criteria for RISK acceptability recorded in the
RISK MANAGEMENT plan.
EXAMPLE 3: Sub-clause 9.8.3.3, Dynamic forces due to loading from persons (Note: IEC 60601-1:2005 + AMD
1:2012 removes reference to unacceptable RISK and replaces the text with reference to maintaining BASIC
SAFETY and ESSENTIAL PERFORMANCE)
EXAMPLE 4: Sub-clause 11.6.3, Spillage on ME EQUIPMENT and ME SYSTEM

Compliance is checked by confirming that the documentation in the RISK MANAGEMENT FILE demonstrates
that after applying the specific requirements of this standard and the acceptance criteria determined by the
manufacturer the RESIDUAL RISK is acceptable using the criteria for RISK acceptability recorded in the RISK
MANAGEMENT plan, i.e. no unacceptable RISK remains. Only the relevant parts of the RISK MANAGEMENT
FILE need to be reviewed, e.g. MANUFACTURER’S calculations or test results, or the determination of RISK

– 14 – IECEE OD-2044-1:2023© IEC 2023
c) Where this standard or its collateral or particular standards identify particular HAZARDS that have to be
investigated without providing specific technical requirements:
– The MANUFACTURER shall determine whether such HAZARDS exist for the particular ME EQUIPMENT or
ME SYSTEM, and
– where such HAZARDS exist for the particular ME EQUIPMENT or ME SYSTEM, the MANUFACTURER shall
evaluate and (if necessary) control these RISKS following the RISK MANAGEMENT PROCESS specified in
4.2/4.2.2.
EXPLE 5: Sub-clause 10.2, Alpha, beta, gamma, neutron and other particle radiation Compliance is checked by
confirming that the documentation in the RISK MANAGEMENT FILE demonstrates that the RESIDUAL RISK is
acceptable using the criteria for RISK acceptability recorded in the RISK MANAGEMENT plan, i.e. no
unacceptable RISK remains.
Only the relevant parts of the RISK MANAGEMENT FILE need to be reviewed, e.g. MANUFACTURER’S
calculations or test results, or the determination of RISK acceptability.
NOTE: When ME EQUIPMENT or an ME SYSTEM has been designed in such way that for a certain type of HAZARD no HAZARDOUS
SITUATION exists, no further RISK ASSESSMENT for that HAZARD is necessary. This can be verified by tests or inspections.
5.6 Evaluating RISK – HAZARDS not identified in the IEC 60601-series

For HAZARDS that are identified for the particular ME EQUIPMENT or ME SYSTEM but are not specifically addressed in
the Standard IEC 60601-1 or its collateral or particular standards, the MANUFACTURER shall address those HAZARDS
in the RISK MANAGEMENT PROCESS as specified in 4.2.2.
EXAMPLE 6: ME EQUIPMENT or an ME SYSTEM for which there are particular RISKS but no particular standard
Compliance is checked by inspection of the RISK MANAGEMENT FILE.
Clause 5.2 of ISO 14971 has caused confusion when used with the IEC 60601 series of standards. The manufacturers
Intended Use statement is information that the CBTL can use to understand the intended purpose of the product. The
manufacturer must identify and document a list of qualitative and quantitative characteristics that could affect safety.
Where clause 5.3 of ISO 14971 is called out in the hazard based clauses of IEC 60601 series, the CBTL must use the
manufacturers’ list of qualitative and quantitative characteristics that could affect safety. For example, high humidity for
extended period of time, the manufacturer should have identified and documented the intended use environment.
One of the IEC 60601-1:2005 risk management requirements is process based and not hazard based. This requirement
will not be found in the manufactures hazard identification. The process based clause is 4.2 and it is expected that the
manufacturer will have implemented appropriate system procedures to address this clause.
Four of the elements (requirements) of ISO 14971 only require single use/review including 4.3, 4.4, 7.6 and 8 since they
are process requirements rather than hazard based requirements. Note that not all of the elements (requirements) of ISO
14971 are required by the IEC 60601 series of standards.
The manufacturer addresses the hazard based clauses of the IEC 60601 series of standards according to the ME
Equipment. The Risk Management Results-Remark in the TRFs are based on the requirements of the IEC 60601 series
of standards. For a specific hazard, a manufacturers’ risk management file may go beyond the specific Risk Management
Results-Remark, or the manufacturers’ risk management file may use only a portion of the risk management elements
and, therefore, it is acceptable to enter NA into some of the identified ISO 14971 Risk Management Results-Remark
clauses based on the specific risk for the ME Equipment.

IECEE OD-2044-1:2023© IEC 2023 – 15 –
For hazard based risk management requirements, the flow diagram below shows the steps that the manufacturer must
consider. For example, if they complete risk evaluation with an acceptable level of risk, they may not proceed to risk
control.

– 16 – IECEE OD-2044-1:2023© IEC 2023
5.7 Risk Management Flowchart (Reference to the ISO 14971:2019, 3rd edition –
Figure B.1)
The following flowchart is used to process each identified hazard

IECEE OD-2044-1:2023© IEC 2023 – 17 –
5.8 IEC 60601-1 Test Report Form (TRF)

To assess the requirements for Risk Management process required by IEC 60601 series, the CB Scheme utilizes Risk
Management Results table for Clause 4.2.2 and utilizes the Result-Remark section for the specific RM clauses within the
IEC 60601 series TRF in conjunction with the test data tables, containing reference to the manufacturer’s documents
intended to support objective evidence of compliance.
For a clause from IEC 60601-1 which makes reference to the RM file refer to TABLE 1 – IEC 60601- 1 / ISO 14971
CLAUSE MAPPING GUIDE to identify which clauses from ISO 14971 need to be documented.
For example, IEC 60601-1:2005 +AMD 2:2020 Clause 9.2.4 requires reference to the RM file; Table 1 of this OD 2044
specifies that documents demonstrating compliance with clauses 5.2 to 7.5 of ISO 14971:2019 shall be provided for
evaluation.
IEC 60601-1
Clause Requirement + Test Result - Remark Verdict
9.2.4 Emergency stopping devices
Where necessary to have one or more emergency
stopping device(s), emergency stopping device
complied with all the following, except for actuating
switch capable of interrupting all
power……………………………:
a) Emergency stopping device reduced RISK to an
acceptable level
RISK MANAGEMENT FILEindicates the use of an RMF Reference to specific
emergency stopping device reduces the RISK to an RISKS:
acceptable level………………………………..: (ISO 14971 Cl. __)
(ISO 14971 Cl. 5.2-5.5, 6, 7.1-7.5)

– 18 – IECEE OD-2044-1:2023© IEC 2023
After review of the manufacturer’s risk management file, the appropriate section in the TRF should be completed. The
REMARKS-RESULT section should indicate the Manufacturer’s Risk Management document reference, the specific risk
and ISO 14971 Clause references. Using the example provided below based on the use of the older version of the TRF
and its risk management table, we can complete the current TRF format as indicated below.
Below is the Risk Management Table from OD-2044 version 2.3. As this table was created based on the 2007 version of
ISO 14971, the numbers in ( ) are the clause numbers based on the 2019 version.
9.2.4 Risk Management Results Table: Emergency stopping devices Pass
Clause
Document Ref. in RMF
ISO Result- Remark Verdict
(Document No. & paragraph)
14971:2007
(2019)
See document 453627 rev 1

The Treadmill is intended to make a patient walk on a
4.2 (5.2) Pass
moving belt.
Product Specifications
(5.3) Not in 2007 version Not in version 2007
See document 1234567 rev 1 The possible hazard of the patient tripping has been
4.3 (5.4) Pass
clause 13.1a identified.
The probability of occurrence of the harm has been

Document 7654321 – rev 2 estimated in “ProbRange C”.
4.4 (5.5) Pass
Refer to clause 13.1a The severity of the harm has been estimated as “SevRange
B”
Document 7654321 – rev 2

5 (6) The risk has been evaluated as “TBR = To Be Reduced” Pass
Refer to clause 13.1a

The measure that has been identified to control the risk is
6.2 (7.1) Pass
the use of an emergency stopping device.
Refer to clause 13.1a

The Treadmill is provided with an emergency stopping
6.3 (7.2) Pass
device.
Design Verification
The emergency stopping device works as intended.

The probability of occurrence of the harm has been
6.4 (7.3) Pass
reduced to “ProbRange A”.
Design Verification
The residual risk has been evaluated as “acceptable”.

IECEE OD-2044-1:2023© IEC 2023 – 19 –
6.5 (7.4) Not deemed necessary N/A
6.6 (7.5) No other hazards generated Pass

– 20 – IECEE OD-2044-1:2023© IEC 2023
Example on how to complete the current version of the TRF (TRF version T) related to Risk Management using
ISO 14971:2019
IEC 60601-1
Requirement + Test Result - Remark Verdict
Emergency stopping devices
Where necessary to have one or more emergency
stopping device(s), emergency stopping device
complied with all the following, except for actuating
switch capable of interrupting all
power……………………………:
a) Emergency stopping device reduced RISK to an
acceptable level
RISK MANAGEMENT FILEindicates the use of an RMF Reference to specific
emergency stopping device reduces the RISK to an RISKS:
acceptable level………………………………..: Doc. 453627 rev 1
(ISO 14971 Cl. 5.2-5.5, 6, 7.1-7.5) (ISO 14971 Cl. 5.2)
Doc. 1234567, rev1, clause
13.1a
(ISO 14971 Cl. 5.4)
Doc. 7654321 rev 2, clause
13.1a
(ISO 14971 Cl. 5.5, 6, 7.1)
Doc. 1726354 rev 3
(ISO 14971 Cl. 7.2, 7.3)

IECEE OD-2044-1:2023© IEC 2023 – 21 –
5.9 Workflow
a) Based on the latest TRF version, establish the relevant clauses of IEC 60601 series that have to be supported by RM
documentation.
b) Verify the required documentation and identify the relevant reference points to be listed in the TRF. To initiate the
assessment process of a manufacturer, the CBTL may use attachment 1, from this Procedure (ISO 14971:2019
Checklist), or equivalent. The form is intended to facilitate an understanding of the manufacturer’s risk management
procedures. The completion of this form documents the assessment of the manufacturer’s risk management process.
(Note: It is not necessary to maintain a copy of the risk management file).
c) In case the use of RM influences the tests (see clause 5.2)
3.1 Identify the test to be conducted
3.2 Identify the test parameters and conditions to be used performing the tests
3.3 Identify the RM Pass/Fail criteria. The Pass/Fail criteria and the rationale for acceptance shall be reported in the
TRF.
d) Perform verification and report the results in the TRF tables.
5.10 Application of Risk Management to the General and Collateral Standards

The evaluation of clauses and sub-clauses of IEC 60601-1 containing risk management requirements are provided in
Table 1 of this document, Clause Mapping Guide.
The evaluation of clauses and sub-clauses in IEC 60601-1-nn, Collateral standards containing risk management
requirements are provided in Tables 1-3 through 1-11 of this document.
Note: Guidance has not yet been developed by the task force for IEC 60601 particular standards IEC 60601-2-nn

– 22 – IECEE OD-2044-1:2023© IEC 2023
6 Clause mapping guide IEC 60601 / ISO 14971

6.1 Application of ISO 14971:2019 in IEC 60601-1:2005 + AMD 1: 2012 + AMD 2:
2020 product evaluation
IEC 60601-1:2005 + AMD 1: 2012 + AMD 2: 2020 (Ed.3) Medical electrical equipment, Part 1: General requirements for
basic safety & essential performance - Guidance for the application of ISO 14971:2019 (Ed.3)

IECEE OD-2044-1:2023© IEC 2023 – 23 –
Clause 4 – General requirements
IEC 60601-1 Subject Considerations for application of RM criteria ISO 14971

Clauses Clauses
4.2.2 General Compliance is checked by: 4.2, 4.3, 5 to

requirements for 8
RISK
MANAGEMENT
- inspection of the MANUFACTURER'S policy for determining criteria for
RISK acceptability
- inspection of the RISK MANAGEMENT plan for the particular ME
EQUIPMENT or ME SYSTEM under consideration; and
- confirming the MANUFACTURER has prepared a RISK
MANAGEMENT FILE containing the RISK MANAGEMENT
RECORDS and other documentation required by this standard for the
particular ME EQUIPMENT or ME SYSTEM under consideration.
Does the manufacturer have a risk management process according to

ISO14971:2019 in place?
Was this process used for the device being considered?
If so, a limited number of more detailed questions can be addressed at this point:
• Are all risk management procedures (that meet the requirements of

ISO14971:2019, including acceptability criteria) developed and applied for
the device considered (clauses 4.2, 4.3, 4.4, 4.5, 5 to 8 of ISO14971:2019)?
• Is there a risk management plan (including resources and commitment) for
the device considered (clause 4.4 of ISO14971:2019)?
• Has the manufacturer established requirements for maintaining a Risk
management file (clause 4.5 of ISO 14971:2019)?
• Is the overall residual risk for the device considered acceptable (clause 8 of
ISO 14971:2019)?
Has the manufacturer established requirements for creating a Risk management

report to document the review of Risk management activities (clause 9 of ISO
14971:2019)?

– 24 – IECEE OD-2044-1:2023© IEC 2023

Clauses Clauses
4.3 Essential Compliance is checked by inspection of the risk management file which means a 5.2 to 7.4
performance careful examination or scrutiny of the contents. The documentation in the risk
management file shall provide objective evidence that the required activities
have been performed. Inspection may include functional tests.
Has, apart from the essential performance identified in the particular standards,
the resulting risk from the loss or degradation of an identified performance of a
clinical function (in normal and single fault condition) beyond the limits specified
by the manufacturer been judged as unacceptable?
If so, has this performance been identified as essential performance for the
device during the risk assessment process?
If so, have risk control measures been identified to reduce the risk from the loss
of degradation of the identified performance to an acceptable level?
If so, have methods been specified used to verify the effectiveness of the risk
control measures and does this include an assessment to determine whether
verification is needed?
If so, has this been checked by inspection and where necessary by functional
test, where the standard requires that the specified limits are maintained or the
equipment or system transitions to a safe state, following a particular test?
Note: Refer to IEC 60601-1:2005/AMD 1:2012/ISH1:2021 for clarification of

requirements which are needed to maintain essential performance in single fault
condition.
4.5 Alternative Risk Compliance is checked by inspection of the risk management file. 5.2 to 6,
Control Measures or
test methods for Are there particular risks for which alternative means of controlling these risks 7.1 to 7.4
MEE or MES are applied such that the resulting risk level is acceptable for these risks?
If so, have these risks been identified as such during the risk assessment
process?
If so, is the resulting risk level equal or less than the residual risk that results
from applying the requirements of this standard?

IECEE OD-2044-1:2023© IEC 2023 – 25 –

Clauses Clauses
4.6 ME equipment or ME Compliance is checked by inspection of the risk management file. 5.2 to 7.4
system parts that
contact the patient Does the manufacturer’s risk management file consider that patient touchable
parts, not considered an applied part be treated as applied parts?
If such parts are identified, does the manufacturer’s risk management file
considered that they should be treated as an Type BF or CF Applied Part?
If so, all the relevant requirements, except cl 7.2.10, of this standard applied for
the Type BF or CF applied part.
If not, the part is treated as a Type B applied part and all the relevant
requirement, except Cl 7.2.10 of this standard are applied.
4.7 Single Fault Compliance is determined by applying the specific requirements and tests 5.2 to 7.4
Condition for ME associated with the single fault conditions identified in 13.2, and tests for the
Equipment failures identified from evaluation of the results of the risk analysis. Compliance
is determined if the introduction of any of the single fault conditions described in
13.2, one at the time, does not lead directly to the hazardous situations
described in 13.1, or any other outcome that results in an unacceptable risk.
Along with the hazardous conditions described in 13.1, has the results of the
RISK ANALYSIS been evaluated to determine if any additional single fault tests
shall be consider on the ME equipment?
Are electrical component faults considered, over the EXPECTED SERVICE LIFE
considered in the risk analysis?
Were the single fault conditions evaluated by simulation. physical evaluation, or

theoretical evaluation?
Risk analysis should consider electrical component faults.
4.8 Components of ME Compliance is checked by inspection and, where necessary, by test. The tests of 5.2 to 7.4
Equipment this standard for motors (see 13.2.8 and 13.2.13.3) and transformers (see
15.5.3) are considered to be comprehensive and together with the evaluation of
the motor or transformer insulation system according to Table 22 represent all
testing required by this standard. ME system components that provide isolation
from non-ME equipment are evaluated to clause 16.
Are specific exceptions made for any component of the device under
investigation to allow it to be used not in accordance with its specified rating?
If so, are these exceptions formulated as the result of the risk management
process?
If so, have inspection or test requirements been formulated to make the

hazardous situations acceptable?

– 26 – IECEE OD-2044-1:2023© IEC 2023

Clauses Clauses
4.9 Use of components Compliance is checked by inspection of the risk management file and the 5.2 to 7.4
with high-integrity selection criteria for the components with high-integrity characteristics.
characteristics in ME
Are components with high-integrity characteristics applied?
If so, have the risks associated with its use been identified as such during the
risk assessment process, or in other words are they selected and evaluated
consistent with their conditions of use and reasonably foreseeable misuse during
the expected service life of the ME equipment?
Clause 5 – General requirements for testing MEE

Clauses Clauses
5.1 Type Tests The tests to be performed are determined taking into 5.2 to 5.5
consideration the requirements of clause 4, in particular 4.2.
For the selection of the tests to be performed, is a risk

management process according to ISO14971:2000 applied?
If so, this requirement is fulfilled.
The results of the risk analysis are used to determine which

combination(s) of simultaneous faults are to be tested.
For the determination of which combination(s) of simultaneous

faults have to be tested, is a risk assessment applied?
5.4 a) Other conditions Unless otherwise specified in this standard, ME equipment is to 5.2 to 5.5
be tested under the least favorable working conditions as
specified in the Instructions for Use that are identified during the
risk analysis.
For testing of the ME equipment, have the least favourable

working conditions been identified via the risk analysis?

IECEE OD-2044-1:2023© IEC 2023 – 27 –
Clause 7- MEE Identification, markings and documents

Clauses Clauses
7.2.2 Identification ME Equipment and its detachable parts not marked with the 5.2 to 6
name or trademark of the manufacturer and with a Model or
Type reference does not present an unacceptable risk?
7.2.13 Physiological Do the instructions for use describe the nature of the HAZARD 5.2 to 6
effects (safety for physiological effects not obvious to the operator and the
signs and precautions for avoiding it or minimizing the associated RISK? 7.2-7.3
warning
statements)
7.2.17 Protective Can premature unpacking of ME Equipment or its parts result in 5.2 to 7.3
packaging an unacceptable RISK?
Is the packaging marked with a suitable safety sign?
7.3.3 Batteries Are there lithium batteries or fuel cells which are incorporated 4.2 to 5,
where incorrect replacement could result in an unacceptable
RISK? If so, is there a warning indicating that replacement by 6.3
inadequately trained personnel could result in a HAZARD?
7.4.2 Control devices In normal use, can the change of the setting of a control result in 5.2 to 7.3
an unacceptable RISK to the patient? If so, review the
manufacturers risk management file for risk analysis, risk
evaluation and where necessary implementation of risk control.
7.5 Safety signs Is marking used to convey a warning, prohibition or mandatory 5.2 to 7.2
action that mitigates a RISK that is not obvious to the operator?
If so, review the manufacturers risk management file for risk
analysis, risk evaluation and where necessary implementation of
risk control.

– 28 – IECEE OD-2044-1:2023© IEC 2023

Clauses Clauses
7.9.2.4 Electrical power If leakage from a battery would result in an unacceptable RISK, 5.2 to 7.2
source do the instructions for use include a warning to remove the
battery if the ME Equipment is not likely to be used for some
time? If so, review the manufacturers risk management file for
risk analysis, risk evaluation and where necessary
implementation of risk control.
If loss of power would result in an unacceptable risk, do the

instructions for use include a Warning that the ME Equipment
must be connected to an appropriate power source? If so,
review the manufacturers risk management file for risk analysis,
risk evaluation and where necessary implementation of risk
control.
7.9.3.2 Replacement of Where replacement of a component could result in an 5.2 to 7.4

fuses, power unacceptable RISK, is there appropriate warnings to identify the
supply cords and nature of the HAZARD and, if the Manufacturer specifies the
other parts component as replaceable by service personnel, is all
information necessary to safely replace the component? Review
the manufacturers risk management file for risk analysis, risk
evaluation and where necessary risk control measures.
Clause 8 - Protection against electrical hazards from MEE

Clauses Clauses
8.2.2 Connection to an Does the Risk Analysis consider that no hazardous situations 5.2 to 6
external d.c. occur when ME Equipment supplied by an external d.c. power
power source supply is connected with the wrong polarity?
8.5.2.2 Type B applied Has the manufacturer identified in their risk management file, 5.2 to 6
parts unearthed Type B applied parts that are not separated from
unearthed conductive accessible parts?
Does the risk analysis document that the unearthed accessible

parts contacting a source of voltage or the leakage current
above acceptable limits are so low there is no hazardous
situations that occur?
If so, accepted.
If not, then one means of protection is required.

IECEE OD-2044-1:2023© IEC 2023 – 29 –

Clauses Clauses
8.5.2.3 Patient Leads Does the risk analysis document that patient leads and cables 5.2 to 6
that do not comply with clause 8.5.2.3 do not lead to an
unacceptable risk from contact with objects other than a mains
socket or a flat surface?
If so, during product safety verification, the test using a straight,

rigid test finger with a force of 10 N is not required, however, the
remaining inspections of this clause are required.
8.6.3 Protective Does the manufacturer’s risk management file indicate the need 5.2 to 7.4
earthing of to bond moving parts to the protective earth connection?
moving parts
If so, has the manufacturer demonstrated the reliability of the
connection during the expected service life?
8.8.4.1 Mechanical If the manufacturer cannot provide design documentation: 5.2 to 7.4
strength and
resistance to Has the manufacturer identified in the risk management file the
heat need for insulations of all types, except wire insulation, to retain
its resistance to heat in the application over the expected
service life?
If not conduct the tests required in this clause.
8.10.1 Fixing of If it is not obvious that components and wiring are adequately 5.2 to 7.4
components secured:
Has the manufacturer identified components the movement of

which could result in an unacceptable risk in their risk
management file?
If so, verify that such identified components are securely

mounted.

– 30 – IECEE OD-2044-1:2023© IEC 2023
Clause 9 - Protection against mechanical hazards of MEE and MES

Clauses Clauses
9.2.1 Hazards Are protective measures used to reduce the risk from contact 5.2 to 7.4
associated with with moving parts?
moving parts -
General Considering use as indicated in the Accompanying Documents
or reasonably foreseeable misuse and bearing in mind the ease
of access, the ME Equipment function, the shape of the parts,
the energy and speed of the motion and the benefits to the
patient, is this risk reduced to an acceptable level?
Is exposure to moving parts needed for MEE to perform its

intended function?
Have all reasonable protective measures including warning

markings on the MEE where the hazards persist been
implemented?
9.2.2.4.4 Protective Are the risks caused by mechanical hazards associated with 5.2 to 7.4
measures moving parts and reduced by the use of protective measures
incorporated in the control system addressed?
9.2.2.5 c Continuous Are the risks caused by mechanical hazards associated with 5. to 7.4
activation accessibility to a trapping zone and reduced by use of the
continuous activation of the movement control addressed?
9.2.4 Emergency Does the MEE use emergency stopping devices? 5.2 to 7.5
stopping devices
Are risks caused by mechanical hazards which are reduced by
the use of the emergency stopping devices reduced to an
acceptable level?
9.2.5 Release of Are the risks caused by mechanical hazards associated with 5.2 to 7.4
patient release of patient addressed?
9.5.1 Protective Have the risks caused by mechanical hazards associated with 5.4 to 7.4
means expelled parts been addressed?
9.6.1 Acoustic energy Have the risks caused by mechanical hazards associated with 5.2 to 7.4
- General acoustic energy and vibration been addressed?
9.6.2.2 Infrasound and Have the risks caused by mechanical hazards associated with 5.2 to 7.4
ultrasound infrasound and ultrasound energy been addressed?
energy

IECEE OD-2044-1:2023© IEC 2023 – 31 –

Clauses Clauses
9.7.2 Pneumatic and Have the risks caused by mechanical hazards associated with 5.4 to 7.4
hydraulic parts pneumatic and hydraulic parts been addressed?
9.7.7 Pressure-relief Have the risks caused by mechanical hazards associated with a 5.2 to 7.4
device pressure-relief device been addressed?
9.8.1 Hazards Have the risks caused by hazards arising from static, dynamic, 5.2 to 7.4
associated with vibration, impact and pressure loading, foundation and other
support systems movements, temperature, environmental, manufacture and
- General service conditions been addressed?
Were all of the following failures considered: excessive

deflection, plastic deformation, ductile or brittle fracture, fatigue
fracture, instability (buckling), stress-assisted corrosion cracking,
wear, material creep, and material deterioration?
Were the following residual stresses resulting from the

manufacturing process, e.g. machining, assembling, welding,
heat treatment or surface coating considered?
9.8.2 Tensile safety When not according to Table 21, what alternative method was 5.4 to 7.4
factor used to determine the tensile safety factor?
Have the risks related to the value of the tensile factor been
addressed?
9.8.3.1 Strength of Have the risks caused by mechanical hazards associated with 5.2 to 7.4
patient or support or suspensions of the patient (including particular
operator support applications) been addressed?
or suspension
systems -
General
9.8.5 Systems without Has the manufacturer determined that the use of mechanical 5.4 to 7.4
mechanical protective devices in the MEE is not required?
protective
devices Has the manufacturer justified the reasons not to use
mechanical protective devices?

– 32 – IECEE OD-2044-1:2023© IEC 2023
Clause 10 - Protection against unwanted and excessive radiation hazards Leo

Clauses Clauses
10.1.2 ME equipment When applicable, has the manufacturer identified applicable 5.2 to 7.4
intended to particular and collateral standards associated with production of
produce X-radiation or if the manufacturer doesn’t apply applicable
diagnostic or particular and collateral standards associated with production of
therapeutic X- X-radiation the risk management process as indicated in the risk
radiation management file?
10.2 Alpha, beta, When applicable, has the manufacturer identified hazards and 5.2 to 7.4
gamma, neutron hazardous situations associated with production of alpha, beta,
and other gamma, neutron or other particle radiation in the risk
particle radiation management file?
10.5 Other visible When applicable, has the manufacturer identified hazards and 5.2 to 7.4
electromagnetic hazardous situations associated with production of visible
radiation electromagnetic radiation, other than produced by lasers, in the
risk management file?
10.6 Infrared radiation When applicable, has the manufacturer identified hazards and 5.2 to 7.4
hazardous situations associated with production of infrared
radiation, other than produced by lasers, in the risk management
file?
10.7 Ultraviolet When applicable, has the manufacturer identified hazards and 5.2 to 7.4
radiation hazardous situations associated with production of ultraviolet
radiation, other than produced by lasers, in the risk management
file?

IECEE OD-2044-1:2023© IEC 2023 – 33 –
Clause 11 - Protection against excessive temperatures and other hazards

Clauses Clauses
11.1.1 Maximum temperature during normal use
Table 23 Has the manufacturer identified accessible parts of the ME 5.2 to

Equipment that are likely to be touched in normal or foreseeable 7.45
misuse that can contact more than 10% of the surface area
operator or patient’s body or 10% of the surface area of the
patient’s or operator’s head?
Has the manufacturer identified the duration of continuous or

aggregate contact?
Has the manufacturer identified and addressed such risks?
Has the RM process determined suitable limits for temperature

based on the risk acceptability criteria and risk benefit analysis
in association with patient state of health and whether adult,
pediatric or neonate?
Table 24 Has the manufacturer identified applied parts of the ME 5.2 to 7.4
Equipment that can contact more than 10% of the surface area
operator or patient’s body or 10% of the surface area of the
patient’s or operator’s head during normal or foreseeable
misuse?
Has the manufacturer identified the duration of continuous or

aggregate contact of these applied parts?
Has the manufacturer identified and addressed such risks?
Has the RM process determined suitable limits for temperature

based on the risk acceptability criteria?
If the temperature limits exceed the values in table 24 has a

favorable risk benefit analysis in association with patient state of
health and whether adult, pediatric or neonate been
documented?
11.1.2.1 Applied parts Is any part of the ME Equipment intended to supply heat or 5.2 to 7.4
intended to otherwise intended to cool a patient?
supply heat to a
patient Has the manufacturer identified and addressed the clinical risks
associated with hazards?
Has the manufacturer disclosed such risks?

– 34 – IECEE OD-2044-1:2023© IEC 2023

Clauses Clauses
11.1.2.2 Applied parts not Does the ME equipment have any applied parts that are not 5.2 to 7.4
intended to intended to heat or cool the patient that could in normal or
supply heat to a foreseeable misuse exceed 41 °C or cool below ambient
patient temperature?
11.1.3 e Measurements Has the manufacturer identified hazardous situations that relate 5.2 to 7.4
to maximum heating effect of nearby surfaces?
If no hazardous situations are apparent has the manufacturer

made appropriate declarations in the RMF?
Has the manufacturer identified all conditions of intended use

and foreseeable misuse to determine occurrence and duration
of contact with parts and applied parts that could be touched?
11.2.2.1 Risk of fire in an Has the manufacturer identified that there is a risk of fire from an 5.2 to 7.4
oxygen rich oxygen rich environment?
environment
Where scenario number 3 is applicable, has the manufacturer
conducted a risk assessment to determine hazards associated
with leaks or component failures causing a source of ignition
been conducted?
11.3 Constructional Have the specific requirements of this clause been employed to 5.2 to 7.4
requirements for comply with cl 13.1.2?
fire enclosures of
ME equipment Has the manufacturer analyzed and addressed risks of not
complying with the constructional requirements and showed
than an equivalent level of risk / benefit has been provided?
11.5 ME equipment Is the ME Equipment intended to (or can it through foreseeable 5.2 to 7.4
and ME systems misuse) come into contact with flammable agents?
intended for use
in conjunction
with flammable
agents
11.6.2 Overflow in ME Does a HAZARDOUS SITUATION or unacceptable risk due to 5.2 to 6

Equipment overflow develop if transportable ME Equipment is tilted through
an angle of 15°? Review the manufacturers risk management
file for risk analysis and risk evaluation.
Does wetting of uninsulated electrical parts or electrical

insulation of parts that could result in a HAZARDOUS
SITUATION occur? Review the manufacturers risk management
file for risk analysis and risk evaluation.

IECEE OD-2044-1:2023© IEC 2023 – 35 –

Clauses Clauses
11.6.3 Spillage on ME Does the ME Equipment require the handling of liquids in normal 5.2 to 7.4
equipment and or foreseeable misuse?
ME system
Could the wetting of the ME equipment result in a hazardous
situation?
Has the manufacturer identified hazardous situations relating to

the worst case volume and type of liquid?
Has the manufacturer identified hazardous situations relating to

the worst location for the equipment to spill?
11.6.6 Cleaning and Has the manufacturer identified the parts of the ME equipment 5.2 to 7.4
disinfection of which may be subject to cleaning or disinfection in normal or
ME equipment foreseeable misuse and the type of cleaning or disinfection?
and ME systems
Based on the ESL of the ME equipment has the manufacturer
extrapolated the number of cleaning processes to which the
equipment will be subjected?
Has the manufacturer identified all related hazards and

addressed such risks in the RMF?
11.6.7 Sterilization of Has the manufacturer identified the parts of the ME equipment 5.2 to 7.4
ME equipment which may be subject to sterilization in normal or foreseeable
and ME systems misuse and the type of sterilization?
11.6.8 Compatibility Has the manufacturer identified all substances to which the ME 5.2 to 7.4
with substances Equipment may come into contact with in normal or foreseeable
used with the misuse?
ME equipment
Clause 12 - Accuracy of controls & instruments; protection against hazardous outputs Claudia

Clauses Clauses
12.1 Accuracy of Has the manufacturer identified all controls and instruments 5.2 to 7.4
controls and contained on the ME Equipment?
instruments
Has the manufacturer conducted a hazard analysis to identify
the risks associated with the accuracy of the above identified
controls and instruments?

– 36 – IECEE OD-2044-1:2023© IEC 2023

Clauses Clauses
12.4.1 Intentional Has the manufacturer identified risks associated with the 5.2 to 7.4
exceeding of intentional exceeding of safety limits?
safety limits
Has the manufacturer addressed such risks to comply with the
manufacturer’s risk acceptability criteria?
12.4.2 Indication of Has the manufacturer identified all functions related to the 5.2 to 7.4
parameters delivery of energy or substances to the patient?
relevant to safety
Has the manufacturer explored such functions for hazardous
situations in which these functions can produce an output to the
patient?
12.4.3 Accidental Has the manufacturer identified all features of the ME 5.2 to 7.4
selection of Equipment that provide an output to the patient for therapeutic
excessive output purposes?
values
Has the manufacturer identified which of these features have
multiple purposes that require different intensities for different
treatments?
Has the manufacturer identified hazards associated with

accidental selection of excessive output values?
12.4.4 Incorrect output Has the manufacturer identified all features of the ME 5.2 to 7.4
Equipment that provide an output?
Has the manufacturer identified hazards associated with

incorrect output?
12.4.5.3 Radiotherapy Has the manufacturer identified if the product is intended for 5.2 to 7.4
equipment radiotherapy purposes?
Has the manufacturer identified and explored risks associated

with emission radiation for therapeutic purposes?
12.4.5.4 Other ME Has the manufacturer identified if the product is intended for 5.2 to 7.4
equipment radiotherapy purposes?
producing
diagnostic or Has the manufacturer identified and explored risks associated
therapeutic with emission radiation for therapeutic purposes?
radiation

IECEE OD-2044-1:2023© IEC 2023 – 37 –

Clauses Clauses
12.4.6 Diagnostic or Has the manufacturer identified if the equipment emits an 5.2 to 7.4
therapeutic acoustic pressure output?
acoustic
pressure Has the manufacturer identified and explored risks associated
with emission of such acoustic pressure?
Clause 13 - Hazardous situations and fault conditions

Clauses Clauses
13.2.6 Leakage of liquid Has the manufacturer determined the appropriate test conditions 5.2 to 7.4
for the evaluation of liquid leakage?
Clause 14 - Programmable Electrical Medical Systems (PEMS)

Clauses Clauses
14.1 Programmable Does the application of ISO 14971 demonstrate that the failure 5.2 to 6
electrical medical of the PEMS does not lead to an unacceptable risk?
systems - General
14.6.1 Identification of Has the manufacturer considered those hazards associated 5.4
known and with the software and hardware aspects of the PEMS including
foreseeable those associated with Network/Data coupling and legacy
hazards subsystems?
14.6.2 Risk control Has the manufacturer identified suitable tools and procedures 7.2
to implement risk control measures?
Are these tools and procedures appropriate to ensure that

each risk control measure effectively reduces the identified
risks?
14.7 Requirement Does the requirement specification include and distinguish any 7.2
specification risk control measures?
14.8 Architecture Does the architecture specification reduce the risk to an 7.2
acceptable level, where appropriate, using levels a) – f)?
Does the architecture specification take into consideration

allocation of risk control measures?

– 38 – IECEE OD-2044-1:2023© IEC 2023

Clauses Clauses
14.10 Verification Is the result of the verification activity documented? 7.2
Have all functions that implement risk control measures been

verified?
14.13 Connection of Is there a list of the HAZARDOUS SITUATIONS resulting from 5.2 to 7.2
PEMS by a failure of the network/data coupling provided with the
network/data specified characteristics? Review the manufacturers risk
coupling to other management file for any risk analysis, risk evaluation and any
equipment necessary risk control measures.
Does a connection of the PEMS to a network/data coupling

that includes other equipment result in previously unidentified
RISKS to patients, operators or third parties? Review the
manufacturers risk management file for any risk analysis, risk
evaluation and any necessary risk control measures.
Clause 15 - Construction of MEE

Clauses Clauses
15.4.1 Construction of Has the manufacturer identified electrical, hydraulic, and 5.2 to 7.4
connectors pneumatic or gas connection terminals and connectors
removable without the use of a tool where incorrect connection
to other outlets intended for other functions would not result in
unacceptable risks?
If so, ensure that incorrect connection does not result in an

unacceptable risk. (Gas connectors must comply with item b) of
this clause).
15.4.2.1 a Temperature and Has the manufacturer identified in the risk management file, 5.2 to 6
overload control any automatic resetting thermal cut-outs or over-current
devices releases where their use would not result in an unacceptable
risk?
- Application
If so, ensure that the resetting of these devices does not result
in unacceptable risks.
15.4.2.1 c Application Has the manufacturer identified the use of a thermostat in the 5.2 to 5.4
MEE in the risk management file?
If so, inspect for an independent non-self-resetting thermal cut-

out with a setting outside the maximum range of the thermostat
but within the safe temperature limit for its intended function.

IECEE OD-2044-1:2023© IEC 2023 – 39 –

Clauses Clauses
15.4.2.1 d Application Has the manufacturer identified that loss of function of the MEE 5.2 to 5.4
could result in a hazardous situation?
If so, ensure that the operation of a thermal cut-out or over-

current release does not result in an unacceptable risk.
15.4.2.1 h Application Has the manufacturer identified the need for fusing each lead 5.2 to 5.4
for the use of tubular heating elements in the risk management
file?
If so, inspect for fuses in both leads and fault either lead to
ground and ensure over-heating does not occur.
15.4.3.1 Housing Has the manufacturer identified the need for ventilated battery 5.2 to 5.4
housings where gases that could result in a hazard can escape
during charging or discharging?
If so, inspect the battery housings for proper ventilation.
Has the manufacturer identified the need for battery polarity

connection construction such that short-circuiting is not
possible?
If so, inspect the battery connection and ensure that incorrect

connection is not possible.
15.4.3.2 Connection If a HAZARDOUS SITUATION might develop by the incorrect 5.2 to 5.4
connection or replacement of a battery, verify the ME
Equipment is fitted with a means of preventing incorrect polarity
of connection. Review the manufacturers risk management file
for any risk analysis.
15.4.3.3 Protection against Does overcharging of any battery of ME Equipment result in an 5.2 to 5.4
overcharging unacceptable RISK, the design shall prevent overcharging?
Review the manufacturers risk management file for any risk
analysis.

– 40 – IECEE OD-2044-1:2023© IEC 2023

Clauses Clauses
15.4.4 Indicators Are indicator lights provided on ME Equipment incorporating 5.2 to 5.4
non-luminous heaters to indicate that the heaters are
operational, if a HAZARDOUS SITUATION could exist unless it
is otherwise apparent to the operator from the normal operating
position? Review the manufacturers risk management file for
any risk analysis.
Are indicator lights provided on ME Equipment to indicate that

an output exists where an accidental or prolonged operation of
the output circuit could constitute a HAZARDOUS SITUATION?
Review the manufacturers risk management file for any risk
analysis.
15.4.5 Pre-set controls Where applicable, has the manufacturer addressed the risk 5.2 to 7.4
associated with pre-set controls?

IECEE OD-2044-1:2023© IEC 2023 – 41 –
Clause 16 – ME Systems

Clauses Clauses
16.1 General After installation or subsequent modification, does the ME 5.2 to 6

Requirements for system result in an unacceptable risk?
ME Systems
Have hazards arising from combining various equipment to
constitute an ME system been considered?
Is the level of safety equivalent to ME system complying with

this standard IEC 60601-1 within the patient environment?
If the ME System is reconfigurable, have risk management

methods been used to determine which configurations
constitute the highest risks and which measures are needed to
ensure that the reconfiguration does not constitute an
unacceptable risk?
16.9.1 Connection Are the design and construction of electrical, hydraulic, 5.2 to 7.4
terminals and pneumatic and gas connection terminals and connectors such
connectors that incorrect connection of accessible connectors, removable
without the use of a TOOL, can be prevented where an
unacceptable RISK could otherwise result? Review the
manufacturers risk management file for any risk analysis, risk
evaluation and risk control measures.
Are plugs for patient leads or patient cables designed to

prevent connection to other outlets of the same ME System
that are likely to be located in the patient environment unless
no unacceptable RISK can result? Review the manufacturers
risk management file for any risk analysis, risk evaluation and
risk control measures.
Clause 17 – Electromagnetic compatibility of MEE and MES

Clauses Clauses
Electromagnetic Does the risk management process address the risks 5.2 to 7.4
compatibility of associated with the electromagnetic disturbances
ME equipment
and ME systems

– 42 – IECEE OD-2044-1:2023© IEC 2023
6.2 IEC 60601-1-2: 2014 + AMD 1:2020

IEC 60601-1-2:2014 +AMD 1:2020 Collateral standard: Electromagnetic disturbances – Requirements and tests
IEC 60601- Subject Considerations for application of RM criteria ISO 14971

1-2 Clauses Clauses
4.1 RISKS resulting from Do entries in the risk management file take reasonably 5.2 to 6
reasonably foreseeable electromagnetic disturbances not addressed by this
foreseeable collateral into account?
ELECTROMAGNETIC
DISTURBANCES Or is it stated in the risk management file, that the normative
requirements specified in this collateral standard address the
risks resulting from reasonably foreseeable electromagnetic
disturbances?
4.2 Non-ME EQUIPMENT Is non-ME EQUIPMENT used in an ME SYSTEM? 5.2 to 7.4

used in an ME
SYSTEM Does the risk management file show whether the non-ME
EQUIPMENT is involved in any way with the BASIC SAFETY or
ESSENTIAL PERFORMANCE of the ME SYSTEM?
Is testing of the non-ME EQUIPMENT required?
If testing is not required, is there objective evidence (i.e. an EMC

test report) showing that the non-ME EQUIPMENT meets its
applicable requirements?
If testing of the non-ME EQUIPMENT is required, it shall fulfil the

pass/fail criteria and immunity test levels of Clause 8.
4.3.1 Configurations Does the risk management file show how the configurations to 5.2 to 7.4
be tested were determined (i.e., experience, engineering
analysis, or pretesting)?
If the ME EQUIPMENT or ME SYSTEM has only one

configuration, is there a comment in the risk management file
stating this?
5.2.1.1 a) Instructions for use, Does the risk analysis determine that certain environments are 5.2 to 7.4
exclusions relevant to excluded?
use environment
If so, are they stated in both the instructions for use and the risk
management file?
8.1 IMMUNITY pass/fail Does the risk analysis determine pass/fail criteria when the 5.2 to 7.4
criteria criteria have not been provided in an applicable part two
standard?

IECEE OD-2044-1:2023© IEC 2023 – 43 –

1-2 Clauses Clauses
8.1 Determination of If any equipment was damaged during testing, does the risk 5.2 to 7.4
whether damaged management file determine that the damage equipment can still
equipment can be used to determine the ability of the ME EQUIPMENT or ME
continue to be used SYSTEM provides basic safety and essential performance
for testing during immunity testing?
8.1 Feedback to the RISK Does the risk management process (e.g., risk management 5.2 to 7.4
MANAGEMENT procedure or risk management plan) established by the
PROCESS manufacturer provide for feedback to the risk management
process concerning any effects that might be observed during
testing?
Is there a provision upon completion of testing, to evaluate the

effects observed to determine if there is a clinical impact that
could lead to unacceptable risk?
Is there a provision to evaluate if additional risk mitigations are

required?
8.5 Subsystem testing If it is decided to perform testing at the subsystem-level, is this 5.2 to 7.4
decision documented in the risk management file?
Does the risk management file determine if normal operating

conditions (representative electrical, mechanical, RF signals,
impedances and cables and their configurations) can be
simulated for subsystem testing?
8.7 Operating modes and Does the ME EQUIPMENT or ME SYSTEMS have multiple 5.2 to 7.4
settings modes of operation or operational settings?
Does the risk management file document the manufacturers

determination of which operating modes and settings are most
likely to result in an unacceptable risk?
Does the risk management file document the manufacturers

determination of which operating modes and settings shall be
tested?
8.8 Non-ME EQUIPMENT Does the risk management file document that the 5.2 to 7.4
used in an ME manufacturer’s knowledge of how the ME SYSTEM operates
SYSTEM was used to determine if testing of the non-ME EQUIPMENT is
required according to 4.2?

– 44 – IECEE OD-2044-1:2023© IEC 2023

1-2 Clauses Clauses
8.9 IMMUNITY TEST Does the risk management file document that the environment 5.2 to 7.4
LEVELS of intended use is known to alter the reasonably foreseeable
electromagnetic disturbance levels specified in this collateral
standard?
Is this information used to increase or decrease the immunity

test levels, according to Annex E?
Does the risk management file document all choices and

justifications for changing the immunity test levels?
Does the risk management file explain how any mitigations

applied or assumed can be reasonably expected to remain
effective over the expected service life, and in all locations of
intended use?
8.9 Test modulation for Does the risk management file document that the manufacturer 5.2 to 7.4
RF swept tests knows that their ME EQUIPMENT or ME SYSTEM is particularly
sensitive to a specific modulation frequency or range of
frequencies?
Does the risk management file document the decision to use

these instead of or in addition to those specified cl. 8.9?
8.10 Proximity fields from Does the risk management file document identification of 5.2 to 7.4
RF wireless communications services that might be encountered in the
communication environment of intended use and that are not listed in Table 9?
equipment
Does the risk management file document consideration to
whether these services present a risk?
Are these communication services incorporated into the test

plan?
Does the risk management file document if the environment(s)

of intended use will routinely allow for exposure to RF wireless
communications equipment at separation distances less than
0.3 m?
If so, does the risk management file document a reasonably

foreseeable minimum separation distance?
If so, is this minimum separation distance used to increase the

immunity test levels?

IECEE OD-2044-1:2023© IEC 2023 – 45 –

1-2 Clauses Clauses
8.11 IMMUNITY to Does the risk management file document that testing immunity 5.2 to 7.4
proximity magnetic to proximity magnetic fields is not necessary because
fields
a) the ME EQUIPMENT or ME SYSTEM does not contain
magnetically sensitive components?
b) a separation distance of magnetically sensitive
components or circuitry of at least 0.15 m from the field
sources specified in Table 11 is ensured by the
enclosure or by the physical design of an attached
accessory?
c) the risk of exposure during intended use to the field
sources specified in Table 11 is acceptable?
Does the risk management file document if the environment(s)

of intended use will routinely allow for exposure to proximity
magnetic fields at separation distances less than 0.15 m?
If so, does the risk management file document a reasonably

foreseeable minimum separation distance?
If so, is this minimum separation distance used to increase the

immunity test levels?
The IEC 60601-1-2: 2014 + AMD 1:2020 standard utilizes a three step approach to compliance involving
1) specific manufacturer documentation requirements related to EMC in their risk management file, according to
the guidance provided by Annex F of IEC 60601-1-2,
2) a manufacturer developed test plan based on the EMC information from the risk management file, including
specific information according to the guidance provided by Annex G of IEC 60601-1-2 and
3) an EMC test report which contains results of testing specified in the test plan, including specific information
required by Clause 9 of IEC 60601-1-2.

– 46 – IECEE OD-2044-1:2023© IEC 2023
6.3 IEC 60601-1-3:2008 + AMD 1: 2013 + AMD 2: 2021 / ISO 14971:2019

IEC 60601-1-3:2008 + AMD 1: 2013 + AMD 2: 2021 Collateral standard: Radiation Protection in Diagnostic X-Ray
Equipment - Guidance for the application of ISO 14971:2019
IEC 60601-1- Subject Considerations for application of RM criteria ISO 14971

3 Clauses Clauses
6.3.2 Reproducibility of Has the manufacturer addressed this risk by applying an 5.2 to 7.3
the RADIATION applicable particular standard?
output
If yes, this requirement does not apply.
If no, does the RISK MANAGEMENT FILE determine the

reproducibility of the RADIATION output relative to fixed
LOADING FACTORS required for the INTENDED USE?
6.4.3 Indication of Has the manufacturer addressed this risk by applying an 5.2 to 7.3
LOADING applicable particular standard?
FACTORS and
MODES OF If yes, this requirement does not apply.
OPERATION
If no, has the Manufacturer determined the accuracy of the
LOADING FACTORS required for the INTENDED USE?
6.5 AUTOMATIC Has the manufacturer addressed this risk by applying an 5.2 to 7.3
CONTROL applicable particular standard?
SYSTEM
If no, does the RISK MANAGEMENT FILE determine the

constancy of AUTOMATIC EXPOSURE CONTROLS required
for the INTENDED USE?
6.7.2 System Has the Manufacturer defined and specified metrics describing 5.2 to 7.5
performance imaging performance for the INTENDED USE?
6.7.3 Nominal focal spot Has the Manufacturer defined The nominal focal spot values 5.2
value of the X-RAY TUBE(s) FOCAL SPOTS in the EQUIPMENT
according to IEC 60336?

IECEE OD-2044-1:2023© IEC 2023 – 47 –

3 Clauses Clauses
6.7.4 RADIATION If a RADIATION DETECTOR or X-RAY IMAGE RECEPTOR is 5.4 to 7.5

DETECTOR or X- integrated in the X-RAY EQUIPMENT, has the Manufacturer
RAY IMAGE specified the contribution to the metrics of imaging
RECEPTOR performance?
Is this contribution sufficient to ensure the efficient use of

RADIATION?
If no X-RAY IMAGE RECEPTOR is integrated in the system,

has the Manufacturer described in the ACCOMPANYING
DOCUMENTS examples of X-RAY IMAGE RECEPTOR types
or performance?
7.2 Waveform of the X- Has the manufacturer addressed this risk by applying an 5.2 to 7.3
RAY TUBE applicable particular standard?
VOLTAGE
If no, has the Manufacturer define the characteristics of The X-

RAY TUBE VOLTAGE waveform, taking in consideration:
• the rising phase of the X-RAY TUBE VOLTAGE;

• the falling phase of the X-RAY TUBE VOLTAGE; and
• the shape and amplitude of the X-RAY TUBE VOLTAGE
RIPPLE.
which, in conjunction with the TOTAL FILTRATION in the

XRAY EQUIPMENT, results in an acceptable RADIATION
dose for the INTENDED USE?
8.1 Limitation of the Has the manufacturer addressed this risk by applying an 5.5 to 7.3
extent of the X-RAY applicable particular standard?
BEAM (General)
If no, does the risk management file consider all the risk
associated not to limit the RADIATION FIELD not contributing
to the formation of the image?

– 48 – IECEE OD-2044-1:2023© IEC 2023

3 Clauses Clauses
8.5.3 Correspondence Has the manufacturer addressed this risk by applying an 5.5 to 7.3
between X-RAY applicable particular standard?
FIELD and
EFFECTIVE If yes, this requirement does not apply.
IMAGE
If no, does the Manufacturer identify and provide means to
RECEPTION AREA
adjust the X-RAY FIELD such that its position and size
correspond to the EFFECTIVE IMAGE RECEPTION AREA?
Is this means designed with an acceptable accuracy?
Note: For clause 4.4 and 5.0 of ISO 14971, see also 8.5.1.
9.1 FOCAL SPOT TO Has the manufacturer addressed this risk by applying an 5.5 to
SKIN DISTANCE applicable particular standard? 7.34
If no, has the Manufacturer identified The FOCAL SPOT TO

SKIN DISTANCES in NORMAL USE sufficiently large to keep
the RADIATION dose to the PATIENT as low as reasonably
achievable?
Has the Manufacturer defined a minimum FOCAL SPOT TO

SKIN DISTANCE?
10.1 ATTENUATION of Has the manufacturer addressed this risk by applying an 5.2 to 7.3
the X-RAY BEAM applicable particular standard?
between the
PATIENT and the If yes, this requirement does not apply.
X-RAY IMAGE
If no, has the manufacturer designed the X-RAY EQUIPMENT
RECEPTOR
in such a way that the ATTENUATION of the X-RAY BEAM by
material interposed between the PATIENT and the X-RAY
IMAGE RECEPTOR is kept as low as reasonably achievable
in order to avoid unnecessarily high doses to the PATIENT
and, through STRAY RADIATION, to the OPERATOR.
Does the risk management file determine the values of

ATTENUATION EQUIVALENT and RADIATION CONDITIONS
for testing required for the INTENDED USE?

IECEE OD-2044-1:2023© IEC 2023 – 49 –

3 Clauses Clauses
11 Protection against Has the manufacturer addressed this risk by applying an 5.4 to 7.5
RESIDUAL applicable particular standard?
RADIATION
If no, does the RISK MANAGEMENT FILE evaluate the

RADIATION dose resulting from the RESIDUAL RADIATION:
• for the PATIENT, relative to the RADIATION dose

resulting from the examination, and
• for other persons, relative to the dose resulting from X-
RADIATION scattered off the PATIENT?
Does the Manufacturer identify the need to incorporate in the

X-RAY EQUIPMENT a PRIMARY PROTECTIVE SHIELDING?
Is this PRIMARY PROTECTIVE SHIELDING taking into

account the RESIDUAL RADIATION which contribute
significantly to the RADIATION dose received by:
• OPERATORS,
• other persons present in the examination room during the
LOADING (e.g. parents holding a child, other PATIENTS
or personnel),
• parts of the PATIENT other than from those being
currently imaged?

– 50 – IECEE OD-2044-1:2023© IEC 2023

3 Clauses Clauses
12.1 Protection against Has the manufacturer addressed this risk by applying and 5.2 to 7.5
LEAKAGE applicable particular standard?
RADIATION
If no, does the RISK MANAGEMENT FILE evaluate the

RADIATION dose resulting from the LEAKAGE RADIATION:
• for the PATIENT, relative to the RADIATION dose

resulting from the examination, and
• for other persons, relative to the dose resulting from X-
RADIATION scattered off the PATIENT?
Does the RISK MANAGEMENT FILE consider the LEAKAGE

RADIATION which contribute significantly to the RADIATION
dose received by:
• OPERATORS,
• other persons present in the examination room during the
LOADING (e.g. parents holding a child, other PATIENTS
or personnel),
• parts of the PATIENT other than from those being
currently imaged?
12.2 Mounting of X-RAY Has the manufacturer addressed this risk by applying an 5.2 to 7.5
SOURCE applicable particular standard?
ASSEMBLIES and
X-RAY IMAGING If yes, this requirement does not apply.
ARRANGEMENTS
If no, does the RISK MANAGEMENT FILE included
exceptions to justify that the X-RAY SOURCE ASSEMBLIES
and/or the X-RAY IMAGE RECEPTOR need to be hand held
during LOADING in NORMAL USE?

IECEE OD-2044-1:2023© IEC 2023 – 51 –

3 Clauses Clauses
13.2 Control of X-ray Has the manufacturer addressed this risk by applying an 5.2 to 7.5
equipment from a applicable particular standard?
protected area
If no, does the RISK MANAGEMENT FILE cover exceptions

related to the following control functions:
• selection and control of MODES OF OPERATION;

• selection of LOADING FACTORS;
• actuation of the IRRADIATION SWITCH;
• other necessary controls for the OPERATOR during
LOADING,
where the control functions are to be implemented from a

PROTECTED AREA after installation, for X-RAY EQUIPMENT
specified exclusively for examinations that do not need the
OPERATOR or staff to be close to the PATIENT during
NORMAL USE?
Supplementary information: See also 13.3

13.3 Protection by Has the manufacturer addressed this risk by applying an 5.2 to 7.5
distance applicable particular standard or some exception applies?
If no, does the RISK MANAGEMENT FILE determine, for the

INTENDED USE, the distance required and the RADIATION
dose resulting from the STRAY RADIATION?
Is this distance sufficiently long to protect operator?
Supplementary information: See also 13.2
6.4 IEC 60601-1-6:2010 + AMD 1:2013 + AMD 2:2020 / ISO 14971:2019 / IEC 62366-
1:2015 + AMD 1:2020
When evaluating compliance with IEC 60601-1-6:2010 + AMD 1:2013 + AMD 2:2020, it is important to understand the
relationships that exist between this standard, IEC 60601-1:2005 + AMD 1:2012 + AMD 2:2020, IEC 62366-1:2015 +
AMD 1:2020 and ISO 14971:2019.
Figure 1 below provides a graphical representation of this relationship. IEC 60601-1-6:2010 + AMD 1:2013 + AMD
2:2020 is a collateral standard in the IEC 60601-1 series covering the requirements for the Usability Engineering
Process. IEC 60601-1:2005 +AMD 1:2012 + AMD 2:2020makes a normative reference to IEC 60601-1-6 for
requirements related to usability. Currently, IEC 60601-1-6:2010 + AMD 1:2013 + AMD 2:2020links the IEC 62366-
1:2015 + AMD 1:2020 which contains requirements for the usability engineering process.
Figure 1: Relationship between USABILITY (IEC 60601-1-6 & IEC 62366) and RISK MANAGEMENT (ISO 14971)

– 52 – IECEE OD-2044-1:2023© IEC 2023
IEC 60601-1-6:2010 + AMD 1:2013 + AMD 2:2020 makes a normative reference to IEC 62366-1:2015 + AMD 1:2020 for
the Usability Engineering Process requirements: In turn, IEC 62366-1:2015 + AMD 1:2020 makes a normative reference
to ISO 14971:2019 for the requirements related to Risk Management.
When performing the usability engineering process and the risk management process there are deliverables from each
process that are used as inputs into the other process. Figure 1 indicates in which process these deliverables are
generated and which deliverables are necessary for completing the other process.
When complying with IEC 60601-1:2005 + AMD 1:2012 + AMD 2:2020, IEC 60601-1-6:2010 + AMD 1:2013 + AMD
2:2020, IEC 62366-1:2015 + AMD 1:2020 and ISO 14971:2019 are all required to satisfy the requirements for the
Usability Engineering Process.

IECEE OD-2044-1:2023© IEC 2023 – 53 –
IEC 60601-1-6:2010 + AMD 1:2013 + AMD 2:2020
Collateral standard: Usability

Guidance for the application of ISO 14971:2019 and IEC 62366-1:2007
IEC 60601-1-1- Subject Considerations for application of RM criteria ISO 14971

6 Clauses Clauses
4.2 General Compliance is confirmed through application of, IEC 62366- 4.2 to 8
Requirements – 1:2015 + AMD 1: 2020 and ISO 14971:2019
(60601-1- Conditions for
6) application to ME Equipment provides adequate USABILITY such that RISKS
EQUIPMENT resulting from NORMAL USE and USE ERROR are considered
acceptable
Has the USABILITY ENGINEERING PROCESS adequately

addressed all RISKS associated with NORMAL USE and USE
ERROR?
4.1.2 Risk Control as it Has the Manufacturer used the following prioritized list to reduce 7.1
(62366-1) Relates to User use-related risk:
Interface Design
Inherently safe design and manufacture
Protective measurements in medical device or

manufacturing process
Information for safety or training to users
5.2 Identify user Has the Manufacturer considered the possibility of the interface 5.3
interface design features contributing to use errors?
(62366-1) characteristics
related to safety Has Manufacturer also considered other use error besides the
and protentional ones arising from Primary Operating Functions?
use errors
Identification of such user interface that could impact safety can
be done using the questions of ISO/TR24971 A.2.31 to A.2.37
E.g. of the questions
Is the MD dependent on user’s knowledge?
Does the use of the MD depend on essential performance?
Does the MD have a degree of autonomy?
Does the MD produce an output that is used as an input in
determining clinical action?
Has Manufacturer documented all use errors?

– 54 – IECEE OD-2044-1:2023© IEC 2023
IEC 60601-1-1- Subject Considerations for application of RM criteria ISO 14971

6 Clauses Clauses
5.3 Identify known or Has the manufacturer as part of their risk analysis considered 5.4
foreseeable known and foreseeable hazards and hazardous situations
(62366-1) hazards and related to use for:
hazardous
situations Patients,
Users, and
Others
Where the following considered during this assessment:
Use specification
Hazards or hazardous situations from similar user

interfaces
User errors from 5.2
Considerations should be on both intended use conditions and

abnormal use conditions
5.9 Perform Have any new use errors, hazards, hazardous situations or 7.3
summative hazard-related use scenarios determined during the summative
(62366-1) evaluation of the evaluation been evaluated per clause 5, as applicable?
usability of the
user interface Have residual risks determined during the summative evaluation
been evaluated in accordance with ISO 14971:2019 clause 7.3?

IECEE OD-2044-1:2023© IEC 2023 – 55 –
6.5 IEC 60601-1-8:2006 +AMD 1:2012 + AMD 2:2020 / ISO 14971:2019

IEC 60601-1-8:2006 +AMD 1:2012 + AMD 2:2020 Collateral standard: General requirements, tests and guidance
for alarm systems in medical electrical equipment and medical electrical systems
Guidance for the application of ISO 14971:2019
IEC 60601- Subject Considerations for application of RM criteria ISO

1-8 14971
Clauses Clauses
4 General As a means of risk control, has the manufacturer provided an alarm 5.2 to 7.5
requirements system that is used to notify the operator that a hazardous situation
can exist for the following:
Patients,
Operators, or
Other persons?
If so, then an alarm system complying with this standard is used for
this purpose.
If not, continue with other risk management requirements.
6.1.2 Alarm condition When an alarm system is provided, does the manufacturer’s risk 5.2 to 7.5
priority management file include the assignment of alarm priorities based on
Table 1?
6.3.1 Generation of Does the manufacturer’s risk management file identify the need for 5.2 to 7.4
Alarm Signals additional alarm signals (audio, verbal, vibratory or produced by
other means)?
• If so, then verify the implementation according to the additional

requirements in IEC 60601-1-8:2006+AMD 1:2012+AMD
2:2020.
6.3.3.1 Characteristics of If using Table 3 and 4 for auditory alarm signals, does the 5.2 to 6
auditory alarm manufacturer’s risk analysis consider the duration of the interburst
signals interval?
6.3.4 Characteristics of If verbal alarm signals are provided does the manufacturer’s risk 5.2 to 7.5
verbal alarm management file, consider its risks?
signals
6.8.3 Global indefinite If global Alarm Off or Global Audio Off is provided does the 5.2 to 6
Alarm Signal manufacturer’s risk management file, considered its functioning as
inactivation states an acceptable risk?

– 56 – IECEE OD-2044-1:2023© IEC 2023
6.2 IEC 60601-1-10:2007 +AMD 1:2013 + AMD 2:2020 / ISO 14971:2019

IEC 60601-1-10:2007 +AMD 1:2013 + AMD 2:2020 Collateral standard: Requirements for the development of
physiologic closed-loop controllers - Guidance for the application of ISO 14971:2019

1-10
Clauses
Clauses
4 General Compliance is checked by inspection of the risk 5.4, 5.5

requirements management file.
Has the risk analysis considered HAZARDS from a PCLC?
• If so, then they shall be included in the RISK

MANAGEMENT PROCESS.
• If not, then this is an unacceptable result.
6.1 Accuracy of Compliance is checked by inspection of the risk 5.4 to 7.2

controls and management file.
instruments and
protection against Has the indication over time not lead to an unacceptable
hazardous outputs RISK?
- Usability See USABILITY
• If so, then the indication over time may be omitted.
• If not, then the information indication over time shall be ENGINEERING
FILE
indicated continuously or by OPERATOR action.
assessment
Have the presentation format and the choice between per IEC
indicating the information continuously or by OPERATOR 60601-1-6
action based on the USABILITY ENGINEERING
PROCESS?
• If so, then they shall be included in the RISK

MANAGEMENT PROCESS.

IECEE OD-2044-1:2023© IEC 2023 – 57 –

1-10
Clauses
Clauses
8.2.1 RECORDS and Compliance is checked by inspection of the risk 5.4, 5.5
PROCESS scaling management file.
Have the RECORDS and documents produced from

application of the PCLC development PROCESS been
established and maintained to provide evidence of
conformity to requirements of this collateral standard?
• If so, then they shall form part of the RISK

MANAGEMENT FILE
Have the results of the RISK ANALYSIS based on

significance of the modification of a PCLC design been
documented?
• If so, then the PCLC development PROCESS shall

include the scaling up or scaling down of that
modification.
• • If not, then this is an unacceptable result.
8.2.2.2 PCLCS attributes Compliance is checked by inspection of the risk 5.4 to 7.4
management file
Has the MANUFACTURER characterized the required

attributes?
Has the MANUFACTURER characterized the limitations

and ranges of the PATIENT TRANSFER ELEMENT?
Has the MANUFACTURER developed a mathematical

model to characterize the PATIENT TRANSFER
ELEMENT?
Was the MANUFACTURER able to justify the

MATHEMATICAL MODEL represents the relevant
PATIENT responses?
If a mathematical model of the PATIENT TRANSFER

ELEMENT was not practicable, was justification for any
assumptions made regarding the PATIENT TRANSFER
ELEMENT?

– 58 – IECEE OD-2044-1:2023© IEC 2023

1-10
Clauses
Clauses
8.2.2.3 FALLBACK MODE Compliance is checked by inspection of the risk 5.4 to 7.4
management file.
Has the MANUFACTURER specified all FALLBACK

MODES of the PCLCS?
• If so, then the FALLBACK MODE shall have no

unacceptable RISK.
8.2.2.4 Specification of Compliance is checked by inspection of the risk 5.4 to 7.4

operating management file.
conditions
Has the MANUFACTURER document operating conditions
to ensure safe performance and effective ness of the
PCLC for the following:
• PATIENT concerns
• OPERATOR concerns, and
• Environment concerns
8.2.2.5 Limitation of the Compliance is checked by inspection of the risk 5.4 to 7.4
MANIPULATED management file.
VARIABLE
If necessary, have the measures been taken or means
provided to eliminate, control, or decrease RISKS to
acceptable levels by controlling of the following?
– the range of the MANIPULATED VARIABLE;
– the integral over a period of time of the MANIPULATED

VARIABLE; or
– the rate of change of the MANIPULATED VARIABLE.
• If so, follow the requirements of the standard.


IECEE OD-2044-1:2023© IEC 2023 – 59 –

1-10
Clauses
Clauses
8.2.2.6 Responses of the Compliance is checked by inspection of the risk 5.4 to 7.1
PCLCS management file.
If the PCLC changes its mode of operation, does the

PCLCS have a means of notifying and indicating to the
OPERATOR of its change in mode of operation?
• If so, the RISK ANALYSIS shall determine the choice

between an INFORMATION SIGNAL and an ALARM
CONDITION and its priority.
8.2.2.7 Range limitation of Compliance is checked by inspection of the risk 5.4 to 7.4
PHYSIOLOGIC management file.
VARIABLE
Does the PCLCS provide the means to monitor the value
of the PHYSIOLOGIC VARIABLE within its acceptable
range? Or limit the value of the MANIPULATED
VARIABLE, or CONTROLLER OUTPUT VARIABLE?
• If so, follow the requirements of the standard and if the

value of the PHYSIOLOGIC VARIABLE exceeds its
specified range, the PCLCS shall switch into a
FALLBACK MODE.
8.2.3.1 General Have measures been taken or means provided in the 5.4 to 7.4
PCLC to eliminate unacceptable RISK to the PATIENT that
could be caused by unfavourable response of the PCLCS
to DISTURBANCE VARIABLES including PATIENT
DISTURBANCE VARIABLES?


– 60 – IECEE OD-2044-1:2023© IEC 2023

1-10
Clauses
Clauses
8.2.3.2 Disturbance Compliance is checked by inspection of the risk 5.4 to 7.4

analysis management file.
Has the analysis of the effect of DISTURBANCE

VARIABLES on the PCLCS in NORMAL USE included the
following activities?
a) identification of foreseeable DISTURBANCE

VARIABLES;
b) characterization of those DISTURBANCE
VARIABLES;
c) analysis of the potential responses of the
PHYSIOLOGIC VARIABLE to those DISTURBANCE
VARIABLES in any mode of operation; and
d) analysis of the response of the PCLCS to those
DISTURBANCE VARIABLES in any mode of operation

8.2.3.3 Disturbance Has the manufacturer shown that the Manipulated variable 5.4 to 7.4
response is an acceptable risk for:
Its range,
Its integral over a period of time, or
Its rate of change?
8.2.4 PCLC Verification Compliance is checked by inspection of the risk 7.2

management file.
Has the PCLC undergone VERIFICATION against all Risk

Management specifications required by this collateral
standard?


IECEE OD-2044-1:2023© IEC 2023 – 61 –

1-10
Clauses
Clauses
8.2.5.1 PCLCS Validation Compliance is checked by inspection of the risk 5.4 to 7.4
management file.
Has the Validation plan been based on the RISK

ANALYSIS and knowledge of the RESIDUAL RISKS?
• If so, follow the method selection requirements of the

standard.
8.2.5.2 Validation Have any design modifications that occur due to PCLCS 5.4 to 7.4
validation been evaluation at part the manufacturer’s risk
assessment?
6.3 IEC 60601-1-11:2015 + AMD 1:2020 / ISO 14971:2019

IEC 60601-1-11:2015 + AMD 1:2020 Collateral standard: Requirements for medical electrical equipment and
medical electrical systems used in the home healthcare environment -

1-11
Clauses
Clauses
4.2.2 Environmental Do the instructions for use state a more restricted range of 5.2 to 5.4
conditions of environmental transport and storage conditions between uses?
transport and
storage between If yes, the range of environmental conditions shall be justified in
uses the Risk Management file.
4.2.3.1 Environmental Do the instructions for use state a more restricted range of 5.2 to 5.4
operating environmental operating conditions of the ME Equipment?
conditions
If yes, the range of environmental conditions shall be justified in
the Risk Management file
7.4.1 Additional For each warning and safety sign, the instructions for use shall 5.2 to 7.3
requirements for describe the nature of the HAZARD, likely consequences that
warning and safety could occur if the advice is not followed, and the precautions for
notices reducing the RISK. Review the manufacturers risk
management file for risk analysis, risk evaluation and where
necessary implementation of risk control.

– 62 – IECEE OD-2044-1:2023© IEC 2023

1-11
Clauses
Clauses
7.4.5 Additional Where the instructions for use include a description of generally 5.4 to 7.3
requirements for known conditions in the HOME HEALTHCARE ENVIRONMENT
operating that can unacceptably affect the BASIC SAFETY and
instructions ESSENTIAL PERFORMANCE of the ME EQUIPMENT and the
steps that can be taken by the LAY OPERATOR to identify and
resolve these conditions, review the manufacturers risk
management file for risk analysis, risk evaluation and
implementation of risk control.
8.4 Additional When loss or failure of the SUPPLY MAINS or INTERNAL 5.2 to 7.6
requirements for ELECTRICAL POWER SOURCE would result in an
interruption of the unacceptable risk, do the time or number of PROCEDURES
power remaining allow for alternative life-supporting methods to be
supply/supply employed? If so, review the manufacturers risk management
mains to ME file for risk analysis, risk evaluation and where necessary
Equipment and implementation of risk control, as well as whether an acceptable
ME System residual risk results.
9 Accuracy of Have the RISKS associated with USABILITY in the HOME See USABILITY
controls and HEALTHCARE ENVIRONMENT included consideration of all ENGINEERING
instruments and factors identified by the Standard, placing particular emphasis FILE
protection against on the limited training of a LAY OPERATOR with respect to the assessment
hazardous ability to intervene and maintain BASIC SAFETY and per IEC
ESSENTIAL PERFORMANCE? If so, review the 60601-1-
outputs manufacturer’s USABILITY ENGINEERING FILE for risk 6:2010
analysis, risk evaluation and where necessary implementation
of risk control, as well as whether an acceptable residual risk
results.
11 Protection against Have means been provided to control the RISK of strangulation 5.2 to 7.5
strangulation or and asphyxiation of the PATIENT and others to an acceptable
asphyxiation level?
If so, review the manufacturers risk management file for risk

analysis, risk evaluation and where necessary implementation
of risk control, including whether other hazards may have been
generated.
6.4 IEC 60601-1-12:2015 + AMD 1:2020 / ISO 14971:2019

IEC 60601-1-11:2015 + AMD 1:2020 Collateral Standard: Requirements for medical electrical equipment and
medical electrical systems intended for use in the emergency medical services environment-

IECEE OD-2044-1:2023© IEC 2023 – 63 –

1-12
Clauses
Clauses
4.2.1 Environmental Do the instructions for use state a more restricted range of 5.2 to 5.4
conditions of environmental transport and storage conditions between uses?
transport and
storage between If yes, the range of environmental conditions shall be justified in
uses the Risk Management file.
4.2.2.1 Continuous Do the instructions for use state a more restricted range of 5.2 to 5.4
conditions
4.2.2.2 Continuous Do the instructions for use state a more restricted range of 5.2 to 5.4
conditions
6.3.4 Additional At a minimum, has the manufacturer considered the following 5.2 to 7.3
requirements for during their risk analysis:
operating
instructions effects of lint, dust, light, etc.,
devices or sources that could interfere with the ME

Equipment,
the effects of degradation or loosing of electrodes or

sensors?
8.2 Additional When loss or failure of the SUPPLY MAINS or INTERNAL 5.2 to 7.6
requirements for ELECTRICAL POWER SOURCE would result in an
interruption of the unacceptable risk, do the time or number of PROCEDURES
power remaining allow for alternative life-supporting methods to be
supply/supply employed? If so, review the manufacturers risk management
mains to ME file for risk analysis, risk evaluation and where necessary
Equipment and implementation of risk control, as well as whether an acceptable
ME System residual risk results.
6.5 IEC 62304:2006 + AMD 1:2015

Medical device software –Software life cycle processes
When the requirements for software apply for the medical devices, 60601-1 requires compliance with applicable clauses
of IEC 62304 that makes normative reference to ISO 14971. In fact in the evaluation of a device with respect to the
requirements of 60601-1 which employs PEMS and PESS, a risk management process is required to be followed.

– 64 – IECEE OD-2044-1:2023© IEC 2023
According to IEC 60601-1, when the requirements in 14.2 to 14.13 apply, the requirements in subclause 4.3, Clause 5,
Clause 7, Clause 8 and Clause 9 of IEC 62304:2006 + AMD 1:2015 shall also apply to the development or modification
of software for PEMS and for each PESS.
IEC 62304 makes a normative reference to ISO 14971. However, some minor additional RISK MANAGEMENT
requirements are identified for software, especially in the area of identification of contributing software factors related to
HAZARDS. These requirements are summarized and captured in Clause 7 of IEC 62304 as the software RISK
MANAGEMENT PROCESS.
The CBTL needs to ensure the manufacturer has taken into account the additional requirement for the Software Risk
Management.

IECEE OD-2044-1:2023© IEC 2023 – 65 –
Annex A- ISO 14971:2019 Checklist (Informative)
Clause Subject Item References
4.2 Management - provision of adequate resources

responsibilities - assignment of qualified personnel
- Policy for determining acceptable risk
4.3 Competence of Persons performing work have appropriate knowledge and

personnel experience
4.4 Risk management a) Scope of risk management activities

plan b) Assignment of responsibilities and authorities
c) Requirements for review of activities
d) Evidence of risk acceptability criteria
e) Verification activities
4.5 Risk management Criteria for the establishment of a risk management file
file providing traceability for each identified hazard
5.1 Risk analysis Procedure for risk analysis.

procedure
5.2, Intended use and Record of safety issue analysis.
reasonably
foreseeable
misusea
5.3 Identification of
characteristics
related to safety
5.4 Identification of Record of hazard analysis
known or
foreseeable
hazards
5.5 Risk estimation a. Definition of methods used for estimating risks.
b. Description of method(s) used.
c. Result of risk estimation activities.

– 66 – IECEE OD-2044-1:2023© IEC 2023
Clause Subject Item References
6 Risk evaluation a. Result of risk evaluation activities.
7.1 Risk control Record of risk control option analysis (including risk-benefit
option analysis analysis, if appropriate).
7.2 Implementation of Inputs from risk management activities
risk control
measures
7.3 Residual risk Final results of the residual risk evaluation and, if
evaluation necessary, information necessary to explain the residual
risk(s) in the appropriate accompanying documents
7.4 Benefit-risk Evidence as necessary.
analysis
7.5 Risks arising from Record of results of review of all risk controls for to identify
risk control if other hazards are introduced by any risk control
measures measures and the associated risk(s) assessment(s)
7.6 Completeness of Record of assessment to assure that the risk(s) from all
risk control identified hazards have been evaluated
8 Evalaution of Records of related meetings, analysis, and overall results.
overall residual
risk
9 Risk management Documented review of risk management process prior to
review commercial distribution

INTERNATIONAL IEC SYSTEM OF CONFORMITY ASSESSMENT
ELECTROTECHNICAL SCHEMES FOR ELECTROTECHNICAL
COMMISSION EQUIPMENT AND COMPONENTS (IECEE SYSTEM)
IECEE Secretariat c/o IEC

3 rue de Varembé 3 rue de Varembé
PO Box 131 PO Box 131
CH-1211 Geneva 20 CH-1211 Geneva 20
Switzerland Switzerland
T +41 22 919 0211 T +41 22 919 0211

info@iec.ch secretariat@iecee.org
www.iec.ch www.iecee.org

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IECEE OD-2044-1

Edition 1.0 2023-06-28

IEC System of Conformity Assessment Schemes for Electrotechnical Equipment

Committee of Testing Laboratories (CTL)

Evaluation of Risk Management in medical electrical equipment according to the

IEC Central Office Tel.: +41 22 919 02 11

3, rue de Varembé Fax: +41 22 919 03 00

CH-1211 Geneva 20 info@iec.ch

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CTL ETF-3 “MEAS, MED”

Date Brief summary of changes

New document to update previous document OD 2044 to IEC60601-

Effective date Next maintenance due date

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IEC 60601-1:2005/AMD 1:2012/ISH1:2021

ISO 14971:2019, Medical devices – Application of risk management to medical devices

3 Terms and definitions

4 Application of Risk Management Principle for IEC 60601 series CB Scheme

5 Assessment of Risk Management principles in the IEC 60601 series CB

5.1 General principles

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5.2 Implementation of ISO 14971 into the IEC 60601 series

5.3 ISO 14971:2019 (3rd edition)

5.4 Description of ISO 14971:2019 clauses application in regards to IEC 60601-1

IEC 60601-1 TRF – RM RESULTS TABLE 4.2 – Risk Management Process

4.2 RM RESULTS TABLE: Risk Management Process for ME Equipment or ME P

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Clause of Document Ref. in RMF Result – Remarks Verdict

4.3 Qualification of Requires the personnel performing risk management tasks P

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Clause of Document Ref. in RMF Result – Remarks Verdict

5.3 Identification of The manufacturer identifies and documents those

5.4 Identification of hazards The manufacturer compiles documentation on known and P

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Clause of Document Ref. in RMF Result – Remarks Verdict

6 Risk evaluation For each identified hazardous situation, the manufacturer P

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Clause of Document Ref. in RMF Result – Remarks Verdict

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Clause of Document Ref. in RMF Result – Remarks Verdict

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Clause of Document Ref. in RMF Result – Remarks Verdict

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Clause of Document Ref. in RMF Result – Remarks Verdict

5.5 Evaluating RISK – HAZARDS identified in the IEC 60601-series

EXAMPLE 2: Sub-clause 9.4.2.1, Instability in transport position

EXAMPLE 4: Sub-clause 11.6.3, Spillage on ME EQUIPMENT and ME SYSTEM

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5.6 Evaluating RISK – HAZARDS not identified in the IEC 60601-series

Compliance is checked by inspection of the RISK MANAGEMENT FILE.

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5.8 IEC 60601-1 Test Report Form (TRF)

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