Essential Principle Checklist

To establish compliance with the Essential requirements, as specified in Clause 6 of Medical Device Rule 2017 for the device throughout the life-cycle. It
involves identifying the applicability or non-applicability of related requirement, applicability of related standard / regulation, compliance or non-
compliance and technical documentation to establish compliance.

Device Name
Device Risk Class
Device Master File

Clause Essential Principle Relevant Specification / Standard / Complies Documentation reference

Sub Clause / reference justification and/ or comments
4 Essential Principles applicable for all categories of medical devices General Principles
4.1 Medical devices should be designed and Yes ISO 13485:2016 Yes Refer Design and Development
manufactured in such a way that, when used under ISO 14971:2019 File (DD/CHIPL/RD-0191,
the conditions and for the purposes intended and, ISO 15223-1:2021 Version 02, Issue date
where applicable, by virtue of the technical ISO 80601-2-12:2011 08.09.2021)
knowledge, experience, education or training, and IEC 60601-1:2005+A2020 Refer the user manual
the medical and physical conditions of intended (MAN/R&D/002, Revision-1.0,
users, they will perform as intended by the Dated 13.12.2022)
manufacturer and not compromise the clinical
condition or the safety of patients, or the safety and
health of users or, where applicable, other persons,
provided that any risks which may be associated
with their use constitute acceptable risks when
weighed against the benefits to the patient and are
compatible with a high level of protection of health
and safety.
4.2 The solutions adopted by the manufacturer for the Yes ISO 13485:2016 Yes Refer Design and Development
design and manufacture of the devices should ISO 14971:2019 File (DD/CHIPL/RD-0191,
conform to safety principles, taking account of the ISO 15223-1:2021 Version 02, Issue date
generally acknowledged state of the art. When EN ISO 20417:2021 08.09.2021)
risk(s) reduction is required, the manufacturer ISO 80601-2-12:2011 Risk management File (RMF/A-
should control the risk(s) so that the residual risk IEC 60601-1:2005+A2020 01, Rev. 01, Date 02.10.2022)
Page 1 of 21
665683051.docx
Clause Essential Principle Relevant Specification / Standard / Complies Documentation reference
Sub Clause / reference justification and/ or comments
associated with each hazard is judged acceptable.
The manufacturer should apply the following
principles in
the priority order listed:
- identify known or foreseeable hazards and
estimate the associated risks arising from the
intended use and foreseeable misuse;
- eliminate risks as far as reasonably practicable
through inherently safe design and manufacture;
- reduce as far as reasonably practicable the
remaining risks by taking adequate protection
measures, including alarms; and
- inform users of any residual risks.
4.3 Medical devices should achieve the performance Yes ISO 13485:2016 Yes Refer Design and Development
intended by the manufacturer and be designed, ISO 14971:2019 File (DD/CHIPL/RD-0191,
manufactured and packaged in such a way that, ISO 80601-2-12:2011 Version 02, Issue date
during normal conditions of use, they are suitable IEC 60601-1:2005+A2020 08.09.2021)
for their intended purpose Risk management File (RMF/A-
01, Rev. 01, Date 02.10.2022)
4.4 The characteristics and performances referred to in Yes ISO 13485:2016 Yes Refer Design and Development
clauses (4.1), (4.2) and (4.3) should not be adversely ISO 14971:2019 File (DD/CHIPL/RD-0191,
affected to such a degree that the health or safety of ISO 80601-2-12:2011 Version 02, Issue date
the patient or the user and, where applicable, of IEC 60601-1:2005+A2020 08.09.2021)
other persons are compromised during the lifetime Risk management File (RMF/A-
of the device, as indicated by the manufacturer, 01, Rev. 01, Date 02.10.2022)
when the device is subjected to the stresses which
can
occur during normal conditions of use and has been
properly maintained in accordance with the
manufacturer’s instructions
4.5 Medical devices should be designed, manufactured Yes ISO 13485:2016 Yes Refer Design and Development
and packaged in such a way that their characteristics ISO 14971:2019 File (DD/CHIPL/RD-0191,
and performances during their intended use will not ISO 80601-2-12:2011 Version 02, Issue date
be adversely affected by transport and storage IEC 60601-1:2005+A2020 08.09.2021)
Page 2 of 21
665683051.docx
Clause Essential Principle Relevant Specification / Standard / Complies Documentation reference
Sub Clause / reference justification and/ or comments
conditions (for example, fluctuations of temperature Risk management File (RMF/A-
and humidity) taking account of the instructions and 01, Rev. 01, Date 02.10.2022)
information provided by the manufacturer.
4.6 All known and foreseeable risks, and any Yes ISO 13485:2016 Yes Refer Design and Development
undesirable effects, should be minimized and be ISO 14971:2019 File (DD/CHIPL/RD-0191,
acceptable when weighed against the benefits of the ISO 80601-2-12:2011 Version 02, Issue date
intended performance of medical devices during IEC 60601-1:2005+A2020 08.09.2021)
normal conditions of use. Risk management File (RMF/A-
01, Rev. 01, Date 02.10.2022)
4.7 Every medical device requires clinical evidence, Yes ISO 13485:2016 Yes Refer Design and Development
appropriate for its intended use and classification of ISO 14971:2019 File (DD/CHIPL/RD-0191,
the medical device, demonstrating that the device ISO 15223-1:2021 Version 02, Issue date
complies with the applicable provisions of the EN ISO 20417:2021 08.09.2021)
essential principles. ISO 80601-2-12:2011 Risk management File (RMF/A-
IEC 60601-1:2005+A2020 01, Rev. 01, Date 02.10.2022)
Clinical Evaluation Report
(Report No.: CER/2022, Date. 16
Dec 2022)
5 Essential Principles applicable to medical devices other than IVD medical devices
5.1 Chemical, physical and biological properties:
5.1.1 The devices should be designed and manufactured No The Device is not an IVD Not The Device is not an IVD
in such a way as to ensure the characteristics and Applicable
performance. Particular attention should be paid to,-
(a) the choice of materials used, particularly as
regards toxicity, biodegradability and, where
appropriate, flammability;
(b) the compatibility between the materials used
and biological tissues, cells, and body fluids taking
account of the intended purpose of the device;
(c) the choice of materials used, reflecting, where
appropriate, matters such as hardness, wear and
fatigue strength
5.1.2 The devices should be designed, manufactured and No The Device is not an IVD Not The Device is not an IVD
packaged in such a way as to minimize the risk Applicable
Page 3 of 21
665683051.docx
Clause Essential Principle Relevant Specification / Standard / Complies Documentation reference
Sub Clause / reference justification and/ or comments
posed by contaminants and residues to the persons
involved in the transport, storage and use of the
devices and to patients, taking account of the
intended purpose of the device. Particular attention
should be paid to tissues exposed and to the
duration and frequency of exposure.
5.1.3 The devices should be designed and manufactured No The Device is not an IVD Not The Device is not an IVD
in such a way that they can be used safely with the Applicable
materials, substances and gases with which they
enter into contact during their normal use or during
routine procedures; if the devices are intended to
administer medicinal products they should be
designed and manufactured in such a way as to be
compatible with the medicinal products concerned
according to the provisions and restrictions
governing these products and that their
performance is maintained in accordance with the
intended use.
5.1.4 The devices should be designed and manufactured No The Device is not an IVD Not The Device is not an IVD
in such a way as to reduce as far as reasonably Applicable
practicable and appropriate the risks posed by
substances that may leach or leak from the device.
Special attention shall be given to substances which
are carcinogenic, mutagenic or toxic to
reproduction.
5.1.5 Devices should be designed and manufactured in No The Device is not an IVD Not The Device is not an IVD
such a way as to reduce as far as reasonably Applicable
practicable and appropriate risks posed by the
unintentional ingress or egress of substances into or
from the device taking into account the device and
the nature of the environment in which it is
intended to be used.
5.2 Infection and microbial contamination:
5.2.1 The devices and manufacturing processes should be Not Not The device is non-sterile and
Page 4 of 21
665683051.docx
Clause Essential Principle Relevant Specification / Standard / Complies Documentation reference
Sub Clause / reference justification and/ or comments
designed in such a way as to eliminate or to reduce Applicabl Applicable have no microbial state.
as far as reasonably practicable and appropriate the e
risk of infection to patients, users and, where
applicable, other persons. The design should,-
(a) allow easy handling, and, where necessary;
(b) reduce as far as reasonably practicable and
appropriate any microbial leakage from the device
and/or microbial exposure during use;
(c) prevent microbial contamination of the device or
specimen, where applicable, by the patient, user or
other person.
5.2.2 Devices labelled as having a special microbiological Not Not The device is non-sterile and
state should be designed, manufactured and Applicabl Applicable have no microbial state.
packaged to ensure they remain so when placed on e
the market and remain so under the transport and
storage conditions specified by the manufacturer.
5.2.3 Devices delivered in a sterile state should be Not Not The device is non-sterile and
designed, manufactured and packaged in a non- Applicabl Applicable have no microbial state.
reusable pack, and/or according to appropriate e
procedures, to ensure that they are sterile when
placed on the market and remain sterile, under the
transport and storage conditions indicated by the
manufacturer, until the protective packaging is
damaged or opened.
5.2.4 Devices labelled either as sterile or as having a Not Not The device is non-sterile and
special microbiological state should have been Applicabl Applicable have no microbial state.
processed, manufactured and, if applicable, e
sterilized by appropriate, validated methods.
5.2.5 Devices intended to be sterilized should be Not Not The device is non-sterile and
manufactured in appropriately controlled (e.g. Applicabl Applicable have no microbial state.
environmental) conditions. e
5.2.6 Packaging systems for non-sterile devices should Not Not The device is non-sterile and
maintain the integrity and cleanliness of the product Applicabl Applicable have no microbial state.
and, if the devices are to be sterilized prior to use,
Page 5 of 21
665683051.docx
Clause Essential Principle Relevant Specification / Standard / Complies Documentation reference
Sub Clause / reference justification and/ or comments
minimize the risk of microbial contamination; the e
packaging system should be suitable taking account
of the method of sterilization indicated by the
manufacturer.
5.2.7 The packaging or labelling of the device should Not Not The device is non-sterile and
distinguish between identical or similar products Applicabl Applicable have no microbial state.
placed on the market in both sterile and nonsterile e
condition.
5.3 Medical devices incorporating a substance considered to be a medicinal product or drug:
5.3.1 Where a medical device incorporates, as an integral No No The device does not contain any
part, a substance which, if used separately, may be drug substance.
considered to be a medicinal product or drug as
defined in the Drugs and Cosmetics Act, 1940 and
which is liable to act upon the body with action
ancillary to that of the device, the safety, quality and
performance of the device as a whole should be
verified, as well as the safety, quality and efficacy of
the substance in the specific application.
5.4 Medical devices incorporating materials of biological origin:
5.4.1 Where a medical device incorporates substances of No No No Material of biological origin
biological origin, the risk of infection must be is found in the device.
reduced as far as reasonably practicable and
appropriate by selecting appropriate sources,
donors and substances and by using, as appropriate,
validated inactivation, conservation, test and control
procedures.
5.4.2 For medical devices incorporating non-viable tissues, No No No Material of biological origin
cells and substances of animal origin should is found in the device.
originate from animals that have been subjected to
veterinary controls and surveillance adapted to the
intended use of the tissues. The manufacturer is
required to retain information on the geographical
origin of the animals. Processing, preservation,
testing and handling of tissues, cells and substances
Page 6 of 21
665683051.docx
Clause Essential Principle Relevant Specification / Standard / Complies Documentation reference
Sub Clause / reference justification and/ or comments
of animal origin should be carried out so as to
provide optimal safety. In particular, safety with
regard to viruses and other transmissible agents
should be addressed by implementation of validated
methods of elimination or inactivation in the course
of the manufacturing process. Explanation: For the
purpose of this clause, veterinary controls shall also
include that an animal source should be tested and
to be free from Transmissible spongiform
encephalopathies (TSEs) and Bovine spongiform
encephalopathy (BSEs)
5.4.3 For medical devices incorporating cells, tissues and No No No Material of biological origin
derivatives of microbial or recombinant origin, the is found in the device.
selection of sources or donors, the processing,
preservation, testing and handling of cells, tissues
and derivatives of such origin should be carried out
so as to provide optimal safety. In particular, safety
with regard to viruses and other transmissible
agents should be addressed by implementation of
validated methods of elimination or inactivation in
the course of the manufacturing process.
5.4.4 For medical devices incorporating non-viable human No No No Material of biological origin
tissues, cells and substances, the selection of is found in the device.
sources, donors or substances of human origin, the
processing, preservation, testing and handling of
tissues, cells and substances of such origin should be
carried out so as to provide optimal safety. In
particular, safety with regard to viruses and other
transmissible agents should be addressed by
implementation of validated methods of elimination
or inactivation in the course of the manufacturing
process.
5.5 Manufacturing and Environmental properties:
5.5.1 If the device is intended for use in combination with Yes ISO 13485:2016 Yes Refer Design and Development
Page 7 of 21
665683051.docx
Clause Essential Principle Relevant Specification / Standard / Complies Documentation reference
Sub Clause / reference justification and/ or comments
other devices or equipment the whole combination, ISO 14971:2019 File (DD/CHIPL/RD-0191,
including the connection system should be safe and ISO 15223-1:2021 Version 02, Issue date
should not impair the specified performance of the EN ISO 20417:2021 08.09.2021)
devices. Any restrictions on use applying to such ISO 80601-2-12:2011 Risk management File (RMF/A-
combinations should be indicated on the label IEC 60601-1:2005+A2020 01, Rev. 01, Date 02.10.2022)
and/or in the instructions for use. Connections Refer
which the user has to handle, such as fluid, gas  Production Work Process
transfer or mechanical coupling, should be designed Flow Diagram (PFD-PRD-
and constructed in such a way as to minimize all 001, Rev. 1.0, Issue Date
possible risks from incorrect connection. 01-02-2023)
 Production Operations
Process Flow Diagram for
Critical Care Ventilator (PFD-
PRD-002, Rev. 1.0, Issue
Date 01-02-2023)

5.5.2 Devices should be designed and manufactured in Yes ISO 13485:2016 Yes Refer Design and Development
such a way as to remove or reduce as far as ISO 14971:2019 File (DD/CHIPL/RD-0191,
reasonably practicable and appropriate: ISO 15223-1:2021 Version 02, Issue date
(i) the risk of injury to the patient, user or EN ISO 20417:2021 08.09.2021)
other persons in connection with their ISO 80601-2-12:2011 Risk management File (RMF/A-
physical and ergonomic features; IEC 60601-1:2005+A2020 01, Rev. 01, Date 02.10.2022)
(ii) the risk of use error due to the Refer
ergonomic features, human factors and  Production Work Process
the environment in which the device is Flow Diagram (PFD-PRD-
intended to be used; 001, Rev. 1.0, Issue Date
(iii) risks connected with reasonably 01-02-2023)
foreseeable external influences or  Production Operations
environmental conditions, such as Process Flow Diagram for
magnetic fields, external electrical and Critical Care Ventilator (PFD-
electromagnetic effects, electrostatic PRD-002, Rev. 1.0, Issue
discharge, radiation associated with Date 01-02-2023)
diagnostic or therapeutic procedures,
pressure, humidity, temperature or
Page 8 of 21
665683051.docx
Clause Essential Principle Relevant Specification / Standard / Complies Documentation reference
Sub Clause / reference justification and/ or comments
variations in pressure and acceleration;
(iv) (iv) the risks associated with the use of
the device when it comes into contact
with materials, liquids, and gases to
which it is exposed during normal
conditions of use;
(v) the risk associated with the possible
negative interaction between software
and the environment within which it
operates and interacts;
(vi) (vi) the risks of accidental penetration of
substances into the device;
(vii) the risks of reciprocal interference with
other devices normally used in the
investigations or for the treatment
given; risks arising where maintenance
or calibration are not possible (as with
implants), from ageing of materials used
or loss of accuracy of any measuring or
control mechanism.
5.5.3 Devices should be designed and manufactured in Yes ISO 13485:2016 Yes Refer Design and Development
such a way as to minimize the risks of fire or ISO 14971:2019 File (DD/CHIPL/RD-0191,
explosion during normal use and in single fault ISO 15223-1:2021 Version 02, Issue date
condition. Particular attention should be paid to EN ISO 20417:2021 08.09.2021)
devices whose intended use includes exposure to or ISO 80601-2-12:2011 Risk management File (RMF/A-
use in association with flammable substances or IEC 60601-1:2005+A2020 01, Rev. 01, Date 02.10.2022)
substances which could cause combustion. Refer
 Production Work Process
Flow Diagram (PFD-PRD-
001, Rev. 1.0, Issue Date
01-02-2023)
 Production Operations
Process Flow Diagram for
Critical Care Ventilator (PFD-
Page 9 of 21
665683051.docx
Clause Essential Principle Relevant Specification / Standard / Complies Documentation reference
Sub Clause / reference justification and/ or comments
PRD-002, Rev. 1.0, Issue
Date 01-02-2023)
5.5.4 Devices should be designed and manufactured in Yes ISO 13485:2016 Yes Refer Design and Development
such a way that adjustment, calibration, and ISO 14971:2019 File (DD/CHIPL/RD-0191,
maintenance, where such is necessary to achieve ISO 15223-1:2021 Version 02, Issue date
the performances intended, can be done safely. EN ISO 20417:2021 08.09.2021)
ISO 80601-2-12:2011 Refer
IEC 60601-1:2005+A2020  Production Work Process
Flow Diagram (PFD-PRD-
001, Rev. 1.0, Issue Date
01-02-2023)
 Production Operations
Process Flow Diagram for
Critical Care Ventilator (PFD-
PRD-002, Rev. 1.0, Issue
Date 01-02-2023)

5.5.5 Devices should be designed and manufactured in Yes ISO 15223-1:2021 Yes Refer the user manual
such a way as to facilitate the safe disposal of any EN ISO 20417:2021 (MAN/R&D/002, Revision-1.0,
waste substances. Dated 13.12.2022)
5.6 Devices with a diagnostic or measuring function:
5.6.1 Diagnostic devices should be designed and Not Not The is device is not an IVD
manufactured in such a way as to provide sufficient Applicabl Applicable
accuracy, precision and stability for their intended e
use, based on appropriate scientific and technical
methods. In particular the design should address
sensitivity, specificity, trueness, repeatability, and
reproducibility, control of known relevant
interference and limits of detection, as appropriate.
5.6.2 Where the performance of devices depends on the Not Not The device is not an IVD
use of calibrators or control materials, the Applicabl Applicable
traceability of values assigned to such calibrators or e
control materials should be assured through a
quality management system.
Page 10 of 21
665683051.docx
Clause Essential Principle Relevant Specification / Standard / Complies Documentation reference
Sub Clause / reference justification and/ or comments
5.6.3 Any measurement, monitoring or display scale Yes ISO 13485:2016 Yes Refer Design and Development
should be designed in line with ergonomic ISO 14971:2019 File (DD/CHIPL/RD-0191,
principles, taking account of the intended purpose of ISO 80601-2-12:2011 Version 02, Issue date
the device. IEC 60601-1:2005+A2020 08.09.2021)
Risk management File (RMF/A-
01, Rev. 01, Date 02.10.2022)
5.6.4 Wherever possible values expressed numerically Yes ISO 13485:2016 Yes Refer Design and Development
should be in commonly accepted, standardized ISO 14971:2019 File (DD/CHIPL/RD-0191,
units, and understood by the users of the device. ISO 80601-2-12:2011 Version 02, Issue date
IEC 60601-1:2005+A2020 08.09.2021)
Risk management File (RMF/A-
01, Rev. 01, Date 02.10.2022)
5.7 Protection against radiation:
General:
5.7.1 Devices should be designed and manufactured and Yes ISO 13485:2016 Yes Refer Design and Development
packaged in such a way that exposure of patients, ISO 14971:2019 File (DD/CHIPL/RD-0191,
users and other persons to any emitted radiation ISO 15223-1:2021 Version 02, Issue date
should be reduced as far as reasonably practicable EN ISO 20417:2021 08.09.2021)
and appropriate, compatible with the intended ISO 80601-2-12:2011 Risk management File (RMF/A-
purpose, whilst not restricting the application of IEC 60601-1:2005+A2020 01, Rev. 01, Date 02.10.2022)
appropriate specified levels for therapeutic and Refer
diagnostic purposes.  Production Work Process
Flow Diagram (PFD-PRD-
001, Rev. 1.0, Issue Date
01-02-2023)
 Production Operations
Process Flow Diagram for
Critical Care Ventilator (PFD-
PRD-002, Rev. 1.0, Issue
Date 01-02-2023)
5.7.2 Intended radiation: Where devices are designed to No No The device is free from any
emit hazardous, or potentially hazardous, levels of radiation or radiating material.
visible or invisible radiation necessary for a specific
medical purpose the benefit of which is considered
Page 11 of 21
665683051.docx
Clause Essential Principle Relevant Specification / Standard / Complies Documentation reference
Sub Clause / reference justification and/ or comments
to outweigh the risks inherent in the emission, it
should be possible for the user to control the
emissions. Such devices should be designed and
manufactured to ensure reproducibility of relevant
variable parameters within acceptable tolerance.
Where devices are intended to emit potentially
hazardous, visible or invisible radiation, they should
be fitted, where reasonably practicable, with visual
displays or audible warnings of such emissions.
5.7.3 Unintended radiation: Devices should be designed No No The device is free from any
and manufactured in such a way that exposure of radiation or radiating material.
patients, users and other persons to the emission of
unintended, stray or scattered radiation is reduced
as far as reasonably practicable and appropriate.
5.7.4 Ionizing radiation: No No The device is free from any
(a) Devices intended to emit ionizing radiation radiation or radiating material.
should be designed and manufactured in
such a way as to ensure that, where
reasonably practicable, the quantity,
geometry and energy distribution (or
quality) of radiation emitted can be varied
and controlled taking into account the
intended use.
(b) Devices emitting ionizing radiation intended
for diagnostic radiology should be designed
and manufactured in such a way as to
achieve appropriate image and/or output
quality for the intended medical purpose
whilst minimizing radiation exposure of the
patient and user.
(c) Devices emitting ionizing radiation, intended
for therapeutic radiology should be designed
and manufactured in such a way as to
enable reliable monitoring and control of
Page 12 of 21
665683051.docx
Clause Essential Principle Relevant Specification / Standard / Complies Documentation reference
Sub Clause / reference justification and/ or comments
the delivered dose, the beam type and
energy and where appropriate the energy
distribution of the radiation beam.
5.7.5 The operating instructions for a medical device that No No The device is free from any
emits radiation must include detailed information radiation or radiating material.
about the following matters:
(a) the nature of the radiation emitted;
(b) the means by which patients and users can be
protected from the radiation;
(c) ways to avoid misusing the device; and (d) ways
to eliminate any risks inherent in the installation of
the device.
5.8 Medical devices that incorporate software and standalone medical device software:
5.8.1 Devices incorporating electronic programmable Yes ISO 13485:2016 Yes Refer Design and Development
systems, including software, or standalone software ISO 14971:2019 File (DD/CHIPL/RD-0191,
that are devices in themselves, should be designed ISO 80601-2-12:2011 Version 02, Issue date
to ensure repeatability, reliability and performance IEC 60601-1:2005+A2020 08.09.2021)
according to the intended use. In the event of a Risk management File (RMF/A-
single fault condition, appropriate means should be 01, Rev. 01, Date 02.10.2022)
adopted to eliminate or reduce as far as reasonably
practicable and appropriate consequent risks.
5.8.2 For devices which incorporate software or for Yes ISO 13485:2016 Yes Refer Design and Development
standalone software that are devices in themselves, ISO 14971:2019 File (DD/CHIPL/RD-0191,
the software must be validated according to the ISO 80601-2-12:2011 Version 02, Issue date
state of the art taking into account the principles of IEC 60601-1:2005+A2020 08.09.2021)
development lifecycle, risk management, verification Risk management File (RMF/A-
and validation. 01, Rev. 01, Date 02.10.2022)

5.9 Active medical devices and devices connected to them:

5.9.1 For active medical devices, in the event of a single Yes ISO 13485:2016 Yes Refer Design and Development
fault condition, appropriate means should be ISO 14971:2019 File (DD/CHIPL/RD-0191,
adopted to eliminate or reduce as far as reasonably Version 02, Issue date
practicable and appropriate consequent risks. 08.09.2021)
Risk management File (RMF/A-
Page 13 of 21
665683051.docx
Clause Essential Principle Relevant Specification / Standard / Complies Documentation reference
Sub Clause / reference justification and/ or comments
01, Rev. 01, Date 02.10.2022)
5.9.2 Devices where the safety of the patients depends on Yes ISO 13485:2016 Yes Refer Design and Development
an internal power supply should be equipped with a ISO 14971:2019 File (DD/CHIPL/RD-0191,
means of determining the state of the power supply. Version 02, Issue date
08.09.2021)
Risk management File (RMF/A-
01, Rev. 01, Date 02.10.2022)
5.9.3 Devices where the safety of the patients depends on Yes ISO 13485:2016 Yes Refer Design and Development
an external power supply should include an alarm ISO 14971:2019 File (DD/CHIPL/RD-0191,
system to signal any power failure. Version 02, Issue date
08.09.2021)
Risk management File (RMF/A-
01, Rev. 01, Date 02.10.2022)
5.9.4 Devices intended to monitor one or more clinical No ISO 13485:2016 Not Refer Design and Development
parameters of a patient should be equipped with ISO 14971:2019 Applicable File (DD/CHIPL/RD-0191,
appropriate alarm systems to alert the user of ISO 80601-2-12:2011 Version 02, Issue date
situations which could lead to death or severe IEC 60601-1:2005+A2020 08.09.2021)
deterioration of the patient's state of health. Risk management File (RMF/A-
01, Rev. 01, Date 02.10.2022)
5.9.5 Devices should be designed and manufactured in Yes ISO 13485:2016 Yes Refer Design and Development
such a way as to reduce as far as reasonably ISO 14971:2019 File (DD/CHIPL/RD-0191,
practicable and appropriate the risks of creating ISO 15223-1:2021 Version 02, Issue date
electromagnetic interference which could impair the EN ISO 20417:2021 08.09.2021)
operation of this or other devices or equipment in Risk management File (RMF/A-
the usual environment. 01, Rev. 01, Date 02.10.2022)
Refer
 Production Work Process
Flow Diagram (PFD-PRD-
001, Rev. 1.0, Issue Date
01-02-2023)
 Production Operations
Process Flow Diagram for
Critical Care Ventilator (PFD-
PRD-002, Rev. 1.0, Issue
Page 14 of 21
665683051.docx
Clause Essential Principle Relevant Specification / Standard / Complies Documentation reference
Sub Clause / reference justification and/ or comments
Date 01-02-2023)
5.9.6 Devices should be designed and manufactured in Yes ISO 13485:2016 Yes Refer Design and Development
such a way as to provide an adequate level of ISO 14971:2019 File (DD/CHIPL/RD-0191,
intrinsic immunity to electromagnetic disturbance to ISO 15223-1:2021 Version 02, Issue date
enable them to operate as intended. EN ISO 20417:2021 08.09.2021)
Risk management File (RMF/A-
01, Rev. 01, Date 02.10.2022)
Refer
 Production Work Process
Flow Diagram (PFD-PRD-
001, Rev. 1.0, Issue Date
01-02-2023)
 Production Operations
Process Flow Diagram for
Critical Care Ventilator (PFD-
PRD-002, Rev. 1.0, Issue
Date 01-02-2023)
5.9.7 Devices should be designed and manufactured in Yes ISO 13485:2016 Yes Refer Design and Development
such a way as to avoid, as far as reasonably ISO 14971:2019 File (DD/CHIPL/RD-0191,
practicable, the risk of accidental electric shocks to ISO 15223-1:2021 Version 02, Issue date
the patient, user or any other person, both during EN ISO 20417:2021 08.09.2021)
normal use of the device and in the event of a single ISO 80601-2-12:2011 Risk management File (RMF/A-
fault condition in the device, provided the device is IEC 60601-1:2005+A2020 01, Rev. 01, Date 02.10.2022)
installed and maintained as indicated by the Refer
manufacturer.  Production Work Process
Flow Diagram (PFD-PRD-
001, Rev. 1.0, Issue Date
01-02-2023)
 Production Operations
Process Flow Diagram for
Critical Care Ventilator (PFD-
PRD-002, Rev. 1.0, Issue
Date 01-02-2023)
5.10 Protection against mechanical risks:
Page 15 of 21
665683051.docx
Clause Essential Principle Relevant Specification / Standard / Complies Documentation reference
Sub Clause / reference justification and/ or comments
5.10.1 Devices should be designed and manufactured in Yes ISO 13485:2016 Yes Refer Design and Development
such a way as to protect the patient and user against ISO 14971:2019 File (DD/CHIPL/RD-0191,
mechanical risks connected with, for example, ISO 15223-1:2021 Version 02, Issue date
resistance to movement, instability and moving EN ISO 20417:2021 08.09.2021)
parts. ISO 80601-2-12:2011 Risk management File (RMF/A-
IEC 60601-1:2005+A2020 01, Rev. 01, Date 02.10.2022)
Refer
 Production Work Process
Flow Diagram (PFD-PRD-
001, Rev. 1.0, Issue Date
01-02-2023)
 Production Operations
Process Flow Diagram for
Critical Care Ventilator (PFD-
PRD-002, Rev. 1.0, Issue
Date 01-02-2023)
5.10.2 Devices should be designed and manufactured in Yes ISO 13485:2016 Yes Refer Design and Development
such a way as to reduce to the lowest practicable ISO 14971:2019 File (DD/CHIPL/RD-0191,
level the risks arising from vibration generated by ISO 15223-1:2021 Version 02, Issue date
the devices, taking account of technical progress and EN ISO 20417:2021 08.09.2021)
of the means available for limiting vibrations, Risk management File (RMF/A-
particularly at source, unless the vibrations are part 01, Rev. 01, Date 02.10.2022)
of the specified performance. Refer
 Production Work Process
Flow Diagram (PFD-PRD-
001, Rev. 1.0, Issue Date
01-02-2023)
 Production Operations
Process Flow Diagram for
Critical Care Ventilator (PFD-
PRD-002, Rev. 1.0, Issue
Date 01-02-2023)
5.10.3 Devices should be designed and manufactured in Yes ISO 13485:2016 Yes Refer Design and Development
such a way as to reduce to the lowest practicable ISO 14971:2019 File (DD/CHIPL/RD-0191,
Page 16 of 21
665683051.docx
Clause Essential Principle Relevant Specification / Standard / Complies Documentation reference
Sub Clause / reference justification and/ or comments
level the risks arising from the noise emitted, taking ISO 15223-1:2021 Version 02, Issue date
account of technical progress and of the means EN ISO 20417:2021 08.09.2021)
available to reduce noise, particularly at source, ISO 80601-2-12:2011 Risk management File (RMF/A-
unless the noise emitted is part of the specified IEC 60601-1:2005+A2020 01, Rev. 01, Date 02.10.2022)
performance.
5.10.4 Terminals and connectors to the electricity, gas or Yes ISO 13485:2016 Yes Refer Design and Development
hydraulic and pneumatic energy supplies which the ISO 14971:2019 File (DD/CHIPL/RD-0191,
user has to handle should be designed and ISO 15223-1:2021 Version 02, Issue date
constructed in such a way as to minimize all possible EN ISO 20417:2021 08.09.2021)
risks. Risk management File (RMF/A-
01, Rev. 01, Date 02.10.2022)
Refer
 Production Work Process
Flow Diagram (PFD-PRD-
001, Rev. 1.0, Issue Date
01-02-2023)
 Production Operations
Process Flow Diagram for
Critical Care Ventilator (PFD-
PRD-002, Rev. 1.0, Issue
Date 01-02-2023)
5.10.5 Devices should be designed and manufactured in Yes ISO 13485:2016 Yes Refer Design and Development
such a way as to reduce to the lowest practicable ISO 14971:2019 File (DD/CHIPL/RD-0191,
level, the risk of error when certain parts within the ISO 15223-1:2021 Version 02, Issue date
device are intended to be connected or reconnected EN ISO 20417:2021 08.09.2021)
before or during use. ISO 80601-2-12:2011 Risk management File (RMF/A-
IEC 60601-1:2005+A2020 01, Rev. 01, Date 02.10.2022)
Refer
 Production Work Process
Flow Diagram (PFD-PRD-
001, Rev. 1.0, Issue Date
01-02-2023)
 Production Operations
Process Flow Diagram for
Page 17 of 21
665683051.docx
Clause Essential Principle Relevant Specification / Standard / Complies Documentation reference
Sub Clause / reference justification and/ or comments
Critical Care Ventilator (PFD-
PRD-002, Rev. 1.0, Issue
Date 01-02-2023)
5.10.6 Accessible parts of the devices (excluding the parts Yes ISO 13485:2016 Yes Refer Design and Development
or areas intended to supply heat or reach given ISO 14971:2019 File (DD/CHIPL/RD-0191,
temperatures) and their surroundings should not ISO 15223-1:2021 Version 02, Issue date
attain potentially dangerous temperatures under EN ISO 20417:2021 08.09.2021)
normal conditions of use. Risk management File (RMF/A-
01, Rev. 01, Date 02.10.2022)
Refer
 Production Work Process
Flow Diagram (PFD-PRD-
001, Rev. 1.0, Issue Date
01-02-2023)
 Production Operations
Process Flow Diagram for
Critical Care Ventilator (PFD-
PRD-002, Rev. 1.0, Issue
Date 01-02-2023)
5.11 Protection against the risks posed to the patient or user by supplied energy or substances:
5.11.1 Devices for supplying the patient with energy or Yes ISO 13485:2016 Yes The device have several modes
substances should be designed and constructed in ISO 14971:2019 and control parameters to
such a way that the delivered amount can be set and ISO 15223-1:2021 provide supply and equipped
maintained accurately enough to guarantee the EN ISO 20417:2021 with an alarm system to control
safety of the patient and of the user. ISO 80601-2-12:2011 the supply.
IEC 60601-1:2005+A2020 Refer Design and Development
File (DD/CHIPL/RD-0191,
Version 02, Issue date
08.09.2021)
Risk management File (RMF/A-
01, Rev. 01, Date 02.10.2022)
5.11.2 Devices should be fitted with the means of Yes ISO 13485:2016 Yes The device have several modes
preventing and/or indicating any inadequacies in the ISO 14971:2019 and control parameters to
delivered amount which could pose a danger. ISO 15223-1:2021 provide supply and equipped
Page 18 of 21
665683051.docx
Clause Essential Principle Relevant Specification / Standard / Complies Documentation reference
Sub Clause / reference justification and/ or comments
Devices should incorporate suitable means to EN ISO 20417:2021 with an alarm system to control
prevent, as far as possible, the accidental release of ISO 80601-2-12:2011 the supply.
dangerous levels of energy or substances from an IEC 60601-1:2005+A2020 Refer Design and Development
energy and/or substance source. File (DD/CHIPL/RD-0191,
Version 02, Issue date
08.09.2021)
Risk management File (RMF/A-
01, Rev. 01, Date 02.10.2022)
5.11.3 The function of the controls and indicators should be Yes ISO 15223-1:2021 Yes Refer the user manual
clearly specified on the devices. Where a device EN ISO 20417:2021 (MAN/R&D/002, Revision-1.0,
bears instructions required for its operation or ISO 80601-2-12:2011 Dated 13.12.2022)
indicates operating or adjustment parameters by IEC 60601-1:2005+A2020
means of a visual system, such information should
be understandable to the user and, as appropriate,
the patient.
5.12 Protection against the risks posed by medical devices intended by the manufacturer for use by lay persons:
5.12.1 Devices for use by lay persons should be designed No ISO 15223-1:2021 No The Device is not intended to
and manufactured in such a way that they perform EN ISO 20417:2021 used by Lay person.
appropriately for their intended purpose taking into ISO 80601-2-12:2011 Refer the user manual
account the skills and the means available to lay IEC 60601-1:2005+A2020 (MAN/R&D/002, Revision-1.0,
persons and the influence resulting from variation Dated 13.12.2022)
that can reasonably be anticipated in the
layperson‟s technique and environment. The
information and instructions provided by the
manufacturer should be easy for the lay person to
understand and apply.
5.12.2 Devices for use by lay persons should be designed No ISO 15223-1:2021 No The Device is not intended to
and manufactured in such a way as to reduce as far EN ISO 20417:2021 used by Lay person.
as reasonably practicable the risk of error during use ISO 80601-2-12:2011
by the lay person in the handling of the device and IEC 60601-1:2005+A2020
also in the interpretation of results.
5.12.3 Devices for use by lay persons should, where No ISO 15223-1:2021 No Refer the user manual
reasonably possible, include a procedure by which EN ISO 20417:2021 (MAN/R&D/002, Revision-1.0,
the lay person can verify that, at the time of use, the ISO 80601-2-12:2011 Dated 13.12.2022)
Page 19 of 21
665683051.docx
Clause Essential Principle Relevant Specification / Standard / Complies Documentation reference
Sub Clause / reference justification and/ or comments
product will perform as intended by the IEC 60601-1:2005+A2020
manufacturer.
5.13 Label, direction or Instructions For Use (IFU):
5.13.1 Users should be provided with the information Yes ISO 15223-1:2021 Yes Refer the user manual
needed to identify the manufacturer, to use the EN ISO 20417:2021 (MAN/R&D/002, Revision-1.0,
device safely and to ensure the intended Dated 13.12.2022)
performance, taking account of their training and
knowledge.
5.13.2 This information should be easily understood and Yes ISO 15223-1:2021 Yes Refer the user manual
detailed information for labelling should be EN ISO 20417:2021 (MAN/R&D/002, Revision-1.0,
incorporated as provided in the Chapter VI: labelling Dated 13.12.2022)
of Medical device, of the Medical Device Rules,
2017.
5.14 Clinical Evaluation:
5.14.1 For all medical devices, the demonstration of Yes ISO 15223-1:2021 Yes Refer the user manual
conformity with essential principles includes a EN ISO 20417:2021 (MAN/R&D/002, Revision-1.0,
clinical evaluation. The clinical evaluation should Dated 13.12.2022)
review clinical data in the form of any,
(a) clinical investigation reports; or
(b) literature reports/reviews; or
(c) clinical experience, to establish that a favorable
benefit risk ratio exists for the device.
5.14.2 Clinical investigations: Clinical Investigations on No ISO 15223-1:2021 No Refer the user manual
human subjects should be carried out in accordance EN ISO 20417:2021s (MAN/R&D/002, Revision-1.0,
with the provisions of Medical Devices Rules, 2017. Dated 13.12.2022)
This includes every step in the clinical investigation Clinical Evaluation Report
from first consideration of the need and justification (Report No.: CER/2022-01, Date.
of the study to publication of the results. 16 Dec 2022)

Page 20 of 21
665683051.docx
 Page 21 of 21
665683051.docx