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    Product Manual 7620

    Uploaded by

    amitonline09
    This document provides guidelines for testing and certification of diagnostic x-ray machines according to Indian Standard IS 7620 (Part 1): 1986 on Mechanical & Electrical Safety. It outlines the required test equipment, tests to be conducted, levels of control and process for inspection and testing for quality assurance and compliance with the standard. Key tests include insulation resistance, high voltage test, leakage current and earth resistance testing, which must be conducted on each machine. Temperature rise and overcurrent protective device testing is required once every six months for machines of the same type, design and rating. Non-compliant products must be rejected in a manner that ensures no BIS Act violations.

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    © All Rights Reserved
    Download as PDF, TXT or read online from Scribd

    Product Manual 7620

    Uploaded by

    amitonline09
    30 views4 pages
    This document provides guidelines for testing and certification of diagnostic x-ray machines according to Indian Standard IS 7620 (Part 1): 1986 on Mechanical & Electrical Safety. It outlines the required test equipment, tests to be conducted, levels of control and process for inspection and testing for quality assurance and compliance with the standard. Key tests include insulation resistance, high voltage test, leakage current and earth resistance testing, which must be conducted on each machine. Temperature rise and overcurrent protective device testing is required once every six months for machines of the same type, design and rating. Non-compliant products must be rejected in a manner that ensures no BIS Act violations.

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    This document provides guidelines for testing and certification of diagnostic x-ray machines according to Indian Standard IS 7620 (Part 1): 1986 on Mechanical & Electrical Safety. It outlines the required test equipment, tests to be conducted, levels of control and process for inspection and testing for quality assurance and compliance with the standard. Key tests include insulation resistance, high voltage test, leakage current and earth resistance testing, which must be conducted on each machine. Temperature rise and overcurrent protective device testing is required once every six months for machines of the same type, design and rating. Non-compliant products must be rejected in a manner that ensures no BIS Act violations.

    Copyright:

    © All Rights Reserved
    Download as PDF, TXT or read online from Scribd
    Download as pdf or txt
    30 views4 pages

    Product Manual 7620

    Uploaded by

    amitonline09
    This document provides guidelines for testing and certification of diagnostic x-ray machines according to Indian Standard IS 7620 (Part 1): 1986 on Mechanical & Electrical Safety. It outlines the required test equipment, tests to be conducted, levels of control and process for inspection and testing for quality assurance and compliance with the standard. Key tests include insulation resistance, high voltage test, leakage current and earth resistance testing, which must be conducted on each machine. Temperature rise and overcurrent protective device testing is required once every six months for machines of the same type, design and rating. Non-compliant products must be rejected in a manner that ensures no BIS Act violations.

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    You are on page 1of 4

    PM/ IS 7620 (Part 1)/ 1/ May 2019

    PRODUCT MANUAL FOR


    MEDICAL ELECTRICAL EQUIPMENT- DIAGNOSTIC X-RAY MACHINE
    PART 1- MECHANICAL & ELECTRICAL SAFETY
    ACCORDING TO IS 7620 (Part 1): 1986
    This Product Manual shall be used as reference material by all Regional/Branch Offices &
    licensees to ensure coherence of practice and transparency in operation of certification under
    Scheme-I of Bureau of Indian Standards (Conformity Assessment) Regulations, 2019 for
    various products. The document may also be used by prospective applicants desirous of
    obtaining BIS certification licence/certificate.

    1. Product : IS 7620 (Part 1): 1986


    Medical Electrical Equipment- Diagnostic X-ray Machine -
    Title :
    Mechanical & Electrical Safety
    No. of Amendments : 3

    2. Sampling Guidelines:
    a) Raw material : As per Cl 3.1.2 of IS 7620 (Part 1)
    b) Grouping guidelines : Each variety to be tested for GoL/ CSoL
    Two X-ray machines shall be tested in the factory for all the
    c) Sample Size :
    requirements.

    List of Test
    3. : Please refer ANNEX – A.
    Equipment

    Scheme of Inspection
    4. : Please refer ANNEX – B.
    and Testing

    Possible tests in a As the licence is operated on Factory Testing basis, complete


    5. :
    day testing of a sample shall be done in factory.

    Scope of the Licence :


    Licence is granted to use Standard Mark as per IS 7620 (Part 1): 1986 with the following
    scope:
    “Sationary/ Mobile Medical electrical equipment- Diagnostic X-ray machine ________
    6. type, ___________ frequency generator, for rated line voltage _____V, frequency ______
    Hz, ____ phase, current ______ A, Rated Peak Output Voltage _______kVp, output
    power _____ W”
    Other relevant aspects may also be mentioned in the scope.

    BUREAU OF INDIAN STANDARDS


    Manak Bhawan, 9, Bahadur Shah Zafar Marg,
    New Delhi – 110002
    Page 1
    PM/ IS 7620 (Part 1)/ 1/ May 2019

    ANNEX A

    List Of Test Equipment

    Major test equipment required to test as per the Indian Standard

    Sr. No. Test Equipment Tests used in with Clause Reference


    Sheet metal thickness- Cl 3.1.4
    Metal plate thickness- Cl 3.6.11
    1 Vernier Callipers
    Clearances – Cl 3.8.7
    Barrier thickness- Cl 3.8.8
    2 Scale X-Ray table drift- Cl 3.11.1
    3 Steel probe Enclosure protection test- Cl 3.1.9
    a)Humidity chamber Insulation resistance test – Cl 6.2.1 & Cl
    4
    b)Megger 6.2.2
    5 HV tester High Voltage test- Cl 6.3
    6 Leakage current tester Leakage current test- Cl 6.4
    Earth Resistance tester with
    a)Ammeter
    7 Earth Resistance test- Cl 6.2.5
    b)Voltmeter
    c) Current Source
    a) Dummy Load Testing of Over current protective
    8
    b) Multimeter devices and meters- Cl 6.6
    Temperature indicator with
    9 Temperature rise test – Cl 3.4, Cl 6.7
    thermocouples

    The above list is indicative only and may not be treated as exhaustive.

    Page 2
    PM/ IS 7620 (Part 1)/ 1/ May 2019

    ANNEX B

    Scheme Of Inspection And Testing

    1. LABORATORY - A laboratory shall be maintained which shall be suitably equipped


    (as per the requirement given in column 2 of Table 1) and staffed, where different tests given
    in the specification shall be carried out in accordance with the methods given in the
    specification.

    1.1 The manufacturer shall prepare a calibration plan for the test equipment.

    2. TEST RECORDS – The manufacturer shall maintain test records for the tests carried out
    to establish conformity.

    3. LABELLING AND MARKING – As per the requirements of IS 7620 (Part 1): 1986.

    4. CONTROL UNIT – All X-ray machine, tables, tubes stands of the same type, design and
    rating manufactured in a month shall constitute a control unit.

    5. LEVELS OF CONTROL - The tests as indicated in column 1 of Table 1 and the levels of
    control in column 3 of Table 1, shall be carried out on the whole production of the factory
    which is covered by this plan and appropriate records maintained in accordance with
    paragraph 2 above.

    6. REJECTIONS – Disposal of non-conforming product shall be done in such a way so as to


    ensure that there is no violation of provisions of BIS Act, 2016.

    Page 3
    PM/ IS 7620 (Part 1)/ 1/ May 2019

    TABLE 1

    (1) (2) (3)


    Test Details Test equipment Levels of Control
    Test Methods requirement
    R: required (or) S:
    Cl. Requirement No. of Sample Frequency
    Sub- contracting
    Clause Ref
    permitted
    3 General requirements 3, 6.1 - Each machine*
    4 Marking 4 - Each machine
    6.2.1 R Each machine
    6.2 Insulation resistance Once in six months of the same type,
    6.2.2 R One
    design and rating
    6.3 High Voltage test 6.3 IS 7620 (Part 1) R
    6.4 Leakage current 6.4 R Each machine
    6.5 Earth resistance test 6.5 R
    Testing of over-current protective
    6.6 6.6.1, 6.6.2 R Once in six months of the same type,
    device for X-Ray control One
    design and rating
    6.7 Temperature rise test 3.4, 6.7 R
    * The components and parts of X-Ray equipment under mandatory certification shall be ISI marked. Other components/ parts shall be either ISI marked
    or a test certificate shall be obtained from the supplier of components or parts.

    Note: Levels of control given in column 3 are obligatory in nature, to which the licensee shall comply with.

    Page 4

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