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1 |
IS/ISO 10993 : Part 1 : 2009 |
Biological evaluation of medical devices Part 1 Evaluation and Testing within a risk management process |
Methods of tests |
IS 17932 (Part 1):2023 |
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2 |
IS/ISO 10993 : Part 10 : 2010 |
Biological evaluation of medical devices Part 10 Tests for irritation and skin sensitization |
Methods of tests |
IS 17932 (Part 6) : 2023 |
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3 |
IS 12024 : 1986 |
Code of practice for field monitoring of movement of structures using tape extensometer |
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4 |
IS 12572 : Part 1 : 1994 |
Biological Evaluation of Medical Devices - Part 1 : Guidance on Selection of Tests |
Code of Practice |
decided by council |
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5 |
IS 12572 : Part 2 : 1995 |
Biological evaluation of medical devices: Part 2 animal welfare requirements |
Others |
IS/ISO 10993-2 : 2006 |
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6 |
IS 12572 : Part 3 : 1988 |
Guide for evaluation of medical devices for biological hazards: Part 3 method of testing by tissue implantation |
Methods of tests |
decided by council |
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7 |
IS 12572 : Part 4 : 2016 |
Biological evaluation of medical devices: Part 4 selection of tests for interaction with blood |
Methods of tests |
decided by council |
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8 |
IS 12572 : Part 5 : 1988 |
Guide for evaluation of medical devices for biological hazards: Part 5 method of test for intracutaneous reactivity of extracts from medical devices |
Methods of tests |
decided by council |
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9 |
IS 12572 : Part 6 : 1988 |
Guide for evaluation of medical devices for biological hazards: Part 6 method of test for systemic toxicity: assessment of pyrogenicity in rabbits of extracts from medical devices |
Methods of tests |
decided by council |
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10 |
IS 12572 : Part 7 : 1988 |
Guide for evaluation of medical devices for biological hazards: Part 7 methods of test for sensitization : assessment of potential of medical devices to produce delayed contact dermatitis |
Methods of tests |
decided by council |
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11 |
IS 12572 : Part 8 : 1988 |
Guide forevaluationofmedical devices for biological hazards: Part 8 method of test for skin irritation of extracts from medical devices |
Methods of tests |
decided by council |
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12 |
IS 12572 : Part 9 : 1988 |
Guide for evaluation of medical devices for biological hazards: Part 9 method of test for skin irritation by solid medical devices |
Methods of tests |
decided by council |
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13 |
IS 12572 : Part 10 : 1988 |
Guide for Evaluation of Medical Devices for Biological Hazards Part 10 Biological Testing and Evaluation of Dental Materials |
Methods of tests |
IS/ISO 7405 : 2008 |
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14 |
IS 12572 : Part 11 : 1990 |
Guide for evaluation of medical devices for biological hazards: Part 11 method of test for eye irritation |
Methods of tests |
decided by council |
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15 |
IS 12572 : Part 13 : 1995 |
Biological Evaluation of Medical Devices - Part 13 : Tests for Genotoxicity, Carcinogenicity and Reproductive Toxicity |
Methods of tests |
IS/ISO 10993-3 : 2014 |
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16 |
IS 12572 : Part 14 : 1994 |
Biological Evaluation of Medical Devices - Part 14 : Selection of Tests for Interactions with Blood |
Methods of tests |
IS/ISO 10993-4 : 2017 |
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17 |
IS 13020 : Part 1 : 1991 |
Medical Electrical Equipment - Ultrasonic Therapy Equipment - Part 1 : Particular Requirements for the Safety |
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18 |
IS 13020 : Part 2 : 1990 |
Medical Electrical Equipment - Ultrasonic Therapy Equipment - Part 2 : Constructional and Performance Requirements |
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19 |
IS 13728 : 1993 |
Entrance field sizes of elctro-optical X-ray image intensifiers |
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20 |
IS 13729 : 1993 |
Determination of the luminance distribution of electro-optical X-ray image intensifiers |
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21 |
IS 13807 : 1994 |
Medical radiology - Terminology |
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22 |
IS 13813 : 1993 |
Measurement of the conversion factor of electro-optical X-ray image intensifiers |
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23 |
IS/ISO 14155 : 2011 |
Clinical investigation of medical devices for human subjects - Good clinical practice |
Methods of tests |
IS/ISO 14155 : 2020 |
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24 |
IS/IEC 61010 : Part 1 : 2010 |
Safety requirements for electrical equipment for measurement, control, and laboratory use Part 1 General requirements |
Safety Standard |
IS 17724 (Part 1) : 2023 |
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25 |
IS 7064 : 1973 |
Radiation protection in medical X-ray equipment operating at 10 kV to 400 kV |
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26 |
IS 8607 : Part 3 : 1978 |
General and safety requirements for electrical equipment used in medical practice: Part 3 Protection against mechanical hazards |
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27 |
IS 8607 : Part 4 : 1985 |
General and safety requirements for electrical equipment used in medical practice: Part 4 Protection against unwanted or excessive radiation |
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28 |
IS 8607 : Part 5 : 1983 |
General and Safety Requirements for Electrical Equipment Used in Medical Practice - Part 5 : Protection Against Explosion Hazards |
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29 |
IS 8607 : Part 6 : 1984 |
General and safety requirements for electrical equipment used in medical practice: Part 6 Protection against excessive temperatures, fire and other hazards |
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30 |
IS 8607 : Part 7 : 1985 |
General and safety requirements for electrical equipment used in medical practice: Part 7 Construction |
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31 |
IS 8607 : Part 8 : 1985 |
General and safety requirements for electrical equipment used in medical practice: Part 8 Behaviour and reliability |
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32 |
IS 8902 : 1978 |
Area exposure product meter |
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33 |
IS 9286 : Part 2 : 1988 |
Cardiac Defibrillators - Part 2 : Construction and Performance Requirements |
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IS 13450(Part 2/Sec 4):2009 |
