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IS Number : IS 17932 (Part 1):2023

IS Title [Eng-Hn] : Biological evaluation of medical devices Part 1: Evaluation and testing within a risk management process (ISO 10993-1 : 2018, MOD)
No of Revision : 0
No of Amendments : 0
Technical Department : Medical Equipment and Hospital Planning Department
Technical Committee : MHD 19 ( In-vitro Diagnostic Medical Devices and Biological Evaluation of Medical Devices )
Language : English

Group : Medical and Hospital Equipments
Sub Group: Clinical, pathological, anaesthetic and respiratory equipments and systems
Sub Sub Group : Biological tests
Aspects: Methods of tests
Certification:
Ministry : Ministry of Health and Family Welfare
Short Commom Man's Title:
Itchs: N/A
Degree of Equivalence: Modified/Technically Equivalent
Identical/Equivalent Standards:ISO 10993-1:2018
Organisation :

Indian Standards Refered In IS IS 17932 : Part 1 : 2023 :
SNo IS Number Title Technical Committee
1
IS/ISO 10993 : Part 3 : 2014 Biological evaluation of medical devices Part 3 Tests for Genotoxicity, Carcinogenicity and Reproductive toxicity (First Revision) MHD 19
2
IS/ISO 10993 : Part 4 : 2017 Biological evaluation of medical devices Part 4 Selection of tests for interactions with blood MHD 19
3
IS/ISO 10993 : Part 5 : 2009 Biological evaluation of medical devices Part 5 Tests for in vitro cytotoxicity MHD 19
4
IS/ISO 10993 : Part 6 : 2016 Biological evaluation of medical devices Part 6 Tests for local effects after implantation MHD 19
5
IS/ISO 10993 : Part 7 : 2018 Biological evaluation of medical devices Part 7 Ethylene oxide sterilization residuals MHD 19
6
IS/ISO 10993 : Part 9 : 2009 Biological evaluation of medical devices Part 9 Framework for identification and quantification of potential degradation products MHD 19
7
IS/ISO 10993 : Part 10 : 2010 Biological evaluation of medical devices Part 10 Tests for irritation and skin sensitization MHD 19
8
IS/ISO 10993 : Part 11 : 2017 Biological evaluation of medical devices Part 11 Tests for systemic toxicity MHD 19
9
IS/ISO 10993 : Part 15 : 2000 Biological evaluation of medical devices: Part 15 identification and quantification of degradation products from metals and alloys MHD 19
10
IS/ISO 10993 : Part 16 : 2017 Biological Evaluation of Medical Devices Part 16 Toxicokinetic Study Design for Degradation Products and Leachables MHD 19
11
IS/ISO 10993 : Part 17 : 2002 Biological Evaluation of Medical Devices Part 17 Establishment of Allowable Limits for Leachable Substances MHD 19
International Standards Refered In IS 17932 : Part 1 : 2023
SNo International Standard Number
1 ISO 10993 : 1 : 0 0
2 ISO 10993 : 6 : 0 0
3 ISO 0 : 0 : 0 0
IS 17932 : Part 1 : 2023 is Refered in following Indian Standards :
SNo IS Number Title Technical Committee
1 IS 17874 : Part 1 : 2022 Glossary of Yoga Terminology Part 1 Standardized Terminology for Commonly used Terms related to Yoga AYD 2
2 IS 17929 : Part 3 : 2022 Fibre ropes for offshore station keeping part 3: High modulus polyethylene HMPE TXD 9
3 IS 13360 : Part 11 : Sec 15 : 2022 PLASTICS - METHODS OF TESTING PART 11 SPECIAL PROPERTIES Section 15 Determination of Viscosity using a Falling-Ball Viscometer Inclined-tube method PCD 27
4 IS 14702 : 2022 Solvent Extracted Undecorticated Sunflower Oilcake as Livestock Feed Ingredient � Specification FAD 5
5 IS/IEC 61400 : Part 2 : 2013 Wind Turbines Part 2: Small Wind Turbines ETD 42
6 IS 14458 : Part 7 : 2022 Retaining Wall for Hill Area - Guidelines: Part 7 Construction of Peripheral Reinforced Gabion Walls CED 56
7 IS 10971 : PART 2 : 2022 Textiles — Determination of Fabric Propensity to Surface Pilling Fuzzing or Matting Part 2: Modified Martindale Method (second revision) TXD 1
8 IS 17996 : 2022 Technical Documentation for the Assessment of Electrical and Electronic Products with respect to the Restriction of Hazardous Substances ETD 43
9 IS/ISO 7439 : 2015 Copper - Bearing contraceptive intrauterine devices - Requirements and tests (First Revision) MHD 3
10 IS/ISO 7439 : 2015 Copper - Bearing contraceptive intrauterine devices - Requirements and tests (First Revision) MHD 3
11 IS 3937 : Part 2 : 2022 RECOMMENDATIONS FOR SOCKETING OF WIRE ROPES - PART 2 SOCKETING WITH WHITE METAL Second Revision MED 10
12 IS 4707 : Part 4 : 2022 Classification Of Cosmetic Raw Materials And Adjuncts -List of UV Filters Allowed In Cosmetics With Restriction-IS 4707 Part 4 PCD 19
13 IS 14962 : Part 3 : 2022 ISO general purpose metric screw threads � Tolerances � Part 3: Limit deviations for screw threads PGD 37
14 IS 5457 : 2022 SIZES OF FOLDERS AND FILES SPECIFICATION CHD 15
15 IS/ISO 10651 : Part 4 : 2002 Lung ventilators for medical use - Particular requirements for basic safety and essential performance: Part 4 particular requirements for operator - Powered resuscitators MHD 11
16 IS/ISO 10651 : Part 4 : 2002 Lung ventilators for medical use - Particular requirements for basic safety and essential performance: Part 4 particular requirements for operator - Powered resuscitators MHD 11
17 IS/ISO/IEC GUIDE 41 : 2018 Packaging - Recommendations for addressing consumer needs First Revision MSD 15
18 IS/ISO 3691 : Part 6 : 2021 INDUSTRIAL TRUCKS SAFETY REQUIREMENTS AND VERIFICATION PART 6: BURDEN AND PERSONNEL CARRIERS TED 22
19 IS 19002 : 2023 Test Conditions for Vertical Surface Type Broaching Machines Testing of Accuracy PGD 35
20 IS 16792 : Part 1 : Sec 7 : 2023 Measurement Procedures for Materials Used in Photovoltaic Modules Part 1-7: Encapsulates Test Procedure of Optical Durability ETD 28
21 IS 17969 : 2023 Molecular biomarker analysis � Methods of analysis for the detection and identification of animal species in foods and food products nucleic acid-based methods � General requirements and definitions FAD 23
22 IS 4155 : 2023 Glossary of Terms Relating to Chemical and Radiation Hazards and Hazardous Chemicals (First Revision) CHD 7
23 IS 16150 : Part 3 : 2023 Fish feed - Specification Part 3 Marine shrimp feed FAD 12
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28 IS 18115 : 2023 Non-destructive testing - Ultrasonic testing - Characterization and sizing of discontinuities MTD 21
29 IS/ISO 14015 : 2022 Environmental management Guidelines for environmental due diligence assessment first revision EED 1
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31 IS/ISO 1039 : 1995 CINEMATOGRAPHY - CORES FOR MOTION-PICTURE AND MAGNETIC FILM ROLLS DIMENSIONS ADOPTION OF ISO 1039: 1995 MED 32
32 IS 17932 : Part 1 : 2023 Biological evaluation of medical devices Part 1: Evaluation and testing within a risk management process (ISO 10993-1 : 2018, MOD) MHD 19
33 IS 17932 : Part 1 : 2023 Biological evaluation of medical devices Part 1: Evaluation and testing within a risk management process (ISO 10993-1 : 2018, MOD) MHD 19
34 IS 17932 : Part 1 : 2023 Biological evaluation of medical devices Part 1: Evaluation and testing within a risk management process (ISO 10993-1 : 2018, MOD) MHD 19
35 IS 17932 : Part 1 : 2023 Biological evaluation of medical devices Part 1: Evaluation and testing within a risk management process (ISO 10993-1 : 2018, MOD) MHD 19
36 IS 17932 : Part 1 : 2023 Biological evaluation of medical devices Part 1: Evaluation and testing within a risk management process (ISO 10993-1 : 2018, MOD) MHD 19
37 IS 17932 : Part 1 : 2023 Biological evaluation of medical devices Part 1: Evaluation and testing within a risk management process (ISO 10993-1 : 2018, MOD) MHD 19
38 IS 17932 : Part 1 : 2023 Biological evaluation of medical devices Part 1: Evaluation and testing within a risk management process (ISO 10993-1 : 2018, MOD) MHD 19
39 IS 17932 : Part 1 : 2023 Biological evaluation of medical devices Part 1: Evaluation and testing within a risk management process (ISO 10993-1 : 2018, MOD) MHD 19
40 IS 17932 : Part 1 : 2023 Biological evaluation of medical devices Part 1: Evaluation and testing within a risk management process (ISO 10993-1 : 2018, MOD) MHD 19
41 IS 17932 : Part 1 : 2023 Biological evaluation of medical devices Part 1: Evaluation and testing within a risk management process (ISO 10993-1 : 2018, MOD) MHD 19
42 IS 17932 : Part 1 : 2023 Biological evaluation of medical devices Part 1: Evaluation and testing within a risk management process (ISO 10993-1 : 2018, MOD) MHD 19
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