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Indian Standard Details

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Basic Details
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

Classification Details
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 :

Cross Referencing Details
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 :
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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