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Indian Standard Details

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Basic Details
IS Number : IS 17932 (Part 2) : 2024
IS Title [Eng-Hn] : Biological Evaluation of Medical Devices Part 2 Framework for identification and quantification of potential degradation products
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 Consumer Affairs, Food and Public Distribution - Department of Consumer Affairs
Short Commom Man's Title:
Itchs: N/A
Degree of Equivalence: Modified/Technically Equivalent
Identical/Equivalent Standards:ISO 10993-9: 2019
Organisation :

Cross Referencing Details
Indian Standards Refered In IS IS 17932 : Part 2 : 2024 :
SNo IS Number Title Technical Committee
1
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
2
IS/ISO 10993 : Part 2 : 2006 Biological Evaluation of Medical Devices Part 2 Animal Welfare Requirements (First Revision) MHD 19
3
IS/ISO 10993 : Part 13 : 2010 Biological evaluation of medical devices Part 13 Identification and quantification of degradation products from polymeric medical devices MHD 19
4
IS/ISO 10993 : Part 14 : 2001 Biological evaluation of medical devices Part 14 Identification and quantification of degradation products from ceramics MHD 19
5
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
International Standards Refered In IS 17932 : Part 2 : 2024 Standard contains no Cross Referenced International Standard.
IS 17932 : Part 2 : 2024 is Refered in following Indian Standards : Standard contains no Cross Referenced Indian Standard.