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Indian Standard Details

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Basic Details
IS Number : IS/ISO 10993-18 : 2020
10993: Part 18
IS Title [Eng-Hn] : Biological evaluation of medical devices Part 18 Chemical characterization of medical device materials within a risk management process
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 :
Short Commom Man's Title: Chemical Characterization of Medical Device Materials
Itchs: N/A
Degree of Equivalence: Identical under single numbering
Identical/Equivalent Standards:ISO 10993-18:2020
Organisation :

Cross Referencing Details
Indian Standards Refered In IS IS/ISO 10993 : Part 18 : 2020 :
SNo IS Number Title Technical Committee
1
IS/ISO 10993 : Part 1 : 2009 Biological evaluation of medical devices Part 1 Evaluation and Testing within a risk management process MHD 19
2
IS/ISO 10993 : Part 17 : 2002 Biological Evaluation of Medical Devices Part 17 Establishment of Allowable Limits for Leachable Substances MHD 19
3
IS/ISO 14971 : 2007 Medical devices - Application of risk management to medical devices MHD 14
International Standards Refered In IS/ISO 10993 : Part 18 : 2020
SNo International Standard Number
1 ISO 14971 : 0 : 0 0
IS/ISO 10993 : Part 18 : 2020 is Refered in following Indian Standards :
SNo IS Number Title Technical Committee
1 IS/ISO 10993 : Part 18 : 2020 Biological evaluation of medical devices Part 18 Chemical characterization of medical device materials within a risk management process MHD 19
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