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Basic Details/ मूल ब्यौरा
Comment
IS Number/
आईएस संख्या
:
IS 17932 (Part 5):2024
IS Title/
आईएस शीर्षक
:
Biological Evaluation of Medical Devices Part 5 Ethylene oxide sterilization residuals
Superseding IS/
सुपरसीडिंग आईएस
:
IS/ISO 10993 : Part 7 : 2018
Degree of Equivalence/
समतुल्यता स्तर
:
Modified/Technically Equivalent
Number of Revisions/
पुनरीक्षणों की संख्या
:
New Standard
Number of Amendments/
संशोधनों की संख्या
:
No amendment issued
Aspect/
पक्ष
:
Methods of tests
Language/
भाषा
:
English
Reaffirmation Year/
पुनर्पुष्टि वर्ष
:
Technical Department/
तकनीकी विभाग
:
MHD (Medical Equipment and Hospital Planning Department)
Technical Committee/
तकनीकी समिति
:
MHD 19 (In-vitro Diagnostic Medical Devices and Biological Evaluation of Medical Devices Sectional Committee)
Member Secretary/
सदस्य सचिव
:
Mr. KATIPALLY KARTHIK REDDY (SCIENTIST-B)
Other Details
Indian Standard
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Amendment : 0
Gazette Document : 1
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License : 0
Product Manual & SIT : 0
Laboratory : 0
Classification Details
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Cross Reference Details
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Composition
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Corrigendum : 0
Cross Reference Details
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Indian Standards Referred In IS IS 17932 (Part 5):2024
:
1
IS 18852 (Part 1):2024
ISO 7755-1:2013
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 10993-3:2014
ISO 10993-3 : 2014
Biological evaluation of medical devices Part 3 Tests for Genotoxicity, Carcinogenicity and Reproductive toxicity (First Revision)
MHD 19
3
IS 5282 (Part 3):2023
Biological Evaluation of Medical Devices Part 12 Sample Preparation and Reference Materials
MHD 19
4
IS/ISO 10993-17:2002
ISO 10993-17 : 2002
Biological Evaluation of Medical Devices Part 17 Establishment of Allowable Limits for Leachable Substances
MHD 19
5
IS 728:1956
Methods for determining of weight, thickness and uniformity of coating on galvanised articles other than wires and sheets
MTD 24
International Standards Referred In IS 17932 (Part 5):2024
Standard contains no Cross Referenced International Standard.
IS 17932 (Part 5):2024
is Referred in following Indian Standards :
1
IS 17996 : 2022
Technical Documentation for the Assessment of Electrical and Electronic Products with respect to the Restriction of Hazardous Substances
ETD 43
Classification Details
Group
:
Medical and Hospital Equipments
Sub Group
:
Clinical, pathological, anaesthetic and respiratory equipments and systems
Sub Sub Group
:
Biological tests
Aspect
:
Methods of tests
Certification
:
