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All the standards published after 01 Oct 2025 are available in new portal. Please click here to view the portal
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Basic Details/ मूल ब्यौरा
Comment
IS Number/
आईएस संख्या
:
IS/ISO 10993-16:2017
ISO 10993-16 : 2017
IS Title/
आईएस शीर्षक
:
Biological Evaluation of Medical Devices Part 16 Toxicokinetic Study Design for Degradation Products and Leachables
Superseding IS/
सुपरसीडिंग आईएस
:
None
Degree of Equivalence/
समतुल्यता स्तर
:
Identical under single numbering
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/ISO 10993-16:2017
ISO 10993-16 : 2017
:
Details could not be found.
International Standards Referred In IS/ISO 10993-16:2017
ISO 10993-16 : 2017
1
ISO 10993 : 1 : 2009
IS/ISO 10993-16:2017
ISO 10993-16 : 2017
is Referred in following Indian Standards :
1
IS/ISO 7198 : 2016
Cardiovascular Implants and Extracorporeal Systems Vascular Prostheses Tubular Vascular Grafts and Vascular Patches
MHD 06
2
IS/IEC 60794 : Part 4 : Sec 20 : 2018
Optical Fibre Cables Part 4 Sectional specification Section 20 Aerial optical cables along electrical power lines Family specification for ADSS all dielectric self-supported optical cables
LITD 11
3
IS 15354 : Part 1 : 2018
Single - Use medical examination gloves: Part 1 specification for gloves made from rubber latex or rubber solution (First Revision)
MHD 12
4
IS/IEC 61400 : Part 2 : 2013
Wind Turbines Part 2: Small Wind Turbines
ETD 42
5
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
Classification Details
Group
:
Medical and Hospital Equipments
Sub Group
:
Clinical, pathological, anaesthetic and respiratory equipments and systems
Sub Sub Group
:
Biotechnology
Aspect
:
Methods of tests
Certification
:
