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Basic Details/ मूल ब्यौरा
Comment
IS Number/
आईएस संख्या
:
IS/ISO 10993-18 : 2020
10993: Part 18
IS Title/
आईएस शीर्षक
:
Biological evaluation of medical devices Part 18 Chemical characterization of medical device materials within a risk management process
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
:
No reaffirmation
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
:
Ms. NAGAVARSHINI M (SCIENTIST-C)
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 10993-18 : 2020
10993: Part 18
:
1
IS/ISO 10993-1 : 2009
ISO 10993-1 : 2009
Biological evaluation of medical devices Part 1 Evaluation and Testing within a risk management process
MHD 19
2
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
3
IS/ISO 14971 : 2019
ISO 14971:2019
Medical devices - Application of risk management to medical devices
MHD 14
International Standards Referred In IS/ISO 10993-18 : 2020
10993: Part 18
Standard contains no Cross Referenced International Standard.
IS/ISO 10993-18 : 2020
10993: Part 18
is Referred in following Indian Standards :
Standard contains no Cross Referenced Indian Standard.
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
:
Voluntary Certification
Relevant Ministries
:
Sustainable development Goals :
Short Commom Man's Title
:
Chemical Characterization of Medical Device Materials
ITC-HS Code
:
N/A
Degree of Equivalence
:
Identical under single numbering
Identical/Equivalent International Standard(s)
:
ISO 10993-18:2020
Harmonized with
:
ISO
Email Ids
ID
Mailing list
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1
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3
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List of Licenses under IS : IS/ISO 10993 : Part 18 : 2020
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Expired or Cancelled Licenses
List of Expired or Cancelled Licenses under IS : IS/ISO 10993 : Part 18 : 2020
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Licence No.
Firm Name & Address
District
State
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Status
Variety
Brand Name
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List of laboratories for : IS/ISO 10993 : Part 18 : 2020
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#
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Address
City
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List of Amendement(s) for : IS/ISO 10993 : Part 18 : 2020
#
Amendment Number
Amendment Year
File Name
Action
List of Gazette Document(s) for : IS/ISO 10993 : Part 18 : 2020
#
IS/Amendment Number
SO. No.
Action
List of Corigenda Document(s) for : IS/ISO 10993 : Part 18 : 2020
#
IS/Amendment Number
File Name
Action
List of Product Manuals & SIT
#
File Type
File Name
Action
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