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Basic Details/ मूल ब्यौरा
Comment
IS Number/
आईएस संख्या
:
IS 17932 (Part 1) : 2023
IS Title/
आईएस शीर्षक
:
Biological evaluation of medical devices Part 1: Evaluation and testing within a risk management process (ISO 10993-1 : 2018, MOD)
Superseding IS/
सुपरसीडिंग आईएस
:
IS/ISO 10993 : Part 1 : 2009
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
:
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 17932 (Part 1) : 2023
:
1
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
2
IS/ISO 10993-4 : 2017
ISO 10993-4 : 2017
Biological evaluation of medical devices Part 4 Selection of tests for interactions with blood
MHD 19
3
IS/ISO 10993-5 : 2009
ISO 10993-5 : 2009
Biological evaluation of medical devices Part 5 Tests for in vitro cytotoxicity
MHD 19
4
IS/ISO 10993-6 : 2016
ISO 10993-6 : 2016
Biological evaluation of medical devices Part 6 Tests for local effects after implantation
MHD 19
5
IS/ISO 10993-7 : 2018
ISO 10993-7 : 2008
Biological evaluation of medical devices Part 7 Ethylene oxide sterilization residuals
MHD 19
6
IS/ISO 10993-9 : 2009
ISO 10993-9 : 2009
Biological evaluation of medical devices Part 9 Framework for identification and quantification of potential degradation products
MHD 19
7
IS/ISO 10993-10 : 2010
ISO 10993-10 : 2010
Biological evaluation of medical devices Part 10 Tests for irritation and skin sensitization
MHD 19
8
IS/ISO 10993-11 : 2017
ISO 10993-11 : 2017
Biological evaluation of medical devices Part 11 Tests for systemic toxicity
MHD 19
9
IS/ISO 10993-15 : 2000
ISO 10993-15 : 2000
Biological evaluation of medical devices: Part 15 identification and quantification of degradation products from metals and alloys
MHD 19
10
IS/ISO 10993-16 : 2017
ISO 10993-16 : 2017
Biological Evaluation of Medical Devices Part 16 Toxicokinetic Study Design for Degradation Products and Leachables
MHD 19
11
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
International Standards Referred In IS 17932 (Part 1) : 2023
Standard contains no Cross Referenced International Standard.
IS 17932 (Part 1) : 2023
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
:
Ministry of Health and Family Welfare
Sustainable development Goals :
Short Commom Man's Title
:
ITC-HS Code
:
N/A
Degree of Equivalence
:
Modified/Technically Equivalent
Identical/Equivalent International Standard(s)
:
ISO 10993-1:2018
Harmonized with
:
ISO
Email Ids
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1
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3
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List of Licenses under IS : IS 17932 : Part 1 : 2023
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Expired or Cancelled Licenses
List of Expired or Cancelled Licenses under IS : IS 17932 : Part 1 : 2023
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Active Licenses
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Firm Name & Address
District
State
Validity Date
Status
Variety
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Scale
ID
Licence No.
Firm Name & Address
District
State
Validity Date
Status
Variety
Brand Name
Scale
List of laboratories for : IS 17932 : Part 1 : 2023
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#
Lab Name
Address
City
State
Contact Number
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List of Amendement(s) for : IS 17932 : Part 1 : 2023
#
Amendment Number
Amendment Year
File Name
Action
List of Gazette Document(s) for : IS 17932 : Part 1 : 2023
#
IS/Amendment Number
SO. No.
Action
List of Corigenda Document(s) for : IS 17932 : Part 1 : 2023
#
IS/Amendment Number
File Name
Action
List of Product Manuals & SIT
#
File Type
File Name
Action
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