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Basic Details/ मूल ब्यौरा
Comment
IS Number/
आईएस संख्या
:
IS/ISO 10993-11 : 2017
ISO 10993-11 : 2017
IS Title/
आईएस शीर्षक
:
Biological evaluation of medical devices Part 11 Tests for systemic toxicity
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 10993-11 : 2017
ISO 10993-11 : 2017
:
1
IS 11162 (Part 1) : 1985
Reviewed In : 2019
Dimensions of non - Insulated terminal tags for electronic equipment: Part 1 type 1
LITD 3
International Standards Referred In IS/ISO 10993-11 : 2017
ISO 10993-11 : 2017
1
ISO 10993 : 1 : 2009
IS/ISO 10993-11 : 2017
ISO 10993-11 : 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 6
2
IS/ISO 15675 : 2016
Cardiovascular Implants and Artificial Organs Cardiopulmonary Bypass Systems Arterial Blood Line Filters
MHD 6
3
IS/ISO 18241 : 2016
Cardiovascular Implants and Extracorporeal Systems Cardiopulmonary Bypass Systems Venous Bubble Traps
MHD 6
4
IS/ISO 18242 : 2016
Cardiovascular Implants and Extracorporeal Systems Centrifugal Blood Pumps
MHD 6
5
IS/ISO 8637 : Part 1 : 2017
Extracorporeal Systems for Blood Purification Part 1 Haemodialysers, Haemodiafilters, Haemofilters and Haemoconcentrators
MHD 6
6
IS/ISO 8637 : Part 2 : 2018
Extracorporeal Systems for Blood Purification Part 2 Extracorporeal Blood Circuit for Haemodialysers, Haemodiafilters and Haemofilters
MHD 6
7
IS/ISO 8637 : Part 3 : 2018
Extracorporeal Systems for Blood Purification Part 3 Plasmafilters
MHD 6
8
IS/ISO 10993 : Part 11 : 2017
Biological evaluation of medical devices Part 11 Tests for systemic toxicity
MHD 19
9
IS/ISO 3826 : Part 1 : 2013
Plastics collapsible containers for human blood and blood components: Part 1 conventional containers
MHD 12
10
IS 13009 : 2000
Contraceptive devices - Tubal ring - Specification (First Revision)
MHD 3
11
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
12
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
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
:
None
Relevant Ministries
:
Ministry of Health and Family Welfare
Sustainable development Goals :
Short Commom Man's Title
:
ITC-HS Code
:
N/A
Degree of Equivalence
:
Identical under single numbering
Identical/Equivalent International Standard(s)
:
ISO 10993-11 : 2017
Harmonized with
:
Others
Email Ids
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3
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List of Licenses under IS : IS/ISO 10993 : Part 11 : 2017
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Expired or Cancelled Licenses
List of Expired or Cancelled Licenses under IS : IS/ISO 10993 : Part 11 : 2017
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Active Licenses
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Firm Name & Address
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State
Validity Date
Status
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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/ISO 10993 : Part 11 : 2017
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#
Lab Name
Address
City
State
Contact Number
Email Id
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List of Amendement(s) for : IS/ISO 10993 : Part 11 : 2017
#
Amendment Number
Amendment Year
File Name
Action
List of Gazette Document(s) for : IS/ISO 10993 : Part 11 : 2017
#
IS/Amendment Number
SO. No.
Action
List of Corigenda Document(s) for : IS/ISO 10993 : Part 11 : 2017
#
IS/Amendment Number
File Name
Action
List of Product Manuals & SIT
#
File Type
File Name
Action
Total Visitors -
7
1
3
9
2
1
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