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Basic Details/ मूल ब्यौरा
Comment
IS Number/
आईएस संख्या
:
IS/ISO 8637-2 : 2018
ISO 8637-2 : 2018
IS Title/
आईएस शीर्षक
:
Extracorporeal Systems for Blood Purification Part 2 Extracorporeal Blood Circuit for Haemodialysers, Haemodiafilters and Haemofilters
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
:
Product Specification
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 06 (Medical and Surgical Cardiology Equipment Sectional Committee)
Member Secretary/
सदस्य सचिव
:
Mr. PAWAN KUMAR (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 8637-2 : 2018
ISO 8637-2 : 2018
:
1
IS 10654 : 2018
ISO 7864 : 2016
Sterile hypodermic needles for single use - Requirements and test methods (Fourth Revision)
MHD 12
2
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
3
IS/ISO 10993-7 : 2018
ISO 10993-7 : 2008
Biological evaluation of medical devices Part 7 Ethylene oxide sterilization residuals
MHD 19
4
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
5
IS/ISO 10993-11 : 2017
ISO 10993-11 : 2017
Biological evaluation of medical devices Part 11 Tests for systemic toxicity
MHD 19
6
IS/ISO 80369-7 : 2016
ISO 80369-7 : 2016
Small-Bore Connectors for Liquids and Gases in Healthcare Applications Part 7 Connectors for Intravascular or Hypodermic Applications
MHD 12
International Standards Referred In IS/ISO 8637-2 : 2018
ISO 8637-2 : 2018
Standard contains no Cross Referenced International Standard.
IS/ISO 8637-2 : 2018
ISO 8637-2 : 2018
is Referred in following Indian Standards :
Standard contains no Cross Referenced Indian Standard.
Classification Details
Group
:
Medical and Hospital Equipments
Sub Group
:
Implants
Sub Sub Group
:
Cardiovascular surgery instrument and implants
Aspect
:
Product Specification
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
:
Identical under single numbering
Identical/Equivalent International Standard(s)
:
ISO 8637-2:2018
Harmonized with
:
Email Ids
ID
Mailing list
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1
Committee members email list
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3
Additional mailing list
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List of Licenses under IS : IS/ISO 8637 : Part 2 : 2018
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Expired or Cancelled Licenses
List of Expired or Cancelled Licenses under IS : IS/ISO 8637 : Part 2 : 2018
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Active Licenses
ID
Licence No.
Firm Name & Address
District
State
Validity Date
Status
Variety
Brand Name
Scale
ID
Licence No.
Firm Name & Address
District
State
Validity Date
Status
Variety
Brand Name
Scale
List of laboratories for : IS/ISO 8637 : Part 2 : 2018
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#
Lab Name
Address
City
State
Contact Number
Email Id
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List of Amendement(s) for : IS/ISO 8637 : Part 2 : 2018
#
Amendment Number
Amendment Year
File Name
Action
List of Gazette Document(s) for : IS/ISO 8637 : Part 2 : 2018
#
IS/Amendment Number
SO. No.
Action
List of Corigenda Document(s) for : IS/ISO 8637 : Part 2 : 2018
#
IS/Amendment Number
File Name
Action
List of Product Manuals & SIT
#
File Type
File Name
Action
Total Visitors -
7
1
3
9
2
1
QCO File Details
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