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Basic Details/ मूल ब्यौरा
Comment
IS Number/
आईएस संख्या
:
IS/ISO 15197:2013
ISO 15197 : 2013
IS Title/
आईएस शीर्षक
:
In vitro Diagnostic Test Systems - Requirements for Blood-Glucose Monitoring System for Self-Testing in Managing Diabetes Mellitus (First Revision)
Superseding IS/
सुपरसीडिंग आईएस
:
None
Degree of Equivalence/
समतुल्यता स्तर
:
Identical under single numbering
Number of Revisions/
पुनरीक्षणों की संख्या
:
1
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
:
Ms. NAGAVARSHINI M (SCIENTIST-C)
Summary/सारांश
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Other Details
Indian Standard
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Amendment : 0
Gazette Document : 0
License : 1
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Product Manual & SIT : 1
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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 15197:2013
ISO 15197 : 2013
:
Standard contains no Cross Referenced Indian Standard.
International Standards Referred In IS/ISO 15197:2013
ISO 15197 : 2013
Standard contains no Cross Referenced International Standard.
IS/ISO 15197:2013
ISO 15197 : 2013
is Referred in following Indian Standards :
Standard contains no Cross Referenced Indian Standard.
Classification Details
Group
:
Medical and Hospital Equipments
Sub Group
:
Diagnostic Instruments
Sub Sub Group
:
Monitoring equipment
Aspect
:
Methods of tests
Certification
:
Voluntary Certification
Relevant Ministries
:
Ministry of Health and Family Welfare
Sustainable development Goals :
Short Commom Man's Title
:
In Vitro DiAGNOSTIC Test Systems - Requirements for Bloos-Glucose Monitoring Systems for Self - Test
ITC-HS Code
:
N/A
Degree of Equivalence
:
Identical under single numbering
Identical/Equivalent International Standard(s)
:
ISO 15197 : 2013
Harmonized with
:
Email Ids
ID
Mailing list
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1
Committee members email list
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2
Licensees email list
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3
Additional mailing list
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List of Licenses under IS : IS/ISO 15197 : 2013
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Expired or Cancelled Licenses
List of Expired or Cancelled Licenses under IS : IS/ISO 15197 : 2013
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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 15197 : 2013
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#
Lab Name
Address
City
State
Contact Number
Email Id
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List of Amendement(s) for : IS/ISO 15197 : 2013
#
Amendment Number
Amendment Year
File Name
Action
List of Gazette Document(s) for : IS/ISO 15197 : 2013
#
IS/Amendment Number
SO. No.
Action
List of Corigenda Document(s) for : IS/ISO 15197 : 2013
#
IS/Amendment Number
File Name
Action
List of Product Manuals & SIT
#
File Type
Action
Total Visitors -
7
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