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All the standards published after 01 Oct 2025 are available in new portal. Please click here to view the portal
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Basic Details/ मूल ब्यौरा
Comment
IS Number/
आईएस संख्या
:
IS 19173 (Part 1):2025
IS Title/
आईएस शीर्षक
:
Medical Device Software Part 1 Guidance on the Application of ISO 14971 to Medical Device Software
Superseding IS/
सुपरसीडिंग आईएस
:
None
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
:
Code of Practice
Language/
भाषा
:
English
Reaffirmation Year/
पुनर्पुष्टि वर्ष
:
Technical Department/
तकनीकी विभाग
:
MHD (Medical Equipment and Hospital Planning Department)
Technical Committee/
तकनीकी समिति
:
MHD 14 (Hospital Planning Sectional Committee)
Member Secretary/
सदस्य सचिव
:
Mr. KATIPALLY KARTHIK REDDY (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 19173 (Part 1):2025
:
1
IS/ISO 62304:2015
ISO 62304 : 2015
Medical device software - Software life cycle processes
MHD 14
2
IS 17781:2021
Medical devices - Application of risk management to medical devices First Revision
MHD 14
International Standards Referred In IS 19173 (Part 1):2025
Standard contains no Cross Referenced International Standard.
IS 19173 (Part 1):2025
is Referred in following Indian Standards :
Standard contains no Cross Referenced Indian Standard.
Classification Details
Group
:
Medical and Hospital Equipments
Sub Group
:
Health care facilities
Sub Sub Group
:
Quality Management of hospitals
Aspect
:
Code of Practice
Certification
:
None
Relevant Ministries
:
Ministry of Health and Family Welfare - Department of Health and Family Welfare
Sustainable development Goals :
Short Commom Man's Title
:
Guidance on the Application of ISO 14971 to Medical Device Software
ITC-HS Code
:
N/A
Degree of Equivalence
:
Modified/Technically Equivalent
Identical/Equivalent International Standard(s)
:
IEC/TR 80002-1 : 2009
Harmonized with
:
IEC
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 19173 : Part 1 : 2025
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Expired or Cancelled Licenses
List of Expired or Cancelled Licenses under IS : IS 19173 : Part 1 : 2025
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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 19173 : Part 1 : 2025
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#
Lab Name
Address
City
State
Contact Number
Email Id
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List of Amendement(s) for : IS 19173 : Part 1 : 2025
#
Amendment Number
Amendment Year
File Name
Action
List of Gazette Document(s) for : IS 19173 : Part 1 : 2025
#
IS/Amendment Number
SO. No.
Action
List of Corigenda Document(s) for : IS 19173 : Part 1 : 2025
#
IS/Amendment Number
File Name
Action
List of Product Manuals & SIT
#
File Type
Action
Total Visitors -
7
1
3
9
2
1
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