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Basic Details/ मूल ब्यौरा
Comment
IS Number/
आईएस संख्या
:
IS/ISO 13408-1 : 2008
ISO 13408-1:2008
IS Title/
आईएस शीर्षक
:
Aseptic processing of health care products Part 1 General requirements
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
:
Code of Practice
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 12 (Hospital Equipment and Surgical Disposable Products Sectional Committee)
Member Secretary/
सदस्य सचिव
:
Ms. UROOSA WARSI (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 13408-1 : 2008
ISO 13408-1:2008
:
1
IS/ISO 9001 : 2015
ISO 9001 : 2015
Reviewed In : 2020
Quality management systems - Requirements (Fourth Revision)
MSD 2
2
IS 10654 : 2018
ISO 7864 : 2016
Sterile hypodermic needles for single use - Requirements and test methods (Fourth Revision)
MHD 12
3
IS/ISO 11135 : 2014
ISO 11135 : 2014
Sterilization of health - Care products - Ethylene oxide - Requirements for the development, validation and routine control of a sterilization process for medical devices
MHD 12
4
IS/ISO 13485 : 2016
Medical Devices — Quality Management Systems — Requirements for Regulatory Purposes ( First Revision )
MHD 14
5
IS 8293 : 1976
Reviewed In : 2022
Specification for phenthoate, technical
FAD 1
6
IS 9000 (Part 20) : 1979
Reviewed In : 2022
Basic environmental testing procedures for electronic and electrical items: Part 20 resistance to cleaning solvents and permanence of markings
LITD 1
7
IS 9000 (Part 21) : 1985
Reviewed In : 2022
Basic environmental testing procedures for electronic & electrical items: Part 21 acoustics noise test
LITD 1
International Standards Referred In IS/ISO 13408-1 : 2008
ISO 13408-1:2008
Standard contains no Cross Referenced International Standard.
IS/ISO 13408-1 : 2008
ISO 13408-1:2008
is Referred in following Indian Standards :
1
IS 729 : 2021
DRAWER LOCKS CUPBOARD LOCKS AND BOX LOCKS - SPECIFICATION
MED 33
2
IS 729 : 2021
DRAWER LOCKS CUPBOARD LOCKS AND BOX LOCKS - SPECIFICATION
MED 33
3
IS 729 : 2021
DRAWER LOCKS CUPBOARD LOCKS AND BOX LOCKS - SPECIFICATION
MED 33
Classification Details
Group
:
Medical and Hospital Equipments
Sub Group
:
Health care facilities
Sub Sub Group
:
Quality Management of hospitals
Aspect
:
Code of Practice
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 13408-1:2008
Harmonized with
:
ISO
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List of Licenses under IS : IS/ISO 13408 : Part 1 : 2008
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Expired or Cancelled Licenses
List of Expired or Cancelled Licenses under IS : IS/ISO 13408 : Part 1 : 2008
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Active Licenses
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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 13408 : Part 1 : 2008
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#
Lab Name
Address
City
State
Contact Number
Email Id
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List of Amendement(s) for : IS/ISO 13408 : Part 1 : 2008
#
Amendment Number
Amendment Year
File Name
Action
List of Gazette Document(s) for : IS/ISO 13408 : Part 1 : 2008
#
IS/Amendment Number
SO. No.
Action
List of Corigenda Document(s) for : IS/ISO 13408 : Part 1 : 2008
#
IS/Amendment Number
File Name
Action
List of Product Manuals & SIT
#
File Type
File Name
Action
Total Visitors -
7
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3
9
2
1
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