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Basic Details/ मूल ब्यौरा
Comment
IS Number/
आईएस संख्या
:
IS 18730 : 2024
ISO 14160:2020
IS Title/
आईएस शीर्षक
:
Sterilization of health care products � Liquid chemical sterilizing agents for single-use medical devices utilizing animal tissues and their derivatives � Requirements for characterization, development, validation and routine control of a sterilization process for medical devices
Superseding IS/
सुपरसीडिंग आईएस
:
None
Degree of Equivalence/
समतुल्यता स्तर
:
Identical under dual numbering
Number of Revisions/
पुनरीक्षणों की संख्या
:
New Standard
Number of Amendments/
संशोधनों की संख्या
:
No amendment issued
Aspect/
पक्ष
:
Process 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 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 18730 : 2024
ISO 14160:2020
:
1
IS 18852 (Part 1) : 2024
ISO 7755-1:2013
Biological evaluation of medical devices Part 1: Evaluation and testing within a risk management process (ISO 10993-1 : 2018, MOD)
MHD 19
2
IS/ISO 10993-17 : 2002
ISO 10993-17 : 2002
Biological Evaluation of Medical Devices Part 17 Establishment of Allowable Limits for Leachable Substances
MHD 19
3
IS 7016 (Part 23) : 2023
ISO 32100:2018
Sterilization of health care products Microbiological methods Part 1: Determination of a population of microorganisms on products
MHD 12
4
IS 4591 (Part 2) : 2022
Aseptic processing of health care products Part 2 Sterilizing filtration
MHD 12
International Standards Referred In IS 18730 : 2024
ISO 14160:2020
Standard contains no Cross Referenced International Standard.
IS 18730 : 2024
ISO 14160:2020
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
:
Sterilizers & incubators
Aspect
:
Process 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 dual numbering
Identical/Equivalent International Standard(s)
:
ISO 14160:2020
Harmonized with
:
ISO
Email Ids
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Mailing list
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1
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3
Additional mailing list
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List of Licenses under IS : IS 18730 : 2024
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Expired or Cancelled Licenses
List of Expired or Cancelled Licenses under IS : IS 18730 : 2024
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Active Licenses
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ID
Licence No.
Firm Name & Address
District
State
Validity Date
Status
Variety
Brand Name
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List of laboratories for : IS 18730 : 2024
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#
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Address
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State
Contact Number
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List of Amendement(s) for : IS 18730 : 2024
#
Amendment Number
Amendment Year
File Name
Action
List of Gazette Document(s) for : IS 18730 : 2024
#
IS/Amendment Number
SO. No.
Action
List of Corigenda Document(s) for : IS 18730 : 2024
#
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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