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Basic Details/ मूल ब्यौरा
Comment
IS Number/
आईएस संख्या
:
IS 18658 (Part 5) : 2024
IS Title/
आईएस शीर्षक
:
Ophthalmic implants Intraocular lenses Part 5:Biocompatibility
Superseding IS/
सुपरसीडिंग आईएस
:
IS/ISO 11979 : Part 5 : 2006
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
:
Methods of tests
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 05 (Ophthalmic Instruments and Appliances Sectional Committee)
Member Secretary/
सदस्य सचिव
:
Ms. HARSHADA GANESH KADAM (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 18658 (Part 5) : 2024
:
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 10993-3 : 2014
ISO 10993-3 : 2014
Biological evaluation of medical devices Part 3 Tests for Genotoxicity, Carcinogenicity and Reproductive toxicity (First Revision)
MHD 19
3
IS/ISO 10993-5 : 2009
ISO 10993-5 : 2009
Biological evaluation of medical devices Part 5 Tests for in vitro cytotoxicity
MHD 19
4
IS/ISO 10993-6 : 2016
ISO 10993-6 : 2016
Biological evaluation of medical devices Part 6 Tests for local effects after implantation
MHD 19
5
IS/ISO 10993-10 : 2010
ISO 10993-10 : 2010
Biological evaluation of medical devices Part 10 Tests for irritation and skin sensitization
MHD 19
6
IS 5282 (Part 3) : 2023
Biological Evaluation of Medical Devices Part 12 Sample Preparation and Reference Materials
MHD 19
7
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
8
IS/IEC 80369-6 : 2016
ISO 80369-6:2016
Ophthalmic implants Intraocular lenses Part 1:Vocabulary First Revision
MHD 5
9
IS/ISO 11979-2 : 1999
ISO 11979 : Part 2: 1999
Reviewed In : 2017
Ophthalmic implants - Intraocular lenses: Part 2 optical properties and test methods
MHD 5
10
IS/ISO 11979-3 : 2012
ISO 11979-3:2012
Ophthalmic implants - Intraocular lenses: Part 3 mechanical properties and test methods
MHD 5
11
IS 17781 : 2021
Medical devices - Application of risk management to medical devices First Revision
MHD 14
12
IS 17731 : 2021
Ophthalmic optics Contact lenses Part 4: Physicochemical properties of contact lens materials First Revision
MHD 5
13
IS/ISO 10668 : 2010
ISO 10668: 2010
Biological Evaluation of Medical Devices Part 2 Animal Welfare Requirements (First Revision)
MHD 19
International Standards Referred In IS 18658 (Part 5) : 2024
Standard contains no Cross Referenced International Standard.
IS 18658 (Part 5) : 2024
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
:
Ophthalmic implants
Aspect
:
Methods of tests
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
:
Modified/Technically Equivalent
Identical/Equivalent International Standard(s)
:
ISO 11979-5:2020
Harmonized with
:
ISO
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List of Licenses under IS : IS 18658 : Part 5 : 2024
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Expired or Cancelled Licenses
List of Expired or Cancelled Licenses under IS : IS 18658 : Part 5 : 2024
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Status
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ID
Licence No.
Firm Name & Address
District
State
Validity Date
Status
Variety
Brand Name
Scale
List of laboratories for : IS 18658 : Part 5 : 2024
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#
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Address
City
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List of Amendement(s) for : IS 18658 : Part 5 : 2024
#
Amendment Number
Amendment Year
File Name
Action
List of Gazette Document(s) for : IS 18658 : Part 5 : 2024
#
IS/Amendment Number
SO. No.
Action
List of Corigenda Document(s) for : IS 18658 : Part 5 : 2024
#
IS/Amendment Number
File Name
Action
List of Product Manuals & SIT
#
File Type
File Name
Action
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