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Basic Details/ मूल ब्यौरा

IS Number/आईएस संख्या : IS 18639 : 2024

IS Title/आईएस शीर्षक : Ophthalmic implants Ophthalmic viscosurgical devices

Superseding IS/सुपरसीडिंग आईएस : IS/ISO 15798 : 2013

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 : Product 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 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

Indian Standards Referred In IS IS 18639 : 2024
:

1	IS 17932 : Part 1 : 2023	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 10993-6 : 2016 ISO 10993-6 : 2016	Biological evaluation of medical devices Part 6 Tests for local effects after implantation	MHD 19
3	IS/ISO 10993-7 : 2018 ISO 10993-7 : 2008	Biological evaluation of medical devices Part 7 Ethylene oxide sterilization residuals	MHD 19
4	IS/ISO 10993-9 : 2009 ISO 10993-9 : 2009	Biological evaluation of medical devices Part 9 Framework for identification and quantification of potential degradation products	MHD 19
5	IS/ISO 10993-16 : 2017 ISO 10993-16 : 2017	Biological Evaluation of Medical Devices Part 16 Toxicokinetic Study Design for Degradation Products and Leachables	MHD 19
6	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
7	IS/ISO 11137-1 : 2006 ISO 11137-1 : 2006	Sterilization of health care products - Radiation: Part 1 requirements for development, validation and routine control of a sterilization process for medical devices	MHD 12
8	IS/ISO 11137-2 : 2013 ISO 11137-2 : 2013	Sterilization of health care products - Radiation: Part 2 establishing the sterilization dose	MHD 12
9	IS/ISO 11137-3 : 2017 ISO 11137-3 : 2017	Sterilization of Health Care Products â€• Radiation Part 3 Guidance on Dosimetric Aspects of Development, Validation and Routine Control	MHD 12
10	IS 17630 : 2021	Packaging for terminally sterilized medical devices â€” Part 1: Requirements for materials sterile barrier systems and packaging systems First Revision	MHD 12
11	IS/ISO 14155 : 2020 ISO 14155: 2020	Clinical investigation of medical devices for human subjects - Good clinical practice	MHD 19
12	IS 17781 : 2021	Medical devices - Application of risk management to medical devices First Revision	MHD 14
13	IS/ISO 22442-1 : 2015 ISO 22442-1 : 2015	Medical Devices Utilizing Animal Tissues and their Derivatives Part 1 Application of Risk Management	MHD 19
14	IS/ISO 22442-2 : 2015 ISO 22442-2 : 2015	Medical Devices Utilizing Animal Tissues and their Derivatives Part 2 Controls on Sourcing, Collection and Handling	MHD 19
15	IS/ISO 15643 : 2020 ISO 15643 : 2020	Aseptic processing of health care products Part 1 General requirements	MHD 12
16	IS/ISO 8980-3 : 2013 ISO 8980-3 : 2013	Ophthalmic optics - Uncut finished spectacle lenses: Part 3 transmittance specifications and test methods	MHD 5

International Standards Referred In IS 18639 : 2024

Standard contains no Cross Referenced International Standard.

IS 18639 : 2024
is Referred in following Indian Standards :

1	IS 4707 : Part 4 : 2022	Classification Of Cosmetic Raw Materials And Adjuncts -List of UV Filters Allowed In Cosmetics With Restriction-IS 4707 Part 4	PCD 19

Classification Details

Group	:	Medical and Hospital Equipments
Sub Group	:	Surgical instruments and accessories
Sub Sub Group	:	Ophthalmic Surgery instruments
Aspect	:	Product 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	:	Modified/Technically Equivalent
Identical/Equivalent International Standard(s)	:	ISO 15798:2022
Harmonized with	:	ISO

ID	Mailing list	Download
1	Committee members email list	Download
3	Additional mailing list	Download

List of Licenses under IS : IS 18639 : 2024

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

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Basic Details/ मूल ब्यौरा

Other Details

Indian Standard

Amendment : 0

Gazette Document : 1

License : 0

Product Manual & SIT : 0

Laboratory : 0

Classification Details

Cross Reference Details

Composition

Corrigendum : 0

Cross Reference Details

Classification Details

Email Ids

List of Licenses under IS : IS 18639 : 2024

List of Expired or Cancelled Licenses under IS : IS 18639 : 2024

List of laboratories for : IS 18639 : 2024

List of Amendement(s) for : IS 18639 : 2024

List of Gazette Document(s) for : IS 18639 : 2024

List of Corigenda Document(s) for : IS 18639 : 2024

List of Product Manuals & SIT