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Basic Details/ मूल ब्यौरा

IS Number/आईएस संख्या : IS 18864 : 2024

IS Title/आईएस शीर्षक : Ophthalmic optics ï¿½ Contact lenses and contact lens care products Fundamental requirements

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 : 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 18864 : 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 17618 (Part 3) : 2021	Ophthalmic optics Contact lenses and contact lens care products Determination of preservative uptake and release	MHD 5
3	IS/ISO 14155 : 2020	Clinical investigation of medical devices for human subjects - Good clinical practice	MHD 19
4	IS 17781 : 2021	Medical devices - Application of risk management to medical devices First Revision	MHD 14
5	IS/ISO 15223-1 : 2016 ISO 15223-1 : 2016	Medical Devices — Symbols to be Used with Medical Device Labels, Labelling and Information to be Supplied Part 1 General Requirements ( Second Revision )	MHD 14
6	IS/ISO 12776 : 2008 ISO 12776 : 2008	Ophthalmic optics Contact lenses Part 1 Vocabulary classification system and recommendations for labeling specifications First Revision	MHD 5
7	IS/ISO 8601-1 : 2019 8601-1 Reviewed In : 2024	Ophthalmic optics - Contact lenses Part 2: Tolerances First Revision	MHD 5
8	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
9	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
10	IS 17535 : 2021	Information Technology â€” Vocabulary--Part 36 Learning, Education And Training	LITD 19
11	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
12	IS 17618 (Part 3) : 2021	Ophthalmic optics Contact lenses and contact lens care products Determination of preservative uptake and release	MHD 5
13	IS/ISO 14155 : 2020	Clinical investigation of medical devices for human subjects - Good clinical practice	MHD 19
14	IS 17781 : 2021	Medical devices - Application of risk management to medical devices First Revision	MHD 14
15	IS/ISO 15223-1 : 2016 ISO 15223-1 : 2016	Medical Devices — Symbols to be Used with Medical Device Labels, Labelling and Information to be Supplied Part 1 General Requirements ( Second Revision )	MHD 14
16	IS/ISO 12776 : 2008 ISO 12776 : 2008	Ophthalmic optics Contact lenses Part 1 Vocabulary classification system and recommendations for labeling specifications First Revision	MHD 5
17	IS/ISO 8601-1 : 2019 8601-1 Reviewed In : 2024	Ophthalmic optics - Contact lenses Part 2: Tolerances First Revision	MHD 5
18	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
19	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
20	IS 17535 : 2021	Information Technology â€” Vocabulary--Part 36 Learning, Education And Training	LITD 19

International Standards Referred In IS 18864 : 2024

Standard contains no Cross Referenced International Standard.

IS 18864 : 2024
is Referred in following Indian Standards :

1	IS 18225 : 2023	Media and Entertainment Services- Categorization of Programmes offered by Skill Development Service Providers	SSD 13
2	IS 18225 : 2023	Media and Entertainment Services- Categorization of Programmes offered by Skill Development Service Providers	SSD 13

Classification Details

Group	:	Medical and Hospital Equipments
Sub Group	:	Diagnostic Instruments
Sub Sub Group	:	General ophthalmic equipment
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 14534:2011
Harmonized with	:	ISO

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

List of Licenses under IS : IS 18864 : 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

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List of Licenses under IS : IS 18864 : 2024

List of Expired or Cancelled Licenses under IS : IS 18864 : 2024

List of laboratories for : IS 18864 : 2024

List of Amendement(s) for : IS 18864 : 2024

List of Gazette Document(s) for : IS 18864 : 2024

List of Corigenda Document(s) for : IS 18864 : 2024

List of Product Manuals & SIT