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DIN EN ISO 11978

Ophthalmic optics - Contact lenses and contact lens care products - Labelling (ISO 11978:2017)

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Organization: DIN
Publication Date: 1 December 2017
Status: inactive
Page Count: 16
ICS Code (Ophthalmic equipment): 11.040.70
scope:

This document specifies the information to be provided by the manufacturer of contact lenses and contact lens care products to ensure the correct and safe use of these devices and their accessories by both types of user of contact lenses: the eye care professional and the contact lens wearer.

This document does not specify the format in which such information shall be provided.

Document History

DIN EN ISO 11978
April 1, 2021
Ophthalmic optics - Contact lenses and contact lens care products - Labelling (ISO 11978:2017 + Amd 1:2020) (includes Amendment :2020)
A description is not available for this item.
DIN EN ISO 11978/A1
April 1, 2020
Ophthalmic optics - Contact lenses and contact lens care products - Labelling - Amendment 1 (ISO 11978:2017/DAM 1:2020); German and English version EN ISO 11978:2017/prA1:2020
A description is not available for this item.
DIN EN ISO 11978
December 1, 2017
Ophthalmic optics - Contact lenses and contact lens care products - Labelling (ISO 11978:2017)
This document specifies the information to be provided by the manufacturer of contact lenses and contact lens care products to ensure the correct and safe use of these devices and their accessories...
DIN EN ISO 11978
April 1, 2017
Ophthalmic optics - Contact lenses and contact lens care products - Labelling (ISO/FDIS 11978:2017); German and English version FprEN ISO 11978:2017
A description is not available for this item.
DIN EN ISO 11978
February 1, 2015
Ophthalmic optics - Contact lenses and contact lens care products - Labelling (ISO 11978:2014)
This International Standard specifies the information to be provided by the manufacturer of contact lenses and contact lens care products to ensure the correct and safe use of these devices and their...
DIN EN ISO 11978
August 1, 2000
Contact lenses and contact lens care products - Information supplied by the manufacturer (ISO 11978:2000); English version of DIN EN ISO 11978
A description is not available for this item.
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References

This document references:
DIN EN ISO 14534 - Ophthalmic optics - Contact lenses and contact lens care products - Fundamental requirements (ISO 14534:2011)
Published by DIN on August 1, 2015
This International Standard specifies safety and performance requirements for contact lenses, contact lens care products, and other accessories for contact lenses. This International Standard does...
This document references:
DIN EN ISO 14729 - Ophthalmic optics - Contact lens care products - Microbiological requirements and test methods for products and regimens for hygienic management of contact lenses (ISO 14729:2001 + Amd.1:2010)
Published by DIN on January 1, 2011
This International Standard specifies two test methods for evaluating the antimicrobial activity of products to be marketed for contact lens disinfection by chemical means and for products that are...
This document references:
DIN EN ISO 15223-1 - Medical devices - Symbols to be used with medical device labels, labelling and information to be supplied - Part 1: General requirements (ISO 15223-1:2016, Corrected version 2017-03)
Published by DIN on April 1, 2017
This document identifies requirements for symbols used in medical device labelling that convey information on the safe and effective use of medical devices. It also lists symbols that satisfy the...
This document references:
DIN EN ISO 18369-1 - Ophthalmic optics - Contact lenses - Part 1: Vocabulary, classification system and recommendations for labelling specifications (ISO 18369-1:2017, Corrected version 2017-10-01)
Published by DIN on April 1, 2018
This document identifies and defines the terms applicable to the physical, chemical and optical properties of contact lenses, their manufacture and uses. It provides a vocabulary of terms and, when...
This document references:
ISO 14534 - Ophthalmic optics — Contact lenses and contact lens care products — Fundamental requirements
Published by ISO on April 1, 2011
This International Standard specifies safety and performance requirements for contact lenses, contact lens care products, and other accessories for contact lenses. This International Standard does...
This document references:
ISO 14729 - Ophthalmic Optics - Contact Lens Care Products - Microbiological Requirements and Test Methods for Products and Regimens for Hygienic Management of Contact Lenses
Published by ISO on April 15, 2001
This International Standard specifies two test methods for evaluating the antimicrobial activity of products to be marketed for contact lens disinfection by chemical means and for products that are...
This document references:
15223-1 - Medical devices - Symbols to be used with information to be supplied by the manufacturer - Part 1: General requirements
Published by ISO on July 1, 2021
This document specifies symbols used to express information supplied for a medical device. This document is applicable to symbols used in a broad spectrum of medical devices, that are available...
This document references:
ISO 18369-1 - Ophthalmic optics - Contact lenses - Part 1: Vocabulary, classification system and recommendations for labelling specifications
Published by ISO on August 1, 2017
This document identifies and defines the terms applicable to the physical, chemical and optical properties of contact lenses, their manufacture and uses. It provides a vocabulary of terms and, when...
View Less
View All
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