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ISO 11978

Ophthalmic optics - Contact lenses and contact lens care products - Labelling

active, Most Current
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Organization: ISO
Publication Date: 1 August 2017
Status: active
Page Count: 14
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

ISO 11978
October 1, 2020
Ophthalmic optics — Contact lenses and contact lens care products — Labelling AMENDMENT 1
A description is not available for this item.
ISO 11978
August 1, 2017
Ophthalmic optics - Contact lenses and contact lens care products - Labelling
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...
ISO 11978
October 1, 2014
Ophthalmic optics - Contact lenses and contact lens care products - Labelling
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...
ISO 11978
March 15, 2000
Ophthalmic Optics - Contact Lenses and Contact Lens Care Products - Information Supplied by the Manufacturer
A description is not available for this item.

References

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 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...
This document is referenced by:
Z80.18 - For Ophthalmics – Contact Lens Care Products – Vocabulary, Performance Specifications, and Test Methodology
Published by ANSI on December 6, 2016
This American National Standard applies to contact lens care products (CLCP) which are marketed for use with hard (PMMA), rigid gas permeable (RGP), enhanced oxygen permeable materials, and soft...
This document is referenced by:
BS EN ISO 14534 - TC - Tracked Changes (Redline) - Ophthalmic optics — Contact lenses and contact lens care products — Fundamental requirements
Published by BSI on February 26, 2020
A description is not available for this item.
This document is referenced by:
BS EN ISO 14534 - Ophthalmic optics - Contact lenses and contact lens care products - Fundamental requirements
Published by BSI on February 28, 2015
A description is not available for this item.
This document is referenced by:
AS/NZS ISO 14534 - Ophthalmic optics – Contact lenses and contact lens care products – Fundamental requirements
Published by SNZ on April 21, 2023
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...
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