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CEN - EN ISO 11979-4

Ophthalmic implants - Intraocular lenses - Part 4: Labelling and information

active, Most Current
Organization: CEN
Publication Date: 1 December 2008
Status: active
Page Count: 12
ICS Code (Ophthalmic equipment): 11.040.70
scope:

This part of ISO 11979 specifies the labelling requirements for intraocular lenses (IOLs) and the information to be provided within or on the packaging.

NOTE This part of ISO 11979 attempts to harmonize the recognized labelling requirements for IOLs throughout the world. However, there might be additional national requirements.

Document History

EN ISO 11979-4
December 1, 2008
Ophthalmic implants - Intraocular lenses - Part 4: Labelling and information
This part of ISO 11979 specifies the labelling requirements for intraocular lenses (IOLs) and the information to be provided within or on the packaging. NOTE This part of ISO 11979 attempts to...
EN ISO 11979-4
December 1, 2008
Ophthalmic implants - Intraocular lenses - Part 4: Labelling and information
A description is not available for this item.
EN ISO 11979-4
June 1, 2000
Ophthalmic Implants - Intraocular Lenses - Part 4: Labelling and Information
A description is not available for this item.

References

This document references:
EN 1041 - Information supplied by the manufacturer of medical devices
Published by CEN on August 1, 2008
This European Standard specifies requirements for information to be supplied by a manufacturer for medical devices regulated by Council Directive 90/385/EEC relating to active implantable medical...
This document references:
EN 980 - Symbols for use in the labelling of medical devices
Published by CEN on May 1, 2008
This European Standard specifies symbols for use in the information supplied by the manufacturer with medical devices. The requirements of this European Standard are not intended to apply to symbols...
This document references:
11607-1 AMD 1 - Packaging for terminally sterilized medical devices — Part 1: Requirements for materials, sterile barrier systems and packaging systems AMENDMENT 1: Application of risk management
Published by ISO on September 1, 2023
A description is not available for this item.
This document references:
ISO 11607-2 - Packaging for terminally sterilized medical devices - Part 2: Validation requirements for forming, sealing and assembly processes
Published by ISO on February 1, 2019
This document specifies requirements for the development and validation of processes for packaging medical devices that are terminally sterilized. These processes include forming, sealing and...
This document references:
ISO 11979-1 - Ophthalmic implants - Intraocular lenses - Part 1: Vocabulary
Published by ISO on November 1, 2018
This document defines terms applicable to intraocular lenses, and to the methods used to evaluate them. NOTE Terms are listed in the alphabetical order of the English terms in the English version of...
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...
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