UNLIMITED FREE
ACCESS TO THE WORLD'S BEST IDEAS

SUBMIT
Already a GlobalSpec user? Log in.

This is embarrasing...

An error occurred while processing the form. Please try again in a few minutes.

Customize Your GlobalSpec Experience

Select Your Free Newsletters

Industry Newsletters

Select Your Free Product Alerts

Finish!
Privacy Policy

This is embarrasing...

An error occurred while processing the form. Please try again in a few minutes.

New! AI Engineering Assistant 
- Trained on our vast library of engineering resources.

DIN EN ISO 11979-4

Ophthalmic implants - Intraocular lenses - Part 4: Labelling and information (ISO 11979-4:2008 + Amd.1:2012) (includes Amendment A1:2012)

active, Most Current
Buy Now
Organization: DIN
Publication Date: 1 January 2013
Status: active
Page Count: 14
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

DIN EN ISO 11979-4
January 1, 2013
Ophthalmic implants - Intraocular lenses - Part 4: Labelling and information (ISO 11979-4:2008 + Amd.1:2012) (includes Amendment A1:2012)
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...
DIN EN ISO 11979-4
March 1, 2009
Ophthalmic implants - Intraocular lenses - Part 4: Labelling and information (ISO 11979-4:2008)
A description is not available for this item.
DIN EN ISO 11979-4
September 1, 2000
Ophthalmic implants - Intraocular lenses - Part 4: Labelling and information (ISO 11979-4:2000); English version of DIN EN ISO 11979-4
A description is not available for this item.

References

This document references:
DIN EN ISO 11979-10 - Ophthalmic implants - Intraocular lenses - Part 10: Clinical investigations of intraocular lenses for correction of ametropia in phakic eyes (ISO 11979-10:2018)
Published by DIN on August 1, 2018
This document specifies requirements for any intraocular lenses to be implanted in the anterior segment of the eye with the primary indication to modify its refractive power. There are three main...
This document references:
DIN EN ISO 11979-7 - Ophthalmic implants - Intraocular lenses - Part 7: Clinical investigations of intraocular lenses for the correction of aphakia (ISO 11979-7:2018)
Published by DIN on August 1, 2018
This document specifies the particular requirements for the clinical investigations of intraocular lenses that are implanted in the eye in order to correct aphakia.
This document references:
DIN EN ISO 11979-6 - Ophthalmic implants - Intraocular lenses - Part 6: Shelf-life and transport stability testing (ISO 11979-6:2014)
Published by DIN on February 1, 2015
This part of ISO 11979 specifies tests by which the shelf-life of sterile intraocular lenses (IOLs) in their final packaging can be determined. These tests include procedures to establish the...
This document references:
DIN EN ISO 11979-3 - Ophthalmic implants - Intraocular lenses - Part 3: Mechanical properties and test methods (ISO 11979-3:2012)
Published by DIN on April 1, 2013
This part of ISO 11979 specifies requirements and test methods for certain mechanical properties of interocular lenses (IOLs). It is applicable to all types of IOLs intended for implantation in the...
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:
DIN EN 1041 - Information supplied by the manufacturer of medical devices (includes Amendment A1:2013)
Published by DIN on December 1, 2013
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:
DIN EN ISO 11607-1 - Packaging for terminally sterilized medical devices - Part 1: Requirements for materials, sterile barrier systems and packaging systems (ISO 11607-1:2019 + Amd 1:2023) (includes Amendment A1:2023)
Published by DIN on February 1, 2024
A description is not available for this item.
This document references:
DIN EN ISO 11607-2 - Packaging for terminally sterilized medical devices - Part 2: Validation requirements for forming, sealing and assembly processes (ISO 11607-2:2019)
Published by DIN on May 1, 2020
A description is not available for this item.
This document references:
DIN EN ISO 11979-10 - Ophthalmic implants - Intraocular lenses - Part 10: Clinical investigations of intraocular lenses for correction of ametropia in phakic eyes (ISO 11979-10:2018)
Published by DIN on August 1, 2018
This document specifies requirements for any intraocular lenses to be implanted in the anterior segment of the eye with the primary indication to modify its refractive power. There are three main...
This document references:
DIN EN ISO 11979-3 - Ophthalmic implants - Intraocular lenses - Part 3: Mechanical properties and test methods (ISO 11979-3:2012)
Published by DIN on April 1, 2013
This part of ISO 11979 specifies requirements and test methods for certain mechanical properties of interocular lenses (IOLs). It is applicable to all types of IOLs intended for implantation in the...
This document references:
DIN EN ISO 11979-6 - Ophthalmic implants - Intraocular lenses - Part 6: Shelf-life and transport stability testing (ISO 11979-6:2014)
Published by DIN on February 1, 2015
This part of ISO 11979 specifies tests by which the shelf-life of sterile intraocular lenses (IOLs) in their final packaging can be determined. These tests include procedures to establish the...
This document references:
DIN EN ISO 11979-7 - Ophthalmic implants - Intraocular lenses - Part 7: Clinical investigations of intraocular lenses for the correction of aphakia (ISO 11979-7:2018)
Published by DIN on August 1, 2018
This document specifies the particular requirements for the clinical investigations of intraocular lenses that are implanted in the eye in order to correct aphakia.
View Less
View All
Advertisement