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.

ISO 11979-6

Ophthalmic implants - Intraocular lenses - Part 6: Shelf-life and transport stability testing

active, Most Current
Buy Now
Organization: ISO
Publication Date: 1 October 2014
Status: active
Page Count: 18
ICS Code (Ophthalmic equipment): 11.040.70
scope:

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 stability of IOLs in distribution and storage.

Document History

ISO 11979-6
October 1, 2014
Ophthalmic implants - Intraocular lenses - Part 6: Shelf-life and transport stability testing
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...
ISO 11979-6
July 15, 2007
Ophthalmic implants — Intraocular lenses — Part 6: Shelf-life and transport stability
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...
ISO 11979-6
June 1, 2002
Ophthalmic Implants - Intraocular Lenses - Part 6: Shelf-Life and Transport Stability
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...

References

This document references:
F1929 - Standard Test Method for Detecting Seal Leaks in Porous Medical Packaging by Dye Penetration
November 15, 2023
This test method defines materials and procedures that will detect and locate a leak equal to or greater than a channel formed by a 50 µm (0.002 in.) wire in package edge seals formed between a...
This document references:
ISO 10993-12 - Biological evaluation of medical devices - Part 12: Sample preparation and reference materials
Published by ISO on January 1, 2021
This document specifies requirements and gives guidance on the procedures in the preparation of samples and the selection of reference materials for medical device testing primarily in biological...
This document references:
ISO 10993-5 - Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity
Published by ISO on June 1, 2009
This part of ISO 10993 describes test methods to assess the in vitro cytotoxicity of medical devices. These methods specify the incubation of cultured cells in contact with a device and/or extracts...
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 is referenced by:
EN ISO 11979-8 - Ophthalmic implants - Intraocular lenses - Part 8: Fundamental requirements
Published by CEN on May 1, 2017
This document specifies fundamental requirements for all types of intraocular lenses intended for surgical implantation into the anterior segment of the human eye, excluding corneal implants and...
This document is referenced by:
DIN EN ISO 11979-8 - Ophthalmische Implantate - Intraokularlinsen - Teil 8: Grundlegende Anforderungen (ISO 11979-8:2017); Deutsche Fassung EN ISO 11979-8:2017
Published by DIN on August 1, 2017
A description is not available for this item.
This document is referenced by:
DIN EN ISO 11979-8 - Ophthalmic implants - Intraocular lenses - Part 8: Fundamental requirements (ISO 11979-8:2017)
Published by DIN on August 1, 2017
A description is not available for this item.
This document is referenced by:
ISO 11979-8 - Ophthalmic implants - Intraocular lenses - Part 8: Fundamental requirements
Published by ISO on April 1, 2017
This document specifies fundamental requirements for all types of intraocular lenses intended for surgical implantation into the anterior segment of the human eye, excluding corneal implants and...
This document is referenced by:
ISO 11979-10 - Ophthalmic implants - Intraocular lenses - Part 10: Clinical investigations of intraocular lenses for correction of ametropia in phakic eyes
Published by ISO on March 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...
View Less
View All
Advertisement