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CEN - EN ISO 11979-6

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

active, Most Current
Organization: CEN
Publication Date: 1 October 2014
Status: active
Page Count: 22
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

EN 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...
EN ISO 11979-6
July 1, 2007
Ophthalmic implants - Intraocular lenses - Part 6: Shelf-life and transport stability
A description is not available for this item.

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...
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