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DIN EN ISO 11979-6

Ophthalmic implants - Intraocular lenses - Part 6: Shelf-life and transport stability testing (ISO 11979-6:2014)

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Organization: DIN
Publication Date: 1 February 2015
Status: active
Page Count: 19
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

DIN EN ISO 11979-6
February 1, 2015
Ophthalmic implants - Intraocular lenses - Part 6: Shelf-life and transport stability testing (ISO 11979-6:2014)
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...
DIN EN ISO 11979-6
November 1, 2007
Ophthalmic implants - Intraocular lenses - Part 6: Shelf-life and transport stability (ISO 11979-6:2007)
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:
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:
DIN EN 22248 - Packaging; complete, filled transport packages; vertical impact test by dropping (ISO 2248:1985); german version EN 22248:1992
Published by DIN on February 1, 1993
A description is not available for this item.
This document references:
DIN EN ISO 10993-12 - Biological evaluation of medical devices - Part 12: Sample preparation and reference materials (ISO 10993-12:2021)
Published by DIN on August 1, 2021
A description is not available for this item.
This document references:
DIN EN ISO 10993-5 - Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity (ISO 10993-5:2009)
Published by DIN on October 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:
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 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...
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