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BS EN ISO 11979-6:2014

BS EN ISO 11979-6:2014

Current

Current

The latest, up-to-date edition.

Ophthalmic implants. Intraocular lenses Shelf-life and transport stability testing

Available format(s)

Hardcopy , PDF

Language(s)

English

Published date

31-10-2014

Publisher

British Standards Institution

Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 Requirements
5 Test methods and sampling
Annex A (informative) - Shelf-life study example
Annex B (informative) - Tests for shelf-life studies
Bibliography

Defines tests by which the shelf-life of sterile intraocular lenses (IOLs) in their final packaging can be determined.

This part of ISO11979 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.

Committee
CH/172/7
DevelopmentNote
Supersedes BS EN 13503-6 and 05/30097406 DC. (09/2007) Supersedes 13/30254047 DC. (10/2014)
DocumentType
Standard
Pages
22
PublisherName
British Standards Institution
Status
Current
Supersedes

ISO 11607-2:2006 Packaging for terminally sterilized medical devices Part 2: Validation requirements for forming, sealing and assembly processes
ASTM F 1929 : 2015 : REDLINE Standard Test Method for Detecting Seal Leaks in Porous Medical Packaging by Dye Penetration
ISO 2233:2000 Packaging Complete, filled transport packages and unit loads Conditioning for testing
ISO/TR 22979:2017 Ophthalmic implants — Intraocular lenses — Guidance on assessment of the need for clinical investigation of intraocular lens design modifications
ISO 10993-12:2012 Biological evaluation of medical devices Part 12: Sample preparation and reference materials
ISO 11979-1:2006 Ophthalmic implants Intraocular lenses Part 1: Vocabulary
ISO 14971:2007 Medical devices Application of risk management to medical devices
ISO 11607-1:2006 Packaging for terminally sterilized medical devices Part 1: Requirements for materials, sterile barrier systems and packaging systems
ISO 2248:1985 Packaging Complete, filled transport packages Vertical impact test by dropping
ISO 8318:2000 Packaging Complete, filled transport packages and unit loads Sinusoidal vibration tests using a variable frequency

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PDF - English
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