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PREN ISO 11979-6 : DRAFT 2013

Superseded
Superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

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superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

OPHTHALMIC IMPLANTS - INTRAOCULAR LENSES - PART 6: SHELF-LIFE AND TRANSPORT STABILITY (ISO/DIS 11979-6:2013)
Superseded date

10-01-2014

Published date

05-23-2013

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.

Committee
TC 170
DocumentType
Draft
PublisherName
Comite Europeen de Normalisation
Status
Superseded
SupersededBy

Standards Relationship
13/30254047 DC : 0 Identical

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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