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OPHTHALMIC IMPLANTS - INTRAOCULAR LENSES - PART 6: SHELF-LIFE AND TRANSPORT STABILITY TESTING (ISO 11979-6:2014)

Available format(s)

Hardcopy , PDF

Language(s)

English

Published date

01-01-2014

Publisher

National Standards Authority of Ireland

Preview

For Harmonized Standards, check the EU site to confirm that the Standard is cited in the Official Journal.

Only cited Standards give presumption of conformance to New Approach Directives/Regulations.

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

DevelopmentNote	Supersedes I.S. EN 13503-6. (09/2007)
DocumentType	Standard
Pages	26
PublisherName	National Standards Authority of Ireland
Status	Current
Supersedes	I.S. EN ISO 11979-6:2007

Standards	Relationship
UNE-EN ISO 11979-6:2015	Identical
EN ISO 11979-6:2014	Identical
BS EN ISO 11979-6:2014	Identical
ISO 11979-6:2014	Identical
DIN EN ISO 11979-6:2015-02	Identical
NS EN ISO 11979-6 : 2014	Identical
UNI EN ISO 11979-6 : 2015	Identical
NF EN ISO 11979-6 : 2014	Identical
NEN EN ISO 11979-6 : 2014	Identical
NBN EN ISO 11979-6 : 2014	Identical
SN EN ISO 11979-6 : 2014	Identical
DIN EN ISO 11979-6 E : 2015	Identical

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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I.S. EN ISO 11979-6:2014

Current

Table of Contents

Abstract

General Product Information

International Equivalents

Standards Referencing This Book

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