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NEN EN ISO 11979-6 : 2014

Current

Current

The latest, up-to-date edition.

OPHTHALMIC IMPLANTS - INTRAOCULAR LENSES - PART 6: SHELF-LIFE AND TRANSPORT STABILITY TESTING

Published date

01-12-2013

Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 Requirements
  4.1 General
  4.2 Materials and methods
  4.3 Product stability
  4.4 Package integrity
  4.5 Transport stability
  4.6 Results
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.

DevelopmentNote
Supersedes NEN EN 13503-6. (08/2007)
DocumentType
Standard
PublisherName
Netherlands Standards
Status
Current

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