Name: UNI EN ISO 11979-6 : 2015
Brand: UNI

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

Published date

01-15-2015

Publisher

Ente Nazionale Italiano di Unificazione (UNI)

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	CT 44
DevelopmentNote	Supersedes UNI EN 13503-6. (04/2008)
DocumentType	Standard
PublisherName	Ente Nazionale Italiano di Unificazione (UNI)
Status	Current
Supersedes	UNI EN ISO 11979-6 : 2008 UNI EN 13503-6 : 2003

Standards	Relationship
BS EN ISO 11979-6:2014	Identical
ISO 11979-6:2014	Identical
DIN EN ISO 11979-6:2015-02	Identical
NF EN ISO 11979-6 : 2014	Identical
NEN EN ISO 11979-6 : 2014	Identical
NBN EN ISO 11979-6 : 2014	Identical
UNE-EN ISO 11979-6:2015	Identical
EN ISO 11979-6:2014	Identical
NS EN ISO 11979-6 : 2014	Identical
I.S. 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