DIN EN 13503-6:2003-03

Name: DIN EN 13503-6:2003-03
Brand: DIN

Superseded

View Superseded by

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

Superseded date

01-11-2007

Published date

12-01-2013

Publisher

German Institute for Standardisation (Deutsches Institut für Normung)

Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 Requirements
5 Test methods and sampling
Annex A (normative) - Shelf-life and transport stability test
                        table
Annex B (informative) - Test method for the determination of
                        extractable substances
Annex C (informative) - References relating to tests to be
                        performed during shelf-life studies
Bibliography

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

DocumentType	Standard
PublisherName	German Institute for Standardisation (Deutsches Institut für Normung)
Status	Superseded
SupersededBy	DIN EN ISO 11979-6 E : 2015

Standards	Relationship
EN 13503-6 : 2002	Identical
NBN EN 13503-6 : 2003	Identical
NF EN 13503-6 : 2003	Identical
UNI EN 13503-6 : 2003	Identical
NEN EN 13503-6 : 2002	Identical
BS EN 13503-6:2002	Identical
SN EN 13503-6 : 2003	Identical
NS EN 13503-6 : 1ED 2002	Identical
ISO 11979-6:2014	Corresponds
UNE-EN 13503-6:2003	Identical
I.S. EN 13503-6:2002	Identical

ASTM F 1585 : 2000	Standard Guide for Integrity Testing of Porous Barrier Medical Packages (Withdrawn 2006)
ASTM D 4169 : 2016 : REDLINE	Standard Practice for Performance Testing of Shipping Containers and Systems
EN ISO 11979-1:2012	Ophthalmic implants - Intraocular lenses - Part 1: Vocabulary (ISO 11979-1:2012)
EN ISO 11979-4:2008/A1:2012	OPHTHALMIC IMPLANTS - INTRAOCULAR LENSES - PART 4: LABELLING AND INFORMATION (ISO 11979-4:2008/AMD 1:2012)
EN ISO 10993-9:2009	Biological evaluation of medical devices - Part 9: Framework for identification and quantification of potential degradation products (ISO 10993-9:2009)
ASTM F 1929 : 2015 : REDLINE	Standard Test Method for Detecting Seal Leaks in Porous Medical Packaging by Dye Penetration
EN 22248 : 1992	COMPLETE, FILLED TRANSPORT PACKAGES - METHOD FOR DETERMINATION OF RESISTANCE TO VERTICAL IMPACT BY DROPPING (ISO 2248:1985)
EN ISO 11979-2:2014	Ophthalmic implants - Intraocular lenses - Part 2: Optical properties and test methods (ISO 11979-2:2014)
AAMI TIR22 : 2007	GUIDANCE FOR ANSI/AAMI/ISO 11607, PACKAGING FOR TERMINALLY STERILIZED MEDICAL DEVICES - PART 1 AND PART 2:2006
EN ISO 10339 : 1999	OPHTHALMIC OPTICS - CONTACT LENSES - DETERMINATION OF WATER CONTENT OF HYDROGEL LENSES
EN 13503-6 : 2002	OPHTHALMIC IMPLANTS - INTRAOCULAR LENSES - PART 6: SHELF-LIFE AND TRANSPORT STABILITY
ISO 11607:2003	Packaging for terminally sterilized medical devices
EN ISO 3696:1995	Water for analytical laboratory use - Specification and test methods (ISO 3696:1987)
EN 13503-3 : 2000	OPHTHALMIC IMPLANTS - INTRAOCULAR LENSES - PART 3: MECHANICAL PROPERTIES AND TEST METHODS
EN 13503-5 : 2001	OPHTHALMIC IMPLANTS - INTRAOCULAR LENSES - BIOCOMPATIBILITY
EN ISO 8318 : 2002	PACKAGING - COMPLETE, FILLED TRANSPORT PACKAGES AND UNIT LOADS - SINUSOIDAL VIBRATION TESTS USING A VARIABLE FREQUENCY
EN 13503-7 : 2001	OPHTHALMIC IMPLANTS - INTRAOCULAR LENSES - PART 7: CLINICAL INVESTIGATIONS