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CEN
EN 13503-6 : 2002

EN 13503-6 : 2002

Withdrawn

Withdrawn

A Withdrawn Standard is one, which is removed from sale, and its unique number can no longer be used. The Standard can be withdrawn and not replaced, or it can be withdrawn and replaced by a Standard with a different number.

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

Withdrawn date

01-07-2007

Published date

13-11-2002

Publisher

Comite Europeen de Normalisation

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
Annex D (informative) Selected definitions
Bibliography

Gives tests by which the shelf-life of sterile intraocular lenses (IOLs) in their final packaging can be determined. These tests included procedures to establish the stability of IOLs in distribution and storage.

Committee
TC 170
DocumentType
Standard
PublisherName
Comite Europeen de Normalisation
Status
Withdrawn

I.S. EN 13503-8:2000 OPHTHALMIC IMPLANTS - INTRAOCULAR LENSES - PART 8: FUNDAMENTAL REQUIREMENTS
EN 13503-8 : 2000 OPHTHALMIC IMPLANTS - INTRAOCULAR LENSES - PART 8: FUNDAMENTAL REQUIREMENTS
DIN EN 13503-6:2003-03 OPHTHALMIC IMPLANTS - INTRAOCULAR LENSES - PART 6: SHELF-LIFE AND TRANSPORT STABILITY
BS EN 13503-8:2000 Ophthalmic implants. Intraocular lenses Fundamental requirements

ASTM F 1585 : 2000 Standard Guide for Integrity Testing of Porous Barrier Medical Packages (Withdrawn 2006)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)
ISO 11979-7:2014 Ophthalmic implants Intraocular lenses Part 7: Clinical investigations
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)
ISO 10339:1997 Ophthalmic optics Contact lenses Determination of water content of hydrogel lenses
ASTM F 1929 : 2015 : REDLINE Standard Test Method for Detecting Seal Leaks in Porous Medical Packaging by Dye Penetration
ISO 11979-3:2012 Ophthalmic implants — Intraocular lenses — Part 3: Mechanical properties and test methods
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
ISO 11979-1:2006 Ophthalmic implants Intraocular lenses Part 1: Vocabulary
EN ISO 10339 : 1999 OPHTHALMIC OPTICS - CONTACT LENSES - DETERMINATION OF WATER CONTENT OF HYDROGEL LENSES
ISO 11979-4:2008 Ophthalmic implants — Intraocular lenses — Part 4: Labelling and information
ISO 11607:2003 Packaging for terminally sterilized medical devices
ISO 10993-9:2009 Biological evaluation of medical devices Part 9: Framework for identification and quantification of potential degradation products
ISO 3696:1987 Water for analytical laboratory use — Specification and test methods
EN ISO 3696:1995 Water for analytical laboratory use - Specification and test methods (ISO 3696:1987)
ISO 11979-2:2014 Ophthalmic implants — Intraocular lenses — Part 2: Optical properties and test methods
ISO 11979-5:2006 Ophthalmic implants Intraocular lenses Part 5: Biocompatibility
ISO 2248:1985 Packaging Complete, filled transport packages Vertical impact test by dropping
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
ISO 8318:2000 Packaging Complete, filled transport packages and unit loads Sinusoidal vibration tests using a variable frequency

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