EN 13503-6 : 2002
Withdrawn
A Withdrawn Standard is one, which is removed from sale, and its unique number can no longer be used. The Standard can be withdrawn and not replaced, or it can be withdrawn and replaced by a Standard with a different number.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
01-07-2007
13-11-2002
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Withdrawn
|
| Standards | Relationship |
| SN EN 13503-6 : 2003 | Identical |
| NS EN 13503-6 : 1ED 2002 | Identical |
| UNE-EN 13503-6:2003 | Identical |
| I.S. EN 13503-6:2002 | Identical |
| ISO 11979-6:2014 | Identical |
| NBN EN 13503-6 : 2003 | Identical |
| NF EN 13503-6 : 2003 | Identical |
| NBN EN 13503-8 : 2000 | Identical |
| UNI EN 13503-6 : 2003 | Identical |
| NEN EN 13503-6 : 2002 | Identical |
| PN EN 13503-6 : 2005 | Identical |
| BS EN 13503-6:2002 | Identical |
| DIN EN 13503-6:2003-03 | Identical |
| 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| ASTM F 1585 : 2000 | Standard Guide for Integrity Testing of Porous Barrier Medical Packages (Withdrawn 2006) |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) |
| 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 | Packaging - Complete, filled transport packages - Vertical impact test 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 (ISO 8318:2000) |
| 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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