BS EN 13503-6:2002
Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
View Superseded by
Ophthalmic implants. Intraocular lenses Shelf-life and transport stability
Hardcopy , PDF
28-09-2007
English
29-11-2002
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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 |
CH/172
|
| DevelopmentNote |
Supersedes 97/565188 DC (12/2002)
|
| DocumentType |
Standard
|
| Pages |
18
|
| PublisherName |
British Standards Institution
|
| Status |
Superseded
|
| SupersededBy | |
| Supersedes |
| 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 |
| 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 |
| DIN EN 13503-6:2003-03 | 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| ASTM F 1585 : 2000 | Standard Guide for Integrity Testing of Porous Barrier Medical Packages (Withdrawn 2006) |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) |
| 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 |
| AAMI ISO 11607 : 2ED 2000 | PACKAGING FOR TERMINALLY STERILIZED MEDICAL DEVICES |
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