I.S. 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Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
View Superseded by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 - PART 6: SHELF-LIFE AND TRANSPORT STABILITY
Hardcopy , PDF
27-08-2007
English
01-01-2002
For Harmonized Standards, check the EU site to confirm that the Standard is cited in the Official Journal.
Only cited Standards give presumption of conformance to New Approach Directives/Regulations.
Dates of withdrawal of national standards are available from NSAI.
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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.
| DocumentType |
Standard
|
| Pages |
32
|
| PublisherName |
National Standards Authority of Ireland
|
| Status |
Superseded
|
| SupersededBy |
| Standards | Relationship |
| BS EN 13503-6:2002 | Identical |
| SN EN 13503-6 : 2003 | Identical |
| NS EN 13503-6 : 1ED 2002 | Identical |
| EN 13503-6 : 2002 | Identical |
| UNE-EN 13503-6:2003 | Identical |
| ISO 11979-6:2014 | 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 |
| 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| ASTM F 1585 : 2000 | Standard Guide for Integrity Testing of Porous Barrier Medical Packages (Withdrawn 2006) |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 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 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 ISO 3696:1995 | Water for analytical laboratory use - Specification and test methods (ISO 3696:1987) |
| EN 13503-5 : 2001 | OPHTHALMIC IMPLANTS - INTRAOCULAR LENSES - BIOCOMPATIBILITY |
| EN 13503-7 : 2001 | OPHTHALMIC IMPLANTS - INTRAOCULAR LENSES - PART 7: CLINICAL INVESTIGATIONS |
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