I.S. EN 13503-8:2000
Superseded
View Superseded by
OPHTHALMIC IMPLANTS - INTRAOCULAR LENSES - PART 8: FUNDAMENTAL REQUIREMENTS
Hardcopy , PDF
English
01-01-2000
09-01-2006
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.
Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 Safety and performance
5 Materials
6 Clinical evaluation
7 Manufacturing
8 Sterilization
9 Packaging and shelf life
10 Labelling and information
Annex ZA (informative) Clauses of this European Standard
addressing essential requirements or other provisions
of EU Directives
Defines fundamental requirements for all types of intraocular lenses (IOLs) for surgical implementation into the anterior segment of the human eye. Excludes corneal implants and transplants.
| DocumentType |
Standard
|
| Pages |
10
|
| PublisherName |
National Standards Authority of Ireland
|
| Status |
Superseded
|
| SupersededBy |
| Standards | Relationship |
| NS EN 13503-8 : 1ED 2000 | Identical |
| NF EN 13503-8 : 2000 | Identical |
| BS EN 13503-8:2000 | Identical |
| ISO 11979-8:2017 | Identical |
| DIN EN 13503-8:2000-07 | Identical |
| EN 13503-8 : 2000 | Identical |
| NEN EN 13503-8 : 2000 | Identical |
| NBN EN 13503-8 : 2000 | Identical |
| UNE-EN 13503-8:2000 | Identical |
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