I.S. EN ISO 11979-8:2017
Current
The latest, up-to-date edition.
OPHTHALMIC IMPLANTS - INTRAOCULAR LENSES - PART 8: FUNDAMENTAL REQUIREMENTS (ISO 11979-8:2017)
Hardcopy , PDF
English
01-01-2017
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.
National Foreword
European foreword
Foreword
1 Scope
2 Normative references
3 Terms and definitions
4 Safety and performance
5 Optical and mechanical properties
6 Biocompatibility
7 Clinical evaluation
8 Manufacturing
9 Sterilization
10 Packaging and shelf-life
11 Labeling and information
12 Documentation
Bibliography
Annex ZA (informative) - Relationship between this
European Standard and the Essential Requirements
of Directive 93/42/EEC [OJ L 169] aimed to be covered
Defines fundamental requirements for all types of intraocular lenses intended for surgical implantation into the anterior segment of the human eye, excluding corneal implants and transplants.
| DevelopmentNote |
Supersedes I.S. EN 13503-8. (09/2006)
|
| DocumentType |
Standard
|
| Pages |
22
|
| PublisherName |
National Standards Authority of Ireland
|
| Status |
Current
|
| Supersedes |
| Standards | Relationship |
| ISO 11979-8:2017 | Identical |
| DIN EN ISO 11979-8:2016-04 (Draft) | Identical |
| NBN EN ISO 11979-8 : 2015 | Identical |
| EN ISO 11979-8:2017 | Identical |
| NEN EN ISO 11979-8 : 2017 | Identical |
| NS EN ISO 11979-8 : 2017 | Identical |
| UNE-EN ISO 11979-8:2017 | Identical |
| DIN EN ISO 11979-8:2017-08 | Equivalent |
| BS EN ISO 11979-8:2017 | Equivalent |
Please Login or Create an Account so you can add users to your Multi user PDF Later.
Important note : Users cannot be edited or removed once added to your Multi user PDF.