I.S. EN ISO 14534:2015
Current
The latest, up-to-date edition.
OPHTHALMIC OPTICS - CONTACT LENSES AND CONTACT LENS CARE PRODUCTS - FUNDAMENTAL REQUIREMENTS (ISO 14534:2011)
Hardcopy , PDF
English
01-01-2015
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.
Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 Safety and performance
5 Risk assessment
6 Design
7 Materials
8 Clinical evaluation
9 Manufacturing
10 Microbiological requirements
11 Packaging
12 Shelf-life and discard date
13 Labelling and information supplied by
the manufacturer
Bibliography
Annex ZA (informative) - Relationship between
this European Standard and the Essential
Requirements of EU Directive 93/42/EEC
on Medical Devices
Defines safety and performance requirements for contact lenses, contact lens care products, and other accessories for contact lenses.
| DocumentType |
Standard
|
| Pages |
26
|
| PublisherName |
National Standards Authority of Ireland
|
| Status |
Current
|
| Supersedes |
| Standards | Relationship |
| NS EN ISO 14534 : 2015 | Identical |
| BS EN ISO 14534:2015 | Identical |
| ISO 14534:2011 | Identical |
| NF EN ISO 14534 : 2015 | Identical |
| NEN EN ISO 14534 : 2015 | Identical |
| NBN EN ISO 14534 : 2015 | Identical |
| EN ISO 14534:2015 | Identical |
| DIN EN ISO 14534:2015-08 | Identical |
| UNE-EN ISO 14534:2015 | Identical |
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