NEN EN ISO 15798 : 2013 AMD 1 2017
Current
The latest, up-to-date edition.
OPHTHALMIC IMPLANTS - OPHTHALMIC VISCOSURGICAL DEVICES
12-01-2013
Foreword
1 Scope
2 Normative references
3 Terms and definitions
4 Intended performance
5 Design attributes
6 Design evaluation
7 Sterilization
8 Product stability
9 Integrity and performance of the delivery system
10 Packaging
11 Information to be supplied by the manufacturer
Annex A (normative) - Intra-ocular implantation test
Annex B (normative) - Test for intra-ocular pressure
Annex C (informative) - Microscopic assay for particulate
matter
Annex D (informative) - Patient numbers for clinical trials
Bibliography
Defines requirements with regard to safety for the intended performance, design attributes, preclinical and clinical evaluation, sterilization, product packaging, product labelling and information supplied by the manufacturer of these devices.
| DocumentType |
Standard
|
| PublisherName |
Netherlands Standards
|
| Status |
Current
|
| Supersedes |
| Standards | Relationship |
| SN EN ISO 15798:2013 | Identical |
| ISO 15798:2013 | Identical |
| I.S. EN ISO 15798:2013 | Identical |
| UNE-EN ISO 15798:2014 | Identical |
| NBN EN ISO 15798 : 2013 | Identical |
| UNI EN ISO 15798 : 2013 | Identical |
| DIN EN ISO 15798:2014-02 | Identical |
| NF EN ISO 15798 : 2013 AMD 1 2017 | Identical |
| ONORM EN ISO 15798 : 2013 AMD 1 2018 | Identical |
| NS EN ISO 15798 : 2013 AMD 1 2017 | Identical |
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