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
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