NEN EN ISO 16671 : 2015 AMD 1 2017
Current
The latest, up-to-date edition.
OPHTHALMIC IMPLANTS - IRRIGATING SOLUTIONS FOR OPHTHALMIC SURGERY
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 Packaging
10 Information supplied by the manufacturer
Annex A (informative) - Example of a suitable method for pH
measurement and buffer capacity determination
Annex B (normative) - Particulate contamination: visible
particulates
Annex C (informative) - Light obscuration test method for
particulate contamination: subvisible particles
Annex D (informative) - Microscopic test method for
particulate contamination: subvisible particles
Annex E (normative) - Intraocular irrigation test
Annex F (informative) - Clinical investigation
Bibliography
Specifies requirements with regards to safety for the intended performance, design attributes, preclinical and clinical evaluation, sterilization, product packaging, product labelling, and the information supplied by the manufacturer.
| DocumentType |
Standard
|
| PublisherName |
Netherlands Standards
|
| Status |
Current
|
| Standards | Relationship |
| UNI EN ISO 16671 : 2004 | Identical |
| I.S. EN ISO 16671:2015 | Identical |
| DIN EN ISO 16671:2015-12 | Identical |
| NBN EN ISO 16671 : 2015 | Identical |
| UNE-EN ISO 16671:2016 | Identical |
| ISO 16671:2015 | Identical |
| BS EN ISO 16671 : 2015 | Identical |
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