BS EN ISO 16671 : 2015
Current
The latest, up-to-date edition.
OPHTHALMIC IMPLANTS - IRRIGATING SOLUTIONS FOR OPHTHALMIC SURGERY
Hardcopy , PDF
English
01-01-2015
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 - sub-visible particles
Annex D (informative) - Microscopic test method for
particulate contamination - sub-visible particles
Annex E (normative) - Intraocular irrigation test
Annex F (informative) - Clinical investigation
Annex ZA (informative) - Relationship between
this European Standard and the Essential
Requirements of EU Directive 93/42/EEC
Bibliography
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