I.S. EN ISO 16671:2015&A1:2017
Current
The latest, up-to-date edition.
Ophthalmic implants - Irrigating solutions for ophthalmic surgery
Hardcopy , PDF
English
10-12-2017
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.
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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
This International Standard defines 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.
| Committee |
ISO/TC 172
|
| DocumentType |
Standard
|
| Pages |
50
|
| ProductNote |
The date of any NSAI previous adoption may not match the date of its original CEN/CENELEC document.
|
| PublisherName |
National Standards Authority of Ireland
|
| Status |
Current
|
| Supersedes |
| Standards | Relationship |
| ISO 16671:2015/Amd 1:2017 | Identical |
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