DIN EN ISO 11979-7:2014-12
Superseded
View Superseded by
OPHTHALMIC IMPLANTS - INTRAOCULAR LENSES - PART 7: CLINICAL INVESTIGATIONS (ISO 11979-7:2014)
Hardcopy , PDF
English, German
12-01-2014
07-28-2020
National foreword
National Annex NA (informative) - Bibliography
Foreword
1 Scope
2 Normative references
3 Terms and definitions
4 Justification for a clinical investigation
5 Ethical considerations
6 General requirements
Annex A (informative) - Elements of a clinical
investigation
Annex B (informative) - Evaluation of post-operative
adverse event and visual acuity rates
Annex C (informative) - Additional elements for
toric IOLs
Annex D (informative) - Additional elements for
accommodating IOLs
Annex E (informative) - Clinical tests
Bibliography
Defines particular requirements for clinical investigations for posterior and anterior chamber intraocular lenses (IOLs).
| DevelopmentNote |
Supersedes DIN EN 13503-7. (07/2006) DRAFT 2017 issued in March 2017. (03/2017)
|
| DocumentType |
Standard
|
| Pages |
48
|
| PublisherName |
German Institute for Standardisation (Deutsches Institut für Normung)
|
| Status |
Superseded
|
| SupersededBy | |
| Supersedes |
| Standards | Relationship |
| ISO 11979-7:2014 | Identical |
| I.S. EN ISO 11979-7:2014 | Identical |
| NBN EN ISO 11979-7 : 2014 | Identical |
| NF EN ISO 11979-7 : 2014 | Identical |
| BS EN ISO 11979-7:2014 | Identical |
| NEN EN ISO 11979-7 : 2014 | Identical |
| NS EN ISO 11979-7 : 2014 | Identical |
| EN ISO 11979-7:2014 | Equivalent |
| UNE-EN ISO 11979-7:2015 | Identical |
| ISO 11979-7:2014 | Equivalent |
| EN ISO 11979-7:2018 | Identical |
A newer version of this standard is available.
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