UNI EN ISO 11979-7 : 2015
Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
View Superseded by
OPHTHALMIC IMPLANTS - INTRAOCULAR LENSES - PART 7: CLINICAL INVESTIGATIONS
30-08-2022
01-01-2015
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).
| Committee |
U42.00.06
|
| DevelopmentNote |
Supersedes UNI EN 13503-7. (07/2006)
|
| DocumentType |
Standard
|
| PublisherName |
Ente Nazionale Italiano di Unificazione (UNI)
|
| Status |
Superseded
|
| SupersededBy | |
| Supersedes |
| Standards | Relationship |
| NBN EN ISO 11979-7 : 2014 | Identical |
| NS EN ISO 11979-7 : 2014 | Identical |
| BS EN ISO 11979-7:2014 | Identical |
| NEN EN ISO 11979-7 : 2014 | Identical |
| DIN EN ISO 11979-7:2014-12 | Identical |
| ISO 11979-7:2014 | Identical |
| I.S. EN ISO 11979-7:2014 | Identical |
| ONORM EN ISO 11979-7 : 2015 | Identical |
| SN EN ISO 11979-7 : 2014 | Identical |
| NF EN ISO 11979-7 : 2014 | Identical |
| UNE-EN ISO 11979-7:2015 | Identical |
| EN ISO 11979-7:2018 | Identical |
| ISO 11979-10:2006 | Ophthalmic implants Intraocular lenses Part 10: Phakic intraocular lenses |
| ISO/TR 22979:2017 | Ophthalmic implants — Intraocular lenses — Guidance on assessment of the need for clinical investigation of intraocular lens design modifications |
| ISO 11979-1:2006 | Ophthalmic implants Intraocular lenses Part 1: Vocabulary |
| ISO 14155:2011 | Clinical investigation of medical devices for human subjects Good clinical practice |
| ISO 14971:2007 | Medical devices Application of risk management to medical devices |
Access your standards online with a subscription
Features
-
Simple online access to standards, technical information and regulations.
-
Critical updates of standards and customisable alerts and notifications.
-
Multi-user online standards collection: secure, flexible and cost effective.