BS EN ISO 11979-7:2014
Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
View Superseded by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 Clinical investigations
Hardcopy , PDF
06-05-2018
English
09-30-2014
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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 |
CH/172/7
|
| DevelopmentNote |
Supersedes BS EN 13503-7 and 04/30103843 DC. (05/2006) Supersedes 12/30218032 DC. (09/2014)
|
| DocumentType |
Standard
|
| Pages |
50
|
| PublisherName |
British Standards Institution
|
| Status |
Superseded
|
| SupersededBy | |
| Supersedes |
| Standards | Relationship |
| UNI EN ISO 11979-7 : 2015 | Identical |
| NBN EN ISO 11979-7 : 2014 | Identical |
| SN EN ISO 11979-7 : 2014 | Identical |
| NF EN ISO 11979-7 : 2014 | Identical |
| ONORM EN ISO 11979-7 : 2015 | Identical |
| NS 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 |
| UNE-EN ISO 11979-7:2015 | Identical |
| EN ISO 11979-7:2014 | 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 |
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