17/30336158 DC : 0
NA
Status of Standard is Unknown
BS EN ISO 11979-7 - OPHTHALMIC IMPLANTS - INTRAOCULAR LENSES - PART 7: CLINICAL INVESTIGATIONS OF INTRAOCULAR LENSES FOR THE CORRECTION OF APHAKIA
Hardcopy , PDF
English
Foreword
Introduction
1 Scope
2 Normative references
3 Terms, definitions and abbreviated terms
4 Justification for a clinical investigation
5 Ethical considerations
6 General requirements
Annex A (informative) - General elements in the
clinical investigation of IOLs
Annex B (informative) - Additional elements for the clinical
investigation of toric IOLs
Annex C (informative) - Additional elements for the clinical
investigation of multifocal IOLs
Annex D (informative) - Additional elements in the clinical
investigation of accommodating IOLs
Annex E (informative) - Evaluation of post-operative adverse events
and visual acuity rates
Annex F (informative) - Clinical tests
Annex G (informative) - Statistical methods and sample size
calculations
Bibliography
BS EN ISO 11979-7.
| Committee |
CH/172/7
|
| DocumentType |
Draft
|
| Pages |
53
|
| PublisherName |
British Standards Institution
|
| Status |
NA
|
| Supersedes |
| 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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