I.S. 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Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
OPHTHALMIC IMPLANTS - INTRAOCULAR LENSES - PART 7: CLINICAL INVESTIGATIONS OF INTRAOCULAR LENSES FOR THE CORRECTION OF APHAKIA (ISO 11979-7:2018)
Hardcopy , PDF
English
01-01-2014
17-06-2018
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.
National Foreword
European foreword
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 TIOLs
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
Defines the particular requirements for the clinical investigations of intraocular lenses that are implanted in the eye in order to correct aphakia.
| DevelopmentNote |
Supersedes I.S. EN 13503-7. (07/2006)
|
| DocumentType |
Standard
|
| Pages |
54
|
| PublisherName |
National Standards Authority of Ireland
|
| Status |
Superseded
|
| Supersedes |
| Standards | Relationship |
| NF EN ISO 11979-7 : 2014 | Identical |
| ONORM EN ISO 11979-7 : 2015 | 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 |
| NBN EN ISO 11979-7 : 2014 | Identical |
| EN ISO 11979-7:2014 | Equivalent |
| ISO 11979-7:2018 | 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 |
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