I.S. EN ISO 11979-10:2007
Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
View Superseded by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 10: CLINICAL INVESTIGATIONS OF INTRAOCULAR LENSES FOR CORRECTION OF AMETROPIA IN PHAKIC EYES (ISO 11979-10:2018)
Hardcopy , PDF
10-07-2020
English
01-01-2007
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.
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National Foreword
European foreword
Foreword
Introduction
1 Scope
2 Normative references
3 Terms, definitions and abbreviated terms
4 Optical requirements
5 Mechanical requirements
6 Biocompatibility requirements
7 Shelf-life and transport stability requirements
8 Fundamental requirements
9 Justification for a clinical investigation
10 General clinical requirements
11 Information supplied by the manufacturer
Annex A (informative) - Elements in a phakic
IOL clinical investigation
Annex B (informative) - Statistical methods and
sample size calculations
Bibliography
Defines requirements for any intraocular lenses to be implanted in the anterior segment of the eye with the primary indication to modify its refractive power.
| DocumentType |
Standard
|
| Pages |
28
|
| PublisherName |
National Standards Authority of Ireland
|
| Status |
Superseded
|
| SupersededBy |
| Standards | Relationship |
| BS EN ISO 11979-10 : 2006 | Identical |
| SN EN ISO 11979-10 : 2006 AMD 1 2014 | Identical |
| NF EN ISO 11979-10 : 2006 AMD 1 2014 | Identical |
| NS EN ISO 11979-10 : 2006 AMD 1 2014 | Identical |
| DIN EN ISO 11979-10:2014-12 | Identical |
| UNE-EN ISO 11979-10:2007 | Identical |
| NEN EN ISO 11979-10 : 2006 AMD 1 2014 | Identical |
| UNI EN ISO 11979-10 : 2015 | Identical |
| ONORM EN ISO 11979-10 : 2014 | Identical |
| ISO 11979-10:2006 | Identical |
| NBN EN ISO 11979-10 : 2006 AMD 1 2014 | Identical |
| ISO 11979-10:2018 | Identical |
| EN ISO 11979-10:2018 | Identical |
| ISO 11979-7:2014 | Ophthalmic implants Intraocular lenses Part 7: Clinical investigations |
| ISO 11979-3:2012 | Ophthalmic implants — Intraocular lenses — Part 3: Mechanical properties and test methods |
| ISO/TR 22979:2017 | Ophthalmic implants — Intraocular lenses — Guidance on assessment of the need for clinical investigation of intraocular lens design modifications |
| ISO 11979-8:2017 | Ophthalmic implants — Intraocular lenses — Part 8: Fundamental requirements |
| ISO 11979-1:2006 | Ophthalmic implants Intraocular lenses Part 1: Vocabulary |
| ISO 11979-4:2008 | Ophthalmic implants — Intraocular lenses — Part 4: Labelling and information |
| ISO 14155:2011 | Clinical investigation of medical devices for human subjects Good clinical practice |
| ISO 11979-2:2014 | Ophthalmic implants — Intraocular lenses — Part 2: Optical properties and test methods |
| ISO 11979-5:2006 | Ophthalmic implants Intraocular lenses Part 5: Biocompatibility |
| ISO 14971:2007 | Medical devices Application of risk management to medical devices |
| ISO 11979-6:2014 | Ophthalmic implants — Intraocular lenses — Part 6: Shelf-life and transport stability testing |
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