I.S. EN ISO 11979-9:2006
Withdrawn
A Withdrawn Standard is one, which is removed from sale, and its unique number can no longer be used. The Standard can be withdrawn and not replaced, or it can be withdrawn and replaced by a Standard with a different number.
View Superseded by
OPHTHALMIC IMPLANTS - INTRAOCULAR LENSES - PART 9: MULTIFOCAL INTRAOCULAR LENSES (ISO 11979-9:2006)
13-05-2021
01-01-2006
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.
Foreword
1 Scope
2 Normative references
3 Terms and definitions
4 Physical requirements
5 Optical requirements
6 Clinical investigation
7 Information supplied by the manufacturer
Annex A (normative) - Optical characterization
Annex B (informative) - Clinical investigation
Annex C (informative) - Determination of sample
sizes for the clinical investigation
Bibliography
Define to any intraocular lens whose optic provides two or more powers and whose primary indication is the correction of aphakia with the added benefit of useful vision at more than one distance (e.g. far and near).
| DocumentType |
Standard
|
| PublisherName |
National Standards Authority of Ireland
|
| Status |
Withdrawn
|
| SupersededBy |
| Standards | Relationship |
| DIN EN ISO 11979-9:2014-12 | Identical |
| NF EN ISO 11979-9 : 2006 AMD 1 2014 | Identical |
| ISO 11979-9:2006 | Identical |
| NBN EN ISO 11979-9 : 2006 AMD 1 2014 | Identical |
| NEN EN ISO 11979-9 : 2006 AMD 1 2014 | Identical |
| NS EN ISO 11979-9 : 2006 AMD 1 2014 | Identical |
| SN EN ISO 11979-9 : 2006 AMD 1 2014 | Identical |
| UNI EN ISO 11979-9 : 2014 | Identical |
| BS EN ISO 11979-9 : 2006 | Identical |
| ISO 11979-7:2014 | Ophthalmic implants Intraocular lenses Part 7: Clinical investigations |
| EN 1041:2008+A1:2013 | Information supplied by the manufacturer of medical devices |
| 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 11979-1:2006 | 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 14971:2007 | Medical devices Application of risk management to medical devices |
| EN 980:2008 | Symbols for use in the labelling of medical devices |
| ISO 15223:2000 | Medical devices Symbols to be used with medical device labels, labelling and information to be supplied |
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