DIN EN ISO 11979-7:2014-12
Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
View Superseded by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 7: CLINICAL INVESTIGATIONS (ISO 11979-7:2014)
Hardcopy , PDF
28-07-2020
English, German
01-01-2014
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National foreword
National Annex NA (informative) - Bibliography
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).
| DevelopmentNote |
Supersedes DIN EN 13503-7. (07/2006) DRAFT 2017 issued in March 2017. (03/2017)
|
| DocumentType |
Standard
|
| Pages |
48
|
| PublisherName |
German Institute for Standardisation (Deutsches Institut für Normung)
|
| Status |
Superseded
|
| SupersededBy | |
| Supersedes |
| Standards | Relationship |
| ISO 11979-7:2014 | Identical |
| I.S. EN ISO 11979-7:2014 | Identical |
| 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 |
| UNE-EN ISO 11979-7:2015 | Identical |
| BS EN ISO 11979-7:2014 | Identical |
| NEN EN ISO 11979-7 : 2014 | Identical |
| ONORM EN ISO 11979-7 : 2015 | Identical |
| NS EN ISO 11979-7 : 2014 | Identical |
| EN ISO 11979-7:2018 | Identical |
| DIN EN ISO 11979-1:2013-01 | OPHTHALMIC IMPLANTS - INTRAOCULAR LENSES - PART 1: VOCABULARY (ISO 11979-1:2012) |
| DIN EN ISO 11979-5:2010-11 | Ophthalmic implants - Intraocular lenses - Part 5: Biocompatibility (ISO 11979-5:2006) |
| DIN EN ISO 11979-3:2013-04 | OPHTHALMIC IMPLANTS - INTRAOCULAR LENSES - PART 3: MECHANICAL PROPERTIES AND TEST METHODS (ISO 11979-3:2012) |
| DIN EN ISO 11979-6:2015-02 | Ophthalmic implants - Intraocular lenses - Part 6: Shelf-life and transport stability testing (ISO 11979-6:2014) |
| DIN EN ISO 11979-9:2014-12 | OPHTHALMIC IMPLANTS - INTRAOCULAR LENSES - PART 9: MULTIFOCAL INTRAOCULAR LENSES (ISO 11979-9:2006 + AMD.1:2014) |
| DIN EN ISO 11979-4:2013-01 | OPHTHALMIC IMPLANTS - INTRAOCULAR LENSES - PART 4: LABELLING AND INFORMATION (ISO 11979-4:2008 + AMD.1:2012) |
| DIN EN ISO 11979-8:2016-04 (Draft) | OPHTHALMIC IMPLANTS - INTRAOCULAR LENSES - PART 8: FUNDAMENTAL REQUIREMENTS (ISO 11979-8:2017) |
| DIN EN ISO 11979-1:2013-01 | OPHTHALMIC IMPLANTS - INTRAOCULAR LENSES - PART 1: VOCABULARY (ISO 11979-1:2012) |
| ISO 11979-10:2006 | Ophthalmic implants Intraocular lenses Part 10: Phakic intraocular lenses |
| DIN EN ISO 14971:2013-04 | MEDICAL DEVICES - APPLICATION OF RISK MANAGEMENT TO MEDICAL DEVICES (ISO 14971:2007) |
| DIN EN ISO 11979-10:2014-12 | OPHTHALMIC IMPLANTS - INTRAOCULAR LENSES - PART 10: PHAKIC INTRAOCULAR LENSES (ISO 11979-10:2006 + AMD.1:2014) |
| 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 |
| DIN EN ISO 14155:2012-01 | CLINICAL INVESTIGATION OF MEDICAL DEVICES FOR HUMAN SUBJECTS - GOOD CLINICAL PRACTICE (ISO 14155:2011 + COR. 1:2011) |
| 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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