BS EN 13503-7:2002
Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
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Ophthalmic implants. Intraocular lenses Clinical investigations
Hardcopy , PDF
English
05-03-2002
29-02-2012
Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 General requirements
5 Methodology
5.1 General
5.2 Requirements before commencement of the clinical
investigation
5.3 Clinical investigation plan
5.4 Role of sponsor
5.5 Role of monitor
5.6 Role of clinical investigator
6 Presentation of results
Annex A (normative) Selected definitions
Annex C (informative) Elements of an IOL clinical protocol
Annex D (informative) Post-operative adverse event and
visual acuity rates associated with historical
IOL control populations
Annex ZA (informative) A-Deviations
Bibliography
Describes particular requirements for clinical investigation protocols for posterior and anterior chamber monofocal intraocular lenses (IOLs) for the correction of aphakia.
| Committee |
CH/172/7
|
| DevelopmentNote |
Supersedes 99/562424 DC (03/2002)
|
| DocumentType |
Standard
|
| Pages |
32
|
| PublisherName |
British Standards Institution
|
| Status |
Superseded
|
| SupersededBy | |
| Supersedes |
| Standards | Relationship |
| NEN EN 13503-7 : 2002 | Identical |
| DIN EN 13503-7:2002-03 | Identical |
| EN 13503-7 : 2001 | Identical |
| NF EN 13503-7 : 2002 | Identical |
| NBN EN 13503-7 : 2002 | Identical |
| I.S. EN 13503-7:2002 | Identical |
| NS EN 13503-7 : 1ED 2002 | Identical |
| UNE-EN 13503-7:2002 | Identical |
| EN ISO 11979-1:2012 | Ophthalmic implants - Intraocular lenses - Part 1: Vocabulary (ISO 11979-1:2012) |
| EN 540 : 1993 | CLINICAL INVESTIGATION OF MEDICAL DEVICES FOR HUMAN SUBJECTS |
| ISO 11979-3:2012 | Ophthalmic implants — Intraocular lenses — Part 3: Mechanical properties and test methods |
| EN ISO 11979-2:2014 | Ophthalmic implants - Intraocular lenses - Part 2: Optical properties and test methods (ISO 11979-2:2014) |
| ISO 11979-1:2006 | Ophthalmic implants — Intraocular lenses — Part 1: Vocabulary |
| EN ISO 8597 : 1996 | OPTICS AND OPTICAL INSTRUMENTS - VISUAL ACUITY TESTING - METHOD OF CORRELATING OPTOTYPES |
| EN 13503-3 : 2000 | OPHTHALMIC IMPLANTS - INTRAOCULAR LENSES - PART 3: MECHANICAL PROPERTIES AND TEST METHODS |
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