I.S. 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Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
View Superseded by
OPHTHALMIC IMPLANTS - INTRAOCULAR LENSES - PART 7: CLINICAL INVESTIGATIONS
Hardcopy , PDF
English
01-01-2002
21-07-2006
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
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
Specified particular requirements for clinical investigation protocols for posterior and anterior chamber monofocal intraocular lenses (IOLs) for the correction of aphakia.
| DocumentType |
Standard
|
| Pages |
30
|
| PublisherName |
National Standards Authority of Ireland
|
| Status |
Superseded
|
| SupersededBy |
| 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 |
| BS EN 13503-7:2002 | Identical |
| NBN EN 13503-7 : 2002 | Identical |
| NS EN 13503-7 : 1ED 2002 | Identical |
| ISO 11979-7:2014 | Identical |
| UNE-EN 13503-7:2002 | Identical |
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