NS EN 13503-7 : 1ED 2002
Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
OPHTHALMIC IMPLANTS - INTRAOCULAR LENSES - PART 7: CLINICAL INVESTIGATIONS
09-01-2006
01-12-2013
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
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