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Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.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
Hardcopy , PDF
07-21-2006
English
01-01-2002
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.
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
Important note : All end users must be registered with an Account prior to user licenses being assigned.Access your standards online with a subscription
Features
-
Simple online access to standards, technical information and regulations.
-
Critical updates of standards and customisable alerts and notifications.
-
Multi-user online standards collection: secure, flexible and cost effective.