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BS EN 13503-7:2002

Superseded
Superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

View Superseded by
superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.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 Clinical investigations
Available format(s)

Hardcopy , PDF

Superseded date

05-31-2006

Language(s)

English

Published date

03-05-2002

Publisher

British Standards Institution

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Superseded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

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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PDF - English
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