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BS EN ISO 11979-7:2014

Superseded

Superseded

View Superseded by

Ophthalmic implants. Intraocular lenses Clinical investigations

Available format(s)

Hardcopy , PDF

Language(s)

English

Published date

09-30-2014

Superseded date

06-05-2018

Superseded by

BS EN ISO 11979-7:2018

US$439.87
Excluding Tax where applicable
Summarise this standard

Foreword
1 Scope
2 Normative references
3 Terms and definitions
4 Justification for a clinical investigation
5 Ethical considerations
6 General requirements
Annex A (informative) - Elements of a clinical
        investigation
Annex B (informative) - Evaluation of post-operative
        adverse event and visual acuity rates
Annex C (informative) - Additional elements for toric
        IOLs
Annex D (informative) - Additional elements for
        accommodating IOLs
Annex E (informative) - Clinical tests
Bibliography

Defines particular requirements for clinical investigations for posterior and anterior chamber intraocular lenses (IOLs).

Committee
CH/172/7
DevelopmentNote
Supersedes BS EN 13503-7 and 04/30103843 DC. (05/2006) Supersedes 12/30218032 DC. (09/2014)
DocumentType
Standard
Pages
50
PublisherName
British Standards Institution
Status
Superseded
SupersededBy
Supersedes

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US$439.87
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