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BS EN ISO 11979-7:2014

Superseded
Superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

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superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.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Superseded date

06-05-2018

Language(s)

English

Published date

09-30-2014

Publisher

British Standards Institution

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Superseded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

ISO 11979-10:2006 Ophthalmic implants Intraocular lenses Part 10: Phakic intraocular lenses
ISO/TR 22979:2017 Ophthalmic implants — Intraocular lenses — Guidance on assessment of the need for clinical investigation of intraocular lens design modifications
ISO 11979-1:2006 Ophthalmic implants Intraocular lenses Part 1: Vocabulary
ISO 14155:2011 Clinical investigation of medical devices for human subjects Good clinical practice
ISO 14971:2007 Medical devices Application of risk management to medical devices

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Hardcopy - English
PDF - English
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