12/30218032 DC : 0

Superseded

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BS EN ISO 11979-7 - OPHTHALMIC IMPLANTS - INTRAOCULAR LENSES - PART 7: CLINICAL INVESTIGATIONS

Available format(s)

Hardcopy , PDF

Superseded date

09-30-2014

Language(s)

English

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

BS EN ISO 11979-7.

Committee	CH/172/7
DocumentType	Draft
Pages	49
PublisherName	British Standards Institution
Status	Superseded
SupersededBy	BS EN ISO 11979-7:2014

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