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17/30336158 DC : 0

NA
NA

Status of Standard is Unknown

BS EN ISO 11979-7 - OPHTHALMIC IMPLANTS - INTRAOCULAR LENSES - PART 7: CLINICAL INVESTIGATIONS OF INTRAOCULAR LENSES FOR THE CORRECTION OF APHAKIA
Available format(s)

Hardcopy , PDF

Language(s)

English

Foreword
Introduction
1 Scope
2 Normative references
3 Terms, definitions and abbreviated terms
4 Justification for a clinical investigation
5 Ethical considerations
6 General requirements
Annex A (informative) - General elements in the
        clinical investigation of IOLs
Annex B (informative) - Additional elements for the clinical
        investigation of toric IOLs
Annex C (informative) - Additional elements for the clinical
        investigation of multifocal IOLs
Annex D (informative) - Additional elements in the clinical
        investigation of accommodating IOLs
Annex E (informative) - Evaluation of post-operative adverse events
        and visual acuity rates
Annex F (informative) - Clinical tests
Annex G (informative) - Statistical methods and sample size
        calculations
Bibliography

BS EN ISO 11979-7.

Committee
CH/172/7
DocumentType
Draft
Pages
53
PublisherName
British Standards Institution
Status
NA
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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