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17/30335550 DC : 0

NA
NA

Status of Standard is Unknown

BS EN ISO 11979-10 - OPHTHALMIC IMPLANTS - INTRAOCULAR LENSES - PART 10: CLINICAL INVESTIGATIONS OF INTRAOCULAR LENSES FOR CORRECTION OF AMETROPIA IN PHAKIC EYES
Available format(s)

Hardcopy , PDF

Language(s)

English

Foreword
Introduction
1 Scope
2 Normative references
3 Terms, definitions and abbreviated terms
4 Optical requirements
5 Mechanical requirements
6 Biocompatibility requirements
7 Shelf-life and transport stability requirements
8 Fundamental requirements
9 Justification for a clinical investigation
10 General clinical requirements
11 Information supplied by the manufacturer
Annex A (informative) - Elements in a phakic
        IOL clinical investigation
Annex B (informative) - Statistical methods
        and sample size calculations
Bibliography

BS EN ISO 11979-10.

Committee
CH/172/7
DocumentType
Draft
Pages
24
PublisherName
British Standards Institution
Status
NA

ISO 11979-7:2014 Ophthalmic implants Intraocular lenses Part 7: Clinical investigations
ISO 11979-3:2012 Ophthalmic implants — Intraocular lenses — Part 3: Mechanical properties and test methods
ISO/TR 22979:2017 Ophthalmic implants — Intraocular lenses — Guidance on assessment of the need for clinical investigation of intraocular lens design modifications
ISO 11979-8:2017 Ophthalmic implants — Intraocular lenses — Part 8: Fundamental requirements
ISO 11979-1:2006 Ophthalmic implants Intraocular lenses Part 1: Vocabulary
ISO 11979-4:2008 Ophthalmic implants — Intraocular lenses — Part 4: Labelling and information
ISO 14155:2011 Clinical investigation of medical devices for human subjects Good clinical practice
ISO 11979-2:2014 Ophthalmic implants — Intraocular lenses — Part 2: Optical properties and test methods
ISO 11979-5:2006 Ophthalmic implants Intraocular lenses Part 5: Biocompatibility
ISO 14971:2007 Medical devices Application of risk management to medical devices
ISO 11979-6:2014 Ophthalmic implants Intraocular lenses Part 6: Shelf-life and transport stability testing

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