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BS EN ISO 11979-7:2024 – TC

BS EN ISO 11979-7:2024 – TC

$258.95

Tracked Changes. Ophthalmic implants. Intraocular lenses – Clinical investigations of intraocular lenses for the correction of aphakia

Published By Publication Date Number of Pages
BSI 2024 134
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This document specifies the particular requirements for the clinical investigations of intraocular lenses that are implanted in the eye in order to correct aphakia.

PDF Catalog

PDF Pages PDF Title
75 undefined
77 European foreword
Endorsement notice
79 Foreword
80 Introduction
82 1 Scope
2 Normative references
3 Terms and definitions and abbreviated terms
3.1 Terms and definitions
3.2 Abbreviated terms
83 4 Justification for a clinical investigation
5 Ethical considerations
6 General requirements
6.1 General
84 6.2 Design of a clinical investigation
6.2.1 Requirements for all types of IOL
6.2.2 Additional requirements for toric IOLs (TIOL)
6.2.3 Additional requirements for Simultaneous Vision IOL (SVIOL) including MIOL, EDF and FVR lenses
85 6.2.4 Additional requirements for accommodating IOLs (AIOL)
86 6.2.5 Additional requirements for anterior chamber IOLs
6.3 Characteristics of clinical investigations
6.3.1 General
6.3.2 Characteristics to be studied for all types of IOL
87 6.3.3 Additional characteristics to be studied for toric IOL
6.3.4 Additional characteristics to be studied for SVIOLs
6.3.5 Additional characteristics to be studied for accommodating IOL
6.3.6 Additional characteristics applying to anterior chamber IOLs
6.3.7 Additional characteristics
88 6.4 Duration of the investigations
6.5 Enrolment
6.6 Bilateral implantation
89 6.7 Surgical technique
6.8 Examination and treatment of subjects
6.9 Adverse events reports
6.10 Inclusion and exclusion criteria
6.10.1 General
6.10.2 General inclusion criteria
6.10.3 Additional inclusion criteria for toric IOL
90 6.10.4 General exclusion criteria
6.10.5 Additional exclusion criteria for simultaneous vision IOL
6.10.6 Additional exclusion criteria for anterior chamber IOL
92 Annex A (normative) General elements in the clinical investigation of IOLs
97 Annex B (informative) Additional elements for the clinical investigation of toric IOLs
102 Annex C (informative) Additional elements for the clinical investigation of simultaneous vision (SVIOL) IOLs
110 Annex D (informative) Additional elements for the clinical investigation of accommodating IOLs
115 Annex E (informative) Evaluation of post operative adverse events and visual acuity rates
119 Annex F (informative) Clinical tests
127 Annex G (informative) Statistical methods and sample size calculations
132 Bibliography

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BS EN ISO 11979-7:2024 - TC
$258.95