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BS EN ISO 11979-7:2024

BS EN ISO 11979-7:2024

$198.66

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

Published By Publication Date Number of Pages
BSI 2024 60
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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
2 undefined
4 European foreword
Endorsement notice
6 Foreword
7 Introduction
9 1 Scope
2 Normative references
3 Terms and definitions and abbreviated terms
3.1 Terms and definitions
3.2 Abbreviated terms
10 4 Justification for a clinical investigation
5 Ethical considerations
6 General requirements
6.1 General
11 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
12 6.2.4 Additional requirements for accommodating IOLs (AIOL)
13 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
14 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
15 6.4 Duration of the investigations
6.5 Enrolment
6.6 Bilateral implantation
16 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
17 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
19 Annex A (normative) General elements in the clinical investigation of IOLs
24 Annex B (informative) Additional elements for the clinical investigation of toric IOLs
29 Annex C (informative) Additional elements for the clinical investigation of simultaneous vision (SVIOL) IOLs
37 Annex D (informative) Additional elements for the clinical investigation of accommodating IOLs
42 Annex E (informative) Evaluation of post operative adverse events and visual acuity rates
46 Annex F (informative) Clinical tests
54 Annex G (informative) Statistical methods and sample size calculations
59 Bibliography

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BS EN ISO 11979-7:2024
$198.66