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BSI 23/30453001 DC:2023 Edition

BSI 23/30453001 DC:2023 Edition

$13.70

BS EN ISO 11979-7. Ophthalmic implants. Intraocular lenses – Part 7. Clinical investigations of intraocular lenses for the correction of aphakia

Published By Publication Date Number of Pages
BSI 2023 59
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PDF Catalog

PDF Pages PDF Title
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
14 6.2.4 Additional requirements for accommodating IOLs (AIOL)
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
15 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
16 6.3.6 Additional characteristics applying to anterior chamber IOLs
6.3.7 Additional characteristics
6.4 Duration of the investigations
6.5 Enrolment
17 6.6 Bilateral implantation
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
18 6.10.3 Additional inclusion criteria for toric IOL
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
20 Annex€A (normative) General elements in the clinical investigation of IOLs
25 Annex€B (informative) Additional elements for the clinical investigation of toric IOLs
30 Annex€C (informative) Additional elements for the clinical investigation of simultaneous vision (SVIOL) IOLs
38 Annex€D (informative) Additional elements for the clinical investigation of accommodating IOLs
43 Annex€E (informative) Evaluation of post operative adverse events and visual acuity rates
47 Annex€F (informative) Clinical tests
54 Annex€G (informative) Statistical methods and sample size calculations
59 Bibliography

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BSI 23/30453001 DC
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