Ophthalmic implants. Intraocular lenses. Part 10: Clinical investigations of intraocular lenses for correction of ametropia in phakic eyes (ISO 11979-10:2018)
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ISO 11979-10:2018 specifies requirements for any intraocular lenses to be implanted in the anterior segment of the eye with the primary indication to modify its refractive power. There are three main categories of phakic intraocular lenses depending on the optical design: a) Phakic monofocal (PIOL); b) Phakic multifocal (PMIOL); and c) Phakic toric (PTIOL). Each of these categories is further designated for implantation in either the anterior or posterior chamber of the anterior segment of the eye. The basic phakic IOL requirements apply to all the types. Additional requirements apply to PMIOL and PTIOL designs. ISO 11979-10:2018 addresses specific clinical requirements for phakic IOLs that are not addressed in the other parts of ISO 11979.
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Sisällysluettelo
Foreword
Introduction
1 Scope
2 Normative references
3 Terms, definitions and abbreviated terms
3.1 Terms and definitions
3.2 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
10.1 General
10.2 Design of a clinical investigation
10.3 Characteristics
10.4 Duration of the investigation
10.5 Enrolment
10.6 Bilateral implantation
10.7 Surgical technique
10.8 Examination and treatment of subjects
10.9 Adverse events reports
10.10 Inclusion and exclusion criteria
11 Information supplied by the manufacturer
Annex A Elements in a phakic IOL clinical investigation (informative)
Annex B Statistical methods and sample size calculations (informative)
ISO 11979-1:2012 Ophthalmic implants -- Intraocular lenses -- Part 1: Vocabulary
ISO 11979-2:2014 Ophthalmic implants -- Intraocular lenses -- Part 2: Optical properties and test methods
ISO 11979-3:2012 Ophthalmic implants -- Intraocular lenses -- Part 3: Mechanical properties and test methods
ISO 11979-1:2012 Ophthalmic implants -- Intraocular lenses -- Part 1: Vocabulary
ISO 11979-2:2014 Ophthalmic implants -- Intraocular lenses -- Part 2: Optical properties and test methods
ISO 11979-3:2012 Ophthalmic implants -- Intraocular lenses -- Part 3: Mechanical properties and test methods
ISO 11979-4:2008 Ophthalmic implants -- Intraocular lenses -- Part 4: Labelling and information
ISO 11979-5:2006 Ophthalmic implants -- Intraocular lenses -- Part 5: Biocompatibility
ISO 11979-6:2014 Ophthalmic implants -- Intraocular lenses -- Part 6: Shelf-life and transport stability testing
ISO 11979-7:2014 Ophthalmic implants -- Intraocular lenses -- Part 7: Clinical investigations
ISO 11979-8:2017 Ophthalmic implants -- Intraocular lenses -- Part 8: Fundamental requirements
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