16/30337200 DC : 0

Superseded

BS EN ISO 11979-8 - OPHTHALMIC IMPLANTS - INTRAOCULAR LENSES - PART 8: FUNDAMENTAL REQUIREMENTS

Available format(s)

Hardcopy , PDF

Superseded date

30-06-2017

Language(s)

English

Publisher

British Standards Institution

Foreword
1 Scope
2 Normative references
3 Terms and definitions
4 Safety and performance
5 Optical and mechanical properties
6 Biocompatibility
7 Clinical evaluation
8 Manufacturing
9 Sterilization
10 Packaging and shelf-life
11 Labelling and information
12 Documentation
Bibliography
Annex ZA (informative) - Relationship between
         this European Standard and the Essential
         Requirements of Directive 93/42/EEC
         [OJ L 169] aimed to be covered

BS EN ISO 11979-8.

Committee	CH/172/7
DocumentType	Draft
Pages	13
PublisherName	British Standards Institution
Status	Superseded

ISO 11979-10:2006	Ophthalmic implants Intraocular lenses Part 10: Phakic intraocular lenses
ISO 11979-7:2014	Ophthalmic implants Intraocular lenses Part 7: Clinical investigations
ISO 14630:2012	Non-active surgical implants General requirements
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 11979-9:2006	Ophthalmic implants Intraocular lenses Part 9: Multifocal intraocular lenses
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