16/30337200 DC : 0
Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
BS EN ISO 11979-8 - OPHTHALMIC IMPLANTS - INTRAOCULAR LENSES - PART 8: FUNDAMENTAL REQUIREMENTS
Hardcopy , PDF
30-06-2017
English
Important note : Users cannot be edited or removed once added to your Multi user PDF.
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Superseded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 |
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