Ophthalmic implants – Intraocular lenses – Part 8: Fundamental requirements (ISO 11979-8:2006)
Abstract
11979-8:2006 specifies fundamental requirements for all types of intraocular lenses intended for surgical implantation into the anterior segment of the human eye, excluding corneal implants and transplants.
DIN EN ISO 11979-8:2011-09 (E)
Ophthalmic implants – Intraocular lenses – Part 8: Fundamental requirements (ISO
11979-8:2006 + Amd.1:2011)
Contents Page
Annex ZA (informative) Relationship between this European Standard and the Essential
Requirements of EU Directive 93/42/EEC …………………………………………………………………………..
1 Scope ……………………………………………………………………………………………………………………………..5
2 ……………………………………………………………………………………………………………………………………….5
3 Terms and definitions ……………………………………………………………………………………………………..6
4 Safety and performance ………………………………………………………………………………………………….6
5 Optical and mechanical properties ………………………………………………………………………………….6
6 Biocompatibility ……………………………………………………………………………………………………………..6
7 Clinical evaluation …………………………………………………………………………………………………………..6
8 Manufacturing …………………………………………………………………………………………………………………6
9 Sterilization …………………………………………………………………………………………………………………….7
9.1 General …………………………………………………………………………………………………………………………..7
9.2 Bacterial endotoxins ……………………………………………………………………………………………………….7
10 Packaging and shelf-life ………………………………………………………………………………………………….7
11 Labelling and information ……………………………………………………………………………………………….7
12 Documentation ……………………………………………………………………………………………………………….7
………………………………………………………………………………………………………………………………………..8
Bibliography …………………………………………………………………………………………………………………………………….
Normative references ……………………………………………………………………………………………………………………….