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Standard [WITHDRAWN]

DIN EN ISO 11979-8:2011-09

Ophthalmic implants - Intraocular lenses - Part 8: Fundamental requirements (ISO 11979-8:2006 + Amd.1:2011); German version EN ISO 11979-8:2009 + A1:2011

German title
Ophthalmische Implantate - Intraokularlinsen - Teil 8: Grundlegende Anforderungen (ISO 11979-8:2006 + Amd.1:2011); Deutsche Fassung EN ISO 11979-8:2009 + A1:2011
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The standard specifies fundamental requirements for intraocular lenses. It refers to the other parts of the standard series DIN EN ISO 11979 for intraocular lenses regarding special properties or test methods. The standard is directed at all experts dealing with intraocular lenses, especially among manufacturers and test laboratories. Within the framework of Amendment A1 to DIN EN ISO 11979-8:2009-08, which has been incorporated into this consolidated new version of the standard, requirements with regard to bacterial endotoxins (clause 9.2) have been changed. Amendment A1 to the standard DIN EN ISO 11979-8:2009-08 has been prepared by ISO/TC 172/SC 7 "Ophthalmic optics and instruments" (secretariat: DIN, Germany) with German collaboration. The responsible Committee at DIN is Working Committee NA 027-01-20 AA "Intraokulare Medizinprodukte" ("Intraocular medical devices") at NAFuO.


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