Norm

NEN-EN-ISO 11979-5:1995 Ontw. en

Optica en optische instrumenten - Intra-oculaire lenzen - Deel 5: Biocompatibiliteit

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Over deze norm

Status Ingetrokken
Aantal pagina's 24
Commissie Intra-oculaire lenzen en contactlenzen
Gepubliceerd op 01-10-1995
Taal Engels
Indicates the fundamental principles foverning the biological evaluation of medial devices, the definition of categories based on the nature and duration of contact with the body, and selection of appropriate tests. Other parts of ISO 10993 present biological test methods, test for ethylene oxide results, tests for degradation and principles for sample preparation. This standard specifies the requirements for the biological evaluation of intraocular lenses (IOLs) and specifies appropriate test methods. It is applicableto a test material, as defined in 3.1, that is not already known to be biocompatible in intraocular applications.

Details

ICS-code 11.040.70
Nederlandse titel Optica en optische instrumenten - Intra-oculaire lenzen - Deel 5: Biocompatibiliteit
Engelse titel Optics and optical instruments - Intraocular lenses - Part 5: Biocompatibility
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