BS EN ISO 11979-5:2006 - Ophthalmic implants. Intraocular lenses. Biocompatibility – BSI British Standards
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BS EN ISO 11979-5:2006

Ophthalmic implants. Intraocular lenses. Biocompatibility

Status : Superseded, Withdrawn   Published : June 2006 Replaced By : BS EN ISO 11979-5:2020

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BS EN ISO 11979-5:2006 follows the general principles given in ISO 10993-1. ISO 10993-1 and describes the principles governing the biological evaluation of medical devices, the definitions of categories based on the nature and duration of contact with the body, and selection of appropriate tests. Other parts of BS EN ISO 10993 present biological test methods, tests for ethylene oxide residues, tests for degradation and principles for sample preparation.

This standard specifies particular requirements for the biocompatibility evaluation of materials for intraocular lenses (IOLs) including the processing conditions to produce them. These requirements include evaluation of physicochemical properties that are relevant to biocompatibility. It also gives guidance on conducting an ocular implantation test.

BS EN ISO 11979-5:2006 replaces BS EN 13503-5:2001, which has been withdrawn.




Standard NumberBS EN ISO 11979-5:2006
TitleOphthalmic implants. Intraocular lenses. Biocompatibility
StatusSuperseded, Withdrawn
Publication Date30 June 2006
Withdrawn Date12 October 2020
Normative References(Required to achieve compliance to this standard)ISO 10993-12, ISO 10993-10, ISO 10993-2, ISO 11979-3, ISO 10993-3, ISO 10993-6, ISO 11979-2, ISO 11979-1, ISO 14971, ISO 10993-1
Informative References(Provided for Information)No other standards are informatively referenced
Replaced ByBS EN ISO 11979-5:2020
ReplacesBS EN 13503-5:2001
International RelationshipsEN ISO 11979-5:2006,ISO 11979-5:2006
Draft Superseded By04/30103836 DC
DescriptorsBiological analysis and testing, Lenses, Biocompatibility, Physical testing, Optics, Chemical analysis and testing, Ophthalmic equipment, Ophthalmology, Eyes
ICS11.040.70
Title in FrenchImplants ophtalmiques. Lentilles intraoculaires. Biocompatibilite
Title in GermanOphthalmische Implantate. Intraokularlinsen. Biokompatibilitaet
CommitteeCH/172/7
ISBN0 580 48582 X
PublisherBSI
FormatA4
DeliveryYes
Pages36
File Size578 KB
Price£218.00


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