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EVS-EN ISO 10993-6:2009

Biological evaluation of medical devices - Part 6: Tests for local effects after implantation

General information
Withdrawn from 03.01.2017
Base Documents
ISO 10993-6:2007; EN ISO 10993-6:2009

Although the standard’s status is withdrawn, it still has the presumption of conformity in the meaning of regulation 90/385/EEC and conformance with the regulation ’s requirements can be guaranteed by using the withdrawn version of the standard. The presumption of conformity is valid until a corresponding amendment is published in the Official Journal of the European Union.
 
To view the latest lists of harmonised standards published in the Official Journal of the European Union, visit: 
http://ec.europa.eu/growth/single-market/european-standards/harmonised-standards/

Although the standard’s status is withdrawn, it still has the presumption of conformity in the meaning of regulation 93/42/EEC and conformance with the regulation ’s requirements can be guaranteed by using the withdrawn version of the standard. The presumption of conformity is valid until a corresponding amendment is published in the Official Journal of the European Union.
 
To view the latest lists of harmonised standards published in the Official Journal of the European Union, visit: 
http://ec.europa.eu/growth/single-market/european-standards/harmonised-standards/

Standard history
Status
Date
Type
Name
03.01.2017
Main
07.08.2009
Main
Main
EVS-EN ISO 10993-6:2007
This part of ISO 10993 specifies test methods for the assessment of the local effects after implantation of biomaterials intended for use in medical devices. This part of ISO 10993 applies to materials that are: - solid and non-biodegradable; - degradable and/or resorbable; - non-solid, such as porous materials, liquids, pastes and particulates.
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Standard monitoring
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