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SRPS EN ISO 10993-6:2008

Biological evaluation of medical devices - Part 6: Tests for local effects after implantation (ISO 10993-6:2007)

Jun 19, 2008
95.99 Withdrawal of Standard   Aug 29, 2011

General information

95.99     Aug 29, 2011

ISS

Z076

European Norm

11.100.20  

English  

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Scope

This part of ISO 10993 specifies test methods for the assessment of the local effects of an implant material on living tissue, at both the macroscopic and microscopic level. The test specimen is implanted into a site and tissue appropriate for evaluation of the biological safety of the material. The implant is not intended to be subjected to mechanical or functional loading. The local effects are evaluated by a comparison of the tissue response caused by a test specimen to that caused by materials used in medical devices whose clinical acceptability has been established. The test methods for local effects after implantation are used to assess subchronic effects (short-term, up to 12 weeks), or chronic effects (long-term, longer than 12 weeks).

Related directives

Directives related to this standard.

90/385/EEC

Active implantable medical devices

Harmonized
93/42/EEC

Medical devices

Harmonized

Life cycle

NOW

WITHDRAWN
SRPS EN ISO 10993-6:2008
95.99 Withdrawal of Standard
Aug 29, 2011

REVISED BY

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SRPS EN ISO 10993-6:2011

Related project

Adopted from EN ISO 10993-6:2007

Adopted from ISO 10993-6:2007 IDENTICAL