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SSH EN 30993-6:2000

Biological evaluation of medical devices - Part 6: Tests for local effects after implantation (ISO 10993-6:1994)

Jan 1, 2000
95.99 Withdrawal of Standard   Mar 11, 2008

General information

95.99     Mar 11, 2008

DPS

DPS/KT 206

European Norm

11.020  

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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 standards.

90/385/EEC

Active implantable medical devices

Harmonized
93/42/EEC

Medical devices

Harmonized

Life cycle

PREVIOUSLY

WITHDRAWN
SSH EN ISO 10993-6:2009

NOW

WITHDRAWN
SSH EN 30993-6:2000
95.99 Withdrawal of Standard
Mar 11, 2008

Related project

Adopted from EN 30993-6:1994