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Norm
ÖNORM EN 30993-6
Issue date: 1995 06 01
Biological evaluation of medical devices - Part 6: Tests for local effects after implantation (ISO 10993-6:1994)
This part of ISO 10993 specifies test methods for the
assessment of the local effects of an implant material
on lMng tissue, at both the macroscopic and microscopic
le...
Withdrawn: 2007 08 01
§ Legal References
Publisher:
Austrian Standards International
Format:
Digital | 25 Pages
Language:
German
| English
Currently valid:
Optionally co-design standards:
ICS
This part of ISO 10993 specifies test methods for the
assessment of the local effects of an implant material
on lMng tissue, at both the macroscopic and microscopic
level.
The test specirnen is implanted into a site and tissue
appropriate for evaluation of the biological safety of
the material. The implant is not intended to be sub
jected 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).
ÖNORM EN ISO 10993-6
2017 06 15
Biological evaluation of medical devices - Part 6: Tests for local effects after implantation (ISO 1...
Norm
ÖNORM EN ISO 10993-6
2009 09 15
Biological evaluation of medical devices - Part 6: Tests for local effects after implantation (ISO 1...
Norm
ÖNORM EN ISO 10993-6
2007 08 01
Biological evaluation of medical devices - Part 6: Tests for local effects after implantation (ISO 1...
Norm
ÖNORM EN 30993-6
1995 06 01
Biological evaluation of medical devices - Part 6: Tests for local effects after implantation (ISO 1...
Norm
↖
Norm
Issue date :
1992 04 23
Biological evaluation of medical devices — Part 1: Guidance on selection of tests
Norm
Issue date :
1992 12 30
Biological evaluation of medical devices — Part 2: Animal welfare requirements
Norm
Issue date :
2007 08 01
Biological evaluation of medical devices - Part 6: Tests for local effects after implantation (ISO 10993-6:2007)
Norm
Issue date :
1994 07 07
Biological evaluation of medical devices — Part 6: Tests for local effects after implantation
