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Norm
ÖNORM EN ISO 10993-2
Issue date: 2006 11 01
Biological evaluation of medical devices - Part 2: Animal welfare requirements (ISO 10993-2:2006)
This part of ISO 10993 is aimed at those who commission, design and perform tests or evaluate data from
animal tests undertaken to assess the biocompatibility of materia...
Withdrawn: 2023 04 01
§ Legal References
Publisher:
Austrian Standards International
Format:
Digital | 19 Pages
Language:
German
| English
| Download GER/ENG
Currently valid:
Optionally co-design standards:
ICS
This part of ISO 10993 is aimed at those who commission, design and perform tests or evaluate data from
animal tests undertaken to assess the biocompatibility of materials intended for use in medical devices, or that
of the medical devices themselves. It specifies the minimum requirements to be satisfied to ensure and
demonstrate that proper provision has been made for the welfare of animals used in animal tests to assess
the biocompatibility of materials used in medical devices.
It also makes recommendations and offers guidance intended to facilitate future further reductions in the
overall number of animals used, refinement of test methods to reduce or eliminate pain or distress in animals,
and the replacement of animal tests by other scientifically valid means not requiring animal tests.
It applies to tests performed on living vertebrate animals, other than man, to establish the biocompatibility of
materials or medical devices.
It does not apply to tests performed on invertebrate animals and other lower forms; nor (other than with
respect to provisions relating to species, source, health status, and care and accommodation) does it apply to
testing performed on isolated tissues and organs taken from vertebrate animals that have been euthanized.
ÖNORM EN ISO 10993-2
2023 04 01
Biological evaluation of medical devices - Part 2: Animal welfare requirements (ISO 10993-2:2022)
Norm
ÖNORM EN ISO 10993-2
2006 11 01
Biological evaluation of medical devices - Part 2: Animal welfare requirements (ISO 10993-2:2006)
Norm
↖
ÖNORM EN ISO 10993-2
1998 09 01
Biological evaluation of medical devices - Part 2: Animal welfare requirements (ISO 10993-2:1992)
Norm
Norm
Issue date :
2003 07 28
Biological evaluation of medical devices — Part 1: Evaluation and testing
Draft
Issue date :
2006 11 03
Biological evaluation of medical devices — Part 1: Evaluation and testing within a risk management process
Norm
Issue date :
2023 04 01
Biological evaluation of medical devices - Part 2: Animal welfare requirements (ISO 10993-2:2022)
Norm
Issue date :
2006 07 06
Biological evaluation of medical devices — Part 2: Animal welfare requirements