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ISO 10993-2

Biological Evaluation of Medical Devices - Part 2: Animal Welfare Requirements

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Organization: ISO
Publication Date: 1 January 1992
Status: inactive
Page Count: 12
ICS Code (Laboratory medicine): 11.100
scope:

This part of ISO 10993 specifies minimum requirements for the use of animals in biological testing.

This part of ISO 10993 is also intended

a) to establish guidelines which allow the scientist to respect life in general;

b) to reduce the number of animal experiments and the number of animals used in experiments, among other ways by optimization of those performed;

c) to minimize suffering and maintain the quality of life of the animals used in the experiments.

This part of ISO 10993 applies to the experimentation performed on vertebrates. It does not apply to experimentation performed on less differentiated animals; nor does it apply to that part of the experimental work performed on isolated tissues and organs.

This part of ISO 10993 also makes recommendations concerned with the aim of reducing the number of animals used for biocompatibility testing and when possible abolishing animal experiments in this area.

Document History

July 15, 2006
Biological evaluation of medical devices Part 2: Animal welfare requirements
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...
ISO 10993-2
January 1, 1992
Biological Evaluation of Medical Devices - Part 2: Animal Welfare Requirements
This part of ISO 10993 specifies minimum requirements for the use of animals in biological testing. This part of ISO 10993 is also intended a) to establish guidelines which allow the scientist to...

References

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