UNLIMITED FREE ACCESS TO THE WORLD'S BEST IDEAS

close
Already an Engineering360 user? Log in.

This is embarrasing...

An error occurred while processing the form. Please try again in a few minutes.

Customize Your Engineering360 Experience

close
Privacy Policy

This is embarrasing...

An error occurred while processing the form. Please try again in a few minutes.

ISO 10993-2

Biological evaluation of medical devices Part 2: Animal welfare requirements

active, Most Current
Buy Now
Organization: ISO
Publication Date: 15 July 2006
Status: active
Page Count: 20
ICS Code (Biological evaluation of medical devices): 11.100.20
scope:

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.

Document History

February 13, 2020
Biological evaluation of medical devices — Part 2: Animal welfare requirements
This document specifies the minimum requirements to be satisfied to ensure and demonstrate that proper provision has been made to minimize pain and distress, which can negatively affect the validity...
ISO 10993-2
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...
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

Advertisement