Hello. Sign In
Standards Store

ISO 10993-2

2nd Edition, July 15, 2006

Complete Document

Biological evaluation of medical devices Part 2: Animal welfare requirements



View Abstract
Product Details
Document History

Detail Summary

Active, Most Current

EN
Additional Comments:
ENGLISH
Format
Details
Price (USD)
PDF
Single User
$123.00
Print
In Stock
$123.00
Add to Cart

People Also Bought These:

ISO 10993-1
ISO 10993-10
ISO 10993-12
ISO 10993-6

Product Details:


Description / Abstract:

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.

The 9000 Store