CAN/CSA-ISO 10993-10-98:1998 Edition

$22.75

Biological Evaluation of Medical Devices – Part 10: Tests for Irritation and Sensitization

Published By	Publication Date	Number of Pages
CSA	1998	44

Guaranteed Safe Checkout

Category: CSA

If you have any questions, feel free to reach out to our online customer service team by clicking on the bottom right corner. We’re here to assist you 24/7.
Email:[email protected]

Description

Scope

This part of ISO 10993 describes test methods:

(a) to evaluate the potential of devices and their constituent materials to produce irritation; and
(b) to evaluate the potential of devices and their constituent materials to produce sensitization.

These test methods are recommended for most categories of device and mode of body contact given in ISO 10993-1. Of the tests listed, those appropriate to the end use of the device are to be selected. Guidance is also given for the preparation of materials specifically in relation to the above tests.

Note:
Guidance on the conduct of supplementary tests which may be required specifically for use in the oral, rectal, penile and vaginal areas is given in annex D.

Additional information