Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitization (ISO 10993-10:2010, IDT)
This Malaysian Standard describes the procedure for the assessment of medical devices and their constituent materials with regard to their potential to produce irritation and skin sensitization. This standard includes:
a) pretest considerations for irritation, including in silico and in vitro methods for dermal exposure;
b) details of in vivo (irritation and sensitization) test procedures;
c) key factors for the interpretation of the results.
Instructions are given in Annex A for the preparation of materials specifically in relation to the above tests. In Annex B several special irritation tests are described for application of medical devices in areas other than skin.
Published
• (none) / (none) / (none)
PDF
29/05/2019
78
NSC 18 - Medical Devices and Facilities for Healthcare
