AAMI 10993-10

AAM 10993-10 2010-JAN-01 Bologcal evaluaton of medcal devces — Part 10 Tests for rrtaton and skn senstzaton

More details

Download

PDF AVAILABLE FORMATS IMMEDIATE DOWNLOAD
$74.50

$149.00

(price reduced by 50 %)

1000 items in stock

This part of ISO 10993 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 part of ISO 10993 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.

Customers who purchased AAMI 10993-10
also purchased
  • AAMI 10993-1 : Biological evaluation of medical devices — Part 1: Evaluation and testing within a risk management process
  • AAMI 10993-12 : Biological evaluation of medical devices - Part 12: Sample preparation and reference materials
  • AAMI 10993-5 : Biological evaluation of medical devices — Part 5: Tests for in vitro cytotoxicity
  • AAMI 10993-11 : Biological evaluation of medical devices—Part 11: Tests for systemic toxicity
See More Documents

Contact us