Buy this standard

Abstract Preview

ISO 10993-10:2010 describes the procedure for the assessment of medical devices and their constituent materials with regard to their potential to produce irritation and skin sensitization.

ISO 10993-10:2010 includes:

  • pretest considerations for irritation, including in silico and in vitro methods for dermal exposure;
  • details of in vivo (irritation and sensitization) test procedures;
  • key factors for the interpretation of the results.

Instructions are given for the preparation of materials specifically in relation to the above tests and several special irritation tests are described for application of medical devices in areas other than skin.


General information

  • Status :  Published
    Publication date : 2010-08
  • Edition : 3
    Number of pages : 67
  • Technical Committee
    :
    ISO/TC 194
    Biological and clinical evaluation of medical devices
  • ICS :
    11.100.20
    Biological evaluation of medical devices

Sustainable Development Goals

This standard contributes to the following Sustainable Development Goal:

3
Good Health and Well-being

Buy this standard

Format Language
PDF
Paper
  • CHF178

Life cycle

A standard is reviewed every 5 years



Revisions / Corrigenda

Got a question?

Check out our FAQs

Customer care
+41 22 749 08 88

Opening hours:
Monday to Friday - 09:00-12:00, 14:00-17:00 (UTC+1)

Keep up to date with ISO

Sign up to our newsletter for the latest news, views and product information