YY/T 0879.1-2013 (English Version) PDF

Scope: This part of YY/T 0879 provides the testing methods for sensitization testing of medical devices/materials. This section is expected to provide an alternative method for guinea pig sensitization testing, especially for medical devices/materials that only come into contact with intact skin. However, the use of the guinea pig sensitization test is still recommended when assessing sensitization reactions to metallic materials or medical device products/materials intended for use in deep tissue or damaged surfaces. This section only applies to low molecular weight chemicals that can penetrate into the skin. The absorbed chemicals or metabolites can combine with macromolecules, such as proteins, to form immunogenic complexes.

YY/T 0879.1-2013 Referenced Document

GB/T 16886.1 Biological evaluation of medical devices—Part 1: Evaluation and testing within a risk management process*， 2022-04-15 Update
GB/T 16886.10 Biological evaluation of medical devices—Part 10: Tests for irritation and skin sensitization*， 2017-12-29 Update
GB/T 16886.11 Biological evaluation of medical devices—Part 11: Tests for systemic toxicity*， 2021-11-26 Update
GB/T 16886.12 Biological Evaluation of Medical Devices Part 12: Sample Preparation and Reference Materials*， 2023-11-27 Update
GB/T 16886.2 Biological evaluation of medical devices.Part 2: Animal welfare requirements

2013 YY/T 0879.1-2013 Test for sensitization of medical devices.Part 1:Murine local lymph node assay (LLNA) : Radioisotope incorporation method