International Organization for Standardization

Biological evaluation of medical devices - Part 10: Tests for irritation and delayed-type hypersensitivity - Second Edition
 N 10993-10

Annotation

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 delayed-type hypersensitivity.

This part of ISO 10993 includes

a) pretest considerations,

b) details of the test procedures, and

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.

Supplementary tests which are required specifically for devices used intradermally in the ocular, oral, rectal, penile and vaginal areas are given in annex B.

Автоматический перевод:

Биологическая оценка медицинских устройств, часть 10: испытания на раздражение и иперчувствительность замедленного типа - второе издание

Эта часть ISO 10993 описывает процедуру оценки медицинских приспособлений и их составных материалов с точки зрения их потенциала для получения раздражения и гиперчувствительности замедленного типа.