Biologisk värdering av medicintekniska produkter

Kommittébeteckning: SIS/TK 340 (Implantat och biologisk säkerhet)
Källa: CEN
Svarsdatum: den 22 jul 2019
Se merSe mindre
 

This document specifies requirements and gives guidance on the procedures to be followed in the preparation of samples and the selection of reference materials for medical device testing in biological test systems onlyin accordance with one or more parts of ISO 10993. Specifically, this document addresses the following:

— test sample selection;

— selection of representative portions from a medical device;

— test sample preparation;

— experimental controls;

— selection of, and requirements, for reference materials;

— preparation of extracts.

This document is not applicable to live cells, but can be relevant to the material or medical device components of combination products containing live cells.

Kommittébeteckning: SIS/TK 340 (Implantat och biologisk säkerhet)
Källa: CEN
Svarsdatum: den 22 jul 2019
Se merSe mindre
 

This document specifies the procedure for the assessment of medical devices and their constituent materials with regard to their potential to produce irritation. The tests are designed to predict and classify the irritation potential of medical devices, materials or their extracts according to ISO 10993-1 and ISO 10993-12.

This document includes:

— pre-test considerations for irritation, including in silico and in vitro methods for dermal exposure;

— details of in vitro and in vivo irritation test procedures;

— 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 D several special in vivo irritation tests are described for application of medical devices in areas other than skin. In addition, Annex E provides information for conducting human skin irritation testing.