Standard Svensk standard · SS-EN ISO 10993-1:2009

Biologisk värdering av medicintekniska produkter - Del 1: Utvärdering och provning (ISO 10993-1:2003)

Status: Upphävd · Ersätts av: SS-EN ISO 10993-1:2009

Omfattning
This part of ISO 10993 describes
a) the general principles governing the biological evaluation of medical devices;
b) the categorization of devices based on the nature and duration of their contact with the body;
c) the selection of appropriate tests.

This part of ISO 10993 does not cover testing of materials and devices that do not come into direct or indirect contact with the patient's body, nor does it cover biological hazards arising from any mechanical failure.

NOTE Other parts of ISO 10993 cover specific tests (see also the rationale in A.2).

Ämnesområden

Biologisk värdering av medicintekniska produkter (11.100.20)


Produktinformation

Språk: Engelska

Framtagen av: Biologisk säkerhet, SIS/TK 340/AG 02

Internationell titel: Biological evaluation of medical devices - Part 1: Evaluation and testing (ISO 10993-1:2003)

Artikelnummer: STD-70079

Utgåva: 3

Fastställd: 2009-06-22

Antal sidor: 32

Ersätter: SS-EN ISO 10993-1:2004

Ersätts av: SS-EN ISO 10993-1:2009