MEDICAL EQUIPMENT, MEDICAL DEVICES, CATEGORIES, TESTS, BIOLOGICAL TESTS,BIOASSAY, SELECTION
被代替标准
CAN/CSA-ISO 10993-1-98
适用范围
This National Standard of Canada is equivalent to International Standard ISO
10993-1:1997. 1 Scope 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. Other parts of
ISO 10993 cover specific tests as indicated in the foreword. (See also the
rationale in A.2.)