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CAN/CSA-ISO 10993.1-98
Biological Evaluation of Medical Devices - Part 1: Guidance on Selection of Tests (Adopted ISO 10993-1:1992, first edition)
SKU: 2410898
Published by CSA Group
Publication Year 1998
11 pages
Withdrawn
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Scope
This part of ISO 10993 gives guidance on
(a) the fundamental principles governing the biological evaluation of medical devices;
(b) the definition of categories of devices based on the nature and duration of contact with the body;
(c) the selection of appropriate tests.
ISO 10993 does not cover testing of materials and devices that do not come into contact with the patient's body directly or indirectly. 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 A.2, clause 1 Scope.)
This part of ISO 10993 gives guidance on
(a) the fundamental principles governing the biological evaluation of medical devices;
(b) the definition of categories of devices based on the nature and duration of contact with the body;
(c) the selection of appropriate tests.
ISO 10993 does not cover testing of materials and devices that do not come into contact with the patient's body directly or indirectly. 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 A.2, clause 1 Scope.)
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