CAN/CSA-ISO 10993-1-01:2001 Edition

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Biological Evaluation of Medical Devices – Part 1: Evaluation and Testing

Published By	Publication Date	Number of Pages
CSA	2001-01-01	23

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Categories: 11.040 - Medical equipment, 11.060.01 - Dentistry in general, 11.120.01 - Pharmaceutics in general, CSA

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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 patients 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.)

Published Code

CSA

Published By

Canadian Standards Association

Publication Date

2001-01-01

Pages Count

Language

English

Descriptors

Medical Equipment, Medical Devices, Categories, Tests, Biological Tests, Bioassay, Selection

File Size