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CAN/CSA-ISO 10993-1-01
Biological Evaluation of Medical Devices - Part 1: Evaluation and Testing (Adopted ISO 10993-1:1997, second edition, 1997-12-15)
SKU: 2701606
Published by CSA Group
Publication Year 2001
Withdrawn
Product Details
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.)
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.)
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CAN/CSA-ISO 10993-1-01
Biological Evaluation of Medical Devices - Part 1: Evaluation and Testing (Adopted ISO 10993-1:1997, second edition, 1997-12-15)
Withdrawn
English
CAN/CSA-ISO 10993-1-F01
Évaluation biologique des dispositifs médicaux - Partie 1: Evaluation et essais (norme ISO 10993-1:1997 adoptée, deuxième édition, 1997-12-15)
Withdrawn
French
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)
Withdrawn
English
CAN/CSA-ISO 10993.1-F98
Évaluation biologique des dispositifs médicaux - Partie 1: Lignes directrices pour le choix des essais (norme ISO 10993- 1:1992 adoptée, première édition)
Withdrawn
French