Codes & Standards - Subscribe
CAN/CSA-ISO 10993.12-98 (R2002)
Biological Evaluation of Medical Devices - Part 12: Sample Preparation and Reference Materials (Adopted ISO 10993-12:1996, first edition)
SKU: 2700349
Published by CSA Group
Publication Year 1998
Reaffirmed in 2002
Withdrawn
Product Details
Scope
This part of ISO 10993 specifies requirements and gives guidance on procedures to be followed in the preparation of samples of medical devices for testing in biological systems in accordance with one or more other parts of ISO 10993. These include:
(a) test material selection;
(b) selection of representative portions from a device;
(c) test sample preparation;
(d) the selection of reference materials to demonstrate the suitability of the test system and/or to enable relative comparison of the biological activity of the test sample; and,
(e) preparation of extracts.
This part of ISO 10993 specifies requirements and gives guidance on procedures to be followed in the preparation of samples of medical devices for testing in biological systems in accordance with one or more other parts of ISO 10993. These include:
(a) test material selection;
(b) selection of representative portions from a device;
(c) test sample preparation;
(d) the selection of reference materials to demonstrate the suitability of the test system and/or to enable relative comparison of the biological activity of the test sample; and,
(e) preparation of extracts.
items 1 - 1 of 1 result(s)
View 20 | View 100
CAN/CSA-ISO 10993.12-98 (R2002)
Biological Evaluation of Medical Devices - Part 12: Sample Preparation and Reference Materials (Adopted ISO 10993-12:1996, first edition)
Withdrawn
English
CAN/CSA-ISO 10993.12-F98 (C2002)
Évaluation biologique des dispositifs médicaux - Partie 12: Préparation des échantillons et matériaux de référence (norme ISO 10993-12:1996 adoptée, première édition)
Withdrawn
French