CAN/CSA-ISO 10993.12-98 (R2002) PDF

CAN/CSA-ISO 10993.12-98 (R2002) PDF

Name:
CAN/CSA-ISO 10993.12-98 (R2002) PDF

Published Date:
01/19/2000

Status:
[ Withdrawn ]

Description:

Biological Evaluation of Medical Devices - Part 12: Sample Preparation and Reference Materials (Adopted ISO 10993-12:1996, first edition)

Publisher:
Canada National Standard/Canadian Standards - ISO

Document status:
Active

Format:
Electronic (PDF)

Delivery time:
10 minutes

Delivery time (for Russian version):
200 business days

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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.
File Size : 1 file , 910 KB
Number of Pages : 11
Published : 01/19/2000

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