ISO 10993-12:2007
Withdrawn
A Withdrawn Standard is one, which is removed from sale, and its unique number can no longer be used. The Standard can be withdrawn and not replaced, or it can be withdrawn and replaced by a Standard with a different number.
A Withdrawn Standard is one, which is removed from sale, and its unique number can no longer be used. The Standard can be withdrawn and not replaced, or it can be withdrawn and replaced by a Standard with a different number.
Biological evaluation of medical devices Part 12: Sample preparation and reference materials
Hardcopy , PDF 1 User , PDF 3 Users , PDF 5 Users , PDF 9 Users
08-09-2018
English, French
31-10-2007
ISO 10993-12:2007 specifies requirements and gives guidance on the procedures to be followed in the preparation of samples and the selection of reference materials for medical device testing in biological systems in accordance with one or more parts of the ISO 10993 series. Specifically ISO 10993-12:2007 addresses:
- test sample selection;
- selection of representative portions from a device;
- test sample preparation;
- experimental controls;
- selection of and requirements for reference materials;
- preparation of extracts.
ISO 10993-12:2007 is not applicable to materials or devices containing live cells.
Important note : All end users must be registered with an Account prior to user licenses being assigned.Access your standards online with a subscription
Features
-
Simple online access to standards, technical information and regulations.
-
Critical updates of standards and customisable alerts and notifications.
-
Multi-user online standards collection: secure, flexible and cost effective.