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ISO 10993-12

Biological evaluation of medical devices - Part 12: Sample preparation and reference materials

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Organization: ISO
Publication Date: 1 July 2012
Status: active
Page Count: 28
ICS Code (Biological evaluation of medical devices): 11.100.20
scope:

This part of ISO 10993 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 ISO 10993. Specifically, this part of ISO 10993 addresses the following:

- 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.

This part of ISO 10993 is not applicable to live cells, but can be relevant to the material or device components of combination products containing live cells.

Document History

June 19, 2020
Biological evaluation of medical devices — Part 12: Sample preparation and reference materials
This document specifies requirements and gives guidance on the procedures in the preparation of samples and the selection of reference materials for medical device testing primarily in biological...
ISO 10993-12
July 1, 2012
Biological evaluation of medical devices - Part 12: Sample preparation and reference materials
This part of ISO 10993 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...
November 15, 2007
Biological evaluation of medical devices — Part 12: Sample preparation and reference materials
This part of ISO 10993 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...
December 15, 2002
Biological Evaluation of Medical Devices - Part 12: Sample Preparation and Reference Materials
This part of ISO 10993 specifies requirements and gives guidance on the procedures to be followed in the preparation of samples and the selection of reference materials for medical devices testing in...
December 15, 2002
Biological Evaluation of Medical Devices - Part 12: Sample Preparation and Reference Materials
A description is not available for this item.
September 15, 1996
Biological Evaluation of Medical Devices - Part 12: Sample Preparation and Reference Materials
A description is not available for this item.

References

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