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ISO FDIS 10993-12

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

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Organization: ISO
Publication Date: 19 June 2020
Status: active
Page Count: 34
ICS Code (Biological evaluation of medical devices): 11.100.20
scope:

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 test systems primarily in accordance with one or more parts of ISO 10993.

Specifically, this document addresses the following:

- test sample selection;

- selection of representative portions from a medical device;

- test sample preparation;

- experimental controls;

- selection of, and requirements for, reference materials;

- preparation of extracts.

This document is not applicable to live cells but can be relevant to the material or medical device components of combination products containing live cells.

Extractions for chemical characterization are covered in ISO 10993-18. ISO 10993-18:2020, Clauses 7, 8, 9, 10 (except for 10.3.11 b) and 10.5), and 11 can apply to extractions for chemical characterization. Information given in C.1 to C.4 can also be relevant.

Document History

ISO FDIS 10993-12
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...
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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