ÖNORM EN ISO 10993-12

Issue date: 2012 10 01

Biological evaluation of medical devices - Part 12: Sample preparation and reference materials (ISO 10993-12:2012)

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 ...

Withdrawn: 2021 09 15

Publisher:

Austrian Standards International

Format:

Digital | 30 Pages

Language:

German | English | Download GER/ENG

Currently valid:

ÖNORM EN ISO 10993-12:2021 09 15

Optionally co-design standards:

Committee 179: Medical technology

ICS

11.100.20

Topics

Healthcare, Laboratory medicine, Biological evaluation of medical devices

Summary

Norm timeline

Normative References

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.

ÖNORM EN ISO 10993-12

2021 09 15