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99.60 Withdrawal effective Nov 10, 2004
CEN
CEN/TC 206 Biological and clinical evaluation of medical devices
European Norm
11.020 Medical sciences and health care facilities in general
Withdrawn
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.
Legislation related to this standard
WITHDRAWN
EN ISO 10993-12:1996
99.60
Withdrawal effective
Nov 10, 2004
WITHDRAWN
EN ISO 10993-12:2004