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ISO/TR 10993-55:2023

Current Revision

Biological evaluation of medical devices - Part 55: Interlaboratory study on cytotoxicity

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This document describes the results of an international interlaboratory study conducted in 2006 to evaluate the performance of two different test protocols in terms of the cytotoxic effects in the biological evaluation of medical devices. The results of these tests were used for the revision of ISO 10993-5.[2] Furthermore, the results of these tests were used to estimate the accuracy of these test systems with living cells to define a threshold what is considered a cytotoxic effect.

NOTE            The determination of cytotoxic effects has a high relevance in the biological evaluation of medical devices; according to ISO 10993-1[1], it is one of the very few tests which are proposed to be performed for every kind of device.


SDO ISO: International Organization for Standardization
Document Number ISO/TR 10993
Publication Date Not Available
Language en - English
Page Count
Revision Level
Supercedes
Committee ISO/TC 194
Publish Date Document Id Type View
Not Available ISO/TR 10993-55:2023 Revision