Publication

PD ISO/TR 10993-55:2023

Biological evaluation of medical devices - Interlaboratory study on cytotoxicity

Current

•

Published:

28 Feb 2023

1 Scope

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.

BSI recommends this version of standard for organisations operating in or with the UK. The ISO edition is available here if required.

Product Details

Descriptors

Biological sciences

Biological tests

Medical equipment

Biomedical laboratory equipment

Cytotoxicity tests

Work study

ICS Codes

11.100.20 Biological evaluation of medical devices

Committee

CH/194

International relationships

Identical to:

ISO/TR 10993-55:2023

ISBN

978 0 539 23343 8

Publisher

BSI