ISO/TR 10993-55:2023 医療機器の生物学的評価 — Part 55: 細胞毒性に関する研究所間研究 | ページ 2

Foreword

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This document was prepared by Technical Committee ISO/TC 194, Biological and clinical evaluation of medical devices.

A list of all parts in the ISO 10993 series can be found on the ISO website.

Introduction

The first edition of ISO 10993-5, published in 1992, allowed several different ways to assess cytotoxicity of medical devices and gave an imprecise description of how to perform the tests. Qualitative assays were accepted and only a small amount of guidance was given for the interpretation of the results. Not surprisingly, the first interlaboratory study in 2000 resulted in quite low reproducibility of results. Therefore, detailed protocols were included into the standard and in another study the practicability of the protocols and reference materials were evaluated. The results of this second interlaboratory study mainly influenced the revision of ISO 10993-5, which was published in 2009.

This document provides the historical report of the second interlaboratory study, conducted in 2006.

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.

2 Normative references

There are no normative references in this document.

3 Terms and definitions

No terms and definitions are listed in this document.

ISO and IEC maintain terminology databases for use in standardization at the following addresses:

Bibliography