logo

Standards Manage Your Business

We Manage Your Standards

ISO

ISO/TR 10993-55:2023

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

Standard Details

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.

General Information

Status : Published
Standard Type: Main
Document No: ISO/TR 10993-55:2023
Document Year: 2023
Pages: 23
Edition: 1
  • Section Volume:
  • ISO/TC 194. Biological evaluation of medical devices
  • ICS:
  • 11.100.20 Biological evaluation of medical devices

Life Cycle

Currently Viewing

Published
ISO/TR 10993-55:2023
Knowledge Corner

Expand Your Knowledge and Unlock Your Learning Potential - Your One-Stop Source for Information!

© Copyright 2024 BSB Edge Private Limited.

Enquire now +