ISO 10993:2023
ISO 10993:2023 Biological evaluation of medical devices – Part 55: Interlaboratory study on cytotoxicity
CDN $263.00
Description
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.
Edition
1
Published Date
2023-02-06
Status
PUBLISHED
Pages
23
Language
English
Format
Secure PDF
Secure – PDF details
- Save your file locally or view it via a web viewer
- Viewing permissions are restricted exclusively to the purchaser
- Device limits - 3
- Printing – Enabled only to print (1) copy
See more about our Environmental Commitment
Abstract
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.
Previous Editions
Can’t find what you are looking for?
Please contact us at:
Related Documents
-
ISO 10993:2017 Biological evaluation of medical devices – Part 11: Tests for systemic toxicity
CDN $349.00 Add to cart -
ISO 10993:2018 Biological evaluation of medical devices – Part 1: Evaluation and testing within a risk management process
CDN $364.00 Add to cart -
ISO 22442:2020 Medical devices utilizing animal tissues and their derivatives – Part 1: Application of risk management
CDN $263.00 Add to cart -
ISO 17593:2022 Clinical laboratory testing and in vitro medical devices – Requirements for in vitro monitoring systems for self-testing of oral anticoagulant therapy
CDN $397.00 Add to cart
