What is ISO10993-5 Cytotoxicity testing?
Cytotoxicity testing is a fundamental first step in demonstrating the biological safety of medical devices. Regulatory authorities require biological endpoints which prove that materials in contact with human tissue do not cause cell damage or death.
As re-enforced by the ISO 10993-1, cytotoxicity testing is used as an early indicator to identify potentially harmful materials prior to costly downstream testing such as in vivo testing (animal studies).
By working with Test Labs and our team of experts on toxicological assessments, the ISO 10993-5 testing supports faster regulatory approval, reduced development risk, and avoidance of animal testing.
The ISO 10993-5 testing evaluates whether extracts or direct contact with a medical device result in reduced cell viability, altered cell morphology, or cell lysis (death). A test item is considered cytotoxic if cell viability is below 70% compared to the negative control.
Cytotoxicity testing is applicable to any medical device with direct or indirect contact with the human body, including: implantable devices and components; catheters, tubing, and wound dressings; surgical instruments, dental materials and devices; external communicating and surface-contacting devices; raw materials, coatings, and adhesives used in device manufacture.
Biological Evaluation Plan
BEP establishes your product testing requirements. It also helps to prevent unnecessary testing studies.ISO 10993-5 Cytotoxicity test
Cytotoxicity testing using the MTT cytotoxicity assay, this test measures the viability of the cells via targeting the metabolic activity of the cell using the L929 cell line.Biological Evaluation Report
Your report will be issued with in two weeks of experimental phase completion, fully compliant with GLP requirementsISO 10993-5 Cytotoxicity testing
We perform ISO 10993-5 Cytotoxicity studies in compliance with the Principles of Good Laboratory Practice (GLP). GLP is a defined set of Principles designed to be implemented within a quality system of a test facility conducti ng non-clinical health and environmental safety studies intended for regulatory submission. These principles outline how studies should be planned, performed, monitored, recorded, archived, and reported with the aim to harmonise the way in which test facilities work.
The GLP Principles were published for test facilities to comply with to ensure the integrity, quality, consistency, and reliability of data that is produced.
The GLP regulations require that “regulatory studies” to demonstrate the safety or properties where the data is intended for submission must be performed at a test facility that is a member of the respective national compliance monitoring programme. As a member of this programme test facilities are inspected on a regular basis as an assessment of conformity.
Frequently Asked Questions
How long does a cytotoxicity test take?
Depending on the extraction time (which can differ based on the intended use of a medical device), a typical cytotoxicity test is performed within 3 days. At test Labs we ensure that pre-liminary results are notified on the same week of the results.
How should I prepare my device for testing?
The device should be in it’s finalised form – representative of the final market product. If the device is re-usable, Test Labs offer tailored testing to include reprocessing steps within the sample preparation of the test item, which allows for a rhobust and complete cytotoxic evaluation of the medical device.
What information about my device is required for cytotoxicity testing?
As our cytotoxicity testing is compliant with the principles of GLP, alongside the test item we would need further information on the production of the device such as: manufacturer name, address and date, manufacturing methods e.g. sterilisation processes and moulding processes, as well as surface areas and dimensions of test items.
Does cytotoxicity testing require animals?
No, cytotoxicity testing uses culture cells from animal origin , hence the rapid turnover in testing time.
Is cytotoxicity testing the only testing required for a medical device in terms of biocompatibility testing?
This could only be answered through a biological evaluation plan, which adopts a risk-based framework to asses your medical device. Post assessment, a cytotoxicity test could be the only test required to further justify/confirm your medical devices’ safety.
We won’t keep you waiting
We respond to all enquiries within minutes of receiving them.
Our lead times match the urgency and demand in the market – we offer industry-leading turnaround times because we know how critical reliable data is for your project. While what you’ve seen is our typical lead time, the final timeline will depend on your specific study requirements. But rest assured, we’ll do everything we can to deliver even faster.
Think of it like a relay race – we’ll hand over the data baton as quickly as possible, so you can keep moving forward on your medical device journey.