You would like to perform cytotoxicity testing on your medical devices according to ISO 10993-5
Ensuring the biological safety of your medical devices is an essential regulatory requirement.
Cytotoxicity assessment is the first key step in demonstrating biocompatibility and eliminating any risk of cellular toxicity to the patient.
At the FILAB laboratory, we support you in conducting your in vitro cytotoxicity tests (elution, direct or indirect contact) in accordance with ISO 10993-5.
Principle of cytotoxicity testing according to ISO 10993-5
The test is based on observing the response of living cells exposed to the material or its extracts.
Several approaches can be used:
The device or material is placed in an extraction medium to recover any substances that may be released. This extract is then brought into contact with a cell culture.
The material is placed directly onto the cell layer in order to observe the impact on cell viability and morphology.
An intermediate (such as agar) is used to observe the diffusion of any cytotoxic substances into the cells.
The evaluation is then based on several criteria:
- Cell viability
- Morphological alterations
- Inhibition of cell growth
Analytical methods used
Depending on the nature of the device and the biological evaluation strategy, several methods can be implemented:
- Cell viability assay (MTT, XTT, NRU…)
- Microscopic observation of cells
- Measurement of cellular metabolic activity
- Quantitative assessment of cytotoxicity
These assays provide a qualitative and quantitative evaluation of cellular toxicity.
Our other analytical services according to ISO 10993
The FILAB laboratory performs cytotoxicity testing according to ISO 10993-5
Why choose FILAB for cytotoxicity testing of your medical devices according to ISO 10993-5
With the support of a partner laboratory, FILAB assists you in performing cytotoxicity tests on your medical devices according to ISO 10993-5, in addition to chemical characterization tests (ISO 10993-18).
In France, within the medical device sector, FILAB is one of the few laboratories to offer you a complete 5,200 m² analytical facility for physicochemical analyses as part of the biological evaluation of your medical devices.
Our human size, our permanent investments and our knowledge of the medical devices sector guarantee to our customers a reliability of the results, a fast treatment of the requests and a tailor-made support of their needs.
Our other analytical services
R&D support: custom chemical analysis, material and surface characterization, analytical development
Process validation: Cleaning (ISO 19227), surface treatment
Problem solving: non-conformity, breakage, adhesion, corrosion...
Our FAQ
Cytotoxicity testing can be applied to a wide range of products, including:
- implantable medical devices
- devices that come into contact with the skin or mucous membranes
- medical instruments
- polymer materials
- coatings or surface treatments
- adhesives, glues, or inks used in the device
These tests can be performed at various stages of product development: R&D, validation, or quality control.
A cytotoxicity test evaluates the potential effect of a material or device on living cells. It determines whether substances released by a product can cause cell damage, reduced viability, or inhibition of cell growth.
These tests are performed in vitro on cell cultures as part of the biological evaluation of medical devices defined by ISO 10993.
ISO 10993-5 defines the test methods for evaluating the cytotoxicity of medical devices.
It specifies, in particular:
- methods for cell exposure
- criteria for evaluating toxicity
experimental - conditions to be met
The objective is to ensure a standardized and reproducible evaluation of cell toxicity.
Cytotoxicity testing is generally required for most medical devices, especially those that come into contact with the human body:
- implantable devices
- devices that come into contact with the skin or mucous membranes
- surgical instruments
- materials or components of medical devices
The requirements depend on the type of contact, the duration of exposure, and the nature of the material.
Cytotoxicity testing can be performed at several stages of a medical device's lifecycle:
- during product development (R&D)
- during material or process modifications
- as part of a regulatory assessment
- during quality control
They often constitute the first step in biological evaluation.
To obtain a quote, you can contact our team via our contact form, by phone, or by email.
Simply tell us your requirements (type of material, desired analysis, applicable standards, urgency, quantity of samples, etc.). We will then send you a personalized technical and pricing proposal within 24-48 hours.
Turnaround times vary depending on the nature of the analysis and the complexity of the expert assessment project.
However, FILAB is committed to providing fast turnaround times tailored to your industrial constraints and urgent needs.
