Would you 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 testing is the first key step in demonstrating biocompatibility and ruling out any risk of cellular toxicity to the patient.
At the FILAB laboratory, we support you with the help of partner toxicologists in carrying out your in vitro cytotoxicity tests (elution, direct or indirect contact) in accordance with the ISO 10993-5 standard.
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 substances that may be released. This extract is then brought into contact with a cell culture.
The material is placed directly on the cell layer to observe its impact on cell viability and morphology.
An intermediate, such as agar, is used to observe the diffusion of any cytotoxic substances toward the cells.
The assessment is then based on various 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 may be implemented:
- Test of cell viability (MTT, XTT, NRU, etc.)
- Observation microscopique des cellules
- Measurement of cellular metabolic activity
- Quantitative assessment of cytotoxicity
These assays provide a qualitative and quantitative assessment of cellular toxicity.
Our other analytical services according to ISO 10993
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 testing on your medical devices according to the ISO 10993-5 standard, in addition to chemical characterization testing (ISO 10993-18).
In France, in the medical device sector, FILAB is one of the only laboratories offering a complete 5,200 m² analytical facility for physicochemical analysis as part of the biological evaluation of your medical devices.
Our human scale, ongoing investment and expertise in the medical device sector guarantee our clients reliable results, fast processing of requests and tailored support to meet their needs.
Our other analytical services
R&D support: tailor-made chemical analysis, material and surface characterization, analytical development
Process validation: Cleaning (ISO 19227), surface treatment
Problem solving: non-conformity, failure, adhesion, corrosion...
Our FAQ
To request a quote, you can contact our teams via our contact form, by phone or by email.
Simply send us your requirements (type of material, requested analysis, applicable standard, urgency, number of samples, etc.). We will then send you a personalized technical and pricing proposal within 24–48 hours.
Lead times vary depending on the type of analysis and the complexity of the expert assessment project.
FILAB is nevertheless committed to providing fast timelines tailored to your industrial constraints and urgent requirements.
Cytotoxicity tests can be applied to many different products:
- implantable medical devices
- devices that come into contact with the skin or mucous membranes
- medical instruments
- polymer materials
- coatings or surface treatments
- glues, adhesives or inks used in the device
They can be performed at different stages of product development : R&D, validation or quality control.
A cytotoxicity test assesses the potential effect of a material or device on living cells. It determines whether substances released by a product may cause cellular 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 the ISO 10993 standard.
The ISO 10993-5 standard defines test methods for assessing the cytotoxicity of medical devices.
It specifies in particular:
- cell exposure methods
- toxicity assessment criteria
- the experimental conditions to be followed
The objective is to ensure a standardized and reproducible assessment of cellular toxicity.
Cytotoxicity tests are generally required for the majority of medical devices, particularly 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
Requirements depend on the type of contact, duration of exposure and nature of the material.
Cytotoxicity tests can be performed at several stages in the life cycle of a medical device:
- during product development (R&D)
- following a material or process modification
- as part of a regulatory assessment
- during quality control
They often represent the first stage of biological evaluation.
