Would you like to perform genotoxicity, carcinogenicity and toxicity testing on your medical devices according to ISO 10993-3?
Assess the toxicological risks of your medical devices
Medical devices can release substances that may interact with the body. Some of these substances may cause toxic effects, DNA damage or contribute to the development of cancer.
The ISO 10993-3 standard sets out the principles for assessing these risks as part of the biological evaluation of medical devices.
At the FILAB laboratory, our teams support manufacturers in identifying and assessing genotoxic and toxicological risks associated with substances potentially released by their medical devices.
The different risks assessed
- Genotoxicity
Genotoxicity testing aims to determine whether a substance can cause DNA damage or genetic mutations. This damage may lead to cellular dysfunction or contribute to the development of diseases.
- Carcinogenicity
Carcinogenicity assessment aims to determine whether prolonged exposure to certain substances may contribute to the development of tumors or cancer.
- Reproductive and developmental toxicity
Some compounds may also affect fertility, embryonic development or fetal development. These effects must be identified as part of the biological evaluation.
Why assess genotoxicity and toxicity according to ISO 10993-3?
The materials, additives or manufacturing residues present in a medical device may release substances that could affect cells and DNA.
The tests defined in the ISO 10993-3 standard are used in particular to:
- detect substances that may damage genetic material
- identify potential carcinogenicity risks
- assess toxic effects on the body
- ensure the biocompatibility of medical devices
These tests help demonstrate that the device does not pose an unacceptable toxicological risk to the patient.
A risk-based approach
The ISO 10993-3 standard forms part of the overall framework defined by ISO 10993-1
The objective is to determine whether specific tests are necessary, based on several parameters:
- nature of the materials
- type of contact with the body
- duration of exposure
- substances potentially released by the device.
This analysis makes it possible to establish an appropriate toxicological assessment strategy.
Our other analytical services according to ISO 10993
FILAB laboratory performs genotoxicity, carcinogenicity and toxicity testing on your medical devices according to ISO 10993-3
Why choose FILAB for genotoxicity, carcinogenicity and toxicity testing on your medical devices according to ISO 10993-3
With the support of a partner laboratory, FILAB assists you in conducting genotoxicity, carcinogenicity and toxicity testing on your medical devices according to ISO 10993-3, in addition to chemical characterization testing (ISO 10993-18).
In France, within the medical device sector, FILAB is one of the few 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 turnaround times 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
The ISO 10993-3 standard is part of the series of standards dedicated to the biological evaluation of medical devices.
It defines the principles for assessing risks related to genotoxicity, carcinogenicity and reproductive toxicity, in order to ensure the biological safety of medical devices.
Genotoxicity refers to the ability of a substance to damage the genetic material of cells (DNA).
This damage may lead to:
- genetic mutations
- cellular dysfunction
- an increased risk of developing diseases, particularly cancer.
Genotoxicity tests therefore identify substances that may cause genetic damage.
Genotoxicity and carcinogenicity are two related but distinct concepts:
- Genotoxicity: the ability of a substance to cause DNA damage or genetic mutations.
- Carcinogenicity: the ability of a substance to promote the development of tumors or cancers.
A genotoxic substance may pose a carcinogenic risk, but not all carcinogenic substances are necessarily genotoxic.
The tests defined in the ISO 10993-3 standard are not systematically required for all medical devices.
Whether they are necessary depends on several factors:
- the nature of the device
- the duration of contact with the human body
- the presence of chemical substances likely to be released
- the available scientific data.
The decision is based on a biological risk assessment.
To request a quote, you can contact our teams via our contact form, by phone, or by email.
Simply send us your requirements (material type, 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.
However, FILAB is committed to providing fast turnaround times tailored to your industrial constraints and urgent requirements.
