Do you wish to carry out 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 can cause toxic effects, DNA damage, or promote the development of cancer.
ISO 10993-3 defines the principles for assessing these risks within the framework of the biological evaluation of medical devices.
At the FILAB laboratory, our teams support manufacturers in identifying and assessing the 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 alterations or genetic mutations. These alterations can lead to cellular dysfunction or promote the development of diseases.
- Carcinogenicity
Carcinogenicity assessment aims to determine whether prolonged exposure to certain substances can promote the development of tumors or cancers.
- Reproductive and Developmental Toxicity
Some compounds can also have effects on fertility, embryonic development, or fetal development. These effects must be identified as part of the biological assessment.
Why assess genotoxicity and toxicity according to ISO 10993-3?
The materials, additives, or manufacturing residues present in a medical device can release substances that may impact cells and DNA.
The tests defined in ISO 10993-3 allow, in particular, for:
- detecting substances that may damage genetic material;
- identifying potential carcinogenic risks;
- evaluating toxic effects on the body;
- and ensuring the biocompatibility of medical devices.
These tests help demonstrate that the device does not present an unacceptable toxicological risk to the patient.
A risk analysis-based approach
ISO 10993-3 is part of the overall approach 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 likely to be released by the device.
This analysis allows for the development of an appropriate toxicological evaluation strategy.
Our other analytical services according to ISO 10993
The FILAB laboratory performs genotoxicity, carcinogenicity, and toxicity testing on your medical devices according to ISO 10993-3
Why choose FILAB for your genotoxicity, carcinogenicity, and toxicity tests of your medical devices according to ISO 10993-3
With the support of a partner laboratory, FILAB assists you in conducting genotoxicity, carcinogenicity, and toxicity assessments of your medical devices according to ISO 10993-3, 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 comprehensive 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
ISO 10993-3 is part of a 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 a substance's ability to damage the genetic material of cells (DNA).
These alterations can lead to:
- genetic mutations
- cellular dysfunction
- an increased risk of developing diseases, particularly cancer.
Genotoxicity tests therefore make it possible to identify substances likely to 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 ISO 10993-3 are not systematically required for all medical devices.
Their necessity depends on several factors:
- the nature of the device
- the duration of contact with the human body
- the presence of potentially leaching chemicals
- the available scientific data.
The decision is based on a biological risk assessment.
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.
