Toxicological assessment of leachable substances according to ISO 10993-17
Would you like to carry out a toxicological assessment of the leachable substances from your medical devices according to ISO 10993-17?
Medical devices: ISO 10993-17 compliance
Ensuring the biological safety of your medical devices is an essential regulatory requirement.
The assessment of leachable substances is a key step in demonstrating biocompatibility and managing risks for patients.
At the FILAB laboratory, we support you in the toxicological assessment of your extractable and leachable substances in accordance with ISO 10993-17.
Our approach: a rigorous and compliant assessment
ISO 10993-17 applies only to medical devices that come into contact with patients. This standard makes it possible to identify and quantify hazardous toxic substances through a systematic process.
The duration of device use (limited, prolonged or permanent contact).
The route of administration (dermal, circulatory, implant, etc.).
The specific case of vulnerable populations (paediatrics, neonatology).
International toxicological databases (ECHA, IRIS, ToxNet).
The threshold of toxicological concern (TTC) for substances with no available data.
The application of rigorous uncertainty factors to ensure the maximum safety margin.
Our other analytical services according to ISO 10993
The FILAB laboratory carries out the toxicological analysis of leachable substances from your medical devices according to ISO 10993-17
Why choose FILAB for the toxicological assessment of leachable substances from your medical devices according to ISO 10993-17?
With the support of a partner laboratory, FILAB assists you in carrying out the toxicological assessment of leachable substances from your medical devices according to ISO 10993-17, 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 investments, and in-depth knowledge of 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
A leachable substance is a chemical compound that may be released by a medical device during use.
It may originate from the materials, manufacturing processes, or the degradation of the product over time.
Extractables: substances that can be extracted under forced conditions (laboratory testing)
Leachables: substances actually released under normal conditions of use
Toxicological assessment focuses primarily on leachables because they reflect the patient’s actual exposure.
The assessment is generally carried out:
after extractables/leachables studies
during device development
in the event of a material or process change
during regulatory requalification
Risk is determined by comparing:
patient exposure (estimated dose)
acceptable toxicological thresholds (PDE, TTC, etc.)
If exposure is below the threshold, the risk is considered to be controlled.
All devices that come into contact with the patient are concerned, including:
implantable devices
devices involving prolonged or repeated contact
devices involving direct or indirect contact (fluids, skin, mucous membranes)
Toxicological assessment requires:
high-level scientific expertise
mastery of regulatory guidelines
the ability to interpret analytical data
A specialized laboratory helps you secure your technical documentation and avoid refusals or requests for additional information from the authorities.
Timeframes vary depending on the nature of the analysis and the complexity of the expert assessment project.
However, FILAB is committed to providing fast timelines adapted to your industrial constraints and urgent requirements.
To obtain a quote, you can contact our teams via our contact form, by phone, or by email.
Simply send us your requirements (material type, desired analysis, applicable standard, urgency, number of samples, etc.). We will then send you a personalized technical and commercial proposal within 24–48 hours.
