Would you like to conduct a biological evaluation of your medical devices according to ISO 10993-1?
Ensure the biocompatibility of your medical devices with ISO 10993-1
Ensuring the biological safety of your medical devices is an essential regulatory requirement.
Defining a biological evaluation strategy is a key step in identifying the risks associated with materials, released substances and contact with the patient.
The ISO 10993-1 standard provides a framework for this process by defining the overall approach to evaluating the biocompatibility of medical devices. It is based in particular on analysing biological risks and selecting appropriate tests according to the nature and intended use of the device.
At the FILAB laboratory, we support you with the help of partner toxicologists in defining and implementing your biological evaluation strategy, in accordance with the requirements of the ISO 10993-1 standard, to demonstrate the biocompatibility of your medical devices and secure your regulatory file.
Principle of biological evaluation according to ISO 10993-1
The ISO 10993-1 standard does not define a single test, but rather an approach based on biological risk analysis.
The objective is to determine which tests are necessary based on several criteria:
- nature of the materials
- type of contact with the human body
- duration of contact (limited, prolonged, or permanent)
- characteristics of the device
This analysis then makes it possible to establish a testing strategy suited to the medical device.
Our other analytical services according to ISO 10993
FILAB laboratory conducts the biological evaluation of your medical devices according to ISO 10993-1
Why choose FILAB for the biological evaluation of your medical devices according to ISO 10993-1?
With the support of a partner laboratory, FILAB assists you in conducting the biological evaluation of medical devices according to ISO 10993-1, alongside chemical characterization testing (ISO 10993-18).
In France, in the medical device sector, FILAB is one of the few laboratories offering a comprehensive 5,200 m² analytical facility for physicochemical analysis as part of the biological evaluation of your medical devices.
Our human scale, ongoing investments 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
The ISO 10993 standard applies to a wide range of medical devices:
- implantable devices
- surgical devices
- devices in contact with the skin or mucous membranes
- devices in contact with blood
- materials or components used in medical devices.
Biological evaluation consists of analysing the potential risks that a medical device may pose to the patient during use. Its purpose is to demonstrate that the materials and substances present in the device are biocompatible and safe for the body.
This process is governed by the ISO 10993-1 standard, which defines the overall approach to the biological evaluation of medical devices.
This process applies to most medical devices, particularly those that come into contact with the human body:
- implantable devices
- devices in contact with the skin or mucous membranes
- devices in contact with blood
- surgical instruments
- components or materials used in medical devices
The requirements depend primarily on the type and duration of contact with the body.
Yes. The chemical characterization of materials is an important step in biological evaluation.
It notably makes it possible to:
- identify extractable and leachable substances
- detect impurities or manufacturing residues
- assess the toxicological risks associated with the identified compounds
This information helps guide the biological testing strategy.
Yes. Biological evaluation is part of the regulatory requirements for placing medical devices on the market, particularly under the European regulation:
- Regulation (EU) 2017/745 (MDR)
It demonstrates that the medical device does not pose an unacceptable biological risk to the patient.
Biological evaluation can be carried out at different stages:
- during the development of a medical device
- following a material or process modification
- as part of a regulatory evaluation
- during a reevaluation of an existing device
This approach helps anticipate risks and secure market launch.
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.
Turnaround times vary depending on the type of analysis and the complexity of the expert assessment project.
However, FILAB is committed to providing fast timelines tailored to your industrial constraints and urgent requirements.
