You wish to carry out 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 risks related to materials, released substances, and patient contact.
ISO 10993-1 provides the framework for this process by defining the overall approach to evaluating the biocompatibility of medical devices. It is based, in particular, on the analysis of biological risks and the selection of appropriate tests according to the nature and use of the device.
At FILAB Laboratory, we support you in defining and implementing your biological evaluation strategy, in accordance with the requirements of ISO 10993-1, to demonstrate the biocompatibility of your medical devices and ensure the integrity of your regulatory dossier.
Principle of biological assessment according to ISO 10993-1
ISO 10993-1 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 continuous)
- device characteristics
This analysis then allows for the development of a testing strategy tailored to the medical device.
Our other analytical services according to ISO 10993
The FILAB laboratory performs 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 biological evaluation of your medical devices according to ISO 10993-1, 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 within the framework 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 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 involves analyzing the potential risks a medical device may pose to the patient during use. Its aim is to demonstrate that the materials and substances present in the device are biocompatible and safe for the body.
This process is governed by ISO 10993-1, which defines the overall approach to the biological evaluation of medical devices.
This approach applies to the majority of medical devices, particularly those that come into contact with the human body:
- implantable devices
- evices 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. Chemical characterization of materials is an important step in biological evaluation.
It allows, in particular:
- the identification of extractable and leachable substances
- the detection of impurities or manufacturing residues
- the assessment of toxicological risks associated with the identified compounds
This information helps guide the biological testing strategy.
Yes. Biological evaluation is one 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 present an unacceptable biological risk to the patient.
Biological evaluation can be performed at different stages:
- during the development of a medical device
- during a modification of the material or process
- as part of a regulatory assessment
- during a re-evaluation of an existing device
This approach helps to anticipate risks and ensure safe market access.
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.
