Laboratory biocompatibility tests in accordance with ISO 10993
What is biocompatibility?
Biocompatibility is the ability of materials to perform a given function without having undesirable effects in the biological environment (degradation, interference, etc.) in which the material in question is used. A material must be biocompatible if it is used in the design of medical devices that will be in contact with a biological environment.
The biocompatibility of a material does not necessarily depend on the functional purpose of the medical devices that will incorporate this material. Biocompatibility depends above all on the contact time of the material with biological tissue, but also on the type of contact and its ability to fulfil its function. An example of a biocompatible material is titanium, a metallic material used in medical devices such as implants (bone substitutes, prostheses, etc.), for which FILAB performs analyses in accordance with the ISO 5832-3 standard.
Biocompatibility
How is the biocompatibility of a material assessed in accordance with ISO 10993?
In an evolving regulatory context, the harmonised standards in the NF EN ISO 10993 series are the current benchmarks for the biological evaluation of medical devices and the biocompatibility of materials.
Where to start?
First step :
Once this stage has been completed, FILAB will help you with the rest!
ISO 10993-12 : Preparation of samples and reference materials
ISO 10993-18 : Chemical characterization of materials
ISO 10993-13 : Identification and quantification of degradation products from polymer-based medical devices
ISO 10993-14 : Identification and quantification of degradation products from ceramics
ISO 10993-15 : Identification and quantification of degradation products from metals and alloys
ISO 10993-22 : Characterization of nanomaterials
ISO 10993-19 : Physicochemical, morphological and topographical characterization of materials
ISO 10993 standard in detail
ISO 10993 comprises the following parts, presented
under the general title "Biological Evaluation of Medical Devices".
ISO 10993-1
ISO 10993-2
ISO 10993-3
ISO 10993-4
ISO 10993-5
ISO 10993-6
ISO 10993-7
ISO 10993-8
ISO 10993-10
ISO 10993-11
ISO 10993-12
ISO 10993-13
ISO 10993-16
ISO 10993-17
ISO 10993-18
ISO 10993-20
ISO 10993-22
Our FAQs
The ISO 5832 series of standards defines the requirements for metallic materials used in the manufacture of medical devices, including chemical composition, mechanical properties, and other essential criteria to ensure their safety and effectiveness. Each part (ISO 5832-1 to ISO 5832-12) focuses on a specific type of metal or alloy, such as stainless steel, cobalt-chromium alloys, and titanium alloys, among others.
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