Are there other standards for the biocompatibility of surgical implants?

Name: Biocompatibility tests - ISO 10993
Brand: FILAB
SKU: FILAB-11586
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Biocompatibility testing in accordance with the ISO 10993

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FILAB is the only laboratory accredited by COFRAC ISO 17025 for the three material degradation tests: ISO 10993-13: polymers, ISO 10993-14: ceramics, ISO 10993-15: metals.

Definition

What is biocompatibility?

Biocompatibility is the ability of materials to perform a given function without causing adverse effects in the biological environment (degradation, interference, etc.) in which the material is used. A material must be biocompatible if it is used in the design of medical devices that will come into contact with a biological environment.

The biocompatibility of a material does not necessarily depend on the intended function of the medical devices that will include this material. Biocompatibility depends above all on the length of time the material is in contact with biological tissues, but also on the type of contact and its ability to perform its function. An example of a biocompatible material: titanium, a metal material used in implant-type medical devices (bone substitutes, prostheses, etc.), for which FILAB carries out analysis according to ISO 5832-3.

Biocompatibility

How is the biocompatibility of a material assessed according to ISO 10993?

In an evolving regulatory context, the harmonized standards of the NF EN ISO 10993 series are the current reference standards for the biological evaluation of medical devices and the biocompatibility of materials.

Where to start?

First step:

ISO 10993-1: Evaluation and testing with a toxicologist (FILAB partner network). This first step will help you determine the steps to follow to verify the suitability of the materials used in your medical device and their ability to perform their functions without adverse effects in the biological environment (degradation, interference).
Under FDA requirements (U.S. Food and Drug Administration), additional tests may be required.

Once this step is completed, FILAB supports you with the next steps!

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

*Accreditations by COFRAC

ISO 10993 in detail

ISO 10993 includes the following parts, presented under the general title
"Biological Evaluation of Medical Devices"

Our FAQ

Are there other standards for the biocompatibility of surgical implants?

The series of standardsISO 5832defines 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 ona specific type of metal or alloy, such as stainless steel, cobalt-chromium alloys, and titanium alloys, among others.

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