--- type: "WebPage" title: "Analysis and characterization according to medical standards" description: "Would you like to perform an analysis or characterization according to medical standards? Medical standards in the manufacture of medical devices First of all, there are a large number of medical standards governing the market launch of medical devices.These standards..." resource: "https://filab.fr/en/sectors-of-activity/laboratory-analysis-medical-devices/analysis-and-characterization-according-to-medical-standards/" tags: ["EN", "pll_62fcb259dfc8b", "Anaïs DECAUX"] timestamp: "2026-08-25T05:37:06Z" published: "2023-03-24T11:06:55Z" language: "en" author: "bwa" --- # Analysis and characterization according to medical standards ## Would you like to perform an analysis or characterization according to medical standards? ### Medical standards in the manufacture of medical devices First of all, there are a large number of medical standards governing the market launch of medical devices. These standards aim to guarantee the quality and safety of these medical devices by analyzing and characterizing their properties and composition. These standards apply to all types of medical devices, whether they are made of [polymer](https://filab.fr/en/our-services/our-expertise-services/laboratory-biocompatibility-testing/iso-10993-13-medical-devices-characterization.md), [ceramic](https://filab.fr/en/our-services/our-expertise-services/laboratory-biocompatibility-testing/identification-and-quantification-of-degradation-products-on-ceramic-medical-devices-according-to-iso-10993-14.md), or [metallic materials](https://filab.fr/nos-prestations/analyse/laboratoire-caracterisation-des-materiaux/laboratoire-expertise-materiau-metallique.md). Thanks to its extensive experience in the analysis and characterization of nanomaterials, FILAB laboratory is also able to perform [nanomaterial analyses](https://filab.fr/en/our-services/our-expertise-services/laboratory-analysis-nanomaterial/laboratoty-iso-10993-22-nanomaterial-characterization.md) in accordance with medical standards. Consequently, only a laboratory equipped with state-of-the-art analytical facilities capable of performing all kinds of analyses can analyze and characterize products in accordance with medical standards. ### Why perform an analysis or characterization according to medical standards? The [analysis of medical devices](https://filab.fr/en/sectors-of-activity/laboratory-analysis-medical-devices.md) according to medical standards (such as ISO 10993, the European MDR, and FDA requirements) is a crucial and mandatory step for several fundamental reasons. It is not merely a formality, but an approach that directly impacts patient safety, the company’s credibility, and its ability to operate in the global market. ### Analysis According to Medical Standards - Patient safety and clinical effectiveness (biocompatibility) - Regulatory compliance and market access - Operational and financial benefits for the company ## FILAB offers analysis and characterization services according to medical standards ### Why choose FILAB for analysis according to medical standards? To support manufacturers in the development and quality control of their products while keeping pace with regulatory changes, the [FILAB](https://filab.fr/) laboratory provides access to a state-of-the-art [analytical platform](https://filab.fr/en/our-technical-resources.md), enabling analysis and characterizations according to various medical standards. **FILAB is the only laboratory**accredited**by COFRRAC ISO 17025**for the three material degradation tests: - **ISO 10993-13: polymers,** - **ISO 10993-14: ceramics,** - **ISO 10993-15: metals** ## our services [ISO 10993-13: characterization of polymeric medical devices](https://filab.fr/en/our-services/our-expertise-services/laboratory-biocompatibility-testing/iso-10993-13-medical-devices-characterization.md) [ISO 10993-22:2017: Characterization of nanomaterials in medical devices](https://filab.fr/en/our-services/our-expertise-services/laboratory-analysis-nanomaterial/laboratoty-iso-10993-22-nanomaterial-characterization.md) Characterization of passivation on the surface of medical devices according to [ASTM A967\/A967M](https://filab.fr/en/our-services/our-analysis-services/metallurgical-analysis-laboratory/astm-a967-analysis-laboratory.md) and [ASTM F86-21](https://www.astm.org/f0086-21.html) Passivation according to [ASTM F86-21](https://www.astm.org/f0086-21.html) [ISO 10993-14: characterization of ceramic medical devices](https://filab.fr/en/our-services/our-expertise-services/laboratory-biocompatibility-testing/identification-and-quantification-of-degradation-products-on-ceramic-medical-devices-according-to-iso-10993-14.md) [Chemical characterization of materials according to ISO 10993-18](https://filab.fr/en/our-services/our-expertise-services/laboratory-biocompatibility-testing/laboratory-material-chemical-characterization.md) [Testing according to ASTM A380](https://filab.fr/en/our-services/our-analysis-services/metallurgical-analysis-laboratory/analysis-of-stainless-steels-to-astm-a380-standard.md) - A380M [Analysis of cleaning residues on medical devices according to ISO 19227](https://filab.fr/en/our-services/our-expertise-services/laboratory-analyis-standard-iso-19227.md) ## FAQ What is a medical device? A medical device is any instrument, apparatus, implant, reagent, or software intended to be used alone or in combination in humans for medical purposes. This includes the diagnosis, prevention, monitoring, treatment, or alleviation of a disease. Examples range from dressings and surgical gloves to implants, prostheses, MRI scanners, and pacemakers. Why does my medical device need to be analyzed? Analyzing your device is essential for three main reasons: - **Patient safety**: to ensure that the device is safe, effective, and does not pose unacceptable risks to users. - **Regulatory compliance**: to meet the requirements of health authorities (such as the FDA in the United States or the European Union) in order to obtain marketing authorization. - **Commercial credibility**: compliance with standards strengthens healthcare professionals’ and consumers’ confidence in your product. What is biocompatibility analysis? **Biocompatibility** is the ability of a material or device to interact with living tissues without causing adverse reactions (toxic, inflammatory, allergic, etc.). Biocompatibility testing, in accordance with ISO 10993, is mandatory for all devices that come into contact with the human body, even for a short period.