--- type: "WebPage" title: "Particle counting laboratory for medical devices" description: "Do you need particle counting and identification on your medical devices? What does the regulations say about particle counting and identification? European and international regulations such as USP 788, PE 2.9.19, AAMI TIR42, NF EN ISO 8536-9:2015… require the control..." resource: "https://filab.fr/en/our-services/our-expertise-services/laboratory-analysis-particulate-contaminant/particle-counting-laboratory-for-medical-devices/" tags: ["EN", "pll_6282037124a7e", "Anaïs DECAUX"] timestamp: "2026-08-18T14:23:25Z" published: "2022-06-15T14:08:28Z" language: "en" author: "bwa" --- # Particle counting laboratory for medical devices ## Do you need particle counting and identification on your medical devices? ### What does the regulations say about particle counting and identification? European and international regulations such as [USP 788](https://www.uspnf.com/sites/default/files/usp_pdf/EN/USPNF/revisions/788_particulate_matter_in_injections.pdf), PE 2.9.19, AAMI TIR42, NF EN ISO 8536-9:2015… require the **control of [purity](https://filab.fr/en/our-services/our-expertise-services/laboratory-analysis-deposit-contamination/purity-analysis-laboratory.md) of medical devices** and, among other things, the counting and **identification of particulate contamination** on material surfaces. ### Particulate contamination of medical devices When a medical device is placed on the market, it is necessary to check whether it contains any impurities that could be released into the human body after implantation. Indeed, particulate contamination poses risks to the quality of Medical Devices and to human health. Therefore, [controlling the presence or absence of particulate contaminants](https://filab.fr/en/our-services/our-expertise-services/laboratory-analysis-deposit-contamination/laboratory-identification-counting-particulate-contmaninant.md) and/or determining a level of particulate contamination is one of the key steps in a process. It is also mandatory for batch release to the market, according to strict standards. ## The FILAB laboratory supports you in particle counting analysis on your medical devices in accordance with current standards ### Why choose FILAB for particle counting and identification? **The FILAB laboratory is** **currently the only laboratory in France accredited ISO 17025 by COFRAC for these services, covering both particle counting and particle identification by** **SEM-EDX** and **Infrared Microscopy**. FILAB offers medical device manufacturers technical expertise and [state-of-the-art analytical equipment](https://filab.fr/en/our-technical-resources.md) to respond as effectively and promptly as possible to their needs. ### Our particle counting and identification services for medical devices To provide precise and reliable answers to these issues, FILAB offers tailor-made support for the identification of particles on the surface of your medical devices, and for the validation of your cleaning processes. The laboratory is [ISO 17025 accredited by COFRAC](https://filab.fr/en/about-us/accreditations-en/laboratory-analysis-iso-17025.md) for the following scopes: **Particle counting** by [Optical Microscope](https://filab.fr/en/our-technical-resources/laboratory-of-analysis-and-observation-by-optical-microscope-mo.md) according to current standards: ISO 19227 (AAMI TIR), [ISO 10993-19](https://filab.fr/en/our-services/our-expertise-services/laboratory-biocompatibility-testing/medical-device-characterization-in-a-laboratory-iso-10993-19.md), [USP 788](https://filab.fr/en/our-services/our-expertise-services/laboratory-analysis-particulate-contaminant/particle-counting-laboratory-according-to-usp-788.md), [PE 2.9.19](https://filab.fr/en/our-services/our-expertise-services/laboratory-analysis-injectable-drugs/particle-counting-laboratory-according-to-ep-2-9-19.md) ([method 1](https://filab.fr/en/our-services/our-expertise-services/laboratory-analysis-injectable-drugs/particle-counting-ep-2-9-19-method-1.md) and [method 2](https://filab.fr/en/our-services/our-expertise-services/laboratory-analysis-injectable-drugs/particle-counting-ep-2-9-19-method-2.md)), [AAMI TIR 42](https://filab.fr/en/sectors-of-activity/laboratory-analysis-medical-devices/particle-counting-laboratory-according-to-the-aami-tir42-standard.md) **Particle identification** by [SEM-EDX](https://filab.fr/nos-moyens-techniques/laboratoire-d-analysis-par-microscopie-electronique-a-balayage-meb-edx/) and [µ-FTIR](https://filab.fr/en/our-technical-resources/laboratory-analysis-ftir-microscopy.md) according to current standards: ISO 10993-19, PE 2.9.52, PE 2.2. 24, AAMI TIR 42 More broadly, FILAB supports medical device manufacturers with: Les [analyses de résidus de nettoyage selon l'ISO 19227](https://filab.fr/en/our-services/our-expertise-services/laboratory-analyis-standard-iso-19227.md)  La [formation sur le comptage particulaire (USP 788, PE 2.9.19, ISO 16232…)](https://filab.fr/en/our-services/rd/laboratory-analytical-chemistry-training/training-particle-counting.md) Biocompatibility analysis according to ISO 10993 standards: [10993-18](https://filab.fr/en/our-services/our-expertise-services/laboratory-biocompatibility-testing/laboratory-material-chemical-characterization.md), [10993-12](https://filab.fr/en/our-services/our-expertise-services/laboratory-biocompatibility-testing/laboratory-exhaustiveness-verification-iso-10993-12.md), [10993-13](https://filab.fr/en/our-services/our-expertise-services/laboratory-biocompatibility-testing/iso-10993-13-medical-devices-characterization.md), [10993-14](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), [10993-15](https://filab.fr/en/our-services/our-expertise-services/laboratory-biocompatibility-testing/study-of-degradation-products-in-your-medical-devices-according-to-iso-10993-15.md), [10993-22](https://filab.fr/en/our-services/our-expertise-services/laboratory-analysis-nanomaterial/laboratoty-iso-10993-22-nanomaterial-characterization.md)