---
type: "WebPage"
title: "Particle counting laboratory for medical devices according to ISO 19227"
description: "Do you need particle counting according to ISO 19227? What does ISO 19227 say about particle counting on medical devices? The ISO 19227 standard sets out the requirements for the cleanliness of orthopedic implants as well as the validation of..."
resource: "https://filab.fr/en/our-services/our-expertise-services/laboratory-analyis-standard-iso-19227/particle-counting-laboratory-on-dm-according-to-iso-19227-standard/"
tags: ["EN", "pll_62820343cea9e", "Anaïs DECAUX"]
timestamp: "2026-08-18T14:22:24Z"
published: "2022-06-15T14:08:28Z"
language: "en"
author: "bwa"
---

# Particle counting laboratory for medical devices according to ISO 19227

## Do you need particle counting according to ISO 19227?

### What does ISO 19227 say about particle counting on medical devices?

The [ISO 19227](https://www.iso.org/fr/standard/66817.html) standard sets out the requirements for the cleanliness of orthopedic implants as well as the validation of the cleaning processes used.

Particulate contamination poses risks to solution quality and human health; therefore, monitoring the presence or absence of particulate contaminants and/or determining a level of particulate contamination is one of the key steps in a process.

## FILAB, an ISO 17025 laboratory accredited by COFRAC for particle counting according to ISO 19227

### Why choose FILAB?

**FILAB is COFRAC ISO 17025 accredited for [particle counting analysis](https://filab.fr/en/our-services/our-expertise-services/laboratory-analysis-deposit-contamination/laboratory-identification-counting-particulate-contmaninant.md) on medical devices made of ceramic, metal and polymer according to ISO 19227.** (For more information: [www.cofrac.fr](https://www.cofrac.fr/) – accreditation number 1-1793)

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 quickly as possible to their needs and provide them with the most suitable services and tailor-made support.

 [Discover our brochure](https://filab.fr/wp-content/uploads/2025/01/FICHE-SECTEUR-FR_DM.pdf)
### Our analysis services

To provide precise and reliable answers to these issues, FILAB offers tailor-made support for surface particle counting analysis on your medical devices to validate your cleaning processes:

- Particle counting after filtration by [optical microscope (OM)](https://filab.fr/en/our-technical-resources/laboratory-of-analysis-and-observation-by-optical-microscope-mo.md) and counting by image analyzer
- Identification of particles in your medical devices by [scanning electron microscopy (SEM)](https://filab.fr/nos-moyens-techniques/laboratoire-d-analysis-par-microscopie-electronique-a-balayage-meb-edx/) and [infrared microscopy (µ-IRTF](https://filab.fr/en/our-technical-resources/tga-tga-ftir-and-tga-ms-analysis-at-filab-laboratory/atg-irtf-ftir-coupling-analysis-laboratory.md))
- [Analysis of cleaning residues](https://filab.fr/en/our-services/our-expertise-services/laboratory-analyis-standard-iso-19227/analysis-of-heavy-metal-residues-according-to-iso-19227.md) according to [ISO 19227](https://filab.fr/en/our-services/our-expertise-services/laboratory-analyis-standard-iso-19227.md): HCT/COT, inorganic and detergent analysis
- Particle counting according to [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), [AAMI TIR42](https://filab.fr/en/sectors-of-activity/laboratory-analysis-medical-devices/particle-counting-laboratory-according-to-the-aami-tir42-standard.md), [USP 788](https://filab.fr/en/our-services/our-expertise-services/laboratory-analysis-particulate-contaminant/particle-counting-laboratory-according-to-usp-788.md)
- Validation of analytical and extraction methods

  We’re featured in DeviceMed
## How to check the particulate cleanliness of your medical device?

 [Discover our press article](https://filab.fr/wp-content/uploads/2026/05/DEVFR-001.2025-12-13.pdf)