--- type: "WebPage" title: "Particulate counting laboratory in accordance with AAMI TIR42" description: "Would you like to analyze your medical devices according to AAMI TIR42? What is AAMI TIR42? First of all, AAMI develops standards relating to the counting of particulate contamination in Medical Devices.As for AAMI’s Technical Information Report (TIR), entitled \"Evaluation..." resource: "https://filab.fr/en/sectors-of-activity/laboratory-analysis-medical-devices/particle-counting-laboratory-according-to-the-aami-tir42-standard/" tags: ["EN", "pll_6282030e1069b", "Anaïs DECAUX"] timestamp: "2026-08-18T14:22:58Z" published: "2022-06-15T14:08:28Z" language: "en" author: "bwa" --- # Particulate counting laboratory in accordance with AAMI TIR42 ## Would you like to analyze your medical devices according to AAMI TIR42? ### What is AAMI TIR42? First of all, AAMI develops standards relating to the counting of particulate contamination in Medical Devices. As for AAMI’s Technical Information Report (TIR), entitled "Evaluation of Particles Associated with Vascular Medical Devices," it provides guidance to medical device manufacturers for assessing their products’ tendency to release particles, identifying potential sources of these particles, applying appropriate analytical methods for particle testing, and establishing particle limits based on a clinical risk assessment. The standard does not provide specific numerical limits due to the variability of devices and clinical contexts; however, it provides detailed guidelines for developing [particle](https://filab.fr/nos-prestations/expertise/laboratoire-analysis-particules-contamination/) specifications and encourages manufacturers to carry out in-depth analysis to ensure the safety and effectiveness of their products. ### The objectives of AAMI TIR42 AAMI TIR42 has several objectives to help vascular medical device manufacturers: Determine the source of the particles Define appropriate test methods Establish product particle limits Assess the clinical relevance of particulate contamination ## COFRAC ISO 17025 accredited, how does FILAB support you with particle count analysis according to AAMI TIR42? The FILAB laboratory is [an expert in particle contamination counting](https://filab.fr/en/our-services/our-expertise-services/laboratory-analysis-deposit-contamination/laboratory-identification-counting-particulate-contmaninant.md) on medical devices according to the AAMI TIR42 standard. Indeed, the laboratory offers manufacturers specializing in the production of medical devices technical expertise and a [state-of-the-art analytical platform](https://filab.fr/en/our-technical-resources.md). This platform is designed to respond as effectively and quickly as possible to their requests, offering the most suitable services as well as tailored support. ### Our other standards for particle identification To provide precise and reliable answers to these issues, FILAB offers tailored support for particle identification according to: [USP 788](https://filab.fr/en/our-services/our-expertise-services/laboratory-analysis-particulate-contaminant/particle-counting-laboratory-according-to-usp-788.md) [ISO 19227](https://filab.fr/en/our-services/our-expertise-services/laboratory-analyis-standard-iso-19227/particle-counting-laboratory-on-dm-according-to-iso-19227-standard.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)) **FILAB is COFRAC ISO 17025 accredited for [particle count](https://filab.fr/en/our-services/our-expertise-services/laboratory-analysis-deposit-contamination/laboratory-identification-counting-particulate-contmaninant.md) analysis on Medical Devices and Equipment according to ISO 19227 and USP 788.** *For more information: [www.cofrac.fr](https://www.cofrac.fr)* ### Our services Particle identification on medical devices by [scanning electron microscopy (SEM)](https://filab.fr/nos-moyens-techniques/laboratoire-d-analysis-par-microscopie-electronique-a-balayage-meb-edx/) Medical device analysis by [infrared microscopy (FTIR)](https://filab.fr/en/our-technical-resources/tga-tga-ftir-and-tga-ms-analysis-at-filab-laboratory/atg-irtf-ftir-coupling-analysis-laboratory.md) [Contamination analysis by SEM EDX](https://filab.fr/en/our-technical-resources/laboratory-analysis-sem-scanning-electron-microscopy/laboratory-analysis-contaminants.md) Particle extraction from medical devices Particulate counting by filtration using [optical microscopy (OM)](https://filab.fr/en/our-technical-resources/laboratory-of-analysis-and-observation-by-optical-microscope-mo.md) ## FAQ What analytical methodologies are recommended by AAMI TIR42? AAMI TIR42 is a guidance document that provides recommendations on how to test medical device materials for chemicals that may pose a risk to patient safety. To identify and quantify these chemicals, AAMI TIR42 recommends using several different analytical methods. One of the recommended analytical methods is gas chromatography-mass spectrometry (GC-MS), which is used to separate and identify small molecules in complex mixtures. This technique involves examining the individual components of a mixture and analyzing their physical properties to determine what they are. Another method is high-performance liquid chromatography (HPLC), which is used to separate and identify organic molecules in complex mixtures. This technique is particularly useful for identifying chemicals that may be present in very small quantities. A third recommended analytical method is Fourier-transform infrared spectroscopy (FTIR), which makes it possible to identify the chemical functional groups present in a material. FTIR analyzes the wavelengths of light absorbed by a sample, revealing the different chemical bonds present. Finally, inductively coupled plasma optical emission spectroscopy (ICP-OES) is recommended to determine the elemental composition of a sample. This technique involves ionizing the sample and measuring the wavelengths of light emitted by excited atoms. AAMI TIR42 recommends several different analytical methods for identifying and quantifying chemicals in medical device materials, including GC-MS, HPLC, FTIR, XPS, and ICP-OES. These techniques help ensure that medical devices are safe for patient use by identifying any potentially hazardous chemical substances that may be present   Why is it important to perform particulate counting in accordance with AAMI TIR42 standards? Particulate contamination counting is an important aspect of medical device material control, as it can help ensure their safety and effectiveness. The AAMI TIR42 document provides guidelines on how to carry out particulate contamination counting in order to detect any microscopic particles that may be present in the material. Particles can come from various sources, including the manufacturing process, the environment, or the materials themselves. They may be foreign bodies in the material or be generated by wear of the device during use. Particulate contamination can lead to a range of problems, including inflammation, thrombosis, and other adverse reactions, which is why it is important to detect and measure the level of contamination. AAMI TIR42 recommends performing particulate contamination counting using optical microscopy, which involves examining a sample of the material under a microscope in order to count and classify the particles present. The size, shape, and composition of the particles can also be assessed to determine their potential impact on the safety and effectiveness of the device.  By performing particulate contamination counting in accordance with AAMI TIR42 standards, medical device manufacturers can identify and quantify any particulate contamination present in their materials and take appropriate measures to ensure the safety and effectiveness of their devices. This is especially important for medical devices that will be implanted or used in close contact with the body, as particulate contamination can have serious consequences for patient health.   Why outsource particulate contamination counting? Outsourcing particulate contamination counting can be beneficial for several reasons, including ensuring accurate and unbiased results. AAMI TIR42 recommends that particulate contamination counting be carried out by an external testing laboratory specializing in this type of analysis. Outsourcing particulate contamination counting makes it possible to carry out an objective assessment of materials. An external laboratory has no direct stake in the outcome of the analysis, which helps ensure impartial and accurate results. In addition, external laboratories may have access to specialized equipment or techniques that are not available in-house, enabling a more comprehensive and detailed analysis. It ensures compliance with regulatory requirements. External laboratories are often accredited by regulatory bodies and must comply with strict quality control measures, ensuring that their analysis meet the highest standards. By entrusting particulate contamination counting to an accredited laboratory, medical device manufacturers can demonstrate to regulatory authorities that they follow best practices and comply with relevant standards, such as AAMI TIR42. Finally, outsourcing particulate contamination counting saves time and resources. Performing this type of analysis in-house requires investment in specialized equipment, staff training, and valuable laboratory space. By using an external laboratory, medical device manufacturers can free up resources to focus on other areas of product development and ensure accurate, timely results.