Particle counting laboratory according to the AAMI TIR42 standard

Medical device professionals, you want to analyze them according to the AAMI TIR42?

First, AAMI develops standards for counting particulate contamination in Medical Devices. 

The AAMI Technical Information Report (TIR) addresses vascular exposure to particulate matter resulting from the manufacturing environment and use of medical devices.

This TIR has several objectives to assist manufacturers of vascular medical devices, as follows: 

  • Determine the source of the particulate matter,
  • establish product particle limits,
  • define appropriate test methods, and
  • assess the clinical relevance of particulate contamination.

FILAB is an expert in particle contamination counting on medical devices according to the AAMI TIR42 standard.

COFRAC ISO 17025 accredited, how does FILAB support you in particle counting analysis according to AAMI TIR42?

FILAB is able to assist you in the analysis of particle counts according to AAMI TIR42. Indeed, the laboratory offers to industrialists specialized in the manufacture of medical devices technical skills and a state-of-the-art analytical park.

The aim of this equipment is to respond in the best possible way and in a reactive manner to their request and to offer them the most appropriate services and a tailor-made follow-up. It is also possible to perform these analyses on an emergency basis.  

In order to respond accurately and reliably to these issues, FILAB offers tailor-made support for particle identification in your DMs according to AAMI TIR42 but also USP788, PE 2.9.19, and ISO 19227…

  • Particle extraction and counting on implants – AAMI TIR42 methodology
  • Particle counting on implantable DM by Optical Microscope
  • Particle contamination analysis according to AAMI TIR42
  • Identification of particles in your pharmaceutical solutions by Scanning Electron Microscopy (SEM)
  • Analysis of your pharmaceutical solutions by infrared microscopy (FTIR)
  • Analysis and identification of particles in your pharmaceutical solutions by ICP-MS, ICP-AES

For more information, consult our expert’s word or contact us : contact@filab.fr – tel : 03.80.52.32.05 or ask for a quote here.

Thank you !

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