Dispositifs médicaux
ACM Pharma News

Mastering the Microbiological Safety of Your Medical Devices

08/10/2025

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Because the medical device industry holds no secrets for ACM Pharma, we put our expertise at the service of your devices — regardless of their nature, size, or complexity.

Microbiological analysis of medical devices can be particularly demanding. Each product requires tailored methods, strict compliance with regulatory standards, and the development of a specific protocol. This process is one we master at every stage.


1️⃣ Complete Microbiological Pathway of a Medical Device

📄 Accreditation COFRAC n° 1-7464 according to NF EN ISO/IEC 17025 – scope available on www.cofrac.fr

We support you in ensuring the safety and compliance of your devices in accordance with the following standards:

  • NF EN ISO 11137-1: Development, validation, and routine control of sterilization processes by irradiation
  • NF EN ISO 11137-2: Sterility testing
  • NF EN ISO 11737-3: Bacterial endotoxin testing – essential for evaluating the risks related to pyrogens

2️⃣ Evaluation of the Effectiveness of Your Disinfection Technologies

Effective disinfection prior to sterilization helps reduce microbial load, eliminate organic contaminants, and optimize the efficiency of the sterilization process.

ACM Pharma evaluates the effectiveness of your disinfection technologies according to current standards, ensuring both compliance and performance.


3️⃣ Microbiological Monitoring of the Production Environment

A controlled environment is essential to ensure the quality of your medical devices.

Our teams carry out the necessary sampling and microbiological analyses. We also offer a dedicated training course in partnership with UPS Consultants.

🎓 Recommended training:
“UPR21 – Microbiological monitoring of the production environment for medical devices: requirements of standard NF EN 17141”


📞 A question? A specific need?

Our experts are here to offer you tailor-made solutions that comply with regulatory requirements.

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