Microbiology for Medical Devices

Microbiology for Medical Devices

Microbiology for Medical Devices

Microbiological testing is imperative to safeguard patient health. We offer a range of testing services specifically for the healthcare sector, to help prevent microbial contamination and support compliance. This includes test methods for medical devices and wound care.

Manufacturers of medical devices must ensure that their products meet the highest quality control standards. Microbiological testing is essential to ensure that a device is safe and effective, by examining the presence of harmful pathogens that could contaminate it. Furthermore, it is required to stay compliant with regulations.

We offer a range of medical device testing methods, including coating efficacy, bioburden assessment and implantable device assessment. Standard test methods include:

  • ASTM D7907: Standard test methods for determination of bactericidal efficacy on the surface of medical examination gloves
  • BS EN ISO 17664-1 Processing of healthcare products
  • BS EN 1616: Sterile urethral catheters for single use
  • ISO 22196: Measurement of antibacterial activity on plastics and other non-porous surfaces

Wound care

Most chronic wounds are a result of microbial infection. Even if they are not clinically infected, wounds are often colonised, which in itself means they are at risk of infection. Our experienced microbiological technicians can support you in evaluating wound care strategies, such as anti-microbial wound dressings and smart dressings.

Standard test methods include:

  • AATCC Test Method 100: Antibacterial Finishes on Textile Materials. This test method provides a quantitative procedure for the evaluation of a product’s antibacterial activity. Assessment of an antibacterial finish on a textile material is determined by the degree of antibacterial activity intended by the use of such materials.
  • AATCC 30 Antifungal Assessment and Mildew Resistance Test
  • ASTM E2149: Standard Test Method for determining the antimicrobial activity of immobilized antimicrobial agents under dynamic contact conditions.
  • AATCC Test Method 147: Antibacterial Activity Assessment of Textile Materials: Parallel Streak Method
  • BS EN ISO 11737-1: Sterilization of Medical devices. Microbiological Methods. Determination of a population of microorganisms on products (Bioburden)
  • BS EN ISO 20743: Textiles, Determination of antibacterial activity of antibacterial finished products
  • BS EN IS0 20645: Textile fabrics. Determination of antibacterial activity. Agar diffusion plate test

For more information about how we can support your healthcare testing needs, please contact us.