Medical Device Test Methods
Perfectus Biomed provide a number of both standard and customised medical device test methods. We can help support your research and development into microbial infection control of medical devices. Please click here for more information on our expertise.
Infections relating to medical implants such as catheters, stents and joint prosthesis can result in a number of healthcare problems. These include local and systemic infection, implant replacement, patient pain and discomfort and associated healthcare costs. An improvement in the antimicrobial nature of medical implants therefore helps to improve patient well-being while also minimising healthcare costs.
Please contact Perfectus Biomed to discuss how we can support research and development programmes related to infection control on medical devices.
Medical Device Test Methods We Offer:
Our testing experience includes working with:
- Catheter tubing
- Catheter bags
- Negative pressure wound therapy devices
- Implantable medical devices
- Point of care diagnostic devices
- 510(k) submission
We offer a range of customised test methodologies which include:
- Biofilm prevention assays
- Biofilm removal assays
- Bacterial percentage coverage analysis
- LIVE/DEAD imaging
- Confocal microscopy
- Scanning Electron Microscopy (SEM)
- Disinfection efficacy analysis
We also offer a range of standard test methodologies including:
- ASTM D7907: Standard test methods for determination of bactericidal efficacy on the surface of medical examination gloves
- BS EN 1616: Sterile urethral catheters for single use
- BS EN ISO 11737-1: Sterilisation of Medical devices – Microbiological Methods – Part 1: Determination of a population of microorganisms on products (Bioburden)
- ISO 22196: Measurement of antibacterial activity on plastics and other non-porous surfaces
- WHTM 01-01: Decontamination of medical devices within acute services
Our library of test organism includes…
Choose from our library of test organism including standard reference strains, clinical isolates and environmental isolates.
Single or mixed species assays containing:
Enterococcus faecium (VRE)
Staphylococcus aureus (MRSA and MSSA)
WHO Priority organisms.
Other- please ask.
- Perfectus Biomed have successfully maintained UKAS Accreditation
- Perfectus Biomed exhibiting at the 11th annual IPS Conference 2018
- FDA Guidance on Infection Control in Dental Unit Waterlines
- Update to Cosmetics Regulation
- Perfectus Biomed exhibiting at Wild on Wounds 2018
- Perfectus Biomed are attending the EPUAP Conference 2018
- New research shows vesicles containing viral clusters are highly infectious in viral transmission
- Perfectus Biomed’s CEO attends round table session following release of new Export Strategy
- Standard Update – BS EN 13704:2018 Chemical Disinfectants
- Perfectus Biomed successfully maintain ISO 9001:2015 certification