Perfectus Biomed work to a number of standard and customised medical device test methods.
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.
We can help support your research and development into microbial infection control of medical devices. We offer a range of test methods, including coating efficacy, endotoxin detection, bioburden assessment and implantable device assessment. Standard test methods include ASTM D7907, BS EN 1616, BS EN ISO 10993 and ISO 22196, as well as GLP compliant testing.
CUSTOMISED TEST METHODS
- Biofilm prevention assays
- Biofilm removal assays
- Bacterial percentage coverage analysis
- LIVE/DEAD imaging
- Confocal microscopy
- Scanning Electron Microscopy (SEM)
- Disinfection efficacy analysis
STANDARD TEST METHODS
- ASTM D7907: Standard test methods for determination of bactericidal efficacy on the surface of medical examination gloves
- BS EN ISO 10993: Biological evaluation of medical devices.
- 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
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
Our library of test organisms includes:
Enterococcus faecium (VRE)
Staphylococcus aureus (MRSA and MSSA)
Other- please ask.
Get in Touch
We are happy to help with your microbiological requirements and with any other queries you may have.