MEDICAL DEVICES

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.

Please contact us to discuss how we can support research and development programmes related to infection control on medical devices and support your product through medical device regulations.

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
  • Stents
  • Negative pressure wound therapy devices
  • Implantable medical devices
  • Point of care diagnostic devices
  • Endotox testing
  • 510(k) submission

Our library of test organisms includes: 

Acinetobacter baumannii
Actinomyces naeslundii
Adenovirus (human)
Aspergillus brasiliensis
Aspergillums niger
Aureobasidium pullulans
Bacillus cereus
Bacillus subtilis
Camplylobacter jejuni
Candida albicans
Clostridium difficile
Corynebacterium minutissimum
Enterobacter cloacae
Enterococcus faecalis
Enterococcus faecium (VRE)
Enterococcus hirae

Escherichia coli
Fusobacterium nucleatum
Haemophilus influenzae
Heliocbacter pylori
Halomonas magadiensis
Klebsiella pneumoniae
Lactobacillus casei
Neisseria gonorrhoeae
Neisseria subflava
Porphyromonas ginigvalis
Prevotella nigrescens
Propionibacterium acnes
Proteus mirabilis
Pseudomonas aeruginosa
Salmonella enteritidis
Shigella dysenteriae

Staphylococcus aureus (MRSA and MSSA)
Staphylococcus epidermidis
Staphylococcus haemolyticus
Stenotrophomonas maltophilia
Streptococcus mutans
Streptococcus oralis
Streptococcus pneumoniae
Streptococcus pyogenes
Streptococcus zooepidemicus
Tannerella forsythia
Trichophyton rubrum
Veillonella dispar

WHO Priority organisms.
ESKAPE pathogens.

Other- please ask.

Get in Touch

We are happy to help with your microbiological requirements and with any other queries you may have.

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Perfectus Biomed

Perfectus Biomed, a UKAS accredited microbiological contract testing company, represents the new wave of scientific businesses that are proud to call Daresbury home.

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