ISO 10993, ISO 22196, EN 1616, ASTM D7907. Biocompatibility testing of Medical Devices. We can also support with global regulatory submissions such as EU MDR & FDA 510(k)
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 minimizing healthcare costs.
We can help support your research and development into microbial infection control of medical devices. We offer a range of medical device testing 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.
Please contact us to discuss how we can support research and development programs related to infection control on medical devices and support your product through medical device regulations.
CUSTOMIzED TEST METHODS
- Biofilm prevention assays
- Biofilm removal assays
- Bacterial percentage coverage analysis
- Surface topography biofilm assessment
- Microbial migration
- Microbial barrier
- Electrical device returns assessment
- Skin stripping
- LIVE/DEAD imaging
- Confocal microscopy
- Scanning Electron Microscopy (SEM)
- Disinfection efficacy analysis
- Customised studies to reflect real-world use of the device
- ex vivo Porcine Tissue
- ex vivo Human Tissue
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
- ISO 14729: Microbiological requirements and test methods for products and regimens for hygienic management of contact lense
- ISO 10993-5: Biological evaluation of medical devices
- ISO 18189: Ophthalmic optics – Cytotoxicity testing of contact lenses in combination with lens care solution to evaluate lens/solution interactions
- ISO 29701:2010 Nanotechnologies – Endotoxin test on nanomaterial samples for in vitro systems
testing experience includes working with:
- Catheter tubing
- Catheter bags
- Stents
- Wound dressings
- Negative pressure wound therapy devices
- Implantable medical devices
- Point of care diagnostic devices
- Stoma care
- Bone cement
- Joint replacement devices
- MDR submission support
- 510(k) submission
