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Medical Device

BioScience Laboratories provides extensive expertise in efficacy testing of antimicrobial characteristics of medical devices.

Antimicrobial Efficacy standardized In Vitro Testing:
The following assays measure the antimicrobial activities of medical devices, components, and surface-active materials treated with antimicrobial agents. Any of the standard test methods listed can be modified to include different or additional organisms, as well as different/additional exposure times. 

  • Quantitative Methods:
    JIS Z2801:2000, ISO 22196, EN 1040, EN 1275, EN 1276, EN 1650, EN 13727, EN 13610, ASTM E 2149-01, ASTM 2315-03
  • Qualitative Methods:
    ISO 16869, Zone of Inhibition, Inhibitory Minimal Concentration, tailored methods 

Customised In Vitro Antimicrobial Studies:
BioScience Laboratories offers the design and execution of studies customized to meet our clients' specific needs.

Custom Antimicrobial Efficacy studies can be designed for:  

  • Medical Devices: catheter and intensive care, long term implants, orthopaedic
  • Preservatives, Textiles

Download a copy of the Draft Guidance for Industry and FDA Staff - Premarket Notification [510(k)] Submissions for Medical Devices that Include Antimicrobial Agents.

to see how BioScience Laboratories can help your organization with Antimicrobial Coatings Efficacy.

 
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