Efficacy Testing of Antimicrobial Coatings for Medical Devices and Healthcare Products

Medical Device Product Development and Manufacturing Support

An objective assessment of the chemical and antimicrobial properties for a medical device coating is of fundamental interest for developers, manufacturers and regulatory bodies. Comprehensive chemical, physico-chemical and microbiological characterisation of the coating or functionalised surface will be required. Intertek offers extensive expertise and specialist instrumentation for chemical, microbiological and physical characterisation of antimicrobial coatings for medical devices and healthcare products at all stages of development & manufacturing.

Antimicrobial Efficacy Standardized In Vitro Testing

Intertek offers the following assays to measure the antimicrobial activities of medical devices, components or other surface-active materials treated with antimicrobial agents. The standard test methods listed here can be modified to include different/additional organisms as well as different/additional exposure times.

Method Descriptions:

Quantitative Method : JIS Z2801:2000, ISO 22196, EN 1040, EN 1275, EN 1465, EN 13610, ASTM E 2149-01, ASTM 2315-03

Predictions can be made about the bacteria viability of a product after assessment of the total viable count. This facilitates identification of potential antimicrobial effect from ingredients or products.

Qualitative Method : ISO 846, ISO 16869, Zone of Inhibition, Inhibitory Minimal Concentration, tailored method

The test is based on both antimicrobial diffusion and/or contact effects in time exposure of micro-organisms with a solid or liquid incorporated antimicrobial

Customised In Vitro Antimicrobial Studies:
With years of experience conducting Chemical testing and a laboratory dedicated to performing microbiology and custom microbial studies, Intertek offers clients the highest level of state-of-the-art science and tailored services to meet specific needs. Custom studies can be designed for:

• Medical devices: catheter / intensive care, dentology, long term implants, orthopedic implants,

• Material types: Preservatives, Tissue (human and animal), ceramics, plastics, metals, paper, printed substrates, textiles, gels, rubber, multilayer structures
  

Medical Device Services:

• Chemical characterisation and materials chemistry

• Physical characterisation e.g. microscopy, mechanical testing

• Analysis of clinical samples

• Microbiological services

• Regulatory chemical and physical characterisation services

• Product safety testing, certification and regulatory services

  
  

Applications:

• Diagnostic devices
• Drug delivery
• Wound care products
• Implantable devices e.g. catheters
• Medical textiles
• Medical equipment
• Bioprocessing equipment

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