Wound Care Test Methods
Microbial infection is the cause of the majority of chronic wounds. As such, wounds that are not clinically infected are almost certainly colonised. These types of chronic wound can therefore be deemed to be at risk of infection6.
Perfectus Biomed support companies who produce products for chronic wounds. We aim to help decrease patient pain and also decrease the number of amputations resulting from long term chronic wounds. We therefore hope to improve patient quality of life.
Perfectus Biomed can also help support your regulatory submission as well as your company research and development. We can also assist you in demonstrating the USP of commercially available products.
We have experience working with:
- Wound dressings
- Topical wound agents
- Dressing removal agents
- Irrigation solutions
- Plasma devices
- NPWT devices
We offer support with:
- 510(k) submission
- FDA approval
- Dossier submission
- Grant applications
We offer a range of customised test methodologies which include:
- Direct contact dressings testing, a method adapted from Gallant-Behn et al (2005).
- Shake-flask method adapted from upon a method in Parsons et al (2005).
- Bacterial barrier testing.
- Viral/phage barrier testing.
- CDC biofilm reactor model adapted for testing wound dressings based on ASTM E2871 and ASTM E2562.
- Drip flow reactor model adapted for testing wound dressings based on ASTM E2647.
- Porcine skin explant drip flow model based on ASTM E2647.
- Wicking absorbency.
- MMP modulation testing.
- Dressing material strength testing – wet and dry.
- Peel force testing.
More about our wound care testing process
Perfectus Biomed also offer a range of standard test methodologies including:
- AATCC Test Method 100: Antibacterial Finishes on Textile Materials.
- Modified AATCC Test Method 100
- AATCC Test Method 147: Antibacterial Activity Assessment of Textile Materials: Parallel Streak Method.
- BS EN ISO 11737-1: Sterilisation of Medical devices. Microbiological Methods. Determination of a population of microorganisms on products (Bioburden).
- BS EN 13726-1: Test methods for primary wound dressings. Aspects of absorbency: Free swell absorption, fluid retention and absorption under a fixed load.
- BS EN 13726-2: Test methods for primary wound dressings. Moisture vapour transmission rate (MVTR) of permeable film dressings. Section 3.2: Moisture Vapour Transmission Rate – In contact with vapour.
- BS EN 13726-2: Test methods for primary wound dressings. Moisture vapour transmission rate of permeable film dressings. Section 3.3: Moisture Vapour Transmission Rate – In contact with liquid.
- BS EN 13726-3: Test methods for primary wound dressings. Waterproofness.
- BS EN 13726-4: Test methods for primary wound dressings. Conformability.
- BS EN ISO 20743:Textiles, Determination of antibacterial activity of antibacterial finished products.
- BS EN IS0 20645: Textile fabrics. Determination of antibacterial activity. Agar diffusion plate test.
- ASTM E2149: Standard Test Method for determining the antimicrobial activity of immobilised antimicrobial agents under dynamic contact conditions.
Our library of test organism includes…
Choose from our library of test organism including standard reference strains, clinical isolates and environmental isolates.
Single or mixed species assays containing:
Enterococcus faecium (VRE)
Staphylococcus aureus (MRSA and MSSA)
WHO Priority organisms.
Other- please ask.
- Perfectus Biomed have successfully maintained UKAS Accreditation
- Perfectus Biomed exhibiting at the 11th annual IPS Conference 2018
- FDA Guidance on Infection Control in Dental Unit Waterlines
- Update to Cosmetics Regulation
- Perfectus Biomed exhibiting at Wild on Wounds 2018
- Perfectus Biomed are attending the EPUAP Conference 2018
- New research shows vesicles containing viral clusters are highly infectious in viral transmission
- Perfectus Biomed’s CEO attends round table session following release of new Export Strategy
- Standard Update – BS EN 13704:2018 Chemical Disinfectants
- Perfectus Biomed successfully maintain ISO 9001:2015 certification