AATCC TEST METHOD 100, ISO 11737- 1, ASTM E2149
WOUND CARE – FDA 510(K) SUBMISSION
AATCC Test Method 100, EN ISO 11737-1, ASTM E2149. GLP Compliant. We can support with global regulatory submissions such as FDA 510(k)
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 wounds can therefore be deemed to be at risk of infection.
We support the research and development projects of companies who create products for chronic wounds. We aim to help decrease patient pain as well as the number of amputations resulting from long term chronic wounds, with the hope to improve patient quality of life. We carry out safety and efficacy testing to ATCC, BS EN and ASTM standards. Examples include AATCC Test Method 100, BS EN ISO 11737-1 and ASTM E2149. GLP compliant testing is also available.
Perfectus Biomed can also help support your regulatory submission and 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
- Debridement tools
We offer support with:
- 510(k) submission
- FDA approval
- MDR submission support
- Dossier submission
- Irrigation solutions
- Grant applications
Customized Test Methods & Models
- Direct contact dressings testing, a method adapted from Gallant-Behn et al (2005)
- Shake-flask method adapted from Parsons et al (2005)
- Bacterial barrier testing
- Viral/phage barrier testing
- ex vivo human skin
- ex vivo porcine skin
- CDC biofilm reactor model adapted for wound care testing of 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.
- Endotoxin testing
- Haemostatic properties
Standard Test Methods
- 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: Sterilization 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 13726-3: Test methods for primary wound dressings. Waterproofness.
- 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 immobilized antimicrobial agents under dynamic contact conditions.