Wound Care

Wound care ranges from the classic compress to coated high-tech dressings with silver, hydrocolloids or superabsorbents — and on to negative pressure wound therapy with its logistics of devices and consumables. The register lists manufacturers and companies placing products on the market as well as the upstream chain: non-woven converters, coating specialists, packaging firms and sterilisation service providers.

In manufacturing terms the category is a converting and packaging business: cutting, punching, sealing and primary packaging with a sterile barrier to ISO 11607 largely take place under cleanroom conditions of Classes 7 and 8. Sterilisation is carried out, depending on the material, with ethylene oxide, gamma or e-beam irradiation — the choice of process determines material approvals and validation effort and is therefore a central filter criterion when searching for suppliers.

In regulatory terms the spectrum runs from Class I sterile to Class III for dressings with a pharmacological active component. The requirements for biocompatibility evidence to ISO 10993 vary in depth accordingly. Buyers should check whether a provider maintains this evidence product by product or merely refers in general terms to raw material data.