Implementation of the European Standard on surgical gowns, drapes and clean air suits will cause a number of important changes in the best practice in the medical profession and medical industry. The materials and processes used to manufacture these products will now be considered as highly sophisticated protective systems. The new European Standard will provide industry-wide benchmarks, providing peace of mind to patients and healthcare professionals and valuable guidance to hospitals' purchasing departments, garment manufacturers, engineers and scientists active in the medical fabrics industry. The healthcare industry is now provided with a clear set of minimum requirements to be met by all products.

1.For the patient: greater protection and safety against post-operative infection

2.For the hospital: quality assurance, guidance in choice of product, compliance with EU regulations

3.For the nurse and surgeon: greater protection, peace of mind

4.For the garment manufacturer: quality assurance, defined qualification criteria

5.For the fabric manufacturer: quality assurance, defined qualification criteria, new goals for innovation

What will be the impact of the new European Standard on the range of products currently on the market? 

To meet the requirements of EN 13795, all manufacturers of surgical gowns and drapes, as well as suppliers of materials used in these applications, will have to operate quality control systems that will ensure consistent product quality. Re-usable or multi-patient products will need to be tested and certified by laundries as fit-for-use according to EN 13795 before being supplied for re-use in the operating theatre. Laundries will need to track usage and re-usage of surgical gowns and drapes so that the manufacturer's recommended lifetime limitations can be implemented. 

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