In order that the market can grow to the profit of the local industry, good (and therefore reproducible) standards are needed to evaluate medical textiles, and more in particular textiles used in operating theatres subject to European regulations. Textiles used in operation theatres are considered as medical devices and must therefore meet certain requirements (EN 13795) in the framework of CE labelling. The ISO 22610 method to assess the resistance against humid penetration of bacteria is under fire and revised at present, because it cannot be reproduced properly and is deemed unreliable. This problem is recognized on a European scale and the standardisation workgroup ISO/TC94/SC13/WG3 was created to revise and if necessary to adapt the method. Concerning surgical masks, the standard EN 14683 has been published, but no European laboratory is capable of assessing the performances of the masks according to the required methods. This standard is based on American standards, but remains rather vague because of the lack of experience with the proposed methods in Europe.
Objectives of the pre-standard research project "Resisbac"
- creation of a knowledge platform at Centexbel to evaluate medical textiles and more in particular textiles used in operating theatres (EN 13795) including surgical masks (EN 14683) in order to support the Belgian textile companies in the development of new products in this field and to offer them a complete service in the assessment of hospital products
- putting the acquired knowledge at the disposal of the standardisation workgroup to support them in the revision of the ISO 22610 method