[Standardization. Sterilization standards and their impact on hospital services]

The European commission produced series of Directives which were aimed at harmonizing the European market whilst maintaining high standards to protect the citizens. Within each directive drafted Essential Requirements which had to be satisfied in order to market throughout Europe. The Medical Device Directive (93/42/EEC) covers the vast majority of medical devices including active non-implantable and non-active implantable medical devices. Demonstration of compliance to harmonized European Standards (EN) was proof of compliance with Essential Requirements of the Directives. The European Standards Body (CEN) created a series of European Standards which would enable to demonstrate compliance with Essential Requirements. The CEN organisation has a pyramidal structure. Standards are produced in the CEN Technical Committees (TC's) composed of representatives from each country's own standards organization. The Technical Committee in turned created a series of Working Groups (WG), who's job it was to actually generate the text of the standards. Two of standards committees are working to generate standards which relate to sterilizers and sterilization: TC102--the standards emanating from this committee are product related, TC 204--the standards relate to sterilization practice. In Poland, the standarisation activity is provide by Polish Committee of Standardisation. From 5th June 1997 operate Problem Commission number 272 for sterilization affairs. The job of the commission consist on translation of European'offs Standards and transform them to Polish Standards. After accede Poland to European Union, Polish hospitals will have to adjust to European Standards.