MEDICAL DEVICES - HARMONISED STANDARDS
From A harmonised standard is a European standard developed by a recognised European Standards Organisation: CEN, CENELEC, or ETSI. It is created following a request from the European Commission to one of these organisations. Manufacturers, other economic operators, or conformity assessment bodies can use harmonised standards to demonstrate that products, services, or processes comply with relevant EU legislation. The references of harmonised standards must be published in the Official Journal of the European Union. The purpose of this website is to provide access to the latest lists of references of harmonised standards and other European standards published in the Official Journal of the European Union (OJEU). Harmonised Standars for healthcare engineering: Medical Devices> Click Here In Vitro Diagnostic Medical Devices > Click Here Active Implanable Mediac Devices > Click Here Use of harmonised standards The use of these standards remains...