This European Standard has been prepared under a mandate given to the European Community
and the European Free Trade Association and supports corresponding essential requirements of
EU Directive 93/42/EEC concerning medical devices and EU Directive 99/5/EC on radio equipment
and telecommunications terminal equipment.
WARNING Other requirements and other EU Directives may be applicable to the product(s) falling within the scope of this standard.
The clauses of this standard are likely to support requirements of Directive 93/42 EEC concerning
medical devices (see Table ZA.1) and of Directive 99/5/EC on radio equipment and
telecommunications terminal equipment (see Table ZA.2).
Compliance with this standard provides one means of conforming with the corresponding essential
requirements of the Directive concerned and associated EFTA regulations.
Diese ÖNORM enthält Anforderungen und Prüfverfahren für außen liegende Beinprothesen und Orthesen bezüglich Festigkeit, Materialien, Anwendungsbeschränkungen und Gefahren sowie vorzusehende Informationen für den Anwender.