Mieke S
Physikalisch-Technische Bundesanstalt, Institut Berlin, Dienststelle Charlottenburg.
Z Kardiol. 1996;85 Suppl 3:8-12.
Since 1995. non-invasive blood pressure measuring devices (sphygmomanometers) may bear the CE-mark. This indicates conformity of the device with the provisions of the relevant EC directives. The most important directive for non-invasive sphygmomanometers is the Medical Device Directive, which includes only essential requirements, not specific ones for special devices. The detailed requirements for special devices are laid down in harmonized standards. For non-invasive sphygmomanometers a harmonized European standard (EN 1060) was developed in recent years. It specifies performance as well as safety requirements, especially for accuracy. environmental performance and construction. Since the standard (EN 1060) defines the state of the art on a quite high level, no change to the worse in Member States which had a legal quality management system could be expected, but rather an improvement for all users in the whole EU.
自1995年以来，无创血压测量设备（血压计）可能带有CE标志。这表明该设备符合相关欧盟指令的规定。对于无创血压计而言，最重要的指令是《医疗器械指令》，该指令仅包含基本要求，而非针对特殊设备的具体要求。特殊设备的详细要求在协调标准中予以规定。近年来，针对无创血压计制定了一项协调的欧洲标准（EN 1060）。它规定了性能以及安全要求，特别是关于准确性、环境性能和结构方面的要求。由于该标准（EN 1060）在相当高的水平上定义了当前的技术水平，预计拥有合法质量管理体系的成员国不会出现质量变差的情况，反而会使整个欧盟的所有用户受益。
