Safety Standards for Cardiac Pacemakers

Abstract

Although reliability and safety testing of cardiac pacemakers in Austria is not obligatory, it is stated by law that every electrical device on the market has to fulfill all relevant safety regulations and standards. Not to meet those requirements, therefore, constitutes a legal violation which may force the responsible ministry to find the company and prohibit the sale of the device in Austria. Austrian safety standards for electromedical equipment are harmonized with CENELEC standards. General requirements include ÖVE-MG/IEC 601-1 [9], which is the equivalent of the European HD 395.1S2 (1988) and IEC 601-1 (1977 + 1984) [3, 6]. For implantable cardiac pacemakers EN 50061 (1988) and ISO 5841-1 (1989) contain supplementary requirements [4, 5]. The intention of these standards is to protect patients from hazards. Yet at the same time, they are not so cumbersome as to restrict the development of new devices. Standards in effect at this time specifiy: (1) packaging, labeling, and documentation as to intended use/restriction on the device; (2) measures taken to protect against electrical hazards; (3) measures taken to protect against malfunction.