DIN EN 1060-2:2010-03

This text applies to DIN EN 1060-1, -2, and -3. The standards shall be released as a package. The aforementioned standards define, in connection with the European Standards applicable so far, the relevant requirements set out in EU Directive 93/42/EEC concerning medical devices. The standards update the European Standards applicable so far by taking into account the relevant requirements of EU Directive 2007/47/EC of the European Parliament and of the Council of 5 September 2007 amending Directive 93/42/EC of the Council concerning medical devices (OJ No L 247, 21.9.2007, p. 21) in Annex ZA. Among the amendments given in Annex ZA all three parts of the standard also contain precise requirements for the manufacturer. Thus, the manufacturer shall state the date of issue or the latest revision of the instruction leaflet and the name and address of the authorised representative where the manufacturer does not have a place of business in the community. The other specifications of the European Standards applicable so far have not been modified. At CEN the responsible European Committee is CEN/TC 205 "Non-active medical devices". At DIN the Committee responsible for this standard is NA 027-02-14 AA "Nichtinvasive Blutdruckmessgeräte" ("Non-invasive sphygmomanometers").