DIN EN ISO 81060-2:2014-10

In addition to the product standards (DIN EN ISO 81060-1 "Non-invasive sphygmomanometers - Part 1: Requirements and test methods for non-automated measurement type" and DIN EN 80601-2-30 (VDE 0750-2-30) "Medical Electrical Equipment - Part 2-30: Particular requirements for basic safety and essential performance of automated non-invasive sphygmomanometers"), this standard for clinical investigation of non-invasive sphygmomanometers has now also been published. This standard is applicable to all non-invasive sphygmomanometers that periodically measure and work with inflatable cuffs. With DIN EN ISO 81060-2 it was possible for the first time to develop a standard for unification of the requirements for clinical comparative studies which is applied worldwide, for example for CE certification in the European internal market or for FDA approval in the USA. The standard describes several test methods with non-invasive and invasive reference methods. Comparability of the results is achieved by the many detailed specifications. The methods are suitable for many different scopes of modern non-invasive sphygmomanometers. In addition to adults, there are also special requirements for clinical investigations on children, new-borns and pregnant women. Special scopes such as 24 hour measurement and exercise stress testing are also dealt with. In the sense of patient safety it was possible to specify an appropriately high level of measurement accuracy, use safety and static safety of data analysis. The standard is directed at manufacturers and testing institutes. NA 027-02-14 AA "Nicht-invasive Blutdruckmessgeräte" ("Non-invasive sphygmomanometers") which also holds the secretariat of International Working Group ISO/TC 121/SC 1 JWG 7 "Non-invasive sphygmomanometer" is responsible at DIN, the German institute for standardization e. V.