The present technical specification is the official English version of the European technical specification CEN/TS 15127-1 (July 2005 edition). The purpose of this technical specification is to provide methods for specifying a set of verification data, documenting their generation and use in relation to medical software designed, even for certification purposes, to process data in the form of one or more matrices that associate acquired data with related patients. This standard does not cover: - the methods through which the software was certified or produced; - the designation of organizations performing functions related to the creation and use of test data sets; - the working procedures of organizations responsible for creating, using, or evaluating test result outcomes.
UNI CEN/TS 15127-1:2006 history
2006UNI CEN/TS 15127-1:2006 Health informatics - Testing of physiological measurement software - Part 1: General