1.1 In scope
The means to specify test data sets, documenting the creation of the test data, and the use of the test data for
the testing, possibly for certification purposes, of medical software which is designed to process data in the
form of one or more arrays of acquired patient and associated data.
1.2 Out of scope
The means by which medical software is certified or produced.
The nomination of bodies to perform functions related to the creation and use of Test Data Sets.
The working practices of bodies responsible for the creation or use of test data sets or bodies responsible for
the evaluation of the test results.
The means by which the test data are created
PD CEN/TS 15127-1-2005_ Referenced Document
EN ISO/IEC 17025 General requirements for the competence of testing and calibration laboratories*， 2017-12-01 Update