VDI 5703:2015-09

Some test methods for medical devices are defined by international standards. However, the selection and determination of necessary and appropriate test procedures for many medical devices results to be difficult. This applies, for example, to new medical devices being developed, for which there are no test standards or other publications on appropriate test methods. For other medical devices, existing standards define the responsibility to carry out testing for the manufacturer, but do not contain specific guidelines for implementation. The standard systematises the relevant terms and describes a methodical approach for the selection, establishment and any necessary development of testing strategies for medical devices. In the process, measures are derived for risk reduction from a basic risk management process, starting with the purpose of the test and accounting existing test standards.