Depending on the version, medical devices have to perform very delicate tasks: They monitor endogenous functions, manipulate them and can even take the place of these functions, e.g. pacemakers. Sometimes, survival may even depend on the reliable functioning of such a medical device. But even if medical devices are not supposed to directly interfere with bodily functions, they must still strike a delicate balance between being beneficial and harmful, as in the case of X-ray devices, which should only X-ray body parts, not contaminate them with radiation.
Ultimately, for a variety of products it may not be obvious, due to their apparent commonality, that they are in fact medical devices which must meet high standards when used in hospitals everyday, such as electrically heated mattresses and blankets, and which must not pose any danger, even under adverse circumstances.
Standardisation in the Health sector therefore involves, above all, meeting safety and service-related specifications in order to protect patients, staff and private persons. This includes the development stage of health technologies and electronic devices in this field and spans to testing and certification. The consistent objective of work in the Health sector is for technology and innovations to continue to benefit people, not the reverse.