Patient monitoring

Within the scope of accreditations issued by the DAkkS (ILAC ISO 17025) and in the IECEE CB Scheme, SGS Germany GmbH offers the full range of product safety and EMC certifications for patient monitors of all kinds.

Patient monitors are generally used to display and monitor the physiological parameters of a patient. The top models on the market offer extensive options to display the vital data of a patient with the help of various sensors (applied parts) and thus to draw conclusions on the patient’s state of health. Frequently monitored values are the heart rhythm (ECG), blood pressure (IBP or NIBP), oxygen saturation (S_pO₂), body temperature, and the carbon dioxide content in the exhaled air (etCO₂).

For each of these parameters, there are specific normative requirements for functionality and accuracy. These requirements are specifically outlined in the particular standards (IEC/ISO 60601/80601-2-xx). Verification is conducted using specially developed test and simulation equipment.

In addition to these function-specific requirements, there are other conditions that must be fulfilled depending on the intended use of the patient monitor.

In intensive care, i.e. when monitoring a patient who is acutely ill or undergoing an operation, the monitor must be equipped with an alarm system according to IEC 60601-1-8. If the physiological values of the patient register outside certain, usually adjustable, limits, the healthcare staff is alerted by visual and audible alarms and can initiate appropriate measures. But there are also technical alarms, such as for a low battery charge in internally supplied devices, to indicate a malfunction.

For patient monitors that are also to be used outside medically used rooms, for example by lay operators or emergency paramedics, IEC 60601-1-11 (home healthcare environment) or IEC 60601-1-12 (EMS – emergency medical services environment) must also be applied.

The two standards account for the less controlled environmental conditions in these areas and therefore require the patient monitor to be more robust against external influences.

We carry out the complete range of these environmental tests (pressure and climate storages, IP tests, vibration and shock tests) at our new location in Geretsried-Gelting near Munich.

For the testing of patient monitors, SGS Germany GmbH holds accreditations according to the following standards, among others: