UKAS & BSI
UKAS & BSI
Biomedical test equipment is classed as equipment for testing the safety and performance of medical devices. This type of equipment is used almost exclusively by medical device manufacturers, private hospital and healthcare providers, medical device service companies, public sector health organisations (particularly NHS EBME) and third-party equipment maintenance companies operating in the medical devices industry.
It is important to make the distinction between a piece of biomedical test equipment and a medical device. A medical device is classed as any instrument, apparatus, appliance, software, material or other article, whether used alone or in combination, including the software intended by its manufacturer to be used specifically for diagnostic and/or therapeutic purposes and necessary for its proper application.
A medical device is intended by the manufacturer to be used for human beings for the purpose of:
Biomedical test equipment is used to check the performance or electrical safety of a medical device, for example a Rigel Medical 288 + electrical safety analyser would be used to check that a Mindray patient monitor (medical device) is safe electrically, preventing patients and users from potential harm from electrical shocks.
As part of the Seaward Group and working closely with Rigel Medical, Calibrationhouse benefits from over 40 years of experience in development, manufacture and calibration of biomedical test equipment and counts worldwide medical device manufacturers, healthcare organisations and NHS trusts among its many customers in this sector.