Source: IEC Blog (https://blog.iec.ch/)
If you haven’t been in the intensive care unit of a hospital, you’ve probably seen it on TV or in a movie – the moment when the monitor flatlines and a flurry of doctors and nurses rush in to resuscitate the patient. Sometimes the line continues, sometimes it starts to beep, indicating life has been restored.
Medical equipment not only saves lives, it greatly improves the quality of life of people living with medical conditions and diseases. For example, certain types of diabetes can use insulin pumps which monitor insulin levels in real time and administer doses as required. Medical equipment comes in many shapes and sizes, ranging from a wearable that monitors vitals, to X-ray and scanning equipment, cardiac defibrillators or ventilators for emergency medical services.
IEC Technical Committee 62 develops international standards for the basic safety and essential performance of electrical equipment in medical practice. The recent amendments to IEC 60601-1:2020 series of Standards brings key changes in the area of electromagnetic disturbances and alarms.
A booming industry
The medical device industry is booming because of the rising prevalence of chronic diseases, growth in surgical procedures and government investment in new generation medical devices and technological advancements, according to different research.
Keeping everyone safe
Manufacturers of this equipment must keep up with regulations and laws to ensure the safety of equipment operators and patients. They must determine the likelihood of a patient being exposed to various hazards and hazardous situations through a formal risk assessment process.
Standards enable manufacturers to achieve this because they consider safety, performance, environmental and other aspects for the equipment’s entire lifecycle. In particular, the IEC 60601 series identifies many of those hazards and hazardous situations and provides generally accepted methods for controlling the risk to the operator and patient.
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