International standards are critically important in the healthcare environment and cover a wide spectrum of devices, systems and domains. The IEC ensures they are kept up-to-date and improved when needed through the work of several TCs (technical committees), primarily IEC TC 62.
As electrical equipment and systems in medical practice use many components, TC 62 International Standards and those of its SCs also refer to and use international itandards from many other IEC TCs and SCs.TC 62 is also a supplier to, other IEC and ISO (International Organization for Standardization) TCs.
IEC TC 62 has four subcommittees (SCs) that deal with very distinct domains and issue all the publications.
SC 62A covers common aspects of electrical equipment used in medical practice. The increasing digitalization of the medical domain has expanded the scope of the TC’s work. SC 62A has formed nine joint working groups (JWGs) with ISO.
SC 62B prepares international publications on safety and performance for all kinds of medical diagnostic imaging equipment such as X-ray imaging equipment, CT (computed tomography) and MRI (magnetic resonance imaging), including related associated equipment and accessories. SC 62B also works on the development of related terminology, concepts, terms and definitions.
SC 62C covers equipment for radiotherapy, nuclear medicine and radiation dosimetry. The potential health risks posed by these types of equipment (as with some of the diagnostic imaging equipment covered by SC 62B) that use high-energy ionizing radiation were not known initially.
SC 62D covers electromedical equipment and equipment used to diagnose, monitor and treat patients, or used as an aid in their treatment. This includes, for instance, haemodialysis, haemodiafiltration and haemofiltration machines, electrocardiographic monitoring equipment and nerve and muscle stimulators as well as luminaires for surgery and diagnosis, and operating tables. SC 62D has 16 JWGs linked to various ISO TCs and SCs.
Experts regard IEC TC 62 publications as an international reference for reliable, efficient and safe medical care. In a recent development, the US Food and Drug Administration (FDA) has taken steps to harmonize US medical x-ray imaging equipment regulations with IEC standards.
The FDA has told manufacturers of X-ray imaging equipment that conforming to IEC standards would provide at least the same level of protection for public health and safety from electronic radiation as current US rules. In a move designed to help manufacturers avoid duplicating efforts, US companies will be required to complete a declaration of conformity that certifies that a device meets US requirements if it opts to conform to an equivalent IEC standard.
Download the briefing paper to find out more about the IEC and medical devices.