International Standards in the healthcare environment are critically important and cover a wide spectrum of devices, systems and domains. Healthcare includes medical practice as well as emergency medical services, homecare, and the day-to-day support of persons with disabilities in their daily lives (i.e. Active Assisted Living, AAL).
Several IEC Technical Committees (TCs) and their Subcommittees (SCs) prepare International Standards for systems and equipment used in the medical environment and make sure they are constantly kept up-to-date and improved when needed.
IEC TC 62: Electrical equipment in medical practice, plays a central role in ensuring that equipment and systems not necessarily initially intended for medical environments are either fit for this purpose or need adjusting for it.
Over 1 200 experts take part in standardization work from TC 62 and its SCs.
IEC TC 62 has four SCs that deal with distinctive domains and issue all its publications. TC 62 has delegated to its SCs the task of developing standards.
The preparation of International Standards for the design and production of medical electrical equipment requires the participation of many experts from the medical professions, industry, healthcare establishments, the IT (information technology) and software worlds and regulatory bodies.
As electrical equipment and systems in medical practice use a wide range of components, TC 62 International Standards and those of its SCs also refer to and use International Standards from many other IEC TCs and SCs. This means that TC 62 is not only a customer of, but also a supplier to, other IEC and ISO (International Organization for Standardization) TCs. As a result, the safety of medical electrical equipment is an inclusive process that includes work carried out by nearly two dozen other IEC TCs.
Four subcommittees are involved in the preparation of standards for this type of equipment. They deal with common and specific aspects of standardization work for different types of equipment.
SC 62A covers common aspects of electrical equipment used in medical practice. It has two Working Groups (WGs), 10 Maintenance Teams (MTs) and has set up a total of nine Joint Working Groups (JWGs) with ISO.
With the (fairly recent) introduction of ICT (information and communication technologies) applications to the medical domain, the scope of the SC’s work has expanded significantly with the integration of medical devices into IT networks. SC 62A formed JWG 7 with ISO to work on the first standard addressing both networks and medical devices.
As robots are now present in the medical environment, SC 62A set up JWG 9: Medical electrical equipment and systems using robotic technology. Its task is to “develop general requirements and guidance related to the safety of medical electrical equipment and systems that utilize robotic technology.” As of July 2015 IEC SC 62A had issued more than 50 publications.
SC 62B prepares international publications for the safety and performance of all kind of medical diagnostic imaging equipment such as X-ray, computed tomography (CT), magnetic resonance imaging (MRI) equipment, including related associated accessories and systems. TC 62B also works on the development of related terminology, concepts, terms and definitions. It has 2 WGs, 13 MTs and set up a JWG with an ISO SC.
As of July 2015, IEC SC 62B had issued more than 60 publications.
SC 62C covers equipment for radiotherapy, nuclear medicine and radiation dosimetry. The potential health risks posed by such equipment in terms of its use of high-energy ionizing radiation (in common with some of the diagnostic imaging equipment covered by SC 62B) were not known initially. The illness that killed Nobel Prize-winner Marie Sklodowska-Curie is widely attributed to her long-time exposure at work to ionizing radiation without having taken proper protective measures. Today, the awareness of the risks posed by ionizing radiation and protection against these are high on the list of medical safety priorities. SC 62C has 3 WGs dealing with these areas. As of July 2015 it had issued 39 publications.
SC 62D covers electromedical equipment, equipment used to diagnose and monitor patients, and equipment for treating, or used as an aid in the treatment of, patients. This includes, for instance, haemodialysis, haemodiafiltration and haemofiltration machines, electrocardiographic monitoring equipment or nerve and muscle stimulators.
SC 62D has 2 WGs, 11 MTs and also formed 16 JWGs with ISO SCs to work on a wide range of medical equipment. As of July 2015 it had issued 68 publications.
Supplier to other IEC TCs
Other IEC TCs also refer to and use TC 62 International Standards, notable examples are:
TC 29: Electroacoustics, which standardizes instruments used in the field of electroacoustics and appropriate methods of measurement. It covers audiometric equipment as well as the hearing aids and induction-loop systems used by hearing-impaired people.
TC 64: prepares International Standards concerning electrical installations and protection against electric shock. It uses SC 62A Standards.
TC 76: Optical radiation safety and laser equipment, prepares International Standards for equipment and systems incorporating lasers and LEDs (light emitting diodes). These must meet acceptable levels of laser radiation and exposure to optical radiation that are determined by independent organizations such as the International Commission on Non-Ionizing Radiation Protection (ICNIRP) and the International Commission on Illumination (CIE).
TC 87: Ultrasonics, prepares International Standards related to the characteristics, methods of measurement, safety, and specifications of fields, equipment and systems in the domain of ultrasonics. Excluded from the scope of TC 87 are safety standards for medical electrical equipment (MEE) and systems. Despite its apparent scope, human exposure to ultrasonic fields and the need to determine the performance of medical ultrasonic equipment are at the basis of the work of TC 87. A great deal of its work is therefore oriented towards the ultrasonic aspects of medical equipment.
As TC 62, through its SC 62B, prepares, among other things, International Standards for safety and operation of ultrasound scanners some aspects of its work are of direct relevance to the International Standards prepared by TC 87. Both maintain close liaison in fields of common interest.
Electric equipment and systems are present everywhere in the healthcare environment. They use a wide range of often very complex technologies that require many different parts, from cables and connectors to power supplies and more complex components or systems. As a result, many different IEC TCs are involved in the preparation of the variety of International Standards required for the overall safe operation of such equipment.
With greater reliance on technology to treat an aging population in many countries, the use of electrical devices and systems in the medical domain is bound to increase. The work of IEC TC 62 and its SCs will follow a similar trend. The fact that over 1 200 such experts from 27 Participating and 17 Observer countries are represented in TC 62 and its SCs attests to the importance the medical profession and MEE manufacturers attach to the safety of their equipment.