International Standards and Conformity Assessment for all electrical, electronic and related technologies

May 2013

 

Trust your doctor and his equipment

IEC International Standards ensure medical electrical equipment and systems are safe to use and operate

Morand Fachot

Medical care is a matter of trust, patients trust doctors and medical staff who, in turn trust the equipment they use for examining and treating patients. IEC International Standards are developed specifically to ensure medical electrical equipment and systems are safe to operate, for the well-being of patients and users.

Wide domain

International Standards in the health-care 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.


Several IEC TCs (Technical Committees) and their SCs (Subcommittees) prepare International Standards for systems and equipment used in the medical environment and ensure 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.

Coordinating role

IEC TC 62 has four SCs (Subcommittees) that deal with specific 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, health-care 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.

Common aspects

SC 62A covers common aspects of electrical equipment used in medical practice. It has two WGs (Working Groups) and 10 MTs (Maintenance Teams).


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 has now formed JWG (Joint Working Group) 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 has decided to 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." (See article on IEC 62A JWG 9 in this e-tech). SC 62A has set up a total of 9 JWGs with ISO.

Specific areas

SC 62B prepares international publications for the safety and performance of all kind of medical diagnostic imaging equipment such as X-ray, CT (computed tomography), MRI (magnetic resonance imaging) equipment, including related associated accessories and systems. TC 62B also works on the development of related terminology, concepts, terms and definitions. It has 6 WGs and 3 JWGs.


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 three WGs to deal with these areas.


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.

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 ICNIRP (International Commission on Non-Ionizing Radiation Protection) and CIE (International Commission on Illumination).


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 MEE (medical electrical equipment) 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.

Synergies

Electric equipment and systems are present everywhere in the health-care 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 1 000 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.

 

 

  • Haemodialysis machine waiting for patients...
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  • Carl Zeiss PRESBYOND® laser surgery system to treat patients with presbyopia (Photo: Carl Zeiss)

 

 

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