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

March 2011

 

Health matters, standards too

IEC International Standards play a central role to guarantee the safe operation of electrical medical equipment for the well-being of patients and users

International Standards in the health-care environment are critically important and cover a wide spectrum of devices, systems and domains. The IEC ensures these are constantly kept up-to-date and improved when needed through the work of several of its TCs (Technical Committees), primarily TC 62.

TC 62: core role

IEC TC 62: Electrical equipment in medical practice, was established in 1968. It has four SCs (Subcommittees) that deal with very distinct domains and issue all its publications.

 

The preparation of International Standards for the design and production of electrical medical 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. All take part or are represented in TC 62 and its SCs.

 

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 Standards from many other IEC TCs and SCs.

 

However, TC 62 is not only a customer, but also a supplier to other IEC and ISO (International Organization for Standardization) TCs. This means that the safety of electrical medical equipment is an inclusive process that includes work carried out by many IEC TCs.

TC 62 Subcommittees

As electrical medical equipment covers a very wide range of applications and different technologies, four subcommittees are involved in the preparation of standards for this type of equipment.

 

SC 62A: covers common aspects of electrical equipment used in medical practice. With the fairly recent introduction of ICT (information and communication technologies) applications in the medical domain, the scope of its work has expanded significantly as medical devices have been integrated into IT networks. As a result, SC 62A formed a JWG (Joint Working Group) with ISO to work on the first standard addressing both networks and medical devices. This International Standard, IEC 80001-1, Application of risk management for IT-networks incorporating medical devices, was published in October 2010. Its importance cannot be underestimated as it will allow EMDs and IT networks to work better with each other, help prevent a number of potentially hazardous incidents for patients and equipment operators. It will also contribute to securing medical data, its collection, storage and distribution.

 

SC 62B: prepares international publications for safety and performance for all kind of medical diagnostic imaging equipment such as X-ray imaging equipment, CT (computed tomography), MRI (magnetic resonance imaging) including related associated equipment and accessories. TC 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 such equipment (like for some diagnostic imaging equipment covered by SC 62B) that uses high-energy ionizing radiation were not known initially. The illness that killed Nobel Prize-winner Marie Sklodowska-Curie is widely attributed to her long-time exposure to ionizing radiation without proper protective measures during the course of her work. Today, the awareness of the risks posed by ionizing radiation and protection against these are high on the list of medical safety priorities.

 

SC 62D covers electromedical equipment, equipment used to diagnose and monitor patients, and to treat, or 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.

TC 62 as supplier

Other IEC TCs also refer to and use TC 62 International Standards, in particular the following:

 

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 medical electrical equipment and systems. Yet, 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 devices and equipment are present everywhere in the health-care environment. They use a wide range of often very complex technologies, requiring many different elements, from cables and connectors to more complex components or systems. As a result, many different IEC TCs are involved in the preparation of relevant 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. It is to be expected that the work of IEC TC 62 and its SCs will follow a similar trend.