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

April 2014

 

IEC work critical to safe medical care

Standards the heart of safe medical equipment

Morand Fachot

IEC International Standards play a central role in guaranteeing the safe operation of electrical medical equipment for the wellbeing of patients and users. International Standards in the healthcare environment are critically important and cover a wide spectrum of devices, systems and domains. The IEC ensures these are kept constantly up-to-date and improved when needed through the work of several of its TCs (Technical Committees), primarily 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, healthcare establishments, the IT (information technology) and software worlds and regulatory bodies. All take part in or are represented by 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 of, 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.

Subcommittees covering multiple domains

As electrical medical equipment covers a very wide range of applications and different technologies, four SCs 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 to 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. 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 (electric medical devices) and IT networks to work better with each other and will help prevent a number of potentially hazardous incidents for patients and equipment operators occurring. It will also contribute to securing medical data and to its collection, storage and distribution.

 

SC 62A has 9 JWGs linked to various ISO TCs and SCs to cover different aspects of the domain. The latest of these was created in April 2011 to develop general requirements and guidance relating to the safety of medical electrical equipment and systems using robotic technology.

 

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. To do this it created two WGs.

 

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. The illness that killed Nobel Prize-winner Marie Skłodowska-Curie is widely attributed to her long-time exposure to ionizing radiation without taking proper protective measures during the course of her work. Today, the awareness of the risks posed by ionizing radiation and protecting against them are high on the list of medical safety priorities.

 

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 12 JWGs linked to various ISO TCs and SCs.

Links with other TCs

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

  • TC 29: Electroacoustics, develops Standards that cover the measurement of electroacoustic and performance characteristics for various types of hearing aids. It refers to and uses TC 62 Standards. (See article on TC 29 in May 2013 e-tech)
  • 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, develops 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 as 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 relating to the characteristics, methods of measurement, safety, and specifications of fields, equipment and systems in the domain of ultrasonics. Safety standards for medical electrical equipment and systems are excluded from the scope of TC 87. TC 87 uses Standards prepared by TC 62/SC62D/MT18: Therapy equipment. (See article on TC 87 in this e-tech)

Multiple liaisons required

Electric devices and equipment are found everywhere in the healthcare environment. They use a wide range of technologies that are often very complex and involve many different products, from cables and connectors to more complex components or systems. As a result, many different IEC TCs are involved in the preparation of the relevant International Standards required for the overall safe operation of such equipment.

 

As greater reliance is placed 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.

 

The importance of standardization covering safety aspects of medical equipment is highlighted by the fact that over 1 100 experts from 27 Participating and 18 Observer countries are active in TC 62 work .

 

  • Hospital operating rooms are full of electrical equipment
  • CyberKnife®, a robotic radiosurgery non-invasive system, enables high-precision radiation therapy (Photo: ©2011 Accuray Incorporated
  • Magnetoencephalograph (MEG) scanner (Photo: GE)

 

 

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