equipment that must meet "particular requirements for basic safety and essential performance".
TC 87: Ultrasonics, prepares International Standards for equipment and systems in the domain of ultrasonics. They include ultrasonic surgical equipment, medical diagnostic ultrasonic equipment and HITU (high intensity therapeutic ultrasound) and focusing transducers.
Ophthalmology relies to a great and growing extent on MEE and MES. Examples are air-puff tonometers for measuring intraocular pressure and slit-lamps for examining external and internal parts of the eye. Other MEE and MES, including specialist lasers, are used for eye treatment and surgery.
Hundreds of millions of people throughout the world suffer from hearing loss caused by disease or exposure to excessive noise. TC 29: Electroacoustics, prepares International Standards for instrumentation designed to measure sound levels and for medical equipment, such as hearing aids, intended for use by hearing-impaired people.
MEE and MES are also employed extensively in the rehabilitation of patients needing to regain full or partial use of their upper or lower limbs following a traumatic injury. Robot-assisted rehabilitation therapy is being used increasingly for this purpose. IEC SC 62A JWG 9: Medical electrical equipment and systems using robotic technology, "develops general requirements and guidance related to the safety of MEE and MES that utilize robotic technology (i.e. medical robots)".
Robotic technology can also be used to equip mobility aids – such as wheelchairs and walkers – with intelligent navigation and control systems.
"Socially-interactive robots" have been introduced to the care environment and proved effective, calming patients suffering from Alzheimer's disease and having a similar effect on children.
Remote presence robots can provide telemedicine solutions, enabling medical specialists to communicate remotely with patients in hospital, care or home environments.
Safety comes first
TCs prepare IS for specialist MEE and MES used in medical practice, such as imaging devices and surgical equipment. Other TCs, including TC 29, 76 and 87, are involved in standardization work for equipment that has direct medical application. Additional non-medical electrical equipment is also used in medical practice.
Some equipment and components (lighting, power supplies, etc.) may not be specifically designed for medical applications but are used in MEE and MES. These devices that rely on International Standards prepared by two dozen or so other IEC TCs must meet general and specific requirements for basic safety and essential performance when installed or operated in a medical environment.
Family of Standards
TC 62's standardization work concerning the 60601 series focuses on the safety and performance of MEE and MES. Within this series, specific issues related to categories (e.g. diagnostic imaging equipment, equipment for radiotherapy, nuclear medicine and radiation dosimetry, electromedical equipment) are addressed by a series of collateral standards.
IEC/ISO JWGs have also issued over 20 joint publications (80601 series) covering specific requirements for the basic safety and essential performance of various devices. As more and more medical electrical equipment and systems are introduced to healthcare, which itself is constantly and rapidly developing, standardization work in the relevant domains is set to expand significantly in the future.