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

May 2013

 

TC work supports medical devices market

Better and safer treatment with medical electrical equipment and systems

Morand Fachot

The medical devices industry encompasses a wide range of items and technologies, from the simplest wound dressing to highly sophisticated diagnostic and therapeutic equipment. Globally, the sector is worth more than USD 350 billion.

Expanding sector

Worldwide, demand for medical care keeps growing, for a number of reasons. They include aging populations in most regions and increased access to medical services in developing countries. This increasing demand for care drives the need for more MEE (medical electrical equipment) and MES (medical electrical systems). Technology also plays a role in this expansion as traditional manual or mechanical medical equipment and devices, such as blood pressure meters, are being replaced by electronic equivalents.

Not just in hospitals

When MEE and MES are mentioned, the word "hospital" springs to mind as it represents the environment in which they are most widely deployed for diagnostics, surgical intervention, post-surgery care, irradiation and other therapies.

 

However, MEE and MES are also found in other treatment centres. They are used in dental, skin, aural and ophthalmic care, and also for rehabilitation and assistive care.

 

IS (International Standards) for MEE and MES are prepared by a number of IEC TCs (Technical Committees) and SCs (Subcommittees).

 

TC 62: Electrical equipment in medical practice, is central to this process. Its main publication of the IEC 60601 family is, together with its collateral standards, the essential foundation for Standards for MEE and MES. They reference many IS prepared by more than two dozen other IEC TCs and SCs .

From head…

Dental surgery is a sector that makes extensive use of different MEE and MES ranging from essential dedicated pieces of equipment, such as dental chairs and lights, to specialist diagnostic and treatment devices like dental radiography equipment, ultrasound descalers or laser treatment systems that offer effective alternatives to painful hand descalers and drills.

 

SC 62B: diagnostic imaging equipment, prepares International Standards for systems that include "digital X-ray imaging devices intended to be used in (…) dental radiography". TC 76: Optical radiation safety and laser equipment, develops International Standards for surgical, cosmetic, therapeutic and diagnostic laser 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.

…to limbs

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.

…and soul

"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.

 

These requirements are set by SC 62A: Common aspects of electrical equipment used in medical practice, in its IEC 60601-1 series of International Standards.

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.

 

  • A CT (computed tomography) scan uses X-rays and a computer to create detailed images of the inside of a body
  • Electronic blood pressure monitors have widely replaced their mercury counterparts (Photo: Omron)
  • Dental chair

 

 

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