Medicine has come a long way since the days when so called medical miracles were advertised by means of shouts thrown down the back streets: miracle cures were then the province of quacks with strong voices. Since the appearance of the first sticking plaster in the 1920s and the first MRI (Magnetic Resonance Imaging) devices in the 1970s, any number of other developments have also helped move medicine forward. Medical equipment too has changed drastically, to the point at which, with the aid of robots, doctors can diagnose patients who may be located on the other side of the world.
Given that medical equipment is developing and changing at lightning speed, it becomes more and more important that manufacturers of medical electrical and electronic equipment ensure that their products meet the safety, reliability and performance requirements of the industry as well as adhering to the IEC International Standards that apply to them.
IECEE Certification complies with IEC International Standards
IECEE ensures that electrical and electronic devices and equipment are reliable and meet expectations in terms of performance, safety, reliability and other criteria. The scheme applies not only to the medical electrical equipment itself but also covers risks to patients, those who operate the equipment – doctors, nurses and technicians, for instance – and maintenance personnel. IECEE has placed special emphasis on this sector in the last few years.
Medical equipment has its own product category, MED or electrical equipment for medical use, comprising dozens of IEC International Standards against which products are to be tested and certified in the IECEE CB (Certification Body) Scheme. It includes the IEC 60601 series of Standards on the safety and performance of medical electrical equipment.
Greater focus on managing risk
Medical technology may be speeding ahead but IECEE is close behind in terms of managing the risks associated with new technologies. In 2007 it set up the IECEE MEE (Medical Electrical Equipment) Task Force whose responsibility is to deal with the implementation of risk management requirements as set out in the third edition of IEC 60601-1, Medical electrical equipment - Part 1: General requirements for basic safety and essential performance, published in 2005 (Consolidated edition 3.1 of IEC 60601-1 published in 2012).
Task Force moves forward
This Task Force meets once a year and at the end of 2013 it finalized the Guidance for the Evaluation of Risk Management in Medical Electrical Equipment, which will become an IEC Guide in the coming months. This document helps to provide a uniform approach for Certification Body Testing Laboratory and manufacturer alike on how to assess and document compliance with the relevant clauses in the IEC 60601 series as they relate to ISO 14971, Medical devices - Application of risk management to medical devices.
The Task Force is also responsible for:
- establishing a consensus with acceptable methods for determining compliance with all the relevant clauses (in relation to ISO 14971) of IEC 60601-1
- developing a checklist aimed at assisting the medical equipment industry, official authorities and stakeholders around the world to test appropriately
- acting as an Advisory Group on the common understanding of ISO 14971 with respect to IEC 60601-1
- organizing specific training sessions dealing with risk management issues
IECEE focuses on the marketplace
Showing the marketplace that a product is tested and certified can help well-established multinational companies as well as SMEs (small and medium enterprises) as IECEE is recognized in all member countries and beyond, thereby aiding in reducing costs and time to market and in eliminating the need for multiple testing.
IECEE certification, based on the principle of mutual recognition (reciprocal acceptance) by its members, is also essential in facilitating international trade and allowing direct access to the marketplace for regulators, vendors, retailers and buyers.
Since 1985, the IECEE has positioned itself as the global testing and certification system for electrotechnical equipment, issuing more than a million certificates that are recognized worldwide. The System is still developing new programmes to provide manufacturers and consumers alike with the highest possible levels of safety, performance and reliability.
IECEE administers third party conformity testing and certification schemes that address the safety, quality, efficiency and overall performance of components and goods for the home, office and health facilities. Members of the System issue test reports and certificates that are mutually accepted by all other members of the System.
IECEE operates the CB Scheme and the Full Certification Scheme. The latter includes factory inspections. More information on IECEE is available at www.iecee.org