Issue 51 – July 2013
Manufacturers of medical electrical and electronic equipment have a powerful tool at their disposal to ensure that their products meet the strictest requirements for safety, reliability, and performance – the IEC System of Conformity Assessment Schemes for Electrotechnical Equipment and Components (IECEE).
The IECEE ensures that electrical and electronic devices and equipment are reliable and meet expectations for performance, safety, durability, and other criteria. This includes not only medical electrical equipment but also risk hazards for patients, those who operate the equipment – such as doctors and nurses – and maintenance personnel. IECEE has put a special emphasis on this sector in recent years.
Compliance with IEC international standards
In the IECEE Certification Body Scheme, medical equipment has its own product category, MED, comprising dozens of International Electrotechnical Commission (IEC) standards against which products are to be tested and certified. It includes the IEC 60601 series of standards on the safety and performance of medical electrical equipment.
Emphasis on risk management
But IECEE has gone further. In 2007, it set up the IECEE Medical Electrical Equipment Task Force whose responsibility is to deal with the implementation of risk management requirements in the third edition of IEC 60601-1, published in 2005.
The Task Force consists of about 20 members who represent various interests in the field of medical electrical equipment (industry, government agencies, certification bodies, and IEC Technical Committees). The group meets once a year and is responsible for:
- developing guidelines and working instructions on how to implement the relevant clauses of IEC 60601-1 in helping manufacturers demonstrate compliance with the 'risk management process' as defined in International Organization for Standardization (ISO) 14971, Medical devices – Application of risk management to medical devices
- establishing a consensus with methods that are acceptable to determine 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 in the appropriate manner
- acting as an Advisory Group on the common understanding of ISO 14971 for IEC 60601-1
- organising specific training sessions dealing with risk management issues.
IECEE certification, based on the principle of mutual recognition (reciprocal acceptance) by its members of test results for obtaining certification or approval at national level, is also essential in facilitating international trade and allowing direct access to the marketplace for regulators, vendors, retailers, or buyers. It eliminates unnecessary duplicate testing and reduces the costs related to the certification process.
Since 1985, the IECEE has positioned itself as the global testing and certification system for electrotechnical equipment, issuing more than 500 000 certificates that are recognised worldwide. The system is still developing new programmes to provide manufacturers and consumers alike with the highest possible levels of safety, performance, and reliability.
→ More information on IECEE: www.iecee.org
Summarised from IEC's e-tech, May 2013.