A matter of trust
Trust is the key word here. It is essential in the doctor-patient relationship. I had trust in my doctor and in his diagnosis. I believed him when he told me that surgery was the only option open to me. Had I not trusted him, I would have seen another specialist.
But this goes further than the doctor-patient relationship. My ophthalmologist – and by extension any medical practitioner – has to trust the performance of the optometric apparatus he uses to make a diagnosis. And as a surgeon, he has to trust the reliability of the instruments and equipment used in the operation room, be they surgical lighting, lasers or magnifiers, to name but a few.
A powerful tool
Manufacturers of medical electrical and electronic equipment – from well-established multinational companies to SMEs (small and medium enterprises) that specialize in high-technology niche markets – have a powerful tool at their disposal for ensuring that their products meet the strictest requirements in terms of safety, reliability and performance: IECEE.
IECEE (IEC System of Conformity Assessment Schemes for Electrotechnical Equipment and Components) ensures that electrical and electronic devices and equipment are reliable and meet expectations in terms of 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 CB (Certification Body) Scheme, medical equipment has its own product category, MED, comprising dozens of IEC International 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, and in particular IEC 60601-1, Medical electrical equipment - Part 1: General requirements for basic safety and essential performance, which is widely accepted throughout the world. It can be said that compliance with IEC 60601-1 has become a de facto requirement for the commercialization of electrical medical equipment in many countries.
Emphasis on risk management
But IECEE has gone further. 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 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, 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 ISO (International Organization for Standardization) 14971, Medical devices - Application of risk management to medical devices
- establishing a consensus with methods that are acceptable 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 in the appropriate manner
- 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 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 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.
More information on IECEE: www.iecee.org