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

March 2011

 

Risk management

Special IECEE task force responsible for medical equipment

Today, safety is a concept understood by all. We want safety in the home, the workplace, the street, the car. In brief, we want it everywhere. We rightly consider that we are entitled to live in a safe environment. This has not always been the case. Our ancestors lived a much more dangerous life.

Safety: a 20th century concept

For centuries, safety was not a matter of public concern. Accidents were regarded as inevitable.

 

The perception began to change with the Industrial Revolution. Long hours, frequent injuries, unhealthy environment and dangerous machinery were the lot of the factory worker in those days. The second half of the 19th century saw the emergence of the first labour organizations fighting for better work conditions and compensations for on-the-job injuries. The development of electrical machinery in the 20th century was a major technological advancement, but the downside was that it brought with it new types of accidents and injuries. Laws were passed, measures were taken to offer better work conditions. But the evolution was slow. The turning point came after World War II. Safety became a growing concern for everyone, and not just in the workplace.

Public vs. occupational

The concept of public and occupational safety took its full importance in the 1960s and 1970s.

 

Public safety deals with hazards in the home, in travel and recreation, and in other situations that do not fall within the scope of occupational safety.

 

Occupational safety is concerned with protecting the safety, health and welfare of people engaged in work or employment. The goal of all occupational health and safety programs is to foster a safe work environment. It may also protect co-workers, family members, employers, customers, suppliers, nearby communities, and other members of the public who are impacted by the workplace environment. It may involve interactions among many subject areas, including occupational medicine, occupational (or industrial) hygiene, public health, safety engineering, chemistry and health physics.

IECEE brings safety and reliability to electrical equipment

IECEE, the IEC System of Conformity Testing and Certification for Electrotechnical Equipment and Components, ensures that electrical products 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, operators such as doctors and nurses, and maintenance personnel . IECEE has put a special emphasis on this sector in recent years.

MEE Task Force

IECEE set up the IECEE MEE (Medical Electrical Equipment) Task Force in 2007. Its task is to deal with the implementation of risk management requirements in the third edition of IEC 60601-1, Medical electrical equipment - Part 1: General requirements for basic safety and essential performance.

 

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 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 “risk management process” as set down in ISO (International Organization for Standardization) 14971, Medical devices - Application of risk management to medical devices
  • establishing a consensus with acceptable methods to determine compliance with all the relevant clauses (related to ISO 14971) of IEC 60601-1 Ed. 3
  • developing a checklist aimed at assisting the medical equipment industry, official authorities and stakeholders around the world in testing 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

Opening doors

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, 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 recognized worldwide. The system is still developing new programmes to provide manufacturers and consumers alike with the highest possible level of safety, performance and reliability.

 

More information on IECEE: www.iecee.org

 

For more information on risk management, please read the article on the subject in this issue of e-tech

 

  • CAT scan......
  • defibrillators...
  • ...or nuclear cardiology machines are some of the medical equipment tested and certified by IECEE

 

 

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