With the publication of IEC 60601-1:2005 + A1:2012, otherwise known as IEC 60601-1 (Edition 3.1), medical device manufacturers must be aware of the varying regulatory transition periods worldwide. Some countries and regions are changing over to accept medical electrical equipment that complies with edition 3.1, while other markets will continue to recognize one of the previous editions, i.e. IEC 60601-1:1988+A1:1991+A2:1995 (Edition 2.2) or IEC 60601-1:2005 (Edition 3.0), for a limited time.
IEC 60601-1:2005 contains nearly 700 entirely new or more stringent requirements compared to the prior edition (Edition 2.2), and risk management has become a crucial requirement. Manufacturers must now estimate for each applicable risk, the probability of occurrence and the severity of that risk both before and after risk mitigation measures have been applied. This must be in conformance to ISO 14971 – Application of Risk Management to Medical Devices, and these estimates may be challenged at each approval level or destination market. Taken together, all these requirements increase the complexity and associated costs of transition to the new edition.
IEC 60601 is a series of technical standards that ensure the safety of medical electrical equipment. IEC 60601-1 (Edition 3.1) deals with the basic safety and essential performance requirements of medical electrical equipment, and serves to ensure that no single electrical, mechanical or functional failure shall pose an unacceptable risk to patients and/or operators. Public health authorities in many countries recognize IEC 60601-1 (Edition 3.1) as a pre-requisite for the commercialization of electrical medical equipment. IEC 60601-1 (Edition 3.1) is the newest published general standard with around 1500 single specific requirements. The requirements are often recognized as State-Of- The-Art (SOTA), and are required to be met in different markets around the globe.
IEC 60601-1 (Edition 3.1) is a widely accepted standard in the U.S., Canada, the EU, Japan, Brazil, Russia and Australia. Some major import countries for such equipment have started to enforce the implementation of the third edition as early as January 2014. To avoid being denied entry into these and other markets, manufacturers should ensure that their products comply with both the second and third editions of the standard.
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