Undergoing tests is a critical step in the process of transforming an innovative design into a reliable and marketable product
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 recognise 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 recognise IEC 60601-1 (Edition 3.1) as a pre-requisite for the commercialisation 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 recognised 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.
Our experts actively participate in international advisory bodies and standardisation committees. This industry-leading expertise underpins the wide public awareness and first-class international reputation of the TÜV SÜD brand.
TÜV SÜD Product Service offers a full suite of testing and certification services for this standard that can be provided at our state-of-the-art facilities or on-site at your premises.
With over 700 dedicated medical health and services experts situated in major markets worldwide, TÜV SÜD is one of the largest Notified Bodies in the world and the only one to have its own clinical expert team. We also have a dedicated Regulatory Foreign Affairs & Clinical Department to monitor developments in regulations for medical health services and devices globally.
With the widest range of accreditations, we possess an in-depth understanding of international standards and the medical health services sector. In addition to regulatory and quality assurance expertise, TÜV SÜD’s experts are also skilled in advanced medical device assessments for functional and software safety, especially related to essential performance.
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