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.
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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.
- Product testing - We operate some of the world’s most sophisticated test laboratories, which are capable of testing products to various electromagnetic compatibility, environmental and electrical safety and performance standards.
- Certification - TÜV SÜD Product Service provides certification to safety standards and international standards (e.g. CB scheme and NRTL certification) to assist you in gaining market access for your products.