IEC 60601-1 Testing for Medical Electrical Equipment

basic safety & essential performance of medical electrical EQUIPMENT

With the publication of the IEC 60601-1 (Edition 3.2), medical device manufacturers must be aware of the varying regulatory transition periods worldwide. 

The IEC 60601-1 (Edition 3.2) addresses medical electrical equipment and systems' basic safety and essential performance requirements. It ensures that unacceptable risks to patients and/or operators do not arise under normal and fault conditions, for example, related to electrical, mechanical, thermal, and functional hazards.

Based on experience with previous transition periods from international standards, a minimum transition period of 3-4 years should be given in most countries and regions. However, it is also possible that few countries require compliance with the predecessor standard (edition 3.1) for more extended periods.

Public health authorities in many countries recognize IEC 60601-1 (Edition 3.2) as a pre-requisite for the commercialization of electrical medical equipment. The standard will probably become a widely accepted standard in the U.S., Canada, the EU, Japan, Brazil, and Australia. For the marketing of medical devices in major countries and regions (e.g. EU and Australia) manufacturers are required to consider state-of-the-art (SOTA) requirements as the latest IEC/ISO standards cannot be ignored after the expiration of the transition period. To avoid being denied entry into these and other markets, manufacturers should ensure that their products comply with both the Edition 3.1 and 3.2 of the standard.

TÜV SÜD is one of the largest Notified Bodies globally 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, and our experts actively participate in international advisory bodies and standardization committees. This industry-leading experience underpins TÜV SÜD's world-class reputation for testing and certifying medical devices.

View Report: IEC 60601-1 (Edition 3.2)

IEC 60601-1 testing and certification services

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 ISO 17025 accredited test laboratories 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 to your products.