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 + A2:2020, otherwise known as IEC 60601-1 (Edition 3.2), medical device manufacturers must be aware of the varying regulatory transition periods worldwide. Based on past experience with previous transition periods of international standards worldwide, it can be concluded that, as well for the Amendment 2:2020 of IEC 60601-1, a transition period will be given of 3-4 years minimum in the most countries and regions. However, it is also possible that very few countries will require standard compliance with the predecessor standard (edition 3.1) for longer times.
In the general standard of IEC 60601-1 are 78 issues addressed by the amendment 2:2020. Further 32 issues are addressed by several collateral standards such as IEC 60601-1-2, IEC 60601-1-6, IEC 60601-1-8, IEC 60601-1-10, etc. Beyond that referenced standards are either completely new or significantly updated, e.g. IEC 62133-2, IEC 62366-1:2015+A1:2020, IEC 62368-1:2018, ISO 14971:2019. The particular standards IEC 60601-2-XY are planned to be published within 2 years until August 2022, or if the responsible part 2 standard committee will not keep the date, it will be published by the IEC Central Office in a formal way only (update of referenced standards only).
IEC 60601 is a series of technical standards that ensure the safety of medical electrical equipment. IEC 60601-1 (Edition 3.2) deals with the basic safety and essential performance requirements of medical electrical equipment, and serves to ensure that no single electrical, mechanical, thermal or functional failure shall pose an unacceptable risk to patients and/or operators. It is assumed that public health authorities in many countries recognise IEC 60601-1 (Edition 3.2) as a pre-requisite for the commercialisation of electrical medical equipment. IEC 60601-1 (Edition 3.2) 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 3.2) will probably become a widely accepted standard in the U.S., Canada, the EU, Japan, Brazil, Russia and Australia. Some major import countries and regions (e.g. EU and Australia) for such equipment are required to take into account the state-of-the-art (SOTA) requirements why newer IEC/ISO standards cannot be ignored after their typically given transition period of 3-4 years will be expired. 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.
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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.
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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