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Home » IEC 60601: Product Safety Standards for Medical Devices

IEC 60601: Product Safety Standards for Medical Devices

The release of IEC 60601-1:2005, A1:2012 and A2:2020, also referred to by the name of IEC 60601-1 (Edition 3.2) Medical device manufacturers need to know about the different regulations for transition periods across the globe. Based on the experience of prior transition periods for international standards and based on the conclusion that, in addition to the amendment 2:2020 to IEC 60601-1 that a transition timeframe is set at 3-4 years for most regions and countries. However, it’s possible that only a few countries will have to rely on standard conformity with the previous standard (edition 3.1) in longer periods.

In the standard general to IEC 60601-1, there are 78 issues which are covered by Amendment 2:2020. Additional 32 issues are covered by various other standards, including IEC 60601-1-1, IEC 60601-1-6, IEC 60601-1-8 IEC 60601-1-10 and so on. Beyond that , the standards mentioned can be completely brand new, or up-to-date, e.g. IEC 62133-2, IEC 62366-1:2015+A1:2020, IEC 62368-1:2018, ISO 14971:2019. The specific standards IEC 60601-2-XY are scheduled to be published within two years from August 2022 or in the event that the responsible standard committee for part 2 does not adhere to the timeframe the standards will be released in IEC Central Office. IEC Central Office with an official manner only (update of the standards referenced).

What is IEC 60601-1 (EDITION 3.2)?

IEC 60601 refers to a collection of technical standards which guarantee the security of medical electrical equipment. IEC 60601-1 (Edition 3.2) is a standard that addresses the safety basics and requirements for the performance of medical electrical equipment and ensures that any single mechanical, electrical, or functional defect could create a significant risk for users and/or patients. It is presumed that health authorities of public sector in several countries have recognized IEC 60601-1 (Edition 3.2) as an essential requirement for commercialisation of medical equipment using electrical power. IEC 60601-1 (Edition 3.2) is the most current standard that has been published that has around 1500 specific requirements. The requirements are usually regarded as State-of-the-Art (SOTA) and have to be met to be met in all market sectors around the world.

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What is the significance of it?

IEC 60601-1 (Edition 3.2) is likely to become a common standard throughout countries like the U.S., Canada, the EU, Japan, Brazil, Russia, and Australia. Certain major import countries as well as regions (e.g. EU as well as Australia) for these equipment must consider the latest (SOTA) specifications. This is the reason why the latest IEC/ISO standards are not acceptable following their typical three to four years of transition expires. To ensure that they are not denied access to these markets, manufacturers must make sure that their products are compliant with both Edition 3.1 as well as 3.2 in the standards.


IEC 61010-1 describes the global standard for safety standards for electrical equipment used for measuring, controlling and use in laboratories.

Laboratory equipment that is electrical is a reference to

Measurement equipment that displays the presence of, monitors, inspects or analyzes materials is used to make materials
Instrumental diagnostic (IVD) equipment that includes self-testing IVD equipment that can be used at home
Equipment for inspection to be used to verify the quality of material or people when transporting

It is the IEC 61010-1 standard covers the following, but is not limited to, the requirements for mechanical and electrical dangers, spreading of fire in the equipment and laser sources, as well as ultrasonic and sonic pressure. It is also a requirement for sonic and ultrasonic pressure. IEC 61010-2-101 also applies to the in-vitro diagnosis (IVD) medical reasons and self-testing IVD medical uses. This standard includes additional specific requirements to in vitro medical diagnostic (IVD) medical devices in addition to the standard, such as biohazards and dangerous chemical substances.