IEC 60601-1 is the standard entitled “General requirements for basic safety and essential performance“.
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This page provides you with a quick overview of IEC 60601-1 and helps you with references to further articles on the following topics:
You can purchase the 400+ page standard for a lot of money from the IEC or Beuth-Verlag or, more cheaply, from the standardization organization in Estonia. Please also note the requirements of the EU Battery Regulation.
The standard applies to medical electrical equipment (ME equipment), however, only if these devices have an applied part.
Part of ME equipment that in normal use necessarily comes into physical contact with the patient for ME equipment or an ME system to perform its function.
A comparable standard, IEC 61010-1, is applicable for IVDs.
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The standard sets requirements for:
The standard defines various terms such as single fault, single fault safety, essential performance, basic safety, MOP, MOOP, MOPP, and many more.
It refers to other standards for further requirements:
The family of standards consists of three types:
Fig. 1: The family of standards consists of the general, collateral, and particular standards.
The standards are revised regularly. The following versions are valid as of 2023:
| General standard | EMC standard | … | |
| International | IEC 60601-1:2005 + A1:2012 + A2:2020 |
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| EU | EN IEC 60601-1:2006 + A1:2013 + A2:2021 |
EN IEC 60601-1-2:2015 + A1:2021 |
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| USA (FDA) | ANSI AAMI ES60601-1:2005 + A1:2012 + A2:2021 (ab 17.12.2023) |
ANSI AAMI IEC 60601-1-2:2014 + A1:2021 |
Below, you will find articles describing the respective changes and differences between the versions.
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This ensures you can develop your devices quickly and safely and get them onto the market without any problems during approval.
IEC 60601-1 describes essential performance as performance necessary to achieve freedom from unacceptable risk. This article aims to explain what the standard means by that and how this essential performance differs from basic safety. The article also addresses the IEC 60601-1/AMD1/ISH1:2021 INTERPRETATION SHEET 1.
DetailsThe CFDA, the China Food and Drug Administration, was replaced on September 1, 2018 by the National Medical Products Administration (NMPA), which reports to the Chinese Ministry of Health. This article will provide you with further information on the work and responsibilities of the CFDA/NMPA and the approval of medical devices in China. You will…
DetailsThe FDA offers manufacturers the opportunity to use so-called recognized consensus standards for the approval of their devices. The US authority has published a “guidance” document on these consensus standards, presented in this article. It also describes the requirements for using the standards and the advantages for manufacturers, but also points out typical mistakes.
DetailsIEC 61010-2-101 is a harmonized standard for in vitro diagnostics (IVD). IVD manufacturers can use IEC 61010-2-101 to demonstrate conformity with the general safety and performance requirements of the IVD Regulation (IVDR).
IEC 60601-1 defines a PESS, a Programmable Electronic Subsystem, as a system based on one or more central processing units, including their software and interfaces. The standard does not reveal what it means by system; in this context, it is a medical device component. For this, IEC 60601-1 sets out specific requirements for the PESS.
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