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 |
||
| 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.
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