EU Battery Regulation: What medical device manufacturers need to know
The EU plans to replace the existing Directive 2006/66/EC with the new EU Regulation on batteries and waste batteries (“Battery Regulation”). This article clarifies,
DetailsIEC 60601-1 is the standard entitled “General requirements for basic safety and essential performance“.
Content
This page provides you with a quick overview of IEC 60601-1 and helps you with references to further articles on the following topics:
- Applicability of the standard
- Requirements of the standard
- Members of the family of standards
- Latest news on the standard
- Support in dealing with the standard
Tips
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.
1. Applicability of the standard
The standard applies to medical electrical equipment (ME equipment), however, only if these devices have an applied part.
Definition: 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.
IEC 60601-1 3.8
A comparable standard, IEC 61010-1, is applicable for IVDs.
Further information
Read more here
- on the applicability of the standard for medical device PCs, mobile medical apps, multiple socket-outlets
- on the Accreditation Scheme for Conformity Assessment (ASCA)
- on medical device PCs
2. Requirements of IEC 60601-1
a) Requirements for physical and functional safety
The standard sets requirements for:
- Electrical safety
- Mechanical safety
- Thermal safety
- Functional safety
- Labels, markings, and instructions for use
- Life cycle processes of Programmable Electrical Medical Systems (PEMS)
b) Further requirements and concepts
The standard defines various terms such as single fault, single fault safety, essential performance, basic safety, MOP, MOOP, MOPP, and many more.
c) Referenced requirements
It refers to other standards for further requirements:
- Biological safety, e.g., biocompatibility (IEC 10993 family)
- Electromagnetic compatibility (IEC 60601-1-2)
3. Members of the family of standards
The family of standards consists of three types:
- The general standard itself
- The collateral standards of the series supplement cross-sectional aspects
- The particular standards apply to certain types of medical devices
Fig. 1: The family of standards consists of the general, collateral, and particular standards.
4. Latest news on the standard
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 |
|
| 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.
5. Support in working with the standard
Do you still have questions about the standard? Then, please take advantage of our free micro-consulting service.
If you want to delve deeper into the topic, we offer the following options:
- The two-day intensive seminar
- Benefit from the video training of our Medical Device University
Get in touch if you need support with
- the development of safety ME equipment and PEMS,
- the inspection of these devices,
- the selection of a test laboratory,
- the creation of lean and standard-compliant technical documentation.
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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