The EN series of standards known as EN 60601 defines safety requirements and ergonomic standards for medical equipment and medical systems.
These norms are divided into different partial or collateral standards:
EN 60601-1-2:2015 (also known an IEC2 60601-1-2:2014) is a collateral standard, as indicated above, and applies to medical electrical/electronic equipment.
Its full title is:
“Medical Electrical Equipment – Part 1-2: General Requirements for Basic Safety and Essential Performance
– Collateral Standard: Electromagnetic Compatibility – Requirements and Tests.”
Any products, which are defined as a “medical product” or “medical system” according to Section 3 of the German Medical Products Act, need to be tested and certified according to EN 60601 or one of its partial standards. Manufacturers can also certify their products according to this standard or one of its partial standards on a voluntary basis, even if their items are not defined as a medical product.
Medical electrical products have to be absolutely safe. They are not allowed to break down or malfunction if any radiation interference comes from other electrical units like mobile phones or tablets. Conversely, medical products are not allowed to negatively affect the environment through electromagnetic emissions either (such as other medical products, the phone and radio networks, computers or the electricity supply).
In essence, EN 60601-1-2 defines the requirements for electromagnetic compatibility (EMC), which is why it is often referred to it as the EMC standard. The standard defines the term electromagnetic compatibility as the “capacity of a medical device or a medical system to function satisfactorily in its electromagnetic environment without introducing any electromagnetic disturbance into this environment, which also includes other equipment.”
It specifically stipulates the following:
EN 60601-1-2 Edition 4 has been in force since January 2019. It therefore replaces Edition 3, which had been mandatory since 2017. All medical electrical equipment has had to meet the new requirements for electromagnetic compatibility (EMC) since the beginning of 2019.
The environments, where medical equipment is being used, are more complex now than ever before. Technologies are continuing to develop at a rapid pace and this makes it necessary to permanently adapt the requirements that are stipulated in standards. One of the most important new features in EN 60601-1-2 Edition 4 is the stronger focus on “intended usage environments”, for which risk management is necessary in each case, according to EN 149713. This describes the increases in requirements for professional health care, for health care at home and for “special” environments. The tougher EMC test specifications in Edition 4 are also designed to ensure resistance to interference in the relevant conditions.
|Test||Edition 3||Edition 4|
|ESD according to
|± 2, 4, 6 kV
± 2, 4, 8 kV
|± 2, 4, 8 kV
± 2, 4, 8, 15 kV
against radiated fields
|Enclosures||3 V/m, life-sustaining unit 10 V/m
80% AM at 1 kHz or 2 Hz,
80 MHz to 2500 MHz
|3 V/m, home health care 10 V/m
80% AM at 1 kHz or
80 MHz up to 2700 MHz
|Fast transients and
DC input I/O Ports
|± 2kV, 5kHz pulse
± 1kV, 5kHz pulse
|± 2kV, 100kHz pulse repetition frequency
± 1kV, 100kHz pulse repetition frequency
No Man & Machine product is subject to mandatory certification in line with EN 60601 or EN 60601-1-2. Keyboards or computer peripheral items are not defined as medical equipment in the sense of the Medical Products Act. However, in order to provide evidence of their special suitability for use in the relevant fields (clinics, medical practices), some products have been subjected to an EMC test in line with the strict criteria of EN 60601-1-2: 2015 also known as 4th Edition.
As far as customized products are concerned, certification would only become necessary if this involved a medical product/system in line with the Medical Products Act. However, as this would be managed as an individual project, and only if certification was necessary, no general measures can be derived to cover this situation.
|Really Cool||Mighty Mouse|
|Slim Cool Keyboard||Petite Mouse|
|Very Cool Keyboard (VC/W5)|
The products are specifically not certified in line with EN 60601-1-2 (Edition 4). The reason for this is primarily based on risk management, which needs to consider all the relevant areas of medical usage. As a keyboard is part of the so-called general or basic equipment, it can be used in almost any specific environment. It is therefore almost impossible to assess or manage the risks in question (which must take place according to EN 14971) – which is not a beneficial process. In this respect, the tests performed on the keyboards according to EN 60601-1-2 Edition 4 solely relate to their EMC. The model(s) completely passed this EMC test. The products are therefore formally suitable for use in medical and medically-related environments.
This is the best possible way of stating this in English:
(The product) complies with the EMC guidelines in EN 60601-1-2:2015 (or alternatively IEC 60601-1-2:2014) both also referred to as 4th edition.
Man & Machine, Inc, 1 October 2020