IEC 60601-1-2 is an international standard for medical implements which, as a supplementary standard, focuses primarily on the safety aspect of the equipment and specifies requirements for electromagnetic compatibility. The standard is identical to the German DIN standard EN 60601-1-2, which was slightly modified in the third edition from 2007 and over the years.

In 2014, the fourth edition of IEC 60601-1-2 was introduced with some major changes that have not yet been implemented as a European standard. To comply with the supplementary standard, there are no prescribed evaluation criteria, which would be hardly feasible due to the variety of medical equipment with their individual characteristics and characteristics.

Manufacturers of medical devices are therefore required to specify the correct functioning of the device in question and to specify deviations and tolerances according to professional risk management in order to implement the international standard appropriately.

Emissions tests	Key Facts
Radiated Emissions measurement in Semi-Anechoic Chamber	fulfills: NSA acc. to CISPR 16-1-4 chapter 5.7 within 30 MHz to 1 GHz, 3 m and 10 m test distances, test volume of up to 4 m diameter; with additional floor absorbers requirements for free space emission tests up to 18 GHz, requirements acc. to CISPR 16-1-4 chapter 8 for 1 GHz to 6 GHz emissions measurements in 3 m distance, test volume of 4 m diameter / 2.3 m height
Conducted Emissions measurement in Semi-Anechoic Chamber	(10) 150 kHz to 30 MHz acc. to CISPR 16-1-2 on AC and DC supply lines up 400 (700) V / 400 A shielded and unshielded signal lines

 

The adequate implementation of the test criteria according to IEC 60601-1-2 depends essentially on the field of application of the medical devices. Thus, a distinction is made between their use in the home environment of patients or the use in medical facilities, with greater threats in the private environment greater security risks due to improper use. It is also necessary to specify upper limits for the electromagnetic radiation of the equipment, whereby stricter specifications for the private area of ​​application must also be specified. In this aspect, the susceptibility to other sources of interference such as mobile devices plays a role.

Also required by IEC 60601-1-2 are various ESD tests to limit the contact and air discharge of medical equipment. For the basic safety in dealing with the medical device, clear guidelines are made with regard to the partial or complete destruction of the device. I If the implementation of the fourth edition of IEC 60601-1-2 at the European and German level becomes more stringent, the requirements for the correct preparation of the test report will be established in addition to the individual test aspects. This should be done, for example, by means of standardized and easily understandable texts of the documents.