Summary

International Symposium on Electromagnetic Compatibility

2009

Session Number:24R3

Session:

Number:24R3-4

Recent Status and Topics on IEC 60601-1 series (Medical Equipments)

S. Hirano,  

pp.825-827

Publication Date:2009/7/20

Online ISSN:2188-5079

DOI:10.34385/proc.14.24R3-4

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Summary:
The typical standard used for EMC regulations for medical equipments in the world is IEC 60601-1-2. This standard is an EMC product family standard for medical equipments. There are some medical equipments to which particular standards for particular products, such as IEC 60601-2-XX, apply. Therefore, it shall be noted that tests differ according to the type of medical equipments. On the other hand, SC62A MT23 has been discussing a lot in order to issue the fourth edition of IEC 60601-1-2. It contains mainly two elements. The first element is that the test levels are decided in consideration of the environment in which the medical equipments are being used. The second element is that it includes safety and performance requirements. In the new standard being established based on these two points, higher test levels will be required. A questionnaire survey performed on manufacturers by JFMDA shows the substance of various problems in Japan. When the fourth edition of IEC 60601-1-2 is being published, it will have a large influence on manufacturers not only in Japan, but all over the world.