CETECOM is expanding its service portfolio for testing and certification of medical technology products. After a successful audit by the ZLG (Zentralstelle der Länder für Gesundheitsschutz), CETECOM is now offering test services for the fourth edition of the EMC-Directive IEC 60601-1-2.
The tests according to the EMC standard IEC 60601-1-2, 4th edition are compulsory from 31.12.2017. This standard is defined as safety standard for medical electrical devices and replaces the previously valid standard (IEC 60601-1-2, 3rd edition), which is valid only in a transition phase until the end of 2017.
In this transition to the fourth edition, it should be noted, that an interference immunity of up to 2.5 GHz is required in the third edition whereas in the fourth edition, an interference immunity of up to 2.7 GHz is necessary. In addition, tests with respect to irradiation in mobile radio bands up to 6 GHz and with levels of max. 28 V/m have to be performed.
The tests according to the EMC standard IEC 60601-1-2, 4th edition are compulsory from 31.12.2017. This standard is defined as safety standard for medical electrical devices and replaces the previously valid standard (IEC 60601-1-2, 3rd edition), which is valid only in a transition phase until the end of 2017.
In this transition to the fourth edition, it should be noted, that an interference immunity of up to 2.5 GHz is required in the third edition whereas in the fourth edition, an interference immunity of up to 2.7 GHz is necessary. In addition, tests with respect to irradiation in mobile radio bands up to 6 GHz and with levels of max. 28 V/m have to be performed.
