\n\u00a0<\/strong><\/td>\nTest<\/strong><\/td>\n3rd edition<\/strong><\/td>\n4th edition<\/strong><\/td>\n<\/tr>\n\nESD according to
\nEN61000-4-2<\/td>\n | Contact discharge Air discharge<\/td>\n | \u00b1 2, 4, 6 kV
\n\u00b1 2, 4, 8 kV<\/td>\n | \u00b1 2, 4, 8 kV
\n\u00b1 2, 4, 8, 15 kV<\/td>\n<\/tr>\n | \n| Immunity to radiated fields according to EN61000-4-3<\/td>\n | Housing<\/td>\n | 3 V\/m, life support device 10 V\/m
\n80% AM at 1 kHz or 2 Hz,
\n80 MHz to 2500 MHz<\/td>\n | 3 V\/m, Home healthcare 10 V\/m
\n80% AM at 1 kHz or critical frequency,
\n80 MHz to 2700 MHz<\/td>\n<\/tr>\n | \n| Fast transients and bursts according to EN61000-4-4<\/td>\n | \u00a0AC mains or DC input
\nI\/O ports<\/td>\n | \n\n\n\n\u00b1 2kV, 5kHz
\nPulse Repetition Frequency<\/td>\n<\/tr>\n | \n\u00b1 1kV, 5kHz
\nPulse Repetition Frequency<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n<\/td>\n | \n\n\n\n\u00b1 2kV, 100kHz
\nPulse Repetition Frequency<\/td>\n<\/tr>\n | \n\u00b1 1kV, 100kHz
\nPulse Repetition Frequency<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\nMany immunity tests are not applicable to cables shorter than 3 m. However, please note that country-specific variations apply! For example, in the USA, cables shorter than 3 m should also be tested.<\/p>\n A major change with the new edition is the requirement for immunity to radiated fields in ISM frequency bands\u2014a very useful test given the widespread use of cell phones and other radio devices. The requirements are shown in the following table (adapted from Table 9 of the 4th edition):<\/p>\n \n\n\nservice<\/strong><\/td>\nTest frequency in MHz<\/strong><\/td>\nBand in MHz<\/strong><\/td>\nmodulation<\/strong><\/td>\nTest level<\/strong><\/td>\n<\/tr>\n\n| TETRA 400<\/td>\n | 385<\/td>\n | 380 \u2013 390<\/td>\n | 18 Hz pulse modulation<\/td>\n | 27 V\/m<\/td>\n<\/tr>\n | \n| GMRS 460, FRS 460<\/td>\n | 450<\/td>\n | 430 \u2013 470<\/td>\n | 1kHz sine FM modulated \u00b1 5 kHz<\/td>\n | 28 V\/m<\/td>\n<\/tr>\n | \n| LTE Bands 13, 17<\/td>\n | 710, 745, 780<\/td>\n | 704 \u2013 787<\/td>\n | 217 Hz pulse modulation<\/td>\n | 9 V\/m<\/td>\n<\/tr>\n | \n| GSM 800\/900, TETRA 800, iDEN 820, CDMA 850, LTE Band 5<\/td>\n | 810, 870, 930<\/td>\n | 800 \u2013 960<\/td>\n | 18 Hz pulse modulation<\/td>\n | 28 V\/m<\/td>\n<\/tr>\n | \n| GSM 1800, CDMA 1900, GSM 1900, DECT, LTE Band 1, 3, 4, 25; UMTS<\/td>\n | 1720, 1845, 1970<\/td>\n | 1700 \u2013 1990<\/td>\n | 217 Hz pulse modulation<\/td>\n | 28 V\/m<\/td>\n<\/tr>\n | \n| Bluetooth, WLAN, 802.11 b\/g\/n, RFID 2450, LTE Bamd 7<\/td>\n | 2450<\/td>\n | 2400 \u2013 2570<\/td>\n | 217 Hz pulse modulation<\/td>\n | 28 V\/m<\/td>\n<\/tr>\n | \n| WLAN 802.11 a\/n<\/td>\n | 5240, 5500, 5785<\/td>\n | 5100 \u2013 5800<\/td>\n | 217 Hz pulse modulation<\/td>\n | 9 V\/m<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n <\/p>\n During these tests, the distance to the antenna may be reduced to as little as 1 m, which may be necessary to achieve the specified field strengths.<\/p>\n Test plan<\/h3>\nThe EMC test plan was often created even after the 3rd edition. Now, the test plan is defined as a requirement in the standard. An appendix to the 4th edition provides assistance in creating it and lists the necessary content, which must include, among other things:<\/p>\n \n- Description of the system<\/li>\n
- Intended purpose and operating environment<\/li>\n
- Key features<\/li>\n
- Key features<\/li>\n
- Pass\/Fail Criteria<\/li>\n
- Methods of monitoring<\/li>\n
- Number of test subjects<\/li>\n
- Test levels for immunity tests<\/li>\n
- Simulators and other testing equipment<\/li>\n
- ESD test points<\/li>\n<\/ul>\n
<\/p>\n <\/p>\n schedule<\/h2>\nIn 2014, the 4th edition of IEC 60601-1-2 was published, followed by a German version as DIN EN in 2016. A transition period applies in the EU until December 31, 2018. This means that starting next year, only the 4th edition of IEC 60601-1-2 will be valid!<\/p>\n Incidentally, the same deadline also applies to the USA, after the FDA extended the transition period several times. However, there is a difference between the USA and the EU: In the EU, all medical electrical devices tested according to 60601-1 and placed on the market after December 31, 2018, must comply with the 4th edition of 60601-1-2. In the USA, grandfathering applies: Devices already approved according to the previous edition of the standard may continue to be produced and sold. Compliance with the new edition only becomes necessary if the device is modified or re-approved.<\/p>\n For some countries, such as China, it may be necessary to test according to an older edition if these countries still require the 2nd edition of 60601-1 for approval.<\/p>\n <\/p>\n <\/p>\n Our proposal for action<\/h2>\n <\/p>\n Are you pressed for time and would like to transition to the new edition without too much hassle? Then you can utilize our contacts and our methodology. We're happy to support you with the following steps:<\/p>\n \n- Create a gap analysis based on your device. The gap analysis should answer the following questions and generate the necessary documents:\n
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