SGS Informs on Fourth Edition of EMC Standard IEC 60601 for Medical Devices

Helsinki, Finland, April 14, 2015 --(PR.com)-- A new 4th edition of the EMC standard IEC 60601-1-2 was published in February 2014. It is yet to be fully adopted in the industry and there are many questions on its applicability to different medical devices and changes incorporated.

EMC standard IEC 60601-1-2: What Has Changed and Why?

The main reason for publishing this new edition of the EMC standard is the proliferation of mobile phones. When so many people have a mobile radio transmitter in their pocket, the immunity of medical equipment needs to be extended to a level that will allow the unrestricted use of mobile phones in hospitals and near medical devices. In the current 4th edition, the requirements are based on the intended use environment of the equipment:

- Professional healthcare facilities (hospitals, clinics)
- Home healthcare environments (other locations)
- Special environments (military, industrial, planes/helicopters, cars etc.)

The standard includes some new definitions on intended use (medical purpose only) and normal use (including medical use and transport, maintenance, standby)

From Risk Management File to Essential Performance of Mobile Devices

One of the key issues is risk analysis by the manufacturer. In the Risk Management File (RMF), Essential Performance (EP) and Basic Safety with regard to electromagnetic disturbances of the equipment to be tested shall be defined. Changes for the emission requirements are minimal.

Standard IEC 61000 Series and Immunity Requirements

Changes for the immunity requirements are numerous and substantial, for example:

- IEC 61000-4-2 ESD: higher 8/15 kV test levels are required, connector tests modified.
- IEC 61000-4-3 Radiated RF: Extended frequency range 80-2700 MHz, 3/10 V/m levels, transmitter exclusion band eliminated.
- New test for proximity field immunity: 15 discrete frequencies, levels 9-28 V/m, pulse modulations up to 6 GHz.
- IEC 61000-4-4 Burst/EFT: Repetition rate has been increased from 5 kHz to 100 kHz.
- IEC 61000-4-6 Conducted RF: 6V/m test level at ISM frequencies and amateur bands.
- IEC 61000-4-8 Magnetic immunity: Considerably higher test level of 30 A/m instead of 3 A/m.
- IEC 61000-4-11 Voltage dips: Modified dips / interruptions.
- New tests for vehicle equipment, ISO 7637-2 transients (12 VDC) and emissions according to CISPR 25.
- New references to RTCA DO-160G for additional requirements concerning intended use in aircraft.

Selected pre-compliance tests are strongly recommended during development process to ensure that the new requirements can be fulfilled by the system.

Medical Devices and When to Apply the New Edition of the EMC Standard?

There is no transition period for IEC standards. In the CB scheme there a no definite rules on when to apply the new edition of a collateral standard. It is possible to give some guidance, based on IECEE’s Operational Document OD-2055 and private communication with CB experts:

1. When a medical device (MD) is tested and certified according to the 2nd edition of the basic standard IEC 60601-1, the corresponding EMC standard IEC 60601-1-2, ed. 2:2000 + Am.1:2004 is applied.

2. When a MD is tested and certified according to the 3rd edition of the basic standard, the corresponding EMC standard is IEC 60601-1-2, ed. 3:2007. However, it is possible to test and certify the MD against the EMC requirements separately. In that case the 4th edition can be applied.

3. When the MD is tested and certified against requirements of the 3rd edition + Am1:2012 of the basic standard, it is possible to apply both the 3rd and 4th edition of the EMC standard. However, it should be noted that some particular standards include a dated reference to the EMC standard as normative that should be applied. In spite of that, SGS does recommend applying the most recent edition

4. Within the EU region, presumption of conformity is dictated by the list of harmonized standards that is published in the Official Journal. Unfortunately, there is an ongoing clash between the EU Commission and standardization organizations that has practically paralyzed the list of harmonized standards. Because of that, the manufacturer’s Notified Body has to define what represents the state of the art. In most cases, the newest edition of the standard is the safest option.

For further information, please contact an SGS expert.

SGS is the world’s leading inspection, verification, testing and certification company. SGS is recognized as the global benchmark for quality and integrity. With more than 80,000 employees, SGS operates a network of over 1,650 offices and laboratories around the world.