IEC 60601-1-2 Medical EMC Standard

IEC 60601-1-2 or EN 60601-1-2 is one of the EMC standards which is used for medical devices. This EMC standard is one of the requirements for medical devices. On this page we are informing medical device designers, manufacturers, engineers, exporters and importers about the content of IEC 60601-1-2. Recent version of the standard is reviewed.  We are offering both medical EMC testing services and EMC test equipments compliant with the standard. Contact us and certify your medical devices.

IEC 60601-1-2 is one of the most well known EMC test standards for medical devices. On this page, you can find every aspect of recent version of the standard which is IEC 60601-1-2:2014. The standard is published by IEC and harmonised by CENELEC in Europe as EN 60601-1-2. 

1. Title of IEC 60601-1-2

Medical electrical equipment – Part 1-2: General requirements for basic safety and essential performance – Collateral Standard: Electromagnetic disturbances – Requirements and tests

2. Scope of IEC 60601-1-2

IEC 60601-1-2 applies to the Basic Safety and Essential Performance of Medical Electrical Equipment (ME Equipment) and Medical Electrical Systems (ME Systems) in the presence of Electromagnetic Disturbances and to Electromagnetic Disturbances emitted by ME Equipment and ME Systems.

3. Which versions are published? 

IEC publishes the standard. New versions are published due to changes in medical device technology.   

As seen on the history table of IEC 60601-1-2 below, it has four main editions. An edition can have its versions like 4.0 and 4.1.  Recent one is Edition 4.1 which is IEC 60601-1-2:2014+AMD1:2020. Before applying Medical EMC tests, you have to check whether IEC published a new edition. 

Date Publication Edition Status
2020-09-01 IEC 60601-1-2:2014+A1:2020 4.1 Valid
2014-02-25 IEC 60601-1-2:2014 4.0 Valid
2010-03-16 IEC 60601-1-2:2007/ISH1:2010 3.0 Revised
2007-03-30 IEC 60601-1-2:2007 3.0 Revised
2004-11-10 IEC 60601-1-2:2001+AMD1:2004 CSV 2.1 Revised
2004-09-28 IEC 60601-1-2:2001/AMD1:2004 2.0 Revised
2001-09-18 IEC 60601-1-2:2001 2.0 Revised
1993-04-07 IEC 60601-1-2:1993 1.0 Revised

4. Which national versions are published? 

Each region or country publishes its own harmonised version of IEC 60601-1-2. CENELEC publishes EN 60601-1-2. National standard institutes publishes their own versions depending on international version of IEC 60601-1-2. For instance, Polish Committee for Standardization publishes PN EN 60601-1-2 version referencing EN version. As shown below, countries adapting IEC 60601-1-2 into their own regulations. Although, there are national variations, most of the countries accept international version of IEC 60601-1-2.

Country/Region Publication
European Union EN 60601-1-2
United Kingdom BS EN 60601-1-2
Australia AS IEC 60601.1.2
Ireland I.S. EN 60601-1-2
Switzerland SN EN 60601-1-2
France NF EN 60601-1-2
Spain UNE-EN 60601-1-2
Poland PN EN 60601-1-2
Turkey TS EN 60601-1-2
Canada CAN/CSA-C22.2 No. 60601-1-2

If you are selling to Europe, USA or Canada, EMC testing or certification of your medical device must comply with the 4th edition of IEC 60601-1-2 by 31 December 2018.

 

5. Which EMC Tests are applied according to IEC 60601-1-2?
IEC 60601-1-2 list the EMC requirements of medical devices. There are different type of EMC tests which are applicable for medical devices. These tests are may not be applied to every medical device since the standard defines some exemptions. To define exact test plan for your product, you have to check the standard or send us your product’s features. We can define which tests are applicable to your medical device.

In general EMC tests according to IEC 60601-1-2 are categorized into two categories: emissions and immunity.

Emissions Tests
There are four type of EMC tests which are categorized as emissions tests. During emissions tests, measuring instrument is used to measure unwanted signals emitted from the medical device or system tested. There are certain emission limits for each test.

Test Name Reference Standard(s)
Conducted RF Emissions IEC 61000-4-2
Radiated RF Emissions IEC 61000-4-4
Harmonic Distortion IEC 61000-4-5
Voltage Fluctuations and Flicker IEC 61000-4-6

Conducted RF Emissions and Radiated RF Emissions are also named as Conducted Emissions and Radiated Emissions. Harmonic Distortion is also known as Harmonics.

Immunity Tests
There are eight types of EMC tests which are categorized as immunity tests. During immunity tests, medical device or system is subjected to an interfering signal. Tested medical device or system is monitored during immunity tests whether i
nterfering signal affects allowed performance level of the product. 

Test Name Reference Standard(s)
Electrostatic Discharge (ESD) IEC 61000-4-2
Radiated RF EM Fields IEC 61000-4-3
Proximity Fields from RF Wireless Communications Equipment IEC 61000-4-3
Electrical Fast Transients/Bursts IEC 61000-4-4
Surges IEC 61000-4-5
Conducted Disturbance induced by RF Fields IEC 61000-4-6
Rated Power Frequency Magnetic Fields IEC 61000-4-8
Voltage Dips and Interruptions IEC 61000-4-11
Immunity to proximity magnetic fields in the frequency range 9 kHz to 13,56 MHz* IEC 61000-4-39

*With IEC 60601-1-2 Edition 4.1, a new immunity test is added. This new test (Proximity Fields from RF Wireless Communications Equipment) is added due to more potential sources of interference in homes, offices (places where medical equipment may be used), and hospitals. Three common frequencies are 30 kHz, 134.2 kHz and 13.56 MHz. For this test, reference is made to the IEC 61000-4-39 standard for testing of fields in close proximity. The IEC 60601-1-2 test setup can be used to generate these test fields.

Immunity test requirements for ME Equipment and ME Systems are on a port-by-port basis. As given on IEC 60601-1-2:2014 (EN 60601-1-2:2015) there are five type of ports: Enclosure, AC Power, DC Power, Patient Coupling and SIP/SOP.

For further information about EMC tests on IEC 60601-1-2:2014 or EN 60601-1-2:2015 click here.

6. How to define EMC Tests according to IEC 60601-1-2?

IEC 60601-1-2 or EN 60601-1-2 is listing all applicable EMC tests for each type of medical devices/systems. However, not all tests are applied for all products. Standard requires some tests for specific products. In order to define applicable tests for a specific product answer the questions below, check the standard and make a product-specific EMC test plan.

* Is your medical device/system used in an environment of Professional Healthcare Facility or Home Healthcare?

* Is your medical device/system used on a vehicle?

* Does your medical device/system have AC power port? If so, how many? 

* Does your medical device/system have DC power port? If so, how many?

* Does your medical device/system have patient coupling port? If so, how many?

After answering questions above according to your product’s features, test plan is derived from the standard. Then, you can either have EMC testing service from an EMC test laboratory or build your own EMC test laboratory with appropriate test equipments.

 

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