Medical Equipment:  EN 60601-1-2

• Overview
• Updates in EN 60601-1-2:  2007
• Sample Test Matrix
• Technical Notes Concerning I/O Cables
• Technical Note Regarding Japanese Requirements for Medical
• Scheduling

Overview

Typical equipment falling under this category includes any electronic devices that would be used in a hospital environment or in a medical application; this includes, but is not limited to life support equipment, electrosurgical generators, respiratory therapy devices, dialysis machines, X-ray and mammography machines, pulse oximeters, etc. It should also be noted that specific products may have additional requirements defined by “particular standards”. (For example, in addition to being governed by 60601-1-2, pulse oximeters are also governed by ISO 9919, which is the particular standard for pulse oximeters.)

EMC testing for the European Union includes compliance with both emissions and immunity standards.  In addition, compliance with the AC power line harmonics and flicker standard is now required for most products which connect to the AC power mains.

In the United States, compliance of this type of equipment with federal requirements was originally governed by the Federal Communications Commission (FCC).  Limits were defined by the Code of Federal Regulations (CFR) Title 47, Part 18, which regulates the emissions (unintentional and intentional) from industrial, scientific and medical (ISM) products.  However, over the last 15 years, the Food and Drug Administration (FDA) has assumed this role.  Typically, the FDA accepts European Union (EU) data as evidence that a product complies with EMC standards.

Updates in EN 60601-1-2:  2007 [top of page]

The EU most recently updated its EMC standard, EN 60601-1-2, for medical electrical equipment in 2007. This version of the standard is very similar to the 2001 version, which became mandatory on November 1, 2004. While no date of withdrawl was published in the 2007 version, it has generally been adopted since the DOW for the 2001 version was in 2009.

The most significant change made to EN 60601-1-2: 2007 was making the setup very similar to IEC 60601-1-2: 2007. However, manufacturers are still dealing with the significant changes over the 1993 version, as increases in both magnitude and breadth of testing increase the need to take EMC in consideration when designing a product for EU compliance.  Comparing test levels from the 2007 and 1993 version, a list of some of the more significant changes is given below:

• Contact, HCP and VCP testing for electrostatic discharge was increased from a maximum level of ±3 kV to ±6 kV.
• The range of radiated RF immunity testing was changed from 26 – 1000 MHz to 80 MHz to 2.5 GHz.
• The magnitude of electrical fast transient testing was increased from ±1kV on AC power inputs to ±2 kV.
• Conducted RF immunity* testing was added
• Power frequency magnetic field immunity testing was added
• Power quality failure (PQF) testing was added
• Delineates different test levels for equipment that is patient-connected vs. equipment that is not patient connected
• Addition of AC power line harmonics and flicker requirements

In addition to these amendments, the new standard requires that EFT, surge and PQF testing be performed at both high and low AC input conditions on devices which have multiple voltage settings or auto-ranging voltage capability.

*It is important to note that conducted RF immunity applies to all (conductive) I/O cabling, regardless of length.  (Other standards usually limit this testing to cables greater than 3 meters in length.)

Sample Test Matrix [top of page]

An example test matrix for a medical device which is not patient connected, and has an auto-ranging AC power input is given in the table below.  Please note that this matrix will vary depending on a number of variables including product type, configuration or input power.

Technical Notes Concerning I/O Cables [top of page]

Approximately 80% of EMC compliance issues are related to cables.  Power and I/O cables create the “antenna structure” for a product.  These unintentional antennas can both radiate electromagnetic energy generated by electronics inside the product and receive electromagnetic energy impinged upon the product.  The former could result in non-compliance with regard to emissions and the latter could create an immunity problem.

Since cables are an integral part of a product’s function and configuration, clients should realize some significant factors about cables prior to testing for EMC compliance.

• For emissions testing, all I/O ports (excluding service or maintenance) should be loaded with a cable of at least 2 meter in length, per CISPR 16
• For immunity testing, if a cable can be greater than 3 meters in length and it not patient-connected, electrical fast transient testing via capacitive clamp applies to this cable
• The 2007 version of the EN 60601-1-2 specifies conducted RF immunity testing for all (conductive) I/O cabling, regardless of length
• Non conductive cables (e.g., fiber optic or plastic tubes) are exempt from cable testing requirements

Technical Note Regarding Japanese Requirements for Medical [top of page]

It is interesting to note that Japanese Industrial Standard (JIS T 0601-1-2: 2002) for medical equipment is actually very similar to the 1993 version of IEC/EN 60601-1-2. When working with the Japanese equivalent of the FDA, testing is sometimes required to this standard, while sometimes they will prefer the 2007 version of IEC 60601-1-2. It is important to get this defined at an early stage when dealing with the JFDA, as this will affect the test matrix for the product and could also impact the product design.

Regardless of which standard they require, the JFDA will always want testing to be performed at Japan’s in-country voltage: either 100 or 200 Vac and/or 50 or 60 Hz.

Scheduling [top of page]

EMC Integrity generates a detailed quotation for all formal compliance testing that we perform.  Our quotations state the name of the product to be tested, the standards to which the product will be tested, the individual tests that will be performed and any additional testing that may be requested by the client.  Tests are listed on a line-item basis, thus clearly delineating both the scope of work and the cost of each test.  An outline of our process is given below.

Overview of EMCI’s RFQ Process.

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