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Testing & standards for an evolving medical device landscapeAn overview of the 4th edition of IEC 60601-1-2 medical device EMC standard

M E D I C A L & L A B O R AT O R Y E Q U I P M E N T

The dynamics of the global healthcare industry are changing. Rapid market level growth is being complimented by trends which are evolving the face of medical electrical (ME) devices. Portability, for instance, is a defining characteristic of this new era of medical devices. Portable medical devices are noted to be worth $20 Billion USD by 2018.1 As the world becomes more connected, medical devices are moving out of hospitals and into homes and other environments. These environments often have a reduced capability to control electromagnetics as well as reduced levels of medical supervision.

The ME device market encompasses a wide array of products with a global reach. IEC defines ME devices as equipment provided with not more than one connection to a supply main and intended by its manufacturer to be used: in the diagnosis, treatment or monitoring of a patient or for the compensation or alleviation of disease, injury or disability.2 Therefore, a manufacturer can produce many different ME products for markets across the globe. In this new reality of change, manufacturers of medical devices and equipment are faced with reconciling the need to ensure product safety with the need to access their target markets quickly. Compliance with current electromagnetic compatibility (EMC) standards can

help meet all of these needs. Product – and subsequently patient – safety also depends upon the ability of regulators and standards development organizations (SDOs) to work together to advance and adapt existing standards to keep up with emerging technologies.

The International Electrotechnical Commission (IEC) standard 60601-1-2 serves as a guide for fundamental medical EMC requirements. Testing according to the 4th edition of the standard helps to assure basic safety and essential performance of ME equipment. The latest edition of the standard contains updates and will soon be mandatory depending on the target markets of the respective products.Aside from a basic understanding of the latest edition of IEC 60601-1-2, intensive communication between the manufacturer and the testing laboratory is also critical, as the testing laboratory needs essential information, which can be provided only by the manufacturer. Working closely with an experienced Testing, Inspection and Certification (TIC) provider early in the product development process cannot only assist manufacturers in providing healthcare stakeholders with the latest developments in medical device technology as early as possible, but can also help reduce overall costs of conformity assessment and lead to faster market access.

1 Lucintel “Growth Opportunities in the Global Medical Device Market” 20162 Medical Device Academy “Scope of IEC 60601” 2013

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TESTING & STANDARDS FOR AN EVOLVING MEDICAL DEVICE LANDSCAPE

The Evolution of IEC 60601-1-2

A basic standard applicable to all medical devices, IEC 60601-1-2 was first introduced in 1988 and focused primarily on general requirements for safety. Subsequent editions – in 1993, 2001 and 2004 – underwent various technical and non- technical changes including the addition of performance considerations, EMC tests, and clearly defined requirements for essential performance. The emphasis on ‘Essential Performance’ – defined as performance of a clinical function necessary to achieve freedom from unacceptable risk – is an essential element of the latest edition

The 4th - and latest - edition better harmonizes the risk concepts and expectations of medical equipment as well as provides basic safety and essential performance markers. This is measured by ensuring a product’s electromagnetic footprint is mitigated in their usage environments. In addition, the 4th edition does not describe EMC but rather focuses on ‘Electromagnetic Disturbances’. The standard will be a mandatory requirement for all medical device manufacturers after expiration of the transition period.

Not only are there fundamental differences between the 4th edition and previous versions of the standard, the transition period for Europe and North America has also already been determined to end after December 31, 2018. Therefore, medical device manufacturers are strongly advised to inform themselves as soon as possible of the respective changes and take these into account during the development of new products as subsequent design adjustments are usually too complex, time-consuming and costly.

Reviewing the Changes

The 4th edition has followed the former editions in its reliance on the use of a risk management process, and incorporated essential performance and basic safety to the testing criteria. It includes tests against electromagnetic disturbances that help address developments in the industry, requiring manufacturers not only consider these developments but other/new technologies from the intended environment, while continuing to consider single fault conditions as well.

One significant change is the requirement for manufacturers to develop the initial test plan, based on the results of their risk management process, and thoroughly account for the monitoring of essential performance and basic safety throughout the entire testing process.

Another change is the introduction of defined use locations, purposed in determining immunity levels. Immunity levels will no longer only be defined by device type but will also consider the location where the device is being used. The use location has been broken down into three electromagnetic environments:

• Professional healthcare facility environment

• Home healthcare environment

• Special environment

A new test for “Close Field Proximity” has been defined and will be run at least 15 discrete frequencies with the intention of demonstrating the device’s function safely in the presence of a variety of mobile devices including WiFi based stations. This is highly prevalent in modern operating environments.

Industry can greatly benefit from working with a knowledgeable testing laboratory, both in understanding the many new and updated requirements in the standard and in achieving compliance. The technical expertise of CSA Group®, which includes active participation in the IEC Technical Committee that

“One significant change is the requirement for manufacturers to develop the initial test plan”

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TESTING & STANDARDS FOR AN EVOLVING MEDICAL DEVICE LANDSCAPE

developed the new edition of the standard – multilingual in-house experts, global footprint and state-of-the-art EMC testing facilities can help manufacturers meet these new and updated requirements. This expertise and support can contribute to a reduction in the need for repetitive testing, and decrease in costs, and an increase in speed to market for on-time product launches.

To ensure your products comply with the new standard edition, it is important to be aware of some of the following major changes:

Tests

• Electrostatic discharge (ESD) testing up to 15 kV air discharge and 8 kV contact discharge

• Radiated immunity – no exclusion band for radio transmission bands

• New surge test for devices connected to 12V vehicle power and signal input/ output parts (SIP/SOPS).

• Conducted immunity levels are increased in some cases, level calibration requirement deleted and only one CDN terminated.

• Voltage dips & interrupts testing adds additional phase angles.

• Magnetic immunity test levels increased to 30 A/m.

• For airborne equipment ISO 7137 should be referenced.

• Definition of a process which allows for special environments to adopt the specific test level (Annex E).

Emissions

• Lighting equipment – allowance to apply CISPR 15 deleted.

• Type A professional ME equipment and ME systems – allowance deleted.

• Definition which voltage and frequency applies for testing and that it is not necessary to re-test at additional voltages.

• Use of ISO standard for aircrafts in the Home healthcare environment.

New Approach for Immunity – Pass/Fail Criteria, Monitoring and Test Report Requirements

During immunity testing, the basic safety and essential performance should be tested in the modes and settings that are most likely to result in an unacceptable risk, as determined by the manufacturer. Before immunity testing begins, the manufacturer should determine specific and detailed immunity pass/fail criteria, based on applicable part two standards or risk management for basic safety and essential performance with regard to electro-magnetic disturbances. Given that the 4th edition requires a test plan with clear pass/fail criteria prior to testing, working with an experienced testing provider such as CSA Group can reduce common interruptions in the pre-testing report process, saving time and improving overall efficiency.

The manufacturer should also determine how the ME equipment or system will be monitored during the tests to check for compliance with the specific pass/fail criteria. Pass/fail criteria and the monitoring function should be included in the test plan as well as in the test report and the risk management file. Any observed effects on the ME Equipment and ME system during or after the application of the test disturbances should be considered in the ongoing risk management process.

The increased immunity test levels include the range for radiated immunity, magnetic immunity, and conducted immunity, significant increases in ESD levels and voltage dips and interruption phase angles. In addition, immunity testing has been added, which follows the rationale of 60601-1-11 in the form of immunity to proximity fields from RF wireless communications equipment at significantly higher levels than have been used for radiated RF immunity testing in the past.

“During immunity testing, the basic safety and essential performance should be tested”

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TESTING & STANDARDS FOR AN EVOLVING MEDICAL DEVICE LANDSCAPE

Consequently, the test report shall include items such as:

• General Equipment Under Test (EUT) information (e.g. description of the ME equipment or ME system including the device name, model number and manufacturer)

• Information to identify the test result (e.g. Immunity test level for each immunity test and emissions compliance class and group, immunity pass/fail criteria)

• Specific test documentation needs (e.g. Photograph or drawing depicting the exact ESD test points with discharge methods identified)

Details in the Risk Management FileThe standard specifically asks for the Risk Management File to contain evidence that the hazards associated with electromagnetic disturbances have been considered and addressed through the manufacturers risk process. It does not require a separate or different approach from the base 60601-1 standard, only that the specifics or electromagnetic disturbance hazards have been addressed through that risk management process.

The following sub-clauses need to be verified:

• 4.1: Risk management process - Risk resulting from reasonable foreseeable e lec tromagnet ic disturbances

• 4.2: Non-ME equipment used in an ME System – result in loss of basic safety/ essential performance (BS/EP)

• 4.3.1: Configurations

• 8.1: General immunity for inclusion of pass/fail criteria and application of test specified in Table 4 through 9

• 8.5: Subsystem – to determine whether subsystem testing is allowed

• 8.7: Operating modes – to determine which modes are most likely to result in an unacceptable risk

• 8.8: Non-ME Equipment – to determine equipment could affect BS and EP

• 8 .9 : Immunity test levels - documentation of justif ication for special environments and adjusted levels

With all of the new updates and requirements to the 4th edition, working with an experienced test lab is key to making sure your products comply and are safe for both healthcare professionals and patients. To ensure on- time product launches, early contact with a reliable and capable testing & certification company is paramount. This can help lower overall costs of the conformity assessment process by avoiding compliance issues during development and ensuring that your risk management file meets all the requirements before production. CSA Group can test and certify critical medical products and devices to required standards – including IEC 60601, IEC 61010 and IEC 62366. We focus on your needs, with experienced staff who are committed to working within your deadlines, so that you can get your products to clients as quickly and predictably as possible.

“working with an experienced test lab is key to making sure your products comply and are safe for both healthcare professionals and patients”

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