Medical Devices – Are you ready for the 4th Edition of EN 60601-1-2?

As from the 30^th December 2018, the ^3rd edition of the collateral standard for Medical Electrical (ME) Equipment, IEC / EN 60601-1-2, will be repealed and compliance to 4^th Edition of IEC/EN 60601-1-2 will be mandatory for all medical electrical products put on the market thereafter.

As the 30^th December 2018 shall be soon upon us, this is the final opportunity for designers, manufacturers and suppliers to ensure that their equipment complies with all the requirements of the 4^th Edition.

Any equipment that has been assessed against the requirements of the 3^rd  Edition, but that has not yet been against the requirements of the 4^th Edition, cannot be placed onto the market after the end of December 2018.

This will have a significant impact if you are currently importing, manufacturing or designing equipment and is regardless of whether it was first placed on the market prior to this date.

Now’s the time to act to ensure that you can continue to sell your existing products, as well as ensuring that any new products in development will meet the requirements of the standard.

Eurofins York can help you identify gaps in your product designs against the 4^th Edition, and we can provide you with a robust, detailed and effective test plan that will assist you in delivering a compliant product.

All of our laboratories in Grangemouth, Castleford and Bristol are accredited to the 4^th Edition and our experienced engineers can work with you to provide you with the actions needed to help you continue to supply existing products as well as helping you ensure that any new products are compliant before they reach the market.

Get in touch now and let us help you achieve compliance.

3^rd Edition vs 4^th edition overview

There are a number of changes in the 2015 version of EN 60601-1-2 compared to the 2007 version, some of which have far-reaching compliance implications.

Changes arising from a gap analysis include (but are not limited to):

• The standard’s overall philosophy defines tests and limits according to risk and intended use instead of a device type.
• Tests are defined based on where the ME equipment (medical device) is intended to be used:
  • In a “professional healthcare facility environment” where medical professionals are continually available (e.g. intensive care, dental offices)
  • “Home healthcare environment” where medical professionals are not continually available
  • “Special environment” such as; military, heavy industrial, and Medical treatment areas with high-powered medical equipment (e.g. short-wave therapy equipment).
• There are increased requirements for radiated immunity.
• More onerous immunity tests are imposed specifically to improve the safety of medical electrical equipment when portable RF communications are used closer than recommended.
• ME equipment is required to withstand higher levels of electrostatic discharge (ESD).
• When the loss of basic safety or essential performance of an ME equipment system could occur due to non-ME equipment being used in the intended electromagnetic environment, the non-ME equipment must be tested according to the requirements of the standard.
• A test plan is required to be submitted prior to testing as part of the new risk management requirements.
• Radio frequencies (Wifi, LTE, etc.) need to be considered based on the environment and using a risk management approach.

 Increased risk management – RMF and test plan

There is an expanded, more rigorous risk management process in the 4^th edition of EN 60601-1-2 with guidance in Annex F. The updated standard ensures that electromagnetic disturbances are considered in a manner appropriate to the present-day EM environments. It takes into account basic safety plus essential performance, including when there are special considerations of mitigations or intended use with regard to EM disturbances.

The 3^rd edition of EN 60601-1-2 only implies that risk analysis and management should appropriately be considered prior to testing. The 4th edition, however, is much more prescriptive, ensuring that risk management forms a central part of the compliance process.

Example requirements include (but are not limited to):

• The manufacturer’s ME equipment Risk Management File (RMF) needs to; show that the functions and essential performance of the equipment are known and understood; and provide a justification for the intended environment(s) chosen
• The RMF shall contain risk analyses, risk management and a test plan; all of which must be submitted to an accredited test laboratory prior to testing
• In the RMF, each known EMC phenomena needs to be considered for relevance to the device
• The test plan needs to include the method of monitoring, pass/fail criteria and specify any acceptable degradations in device immunity
• Any test level deviations must be documented and justified in detail in the RMF; a reduction in test levels is only allowed for a special environment
• Operating modes must be based on a risk analysis
• The risk management process needs to specifically show the consideration of a number of other factors including:
  • Minimum separation distances, especially where special environments and intentional RF (radio frequency) devices are involved
  • Whether subsystem testing is permitted
  • That reasonably foreseeable magnetic disturbances have been taken into account as defined in the standard.

EM immunity

A number of changes have been implemented regarding electromagnetic immunity in the 4^th edition of EN 60601-1-2 compared to the 3^rd, including the implementation of higher immunity levels, harmonisations and changes in procedures, e.g.:

• The range of testing for radiated immunity has been harmonized up to 2.7 GHz.
• Conducted immunity is performed at higher levels in ISM and/or amateur bands at 6V.
• Higher ESD levels are defined ±8 kV for contact and ±15 kV for air.
• Higher magnetic immunity testing is required at 30 A/m.
• A procedure to continue testing a product that has been damaged by an immunity test is defined.
• Immunity levels have been harmonized with IEC 60601-1-11; a collateral standard which refers to homecare as the intended location of use (the environment).
• Immunity to proximity fields from RF wireless communications equipment is required and has a minimum separation distance of 30 cm.

While the immunity level requirements are more onerous for all medical electrical equipment / medical devices, remember that the requirements now also differ based on the environment. For example in the 4^th edition of IEC / EN 60601-1-2, the requirements for home health care are more stringent and more difficult to meet than those for the professional healthcare environment.

Summary

The latest, 4^th edition of the collateral standard IEC / EN 60601-1-2 brings with it far-reaching changes to both the planning and implementation of the compliance process for Medical Electrical Equipment / Medical Devices.

The risk management approach adopted from the general safety standard EN 60601-1 requires the manufacturer’s Risk Management File (RMF) to provide evidence that the device, its functionality, intended use and all operational environments are understood and accounted for. The RMF and its accompanying test plan have to be submitted to a Notified Body or accredited test facility prior to testing commencing; with defined pass/fail test criteria and any acceptable degradation of use for the intended environment(s).

Electromagnetic (EM) testing and test levels are more onerous than in the third edition of the standard including significantly elevated EM immunity requirements.

The new standard’s transition period ends on 30^th December 2018, by which time all medical electrical equipment being placed on the market must be compliant with the new edition; whether they were first placed on the market prior to that date or not.

Next steps

De-risk your product with pre- or full-compliance testing

Engineers test laboratories are able to work with you to identify the appropriate standards for your medical electrical equipment and to guide you through the testing process, either through a pre-compliance process or full compliance assessment.  We offer accredited testing of Medical Electrical Equipment (Medical Devices) for compliance with:

• IEC / EN 60601-1 | General requirements for basic safety and essential performance.
• IEC / EN 60601-1-2 | Collateral standard: electromagnetic disturbances (EMC) including both the 4th edition.

For manufacturers with products in development, our pre-compliance testing service can provide an early indication of their level of compliance and allows any necessary changes to be incorporated in a cost-effective manner.

So, be ready for the increased test levels and obligatory risk-based management approach in the 4^th Edition of IEC / EN 60601-1-2 when it comes into force in December 2018.

For more information, guidance or assistance, please contact us and we will be pleased to help.