Can you legally sell your medical electrical equipment after 1 January 2019?

On 1 January 2019, the old version of the EMC standard for medical electrical equipment will be expiring. There are significant differences between the two versions of the EMC standard, which are worth looking into if you intend to continue selling your products in the EU. All medical devices, whether newly developed or existing devices continuing to be sold, must conform to the new version of the standard, EN 60601-1-2, 4th edition.

When the transition period expires, manufacturers will no longer be allowed to follow the older version of the EMC standard. Therefore, if you are a manufacturer, it is important for you to learn about the differences between the two versions of this standard so you can ensure that your product can continue to be sold legally. In this article, we give you an overview of the things you should pay particular attention to in comparison to the old EMC standard.

Risk management and the Risk Management File

A key requirement for medical equipment is risk management. The equipment must be constructed in such a manner as to minimise the risk of injury or damage to persons or surroundings. Manufacturers who have their equipment CE-marked are responsible for continually analysing and reducing errors in the equipment itself and malfunctions arising from improper equipment usage.

In the 4th edition of the EMC standard for medical electrical equipment, EN 60601-1-2 (2015), risk management dominates. In a separate risk management file it is required to document that appropriate levels of EMC testing have been chosen for the equipment in question, its use, those persons that will be using the equipment, and the environment in which the equipment will be used. Foreseeable misuses of the equipment must also be accounted for.

Preventing electromagnetic interference

The risk analysis must reveal the possible consequences of the equipment being present in the electromagnetic environment in which it is expected to be used throughout its life cycle. If the equipment is affected by electromagnetic radiation, there may be a risk of the equipment not functioning as intended.

Similarly, the equipment may itself interfere with other nearby equipment. This must be accounted for in the product's design, so as to avoid harmful EMC effects. Manufacturers must remember that many electronic components become degraded over the years, and an apparatus's immunity or emissions will almost always change with time.

According to the EMC standard, producers themselves must specify the activities to be performed in relation to electromagnetic interference. Those activities must be noted in the Risk Management File. The manufacturer — not the testing laboratory — performs these activities, meaning that the manufacturers themselves must establish specific EMC testing levels and functional criteria during testing. For this reason, a Risk Management File with EMC considerations must always be included when Manufacturers send their equipment to a laboratory for EMC testing.

You can see examples of EMC phenomena that should be covered in the Risk Management File in this article

Things to remember

• The risk analysis must reveal the possible consequences of the equipment being present in an electromagnetic environment throughout its life cycle
• During EMC testing, it must be found that the equipment does not do anything unexpected, to the extent that this would constitute an unacceptable risk to "basic safety"
• The equipment's standby mode must also be considered in the risk analysis
• If non-medical equipment is a component of a larger system, it must also be inspected as to its suitability for use in a medical EMC environment. This also applies to equipment developed by a third party. 

Division into three use environments

According to the EMC standard, in the risk analysis, producers must show the likelihood of electromagnetic incompatibility occurring in the use environment, as well as any consequences of such incompatibility. The test house must confirm that this has been accounted for by inspecting the Risk Management File. If the test house does not perform this inspection, the product cannot be considered compliant with the standard. While the test house must inspect the Risk Management File, it does not need to judge the quality of the file — only that it is present and that EMC has been considered.

New in this version of the standard, use environments are now broken up into three groups:

1. Professional health care facilities, such as physiotherapy centres, private practices, rehabilitation centres, dental clinics, offices with medical personnel, maternity wards, hospital environments in general, operating theatres, and intensive care units
2. Domestic/common environments, such as private homes, nursing homes, cars, buses, hotels, restaurants, stores, and markets
3. Special environments, such as military installations, submarines, radar stations, heavy industry locales, mines, power plants, near magnetic scanners, near HF surgical equipment, and near radio equipment.

The standard provides suggested testing levels for each of the three environments. If even one testing level from environment 1 or 2 is changed, a product is said to be designed to function in environment 3. In this case, the manufacturer must define testing levels in the risk analysis for each EMC test to be performed.

Something to be happy about

Manufacturers of medical electrical equipment can be happy that EN 60601-1-2 (and ISO 14971) provide good, standardised processes for how to guard against equipment malfunctions caused by electromagnetic interference. Effective risk management is not only a regulatory requirement to ensure the safety of people and property; it is also a factor in reducing a product's total cost throughout its lifetime. Resolving issues with defective products on the market can quickly run up costs far beyond the costs to design and produce a safe product.