A Practical Guide To The IEC 62353 Electrical Safety Test

Ensuring the safety of any medical electronic device is a critical responsibility for healthcare providers, medical facilities, and manufacturers. One of the most widely recognised safety standards for medical equipment is IEC 62353, an international standard specifically developed for the periodic testing of medical electrical devices.

In this blog, we will explore what the IEC 62353 electrical safety test entails, who it affects, and whether it is mandatory. We’ll also explain the difference between IEC 60601 and IEC 62353, two standards often mentioned in medical equipment safety testing.

What is the IEC 62353 electrical safety test?

The IEC 62353 electrical safety test is an international standard developed by the International Electrotechnical Commission (IEC). It provides guidelines for the routine testing of medical electrical (ME) equipment and systems to ensure they remain safe to use after installation and during their operational life. The goal of the IEC 62353 test is to verify that electrical medical devices do not pose a risk of electrical shock or injury to patients, operators, or maintenance personnel.

IEC 62353 applies to all medical electrical equipment that is classified as “in use” or “subject to routine testing” and includes everything from diagnostic machines to life support systems. The standard outlines procedures for various types of electrical safety tests, including leakage testing, insulation resistance tests, and functional checks. Leakage testing is crucial for measuring different types of leakage currents, such as equipment leakage and applied part leakage, to protect patients and operators from potentially harmful electrical currents. Selecting the appropriate test method as outlined by the IEC 62353 standard is essential for ensuring consistent, reliable, and accurate results in medical device testing.

Who is affected by IEC 62353?

The IEC 62353 electrical safety test affects a wide range of stakeholders in the healthcare industry. These include:

·         Manufacturers, who are responsible for advising on appropriate tests.

·         Biomedical engineering departments, which must adapt to the new guidelines.

·         Clinical engineering departments, which ensure the ongoing safety of medical devices.

Medical service companies also play a crucial role in ensuring compliance with the IEC 62353 standard.

Hospitals and medical facilities

Healthcare providers are responsible for ensuring that all medical electrical devices are regularly tested for safety to comply with national regulations and to maintain operational safety standards.

Medical device manufacturers

Manufacturers must ensure that the devices they produce can meet the IEC 62353 testing requirements, especially when the equipment is installed or maintained. Conducting tests according to the IEC 62353 standard at the final production line stage is crucial, as it allows for recurrent tests to be directly comparable with factory tests, facilitating better monitoring of any variations in leakage measurements before the equipment is put into service.

Maintenance and service providers

Companies that offer medical equipment servicing must perform the tests specified by IEC 62353 to ensure continued safe operation.

Clinical engineers and biomedical technicians

Those involved in maintaining medical equipment need to be familiar with IEC 62353 and its application in routine testing and servicing.

Is IEC 62353 mandatory?

The question of whether the IEC 62353 electrical safety test is mandatory depends on the specific legal and regulatory requirements of a country or region. While IEC 62353 is not an enforceable law on its own, it is widely adopted and often referenced in national standards and guidelines related to medical electrical device safety.

In many countries, complying with IEC 62353 is considered best practice for healthcare providers and medical device manufacturers. It is also often used to fulfil local regulatory requirements for periodic testing. However, whether IEC 62353 is mandatory in a legal sense may depend on the regulations in place within a particular jurisdiction.

For example, in the UK, the Medicines and Healthcare Products Regulatory Agency (MHRA) encourages compliance with IEC 62353 to ensure safe medical practices. Medical equipment that is not regularly tested according to recognised standards could potentially fail safety inspections or lead to liability issues for healthcare providers.

Difference between IEC 60601 and IEC 62353

The difference between IEC 60601 and IEC 62353 is essential for understanding how medical devices are tested and maintained. While both standards deal with the safety of electrical medical devices, they serve different purposes and are applied at different stages of a device's life cycle.

IEC 60601

This is the standard that governs the design and manufacturing of medical electrical devices. It sets out the technical requirements for the safety and performance of new medical equipment. Manufacturers must adhere to IEC 60601 when developing and producing new medical devices. The primary aim of IEC 60601 is to ensure that medical devices are safe before they enter the market.

IEC 62353

Once a medical device is in use, IEC 62353 comes into play. This standard is used for routine and periodic testing of medical devices that are already installed and in use. Its goal is to ensure that the device remains safe over time and after any maintenance or repairs.

In summary, while IEC 60601 focuses on the initial safety design and manufacture of medical devices, IEC 62353 is concerned with ongoing safety testing and maintenance. Both are critical for ensuring the long term safety and functionality of medical electrical equipment.

How to perform IEC 62353 electrical safety tests

The IEC 62353 electrical safety test comprises several types of checks that are designed to assess the electrical safety of medical devices. These include:

Leakage current tests

These tests measure the amount of equipment leakage current that leaks from a medical device, which could pose a danger to patients or operators. The different leakage current tests include earth leakage, enclosure leakage, and patient leakage.

Insulation resistance tests

Measuring protective earth resistance is crucial before conducting insulation resistance tests to ensure compliance with electrical safety standards, especially for medical devices.

This test ensures that the insulation around electrical components is sufficient to prevent electrical shock.

Functional testing

Devices are also subject to performance tests to confirm they are operating as intended.

Medical devices should undergo IEC 62353 electrical safety testing during installation, after repairs or maintenance, and as part of regular safety checks, typically at intervals recommended by the manufacturer or local regulations. Accurate measurement equipment is essential for conducting these functional tests to ensure compliance with international guidelines.

JPen Medical’s support with IEC 62353 compliance

At JPen Medical, we understand that maintaining electrical safety in healthcare environments is essential, not just for compliance but also for ensuring the safety of patients and staff. We offer a comprehensive range of services to help businesses and organisations meet the requirements of the IEC 62353 electrical safety test.

Our services include routine electrical safety testing of medical devices – and we are the first testing/calibration company to test to IEC 62353 as part of our routine testing within all sectors. We work closely with healthcare providers, clinics, and manufacturers to ensure that medical electrical equipment is regularly inspected, tested, and certified as safe. Whether you need initial testing for newly installed devices or ongoing maintenance checks, JPen Medical has the expertise to ensure that your equipment remains compliant and safe.

Supporting businesses with comprehensive testing and maintenance

JPen Medical provides a full range of services, including electrical safety testing, equipment servicing, and maintenance support, to ensure your medical devices comply with the IEC 62353 electrical safety test. Our experienced technicians can help you schedule and manage routine safety inspections to meet your operational needs and regulatory obligations. By partnering with us, you can ensure that your equipment remains in top condition and continues to meet the highest safety standards.

Our expert team is ready to help your organisation maintain compliance with the IEC 62353 electrical safety test and support your ongoing equipment safety and performance requirements. Get in touch with us today to discuss your electrical safety testing needs.