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IEC 60601-1-12 Electrical Safety Testing

IEC 60601-1-12 Safety Testing of Medical Electrical Equipment Used in Emergency Service Environments

The IEC 60601-1-12 evaluates the safety and performance criteria for medical electrical devices used in emergencies. More specifically, IEC 60601-1-12 explains the standard’s applicability to devices designed for emergency use as per manufacturer guidelines. Lastly, the IEC 60601-1-12 excludes devices meant for home healthcare or non-emergency professional settings.

Keystone adopts a consultative stance throughout the entirety of the test program. By crafting a precise test plan, Keystone Compliance aims to prevent the costly process of excessive testing. Following the completion of the product safety standard test, we promptly deliver detailed reports. Our team maintains continuous communication with our clients throughout the test procedure.

To discover why we are among one of the most rapidly expanding compliance test laboratories in the nation, we invite you to request a quote.

Summary of IEC 60601-1-12 Product Safety Testing

This section outlines the application of the 60601-1-12 standard to the basic safety and essential performance of medical electrical equipment and medical electrical systems intended for use in the emergency medical services environment. It emphasizes the manufacturer’s intended use, as specified in the instructions for use, and determines applicability.

The EMS (Emergency Medical Service) environment includes various scenarios such as life support at emergency scenes, patient transport, and monitoring or treatment during transport between healthcare facilities. The standard excludes equipment solely intended for home healthcare or professional healthcare facilities without the additions of IEC 60601-1-11​​.

Scope of IEC 60601-1-12 Medical Equipment Testing

This section addresses general requirements for medical electrical equipment in the EMS environment, emphasizing the need for legibility under diverse lighting conditions, marking for IP classification, instructions for use, and specific requirements for electrical power sources. It discusses operational expectations, including battery life. The section also highlights the importance of disclosing the technical characteristics of internal electrical power sources. Additionally, it emphasizes the need to disclose expected performance under typical conditions.

IEC 60601-1-12 covers mechanical strength requirements, protective measures against electrical hazards, and the necessity of maintaining basic safety and essential performance under various conditions. Conditions include IP classification for equipment protection against water and particulate matter​.

Classification of ME Equipment and ME Systems

This section clarifies that portable and mobile electrical generators without a reliable ground connection are not permitted unless the equipment is fixed or permanently installed in an ambulance. It discusses the risk control measures for protection against electrical shock and the importance of not relying on a protective earth connection for transportable ME equipment intended for the EMS environment.

IEC 60601-1-12 also emphasizes the need for F-TYPE applied parts due to the EMS environment’s potential hazards and the importance of legible markings and instructions for use, including the handling of internal electrical power sources.

IEC 60601-1-12 Testing of Medical Equipment and Systems

The safety testing process involves a combination of laboratory tests and simulations to approximate real-world emergency conditions, ensuring that ME equipment and systems are robust, reliable, and safe for use in the demanding EMS environment.

To conduct safety testing according to the IEC 60601-1-12 standard, manufacturers must consider:

Environmental Conditions

Equipment must be tested to withstand the broad range of environmental conditions expected in the EMS environment, including temperature extremes, humidity, vibration, and shock. The standard provides specific requirements for testing mechanical strength, ingress protection against water and particulate matter, and ensuring the equipment maintains basic safety and essential performance under these conditions.

Electrical Safety

Testing should ensure that ME equipment does not rely on a protective earth connection for safety, particularly for transportable equipment. This includes evaluating the equipment’s design to prevent electrical shock hazards, even in environments with unreliable electrical installations.

Operational Performance

Equipment must be tested for its intended operational performance, including battery life and functionality under typical EMS conditions.

This involves evaluating the equipment’s performance in emergency scenarios, focusing on usability and the legibility of controls and displays under various lighting conditions. It also includes assessing the ability to maintain essential performance during and after rough handling.

Expert IEC 60601-1-12 Safety Testing of Emergency Medical Service Environments

In addition to IEC 60601-1-12 safety testing, Keystone has a full scope of expertise including temperature, EMC/EMI, and NEMA enclosure testing. Keystone has a full lab of test equipment which permits us to provide short lead times on scheduling. Our team strives to give our customers more time and energy on product development instead of testing.

Ready to get started? We are. Contact us to see why so many companies work with us to achieve their product safety standard testing needs. Request a quote to receive testing services tailored to your specific requirements.