IEC 60601-1-2 Testing
IEC 60601-1-2 4th Edition Standard
IEC 60601-1-2 – 4th edition – Medical electrical equipment – Part 1-2: General requirements for basic safety and essential performance – Collateral Standard: Electromagnetic disturbances – Requirements and tests.
NOTICE – IEC 60601-1-2 4th EDITION HAD MANY TECHNICAL AND DOCUMENTATION CHANGES.
Below is an overview of the most significant changes. As with any other standard change, failure to complete these new requirements in a timely manner could cause costly delays in getting your device to market. With the 3rd edition of IEC 60601-1-2 still in use, it is often hard to determine which version of IEC 60601-1-2 should be used. F2 Labs can help with your FDA medical device testing certification.
The most significant changes from IEC 60601-1-2 3rd edition to IEC 60601-1-2 4th edition are as follows:
Specification of immunity test levels according to the environments of intended use, categorized according to locations that are harmonized with IEC 60601-1-11: the professional healthcare facility environment, the home healthcare environment, and special environments.
Specification of tests and test levels by product safety testing service aims to improve the safety of medical electrical equipment and medical electrical systems when portable RF communications equipment is used closer to the medical electrical equipment than was recommended based on the immunity test levels that were specified in the third edition.
Specification of immunity tests and immunity test levels according to the ports of the medical electrical equipment or medical electrical system
Specification of immunity test levels based on the reasonably foreseeable maximum level of electromagnetic disturbances in the environments of intended use, resulting in some immunity test levels that are higher than in IEC 60601-12 3rd edition
Better harmonization with the risk concepts of basic safety and essential performance, including deletion of the defined term “life-supporting”.
The 4th edition also includes the following guidance in the following areas:
- Determination of immunity test levels for special environments
- For adjustment of immunity test levels when special considerations of mitigations or intended use are applicable
- Risk management for basic safety and essential performance with regard to electromagnetic disturbances
- Identification of immunity pass/fail criteria.
Click here to visit the IEC Webstore to purchase a copy of the standards required for medical device testing.
Medical devices were required to comply with the 4th edition of IEC 60601-1-2 by December 31, 2018, for Europe, the United States (FDA), and Canada.
The FDA does not require compliance with the 4th edition for legacy devices unless changes have been made to the product.
In the European Union (that accepts the CE Mark), medical devices must comply with the 4th edition of EN 60601-1-2. There is no allowance for legacy devices, as is allowed by the FDA. Make sure your product complies by performing dependable medical device testing with F2 Labs.
Legacy Device Definition: A legacy device refers to a computing device or equipment that is outdated, obsolete, or no longer in production. This includes all devices that are unsupported or no longer commonly used by most devices and software applications.
IEC 60601-1-2 Version 4.1 Amendment 2020*
*September 2020
A summary of the most significant changes concerning the previous edition includes:
- specification of Immunity Test Levels according to the environments of Intended Use, categorized according to locations that are harmonized with IEC 60601-1-11: the professional healthcare facility environment, the Home Healthcare Environment, and Special Environments.
- specification of tests and test levels to improve the safety of Medical Electrical Equipment and Medical Electrical Systems When Portable RF communications equipment is used closer to the Medical Electrical Equipment than was recommended based on the Immunity Test Levels that were specified in IEC 60601-1-2 3rd edition.
- specification of Immunity tests and Immunity Test Levels according to the Ports of the Medical Electrical Equipment or Medical Electrical System.
- specification of Immunity Test Levels based on the reasonably foreseeable maximum level of Electromagnetic Disturbances in the environments of Intended Use, resulting in some Immunity Test Levels that are higher than in the previous edition.
- better harmonization with the Risk concepts of Basic Safety and Essential Performance, including deletion of the defined term “life-supporting”;
- guidance for the determination of Immunity Test Levels for Special Environments.
- IEC 60601-1-2 4th edition requires guidance for adjustment of Immunity Test Levels when special considerations of mitigations or Intended Use are applicable.
- guidance on Risk Management for Basic Safety and Essential Performance with regard to Electromagnetic Disturbances.
- guidance on the identification of Immunity pass/fail criteria
Frequently Asked Questions
What is the IEC 60601-1-2 Standard?
This standard outlines the essential requirements for electromagnetic compatibility (EMC) of Medical Electrical Equipment (MME). In today’s interconnected world, where medical devices are increasingly integrated with other electronic systems, ensuring they operate without interference or causing disturbances is paramount.
Why do I need to do testing to do IEC 60601-1-2 on my product?
Patient safety is the foremost concern in healthcare. Medical electrical equipment must function correctly and without interruption to prevent harm to patients. IEC 60601-1-2 testing evaluates the immunity of MEE against electromagnetic disturbances from sources such as radio frequency (RF) transmitters, electrical motors, or nearby electronic equipment, and also measures the amount of RF emissions emitted from your product, to ensure it falls within the allowable limits. By subjecting devices to various electromagnetic environments, potential vulnerabilities can be identified and addressed before they reach clinical settings.
What are the potential consequences for medical device manufacturers if they fail to adhere to standards such as IEC 60601-1-2 regarding regulatory compliance?
Regulatory compliance is a significant aspect of medical device development and marketing. Adherence to standards such as IEC 60601-1-2 is often mandated by regulatory bodies worldwide. Conforming to these standards not only demonstrates a manufacturer’s commitment to quality and safety but also facilitates market access. Without proper testing, devices may fail to meet regulatory requirements, leading to delays in approvals or even recalls, which can be costly and damaging to a company’s reputation.
What effect does wireless communication, data exchange and remote monitoring have on medical devices?
The increasing complexity and connectivity of medical devices amplify the risks associated with electromagnetic interference. Wireless communication, data exchange, and remote monitoring are now commonplace in healthcare, introducing new challenges for EMC compliance. IEC 60601-1-2 testing helps manufacturers anticipate and mitigate potential issues arising from electromagnetic disturbances, ensuring seamless interoperability and reliability of Medical Electrical Equipment within the healthcare system.
How does IEC 60601-1-2 testing contribute to safeguarding patient well-being, achieving regulatory compliance, and addressing the dynamic advancements in medical device technology?
By subjecting devices to rigorous testing protocols, manufacturers can instill confidence in their products’ safety and performance, ultimately contributing to improved medical devices.
How do I show compliance with the FDA’s requirements for Common EM Emitters that aren’t covered under IEC 60601-1-2, such as 5G cellular, WPT, X-Ray, Electro-Surgical, EAS Devices, etc.?
F2 Labs has worked to develop test methods that are accepted by the FDA as proof of compliance with the “Electromagnetic Compatibility (EMC) of Medical Devices” published in June 2022. We can perform the testing on your medical device and provide you with test reports as your proof of compliance, so submit with your FDA 510K.
How Can F2 Labs Assist with IEC 60601-1-2 Compliance?
F2 Labs can help navigate the complexities of IEC 60601-1-2 compliance, offering testing certification services for the 4th edition, including guidance on the significant changes and requirements to ensure your medical device meets global market standards.
