IEC 60601: Product Safety Standards for Medical Devices

What is IEC 60601?

IEC 60601 is a series of international standards, published by the International Electrotechnical Commission (IEC), that specify safety and performance requirements for medical electrical equipment and is widely recognized as the benchmark for medical device safety. The IEC 60601 series consists of multiple parts, each focusing on different aspects of medical electrical equipment.

Key Components and Standards encompassed by IEC 60601

General Requirements

• IEC 60601-1: General requirements for basic safety and essential performance. This is the core document that outlines the overall requirements for safety. IEC 60601-1 4th edition updates

Collateral Standards (Part 1-X)

• IEC 60601-1-2: Electromagnetic compatibility (EMC)
• IEC 60601-1-3: Radiation protection in diagnostic X-ray equipment
• IEC 60601-1-6: Usability engineering (aligned with IEC 62366)
• IEC 60601-1-8: Alarm systems in medical devices
• IEC 60601-1-9: Environmentally conscious design
• IEC 60601-1-10: Development of physiologic closed-loop controllers
• IEC 60601-1-11: Requirements for home healthcare environments

Particular Standards (Part 2-X)

• IEC 60601-2-2: High-frequency surgical equipment
• IEC 60601-2-4: Cardiac defibrillators
• IEC 60601-2-22: Laser equipment
• IEC 60601-2-24: Infusion pumps
• IEC 60601-2-52: Medical beds

Benefits of IEC 60601

One of the primary goals of IEC 60601 is to ensure the safety of patients using medical electrical equipment. Compliance with IEC 60601 standards helps to minimize the risk of electrical hazards, such as electric shocks or burns, ensuring that devices are designed and manufactured with patient safety as a top priority. The IEC 60601 standards also provide a consistent framework for safety requirements across different types of medical electrical equipment. This uniformity helps manufacturers understand and implement the necessary safety measures, leading to a higher level of safety across the industry.

Many countries have adopted the IEC 60601 series as the basis for their medical device regulations. Compliance with these standards is often a legal and regulatory requirement for manufacturers to demonstrate the safety and performance of their devices. Adhering to IEC 60601 helps manufacturers meet these regulatory obligations and gain market access in various countries.

Creation of IEC 60601-1 4th Edition

  Stay ahead in medical device compliance with our exclusive webinar on the IEC 60601-1 4th Edition updates. Learn about critical changes, streamlined standards, and how to future-proof your designs for global markets.  

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Intertek Solutions for IEC 60601

As a Nationally Recognized Testing Laboratory (NRTL) approved by OHSA, Intertek is an industry leader providing Testing, Certification and in-lab support to help you navigate the requirements of the IEC 60601 series of standards. With our team of experts globally, Intertek is positioned to help determine standard applicability and execution. Through standards testing, you can support your safety claims throughout North America, Europe and beyond. We offer end-to-end solutions from product development, to review of the Risk Management File and supporting documentation, to comprehensive testing to the 60601/80601 series of standards, including an array of Collateral (IEC 60601-1-X) and Particular (IEC 60601-2-X) Standards. Intertek is your trusted partner throughout the testing process.

• IEC 60601-1-2: Medical Device EMC Testing
• IEC 60601-1-9: Requirements for Environmentally Conscious Design
• ISO 14971: Application of Risk Management for Medical Devices
• Customized On-site & Off-site Training Seminars
• Testing and Certification to IEC/AAMI 60601-1, 3rd Edition including Amendment 1 and 2
• Differences between the EU MDD and the MDR - FAQ Download

IEC 60601 Resources

Knowledge Center

Download the latest information from our medical device compliance experts

Creation of IEC 60601-1 4th Edition

IEC TS 60601-4-2

IEC 60601-1-2 Ed. 4.1 Overview of Requirements

FDA ASCA Program Q&A

Medical OEM Wireless Coexistence Testing

Artificial Intelligence (AI) and Machine Learning (ML) in Medical Devices

Biocompatibility Risk Assessment and Evaluation Plans

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