High-Level Highlights for IEC 60601-1 Version 3.2 Are Available in our Downloadable Guide
We’ve published several blogs detailing IEC 60601-1 3.2 since the FDA has listed it as a recognized standard. Medical device manufacturers need to be mindful of changes to standards for normative references, terminology and definitions, identification and marking, electrical hazard protection, excessive temperature protection, hazardous situations & fault conditions, and programmable electrical medical systems (PEMS). ‘
While it’s necessary to thoroughly review the updated guidelines to ensure compliance and apply for medical device approval, we’ve created an IEC 60601-1 PDF free download for those looking for a high-level list of changes and key sections of the regulation.
The FDA listed IEC 60601-1 Version 3.2 as a recognized standard on May 30, 2022, and by December 17, 2023, this standard will replace version 3.1. All medical device manufacturers need to be up on the latest changes to prevent delays in the rollout of new products.
What is IEC 60601-1?
Basic safety and essential performance guidelines are outlined by IEC 60601, a regulatory standard for medical electrical systems and equipment. When an applied part from medical electrical equipment either transfers energy or detects an energy transfer to or from the patient, plus provides up to one connection to the main power supply (either from the wall or at a level greater than what’s supplied from the wall), IEC 60601 applies.
IEC 60601-1 is a standard under 60601, and the latest version, 3.2, provides updated guidance to protect operators or patients from potential thermal, electrical, functional, and mechanical hazards in both normal and fault conditions. While some risk comes with using any medical electrical equipment, the amendment is concerned with filling in gaps so that no unacceptable risks to patients or operators happen.
To learn more about the differences between Version 3.1 and 3.2, the major sections of IEC 60601-1, and what to think about as you bring a product to market, download our guide now.
Download the Guide
To learn more about the differences between Version 3.1 and 3.2, the major sections of IEC 60601-1, and what to think about as you bring a product to market, sign up and download our guide now.
For manufacturers looking for PC-based power supplies that can keep the road to market smooth, look no further. RAM Technologies has power supplies that are certified to meet IEC 60601-1 Version 3.2 requirements. When it’s time to order your PSU, contact us.
RAM Technologies’ power supplies are 60601-1 3.2 certified and meet 60601-1-2 EMC standards. When you’re designing your medical device and need help with a PSU, contact us for details.
More Resources:
What the FDA Moving to IEC 60601-1 3.2 Means for Manufacturers
Differences Between 3.1 and 3.2 Certification for IEC 60601-1
Understanding IEC 60601-1-2
