IEC 60601-1: Making Computers for Medical Applications Safer

What is IEC 60601-1? 

IEC 60601-1 is an international standard for medical device hardware that outlines general requirements for basic safety and essential performance. It was created by the International Electrotechnical Commission (IEC). Every piece of equipment used for medical applications is rigorously tested and highly scrutinized. Embedded computers and standalone devices used in healthcare are subject to the UL/IEC 60601-1 medical standard. Adherence to this standard ensures healthcare providers that medical devices are safe for use around patients and medical professionals. 

To simplify further, 60601-1 safety listings require compliance to a number of subsections in the standard. Some of the most important are safety, failure modes, risks analysis, software testing, and medical electromagnetic compatibility testing (EMC). For our part, OnLogic has proven compliance for the safety and EMC elements, greatly reducing risk in final 60601-1 certifications, thus reducing time to market for our customers.

So, how can working with computer hardware that has been tested for pre-compliance to IEC 60601-1 help you?

Hardware for Medical Device Applications

Finding hardware for a medical device that meets the requirements of UL/IEC 60601-1 and other requirements for medical solutions, can be challenging. That’s why our engineering and regulatory teams work so hard to make the process as streamlined as possible. Additionally, there are on-staff regulatory engineers highly skilled in all aspects of medical product certifications.

Here are a few benefits of working with OnLogic. With our experience,  we can help you get your medical device market ready faster.

• 60601-1 Pre-qualified Platforms: Choose from pre-qualified computer platforms that have already undergone 60601-1-2 (4th edition) EMC immunity testing (including 15kV ESD, 1kV EFT, 30A/m magnetic immunity, 10V/m RF immunity). In fact, our rugged systems have even been certified for higher limits like 20V/m RF and 2kV EFT through their railway immunity certification testing.
• Simplified Audits: OnLogic is an ISO 9001 manufacturer. If your ISO 13485 company uses OnLogic hardware, your yearly supplier quality audits will be much easier, saving you time and effort.
  
• Medical Industry Experience: Our team has a wealth of expertise in medical compliance and has delivered results to mainstay companies who build surgical robots, medical carts (like ultrasound and EMR workstations), PACS and other Digital Imaging and Communications in Medicine (DICOM) solutions, for both human medical care and veterinary applications.
• Ongoing Product Surveillance: Our pre-qualified, medical tested systems also feature NRTL safety listings, and are part of product surveillance programs. This means your critical components list (CCL) just needs to say “OnLogic…model number… Listed 62368-1” and, in most situations, no open-computer on-site inspections are required by 60601-1 inspectors. This is a way to leverage existing IT safety listings to satisfy many of the Medical requirements. And it also means the hardware has all the necessary approved safety features including recognized fuses and fire resistant materials to name a few.
• Installation Advice: OnLogic can help provide guidance on equipment installation and preparation for final 60601-1-2 EMC and safety CCL items. OnLogic works with your team to assure isolation, leakage current and other power supply requirements are met. Time savings to medical customers are usually measured in months.
• Flexible Safety Listing and EMC Testing: OnLogic will assure your computer equipment is safety listed and EMC tested in the most flexible way possible to allow for future adjustments without the need for retesting. In creating our testing plans, we always consider the potential for both the PC CCL and system level CCL flexibility. Testing is always performed in the most complex configurations possible.
• Testing and Certification Support: OnLogic realizes that additional medical testing will often be required for you to meet the specific needs of your project. We try to eliminate as much risk as possible by conducting initial testing ourselves and then offer supplemental support to get you the results you need. This can save you a tremendous amount of time.

A TIMS Medical device, built on a custom OnLogic computer. Click the image to view our TIMS Medical customer story.

Get your Medical Device Across the Finish Line

We know that bringing a medical device to market can be difficult. Ensuring IEC 60601-1 is just one of the hurdles you need to cross. We can help you avoid costly slowdowns, overlooked certification needs and delays. Let us help you make it possible while avoiding roadblocks.

Ready to get started? Our Helix 500 & 600, P2002, P2102, Karbon 700, Karbon 800, Helix 300 & Karbon 400, and Factor 201 & 202 are all an excellent place to start for your medical device project. Have questions? Call, email or chat with us today.

This blog was originally posted on June 30th, 2021. It was updated for content on July 19th, 2022.