IEC 60601: Product Safety Standards for Medical Devices
IEC 60601 is a widely accepted series of international standards for the Basic Safety and Essential Performance of Medical Electrical Equipment
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.
- Medical Device EMC Testing - IEC 60601-1-2
- IEC 60601-1-9: Requirements for Environmentally Conscious Design
- Risk Management Consulting
- Customized On-site & Off-site Training Seminars
- Risk Management Systems Certification & Auditing: ISO 14971
- Testing and Certification to IEC/UL 60601-1, 3rd Edition including Amendment 1 and 2
IEC 60601-1-8 AMD2 for Medical Alarms Webinar Download
*The Intertek legal entities that provide medical device management system certification services (including ISO 13485 and MDSAP) and Notified Body services (MDR 2017/745 and MDD 93/42/EEC) do not provide any consulting services. Clients who have used other Intertek legal entities’ consulting services are not eligible to receive management system certification services or Notified Body services from Intertek.
IEC 60601 Resources
Knowledge Center
- Ventilator Production: Introductory Guide to Regulatory Requirements
- Critical Care Medical Devices: First-In-Queue Priority
- Medical Robots Fact Sheet
- Product Listing & Marking Strategies White Paper
- IEC 60601-1-2 Edition 4 White Paper
- Updated FCC Approval Process Webinar
- Extractables and Leachables Studies Fact Sheet
- Five Steps to Medical Device Commercialization in the United States White Paper
- Making Green Profitable: Using IEC 60601-1-9 as a Competitive Advantage White Paper
- How to Integrate Human Factors in the Development Process for FDA Compliance Webinar
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