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.
Your new and existing medical devices must demonstrate compliance with the latest revision of IEC 60601. We are a Nationally Recognized Testing Laboratory (NRTL) approved by OHSA, providing testing, certification, and in-lab support to help you navigate the new requirements of the 3rd Edition of IEC 60601 and to support your safety claims throughout North America and Europe. We offer the following solutions, from development all the way through the review of your Risk Management File, to help you reach your target markets.
IEC 60601-1 3rd Edition, 2nd Amendment Fact Sheet
- Medical Device EMC Testing - IEC 60601-1-2
- 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
Intertek does not provide consulting services for management systems certification. Any consulting activities provided by Intertek are separate and independent from certification activities.
IEC 60601 Resources
Knowledge Center
- Commercial Displays: Compliance to ANSI/UL 970 Fact Sheet
- 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
- Updated FCC Approval Process - webinar
- Final Countdown to IEC 60601-1-2 4th Edition EMC - 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
- EMC 4th Edition RMF Requirements - webinar
- Transitioning to IEC 60601-1 Edition 3.1 - white paper
- How to Integrate Human Factors in the Development Process for FDA Compliance - webinar
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