IEC 60601-1 3rd Edition Standard

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 60601-1. 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 and to support your safety claims throughout North America and Europe. From development all the way through the review of your Risk Management File, we offer the following solutions to help you reach your target markets.

  • Risk Management Consulting
  • Customized On-site & Off-site Training Seminars
  • Risk Management Systems Certification & Auditing: ISO 14971
  • Testing and Certification to 60601-1, 3rd Edition including Amendment 1 (Ed. 3.1)

Get expert advise for transitioning to IEC 60601-1 Edition 3.1 in major medical device markets

Download our IEC 60601-1 Edition 3.1 White Paper

 

Intertek does not provide consulting services for management systems certification. Any consulting activities provided by Intertek are separate and independent from certification activities.

 
 
 
 

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Regulatory Requirements for Medical Equipment