IEC 60601-1 3rd Edition Standard Testing

Intertek guides you through the requirements of IEC 60601-1 3rd Edition Standard for medical electrical equipment.

From education to certification, Intertek is your trusted partner to help you navigate the new requirements of the IEC 60601-1 3rd Edition. To address the increased emphasis on risk management, we partner with you in creating your Risk Management Profile (RMF) to provide an interactive and hands-on solution. Our experts support you from the development stage all the way through review of your Risk Management File.

Send a request to partner with us and create your Risk Management Profile today.

IEC 60601-1 3rd Edition Mandatory Adoption Dates

• Europe: June 1, 2012
• Canada: June 1, 2012
• USA: July 1, 2013

Note: Some specific products types may have earlier adoption dates. Mandatory adoptions dates may change based on regulatory body decisions. Contact your Intertek representative for specific and current dates.

4-Step Process to IEC 60601-1 Certification

Developing a Risk Management File (RMF) to meet 3rd Edition certification is a new challenge for manufacturers. The process consists of:

1. Education: Intertek Academy, Compliance to the 3rd Edition
2. Audit to ISO 14971: Increase your Risk Management pass rate up to 80%
3. Preliminary Design Package: Includes preliminary reviews of the product and the Risk Management File
4. Final testing to 60601-1 3rd Edition.

Risk Based Approach 

• Risk Management File Development. We will work with you to evaluate your RMF starting at the beginning of your product development cycle.
• Risk Management File Review. As a Notified Body (EU), a Nationally Recognized Test Lab (US), a Certified Body (Canada), Test House and CB Scheme Testing Laboratory (CBTL) Intertek can provide an evaluation of the determinations contained in your Risk Management File as well as in-lab testing to support safety, EMC and performance claims
• Risk Management File Process. Intertek’s Systems Certification group can evaluate and certify your risk management process in accordance to ISO 14971 

IEC 60601-1 Support Services
Intertek provides a range of services to ensure you bring your products to more markets in less time.

• Training: Customized on-site or off-site training options
• Certification: ETL Listed Mark for North America; CB Scheme for International Markets; S Mark for Europe
• Additional Services: Notified Bodies for CE Marking of Medical Devices; FDA 510(k) Third Party Reviews

IEC 60601-1 2nd to 3rd Edition Transition Services

For products that have already been certified to the 2nd Edition of IEC 60601-1, Intertek offers the fastest route to 3rd Edition compliance.

• Gap Analysis
• Risk Management File Review
• Risk Management Systems Auditing & Certification: ISO 14971

Contact us to see how Intertek can help your organization with IEC 60601-1 3rd Edition Standard Testing.