IEC 60601-1 3rd Edition & Certification Requirements

(On-site or Virtual Private Group/Company Training)

Date: Your Choice

Location: On-site or Virtual

Who: Your entire company, department, project team, you select

Overview:
 
IEC 60601-1 was updated in 2020 as were many in the IEC 60601 family such as IEC 60601-1-2 for EMC and IEC 60601-1-6 for Alarms. Without compliance to the current editions the ability to sell in the U.S. and globally will be affected. Many products sold in the EU (new & current production) now need to comply with the latest IEC 60601 standards. The FDA and Health Canada are expected to allow a transition period. To ensure readiness, devices currently being designed should comply. Now is the time to understand the changes and how they will impact your device including planning and scheduling for new testing or product modifications that may be required. Details of new safety and performance requirements will be presented. The course is appropriate for those new to the standard but will also be valuable to those familiar with the standard by providing valuable insights & experiences gained by working with numerous clients, the new version, and various testing houses. Included will be a review of a typical isolation diagram and how the new requirements affect it; as well as, the continued focus on risk analysis and how it impacts the standard’s requirements.

What you will learn:

• Understanding of IEC 60601-1 and what has changed with the amendments.
• How to meet usability (IEC 60601-1-6) and alarm (IEC 60601-1-8) requirements.
• Review of EMC requirements (IEC 60601-1-2).
• Clear understanding of labeling requirements.
• Transition periods and planning for compliance.
• Impact of risk management & ISO 14971 in the 3rd edition.
• Amendment details and impact, including for the IEC 60601-1-x collaterals.

Benefits of Attending:

• Understanding of what has changed or been clarified in the 3^rd edition.
• Clear understanding of labeling requirements.
• Understanding of impact on standards required by the 3rd edition, including ISO 14971, IEC 60601-2, IEC 60601-1-6, -8.
• Ability to plan for a smooth transition to compliance (although time is now short).
• Understanding of how the amendments impact your products.
• Plan ahead for the latest revisions.

Abbreviated Outline:

• A. Transition deadlines- EU, Canada & U.S. FDA.
• B. Understanding the standard & organization- how to find things quickly
• C. Key changes and impact of the amendments
• D. Understanding details of IEC 60601-1 using an isolation diagram example
• E. Labeling requirements including symbols
• F. Risk management, including ISO 14971; its critical importance in complying with this standard
• G. Amendments to IEC 6060-1-x collaterals
• H. Collateral Standard IEC 60601-1-6 on Usability
• I. Collateral Standard IEC 60601-1-8 on Alarms
• J. Q&As
• K. Review and Summary

Instructor(s): To be determined based on schedule and your specific needs. All instructors are very experienced and experts in the field being taught. Biographies will be provided and a discussion with the instructor(s) will be arranged so that a proposal can be provided for training that meets your needs.

Duration: Standard course is approximately 8 hours. Customized courses can vary. On-site courses are typically taught in 1 day. Virtual courses can be taught over multiple days, e.g. 2 days for 4 hours/day, etc.