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 is the standard of choice for showing safety and performance in the US, Europe and around the world. The IEC 60601 family includes IEC 60601-1-2 for EMC, IEC 60601-1-6 and other collateral standards as well as more than 70 particular standards such as IEC 60601-2-22 for lasers and ISO 80601-2-61 for pulse oximeters. There is even a collection of guidance and interpretation standards such as IEC TS 60601-4-2 for EMC. Without compliance to the current editions the ability to sell in the U.S. and globally will be affected. Devices currently being designed should comply and, for Europe, devices still being produced should comply.

Be sure your team understands the requirements and they impact your device including planning and scheduling for testing or product modifications that may be required. Details of 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 insights & experiences gained by working with numerous clients and various testing houses. Included will be a review of a typical isolation diagram, mechanical and temperature limits, and addressing the focus on risk analysis.

What you will learn:

• Understand and apply the requirements of IEC 60601-1.
• How to meet usability (IEC 60601-1-6) and alarm (IEC 60601-1-8) requirements.
• Review of EMC requirements (IEC 60601-1-2 and IEC TS 60601-4-2).
• Clear understanding of labeling requirements.
• Transition periods and planning for compliance.
• Impact of risk management & ISO 14971.
• Include IEC 60601-1-x collaterals and IEC 60601-2-X / ISO 80601-2-X particulars as relevant.

Benefits of Attending:

• Understanding IEC 60601-1.
• Clear understanding of labeling requirements.
• Understanding of impact of ISO 14971, IEC 60601-2, IEC 60601-1-6, and others.
• Ability to plan for a smooth transition to compliance.
• Understand US differences.

Abbreviated Outline:

• A. Understanding the standard & organization - how to find things quickly.
• B. Understanding details of IEC 60601-1 using an isolation diagram example.
• C. Impact of collateral and, if relevant, particular standards.
• D. Labeling requirements including symbols.
• E. Risk management, including ISO 14971; its critical importance in complying with this standard.
• F. Q&A’s
• G. 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.