Implementing Risk Management into the Design of Electrical Medical Devices
With the publication of the third Edition of 60601-1 in 2005, a new concept in device safety standards was introduced. In addition to the inclusion of traditional requirements for test and measurement activities, the third Edition also established process requirements through the application of risk management and usability engineering, and established alarm system characteristics based on analyses.
To assist medical device manufacturers with the application of risk management, usability engineering, and the design of alarm systems as required by the third Edition of 60601-1, AAMI offered a two-part webinar series that provided insights into the requirements of the following standards with emphasis on the interaction between them:
- ANSI/AAMI/ISO 14971:2007 – Medical devices–Application of risk management to medical devices
- ANSI/AAMI ES60601-1:2005 – Medical electrical equipment, Part 1: General requirements for basic safety and essential performance
- IEC 60601-1-6:2006 – Medical electrical equipment – Part 1-6: General requirements for basic safety and essential performance – Collateral standard: Usability
- IEC 60601-1-8:2006 – Medical electrical equipment – Part 1-8: General requirements for basic safety and essential performance – Collateral Standard: General requirements, tests and guidance for alarm systems in medical electrical equipment and medical electrical systems
Engineering, quality, compliance, and regulatory professionals involved with the design, development, and testing of medical electrical devices and systems can’t afford to miss these two programs.
PROGRAM OBJECTIVES
The first session focused on the important principles of ANSI/AAMI/ISO 14971:2007 and the requirements of ANSI/AAMI ES60601-1:2005. You will learn the basic principles and requirements of risk management with emphasis on changes and new insights in the latest edition of 14971, as well as the most important requirements from 60601-1 that rely on risk management to establish compliance.
The second session included a practical exercise in identifying essential performance and acceptability based on risk for a patient warming blanket. This session included a brief review of what constitutes essential performance, how the IEC 80601-2-35 particular standard views essential performance, its requirements for alarms, and how these requirements are impacted by 60601-1-6, 60601-1-8 and 14971.
PROGRAM AT-A-GLANCE
Session 1:
- Overview of history and requirements of ANSI/AAMI/ISO 14971:2007
- The basic requirements of compliant risk management processes
- Changes and new information found in ANSI/AAMI/ISO 14971:2007
- Examination of the clauses of ANSI/AAMI ES60601-1:2005 that require the application of risk management
- General risk management requirements and what is required to demonstrate compliance
- A step-by-step review of the clauses from 60601-1 that utilize risk management
- Introduction of case study on essential performance
- IEC 80601-2-35 related to essential performance will be reviewed
Session 2
Case Study: Risk management acceptability and identification of essential performance for a patient warming blanket
- Overview on how to use risk management to evaluate the definition of essential performance in IEC 80601-2-35
- Defining essential performance in compound terms
- Evaluating alarm failures in the context of IEC 60601-1-8
- Assessing the usability of the system to assure that correct mitigating actions are taken
SPEAKERS
- Edwin Bills, Principal Consultant, Bilanx Consulting
- Mike W. Schmidt, Principal Consultant, Strategic Device Compliance Services
WEBINAR CD
- Includes handout material and CD.
- $560 for webinar registrants | $760 for non-registrants
- Please note that domestic and international shipping rates apply
THREE WAYS TO ORDER
1. Phone – 1-877-249-8226 or 240-646-7031 to order with a credit card
2. Fax – Select and download the order form and fax to 240-396-5781
3. Mail – Select and download the order form and mail with payment to:
Risk and Design Webinar CD Package
AAMI Publications
PO Box 0211
Annapolis Junction, MD 20701-0211
QUESTIONS?
For questions about ordering the CD, please contact AAMI Publications at 1-877-249-8226 / 240-646-7031.