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IEC 60601-1: Managing the Transition (On-Demand Webinar)


Description

UL Health Sciences subject matter experts gathered to present timely topics on the transition to IEC 60601-1 3rd edition. This series of presentations, titled: "60601 - Managing the Transition" is designed to support manufacturers of electromedical devices as you transition from IEC/UL 60601 2nd Edition to IEC 60601 3rd Edition. These recordings of live presentations showcase UL experts from all over the world along with experts well versed in the workings of the FDA and Human Factors Engineering, who share their knowledge and experience in working on 3rd edition projects.

These presentations are now available to further support you and your team as you work to meet the upcoming transition dates.

 

Topics Covered:

  • IEC 60601 3rd Edition Update on Regulatory Requirements - Some of the major differences between 2nd & 3rd Edition
    • Scope
    • Influence of ISO 14971
    • Risk Management deliverables required for 3rd Edition Certification
    • Leakage Current
    • Insulation coordination
    • Separation of parts
    • Isolation requirements
    • Temperature limits

     

  • Risk Management in IEC 60601-1:2005 (3rd Edition)
    • Overview of Risk Management in 3rd Edition
    • Evaluating the Risk Management in the 3rd Ed
    • Preparing for the Evaluation

     

  • Top items to consider when transitioning a 2nd Edition product to 3rd edition
    • What is an ISO 14971 Compliant Risk Management Process
    • Risk Management Assessment Options
    • Essential Performance
    • Major Construction Changes
    • Major Testing Changes
    • Power Supplies in the 3rd Edition
    • Leveraging your 2nd Edition Certification Report

     

  • Choices – IEC 60601-1 3rd Edition and Component Selection
    • Current Practices
    • Going Forward
    • Scope of Risk Management for Components
    • Business Implications
    • Components without Risk Management
    • Components with Risk Management

     

  • FDA and Healthcare Reform:  Anticipating the global regulatory environment and the impact of risk management and 60601 3rd Edition
    • FDA basics
    • FDA and 60601/Risk Management basics
    • Recent and relevant developments
    • The Infusion Pump Guidance of 2010
    • CDRH: An organization in transition?
    • What’s going on globally - GHTF?

     

  • Safety in Software Through Standards
    • Concepts of safety in medical device software, ISO 14971
    • Software Development Standards, IEC 60601-1-4, IEC 62304
    • Lifecycle Requirements

     

  • Documentation Needed to Support the 3rd Edition of IEC 60601- Best Practices Test Report Form (TRF) Risk Management (RM) Upgrade from 2nd to 3rd Edition New Model 3rd Edition UL Certification
    • Human Factors in Medical Device Development
    • Human factors and its importance in medical device development
    • Human factors-related regulations and expectations
    • How the application of human factors can enhance a device
    • Usability testing as a keystone in the overall human factors process
    • Human factors reporting priorities
    • The future of human factors in medical device development

 

Presenters:

  • Mark Leimbeck, PE - 60601 3rd Edition Program Manager
  • Chantel Carson, Lead Engineering Instructor, UL Knowledge Services
  • Larry Kessler, Sc.D, Former FDA Director, Professor & Chair - University of Washington
  • Denise Klinker, Staff Engineer, UL Health Sciences
  • Joseph P. Murnane Jr., PDE - Medical Devices
  • Steve McRoberts, PDE - Regulatory Services
  • Michael Wiklund, Owner, Wiklund R&D
  • Robert Miller, Senior Staff Engineer, EMC

    Target Audience

    • Product safety engineers
    • Medical device manufacturers
    • Compliance engineers
    • Product designers with knowledge of IEC 61010-1 2nd Edition
    • Managers or executives with responsibility for strategy
    Click here for terms and conditions...

    Media

    Time Requirement

    Cost

    Web-Based Modules 5 1/2 hours $499.00
     









     
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