IEC 60601-1 (3.1) The New Paradigm for Medical Device Safety: One and a Half Day In-Person Seminar

By: Mike Colvin Ph.D, Medical Device Technical Adviser/Consultant
Location :- Valhalla, NY | Tuesday, September 11, 2018 | Wednesday, September 12, 2018

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Course Description:

The medical device field is one of the most heavily regulated industries, for obvious reasons. Medical devices are an important tool in efforts to improve patient care and treatment outcomes. However, today’s advanced medical devices usually consist of unique combinations of mechanical, electrical and electronic components and technologies that are frequently controlled by software or programmable controllers. As a result, international regulations and standards applicable to medical devices are being continuously revised and updated to reflect potential safety issues that can result from increasingly complex device designs.

First published in 1977 by the International Electrotechnical Commission (IEC), IEC 60601-1, Medical electrical equipment – Part 1: General requirements for basic safety and essential performance, is the internationally recognized standard addressing general requirements for medical electrical equipment and devices. IEC 60601-1 has undergone a number of significant revisions over the years in an effort to remain current with new and advanced medical technologies. The latest set of changes was introduced with the 2012 publication of Amendment 1 to IEC 60601-1.

This seminar provides an overview of the IEC 60601. It also covers the modified requirements presented in IEC 60601-1 Edition 3.1. Beginning with a brief summary of the history of the standard, the seminar then offers a detailed review of the significant additions and changes presented in Amendment 1, as well as information on other changes that may affect medical device manufacturers, and concludes with some guidelines and recommendations for manufacturers.

Learning Objectives:

After completing this seminar, participants should be familiar with the full scope of IEC 60601-1, including the current version. The topics covered will include:

  • Determine the applicable medical equipment requirements to design products for compliance
  • Risk Assessment, Designing a Risk Management system
  • Establishing essential performance limits on medical electrical equipment, and evaluating these performance characteristics under abnormal or fault conditions
  • Requirements for PEMS (programmable electrical medical systems)
  • Humidity testing requirements
  • Mechanical hazards
  • Temperature testing
  • Marking and labeling
  • Documentation, user manuals, instructions for use (IFU)
  • Define insulation parameters and requirements
  • Generate diagrams that determine creepage, clearance, insulation thickness, and dielectric strength requirements
  • Determine appropriate grounding, fire protection, and mechanical requirements
  • Identify performance testing

Areas Covered :

The areas that will be discussed in the seminar will include the following topics throughout the agenda:

  • History of IEC 60601-1
  • Overview of collateral standards, i.e., IEC 60601-1-XX
  • Overview of particular standards, i.e., IEC 60601-2-XX and IEC/ISO 80601-2-XX
  • Review of ISO 14708, Active Implantable Medical Devices
  • Review of 14971 Risk Management File
  • Review full scope of IEC 60601

Who will Benefit:

  • Medical Device Industry Managers, Supervisors, Employees
  • Electronic Industry Managers, Supervisors, Employees
  • Quality Assurance Personnel
  • Technical Consultants

Course Outline

Day One (8:30 AM – 4:30 PM)
  • 08.30 AM - 08.59 AM: Registration and Meet & Greet.
  • 09.00 AM - 10.00 AM:
    • Seminar outline
    • History of IEC 60601-1
  • 10.00 AM - 11.00 AM:
    • Overview of collateral standards, i.e., IEC 60601-1-XX
    • Overview of particular standards, i.e., IEC 60601-2-XX and IEC/ISO 80601-2-XX
  • 11.00 AM - 12.00 PM:
    • Review of ISO 14708, Active Implantable Medical Devices
    • Review of 14971 Medical devices –Application of risk management to medical devices
  • 12.00 PM - 01.00 PM: Lunch
  • 01.00 PM - 02.00 PM: Review full scope of IEC 60601
    • Terminology and definitions
    • General requirements
  • 02.00 PM - 03.00 PM:
    • General requirements for testing ME equipment
    • Classification of ME Equipment and ME Systems
  • 03.00 PM - 04.00 PM:
    • ME Equipment identification, marking and documents
    • Protection against electrical Hazards from ME Equipment
  • 04.00 PM - 04.30 PM:
    • Review & Summary
    • Adjourn
Day Two (8:30 AM – 12:30 PM)
  • 08.30 AM - 10.00 AM: Review full scope of IEC 60601 (continued)
    • Protection against Mechanical Hazards of ME Equipment and ME Systems
    • Protection against unwanted and excessive radiation Hazards
    • Protection against excessive temperatures and other Hazards
  • 10.00 AM - 11.00 AM:
    • Accuracy of controls and instruments and protection against hazardous outputs
    • Hazardous situations and fault conditions for ME Equipment
    • Programmable Electrical Medical Systems (PEMS)
  • 11.00 PM - 12.00 PM:
    • Construction of ME Equipment
    • ME Systems
    • Electromagnetic compatibility of ME Equipment and ME Systems
  • 12.00 PM - 12.30 PM: Seminar wrap up

Meet Your Instructors

Mike Colvin
Mike Colvin Ph.D,
Medical Device Technical Adviser/Consultant

Dr. Mike Colvin has over 30 years direct experience in managing Biocompatibility assessment and testing, working in the medical device and combination products field. He has worked on/contributed to many domestic and international Biocompatibility committees, and has been a consultant to the medical device industry on the proper Biocompatibility strategies for success.

Venue

Location :
Valhalla, NY (Venue to be announced shortly)

September 11-12, 2018
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$1,699

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September 11-12, 2018, Valhalla, NY
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