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
Coming soon.. Please contact customer care for new schedule

We need the below information to serve you better

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.

Register Online

Register Online

Get the Invitation
Pre-Register yourself and get the official Invite when venue and dates are announced for this seminar.
Call here to register +1-1-888-771-6965 or email at

Register by Wire Transfer

If you wish to pay by wire transfer: Please call us at
Toll Free +1-1-888-771-6965

Download Registration Form

Yes, I want to attend "IEC 60601-1 (3.1) The New Paradigm for Medical Device Safety: One and a Half Day In-Person Seminar"
Click here to Download Registration Form
If you are paying by check:
Checks should be payable to MetricStream Inc. (our parent company). and mailed to:
2479 East Bayshore Road, Suite 260
Palo Alto, CA 94303

Terms & Conditions to register for the Seminar/Conference/Event

Your Registration for the seminar is subject to following terms and conditions. If you need any clarification before registering for this seminar please call us @ +1-888-771-6965 or email us @


Payment is required before 2 days of the date of the conference. We accept American Express, Visa and MasterCard. Make checks payable to MetricStream Inc. ( our parent company)

Cancellations and Substitutions:

Written cancellations through fax or email (from the person who has registered for this conference) received at least 10 calendar days prior to the start date of the event will receive a refund — less a $300 administration fee. No cancellations will be accepted — nor refunds issued — within 10 calendar days from the start date of the event.

On request by email or fax (before the seminar) a credit for the amount paid minus administration fees ($300) will be transferred to any future GRC Seminars event and a credit note will be issued.

Substitutions may be made at any time. No-shows will be charged the full amount.

We discourage onsite registrations, however if you wish to register onsite payment to happen through credit card immediately or check to be submitted onsite. Conference material will be given on the spot if it is available after distributing to other attendees. In case it is not available we will send the material after the conference is over.

In the event GRC Seminars cancels the seminar, GRC Seminars is not responsible for any airfare, hotel, other costs or losses incurred by registrants. Some topics and speakers may be subject to change without notice.

Attendance confirmation and Documents to carry to the seminar venue:

After we receive the payment from the registered attendee an electronic event pass will be sent to the email address associated with the registrant before 5 working days from the seminar date. Please bring the pass to the venue of the event.

Conference photograph / video:

By registering and attending GRC Seminars conference you agree to have your photographs or videos taken at the conference venue and you do not have any objections to use these photos and videos by GRC Seminars for marketing, archiving or any other conference related activities. You agree to release GRC Seminars for any kind of claims arising out of copyright or privacy violations.

Media Partners

If you wish to partner with us for this event please contact us: or call us: +1-888-771-6965.
Media Partner Benefits
  • Logo and company data on the event website.
  • Logo on the conference material distributed during the conference.
  • Media Partner’s brochure distributed along with conference material.
  • Logo on all the mailings before and after the event.
  • 10% discount to media partner's subscribers.
Media Partner to do
  • Banner (min 728x90 or 468x60) on the Media Partner website.
  • Insertion of the event in the event calendar, both printed and/or online.
  • Announcement article of the conference on the Magazine and/or Website.
  • Dedicated email blast to all subscribers of Media Partner.
  • Article on the Magazine and/or Website after the conference.

Local Attractions of Valhalla, NY

Coming soon...