IEC 60601 Standards Status Update for Medical Electrical Equipment

Leo Eisner’s free webinar will provide a status update on IEC 60601 Standards for Medical Electrical Equipment on August 23rd, 2017 @ 10:00am EDT.

Leo Eisner will be giving two presentations at the 510(k) Workshop in Amsterdam on October 11-12, 2017.

When is the IEC 60601 Standards Webinar?

The IEC 60601 Standards webinar will be presented live by Leonard (Leo) Eisner on Wednesday, August 23rd, 2017 @ 10:00am EDT. It’s free to register as long as you ask Leo a question. As new questions are submitted we will create blogs to answer your questions and add the questions to our 510k FAQs page. To register for the free webinar, fill in the form below.

Contents of IEC 60601 Standards Webinar

Leo will be providing a status update on the IEC 60601 Standards and related important standards for medical electrical equipment. This webinar will help you stay up to date on the changes in process and some recent standards in the IEC 60601 series:

  • IEC 60601-1,
  • 60601-1-2 (EMC),
  • 60601-1-6 (Usability),
  • IEC 60601-1-8 (Alarms),
  • IEC 60601-1-10 (physiologic closed-loop controllers),
  • IEC 60601-1-11 (Home Healthcare Environment),

and related standards/technical reports

  • Medical Device Risk Management (ISO 14971),
  • Usability (IEC 60601-1-6, IEC 62366, IEC 62366-1, & IEC TR 62366-2),
  • Software life cycle processes (IEC 62304), and
  • Health Software (IEC 82304).

In conjunction with all these updates Leo will provide additional regulatory and CB Scheme testing information related to these standards.

In addition, Leo prepares a yearly report that he recently issued for medical electrical equipment Annual Standards Trends Reports. The yearly report is just over 100 pages long this year. Leo will add in a small intro to the IEC 60601 series at the beginning of the webinar to explain how the General Standard interrelates with Collaterals (60601-1-X) and Particular Standards (60601-2-XX). This understanding is critical to the your success with submissions to any country.

Registrants will receive a confirmation email, and then after confirmation they will receive login information for the live IEC 60601 Standards webinar. We will also provide a link to download a recording of the webinar and the native slide deck.

Related IEC 60601 Blog Content from Leo Eisner

About Your IEC 60601 Standards Webinar Instructor

35ebc9d IEC 60601 Standards Status Update for Medical Electrical EquipmentLeonard (Leo) Eisner is the head of Eisner Safety Consultants. He is a licensed professional engineer in safety engineering, a certified Quality System lead auditor, an expert in product safety for medical electrical devices (IEC 60601 series of standards) and an expert in CE marking for the medical device directive. Leo Eisner helped countless clients thru the Product Safety and Regulatory maze over his career.  He has over 30 years experience in product safety/compliance. Leo ran the Compliance Engineering Group at Karl Storz & was a Senior Product Safety engineer at TÜV Product Service. Leo has audited for several EU Notified Bodies and has been a technical reviewer on Medical Electrical Equipment.


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