Single Fault Condition – Eisner Safety Consultants

Leo Eisner the “IEC 60601 Guy” co-presenter in BSI Webinar

Webinar: Leveraging the CB Scheme: A Guide for North American Medical Device Manufacturers

When: Tuesday, June 25, 2024

Time: 11:00 a.m – 12:00 p.m. EDT

About the Event: Join BSI & Leo Eisner for an insightful webinar that explores how North American medical device manufacturers can harness the power of the CB Scheme to enhance their global market access. Leo the “IEC 60601-1 Guy” will be presenting on the significant updates introduced in the latest edition of IEC 60601-1 Ed. 3.2, which will impact medical device manufacturers.

IEC 60601-1 4th Ed Initial Launch: Positive Impacts Healthcare Standardization

Last week, 29 Apr – 3 May 2024, marked a significant milestone for the advancement in the world of patient safety and healthcare. The IEC TC 62/SC 62A convened its IEC 60601-1, 4th edition project kick-off meeting at AAMI in Arlington, Virginia. More than 200 experts from all corners of the globe attended in person, contributing to an inspiring and impactful week-long meeting.

IEC 60601-1, 4th Ed. – Time to Get Involved Is Now!

We need young(er) and experienced professionals to join in the development of IEC 60601-1, 4th ed. for the future success of medical electrical equipment standards development.

This is a follow-up to the original post of IEC 60601-1, 4th Edition Project – Where Do We Stand? – UPDATED 30 November

This post talks about the Call for Experts and nomination of convenors and the short time periods. Get moving if you are interested.

Interpretation Sheet on Essential Performance & Single Fault Condition for IEC 60601-1:2005+A1:2012

Essential Performance (EP) initially came into the IEC 60601 series of standards when the 3rd edition of IEC 60601-1:2005 was published. The definition was quite confusing and many manufacturers, regulators and test houses had a hard time with it and how to apply it properly. In 3rd edition (2005) + amendment 1 (2012) some clarification came into play which made it easier to understand but there is still a fair amount of confusion.