Standards Development – Page 7 – Eisner Safety Consultants

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.

FDA Announces Consensus Standards Guidances, Podcast & Webinar

On September 13, 2018 the FDA posted 2 Guidance Documents Recognition and Withdrawal of Voluntary Consensus Standards: Draft Guidance Appropriate Use of Voluntary Consensus Standards in Premarket Submissions for Medical Devices : Final Guidance Podcast on Standards & FDA’s Release

Standards & Regulatory Update – Medical Electrical Devices – Article

In the June issue of InCompliance Magazine I provide advice in an article on how to remain current on medical electrical device standards (including those in development) and regulatory guidance documents. I start up at the International level (IEC & ISO)

Free Webinar – What You Need to Know About Medical Electrical Standards Updates

Jon Speer, founder and VP of QA/RA @ greenlight.guru (moderator of the webinar) and I, Leo the “IEC 60601-1 guy” Eisner, Principal Consultant of Eisner Safety Consultants, will be presenting a webinar “What You Need to Know About Medical Electrical Equipment