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

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.

Webinar – Standards, Standards, Standards – Makes the Medical Device World go Around

Webinar – Standards, Standards, Standards – Makes the Medical Device World go Around

Standards are a key priority for the International Medical Device Regulators Forum (IMDRF). Its forthcoming guidance, “Optimizing Standards for Regulatory Use,” encourages the development of ‘regulatory ready’ standards, including direction to Standards Development Organizations (SDOs) to consider medical device ‘essential

FDA Announces Consensus Standards Guidances, Podcast & Webinar

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On September 13, 2018 the FDA posted 2 Guidance Documents Recognition and Withdrawal of Voluntary Consensus Standards: Draft Guidance Appropriate Use of Voluntary Consensus Standards in Premarket Submissions for Medical Devices : Final Guidance Podcast on Standards & FDA’s Release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

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)