Eisner Safety Consultants

  Biomedical Division Northern California Discussion Group  andSan Francisco Bay Area Chapter Topic: ”Evolving Risk-Based Regulatory Requirements” whole day workshop covering 3 key quality & regulatory areas: IEC 60601-1, 3rd ed. general, collateral, and particular standards including essential performance, risk management integration, and the impact of change on industry Usability and Human Factors verification, validation, and regulatory [...]

Topic: “Make sense of the IEC 60601-1-11 standard” The Medical Electrical Device Collateral Standard in the Home Healthcare Environment Presenters: Leo Eisner of Eisner Safety Consultants will be co-presenting with Joseph Murnane of Underwriters Laboratories When: Feb 10, 2011 (Thursday) Where: Anaheim Convention Center while you are at the MD&M West Conference What’s it about: [...]

A New Work Item Proposal for Medical Electrical Equipment & Medical Electrical Systems used in the Emergency Medical Services Environment will be submitted to ISO by the end of November 2010.  This proposed standard follows the structure of the Collateral Standard IEC 60601-1-11 Medical Equipment and Medical Systems for Home Use that was published April 2010. [...]

The QuadTech 5th Edition Electrical Safety Testing Guide is a useful document to help you understand the basics of Leakage Current and Dielectric Tests for 60601-1 and for additional standards.  This document is a useful resource for understanding some of the basics of electrical safety testing.  To obtain this document click here.

Eisner Safety Consultants is attending the 74th Annual IEC General Meeting in Seattle Washington thru Oct 16, 2010.  As a US National Committee member of Technical Committee (TC) 62, Subcommittees (SC) 62A & 62D we are attending the committee meetings that will help medical device manufacturer’s better understand the coming & current standards requirements.  We [...]