From Information Week — 29-JAN-2011 there is a great article showing twelve advances in Medical Robots A proposal has been circulated, on 21-JAN-2011, for a vote to form a Joint Working Group between ISO/TC 184/SC 2, Robots and robotic devices
Leo Eisner Presenting at RAPS/ASQ on IEC60601-1 3rd ed.
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,
IEC 80001-1 1st ed Application of Risk Mgmt for IT Networks Incorporating Med Dvcs
IEC 80001-1 edition 1 was published Oct 27, 2010 and is for the “Application of risk management for IT-networks incorporating medical devices – Part 1: Roles, responsibilities and activities” The scope states, noting that all ALL CAPITAL words are defined
NWIP – Collateral Std IEC60601-1-XX Emergency Med Srvcs
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
QuadTech 5th Ed. Electrical Safety Testing Guide
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