Eisner Safety Consultants

Come join Eisner Safety Consultants at one or both conferences March 3 & 4th.  Both are related to the 60601 series of standards. On March 3rd join FX Conferences and Leo Eisner to learn about the home healthcare environment and the proposed emergency medical services standards, respectively IEC 60601-1-11 & IEC 60601-1-12 (hopefully).  More information [...]

Topic: “Implications of the Electro-medical Standards IEC 60601-1-11:2010 & Proposed IEC 60601-1-12” The Medical Electrical Device Collateral Standards in the Home Healthcare Environment and the Proposed Emergency Medical Services Environment, respectively Presenter: Leo Eisner of Eisner Safety Consultants When: March 3, 2011 (Thursday), 8:30 – 9:30AM (Pacific), 11:30AM – 12:30PM (Eastern) Where: At your office [...]

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 (non-medical robots) and IEC/TC 62 and its subcommittees to establish a new Joint Working Group on [...]

  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 [...]

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 either in this standard or other referenced standards: