The Global Harmonization Task Force Ad Hoc Working Group has drafted a proposal for Unique Device Indentification (UDI). The document is GHTF/AH/(PD2)N2R2 and can be accessed by clicking here. The document was posted on 22 Nov 2010 and comments are
Eucomed requests improvements in EU Notified Body Based System
26 Oct 2010 From ‘MTB europe – Technology for healthcare’ Eucomed calls for improvements in EU Notified Body based system http://www.mtbeurope.info/news/2010/1010051.htm
IEC 62A/726/NP Collateral IEC 60601-1-XX Emergency Med Srvcs Circulated for Vote
The New Work Proposal IEC 62A/726/NP and ISO TC121 SC3 N1534 was circulated on 5-Nov-2010 within IEC TC 62 (Technical Committee on Electrical Equipment in Medical Practice) and its’ subcommittees 62A – 62D, as well as ISO TC 121 (Tech
IEC 62502 1st ed. Event Tree Analysis (ETA) Techniques
Just published Oct 27, 2010 – IEC 62502 1st edition – “Analysis techniques for dependability – Event tree analysis (ETA)” The scope of the standard states:
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
