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
AUS & CAN Sign MoU Recognition Mfr’s QS
On Oct 22, 2010 the TGA posted on their website the following info: “The Therapeutic Goods Administration (TGA) and Health Canada (HC) are pleased to announce that the Memorandum of Understanding (MoU) on reciprocal recognition of quality management system (QMS)
FDA Modifications to List of Recognized Standards, List 025
On Oct 4, 2010 the Federal Register published the “Modifications to the List of Recognized Standards, Recognition List Number: 025“. This list will assist medical device manufacturers who elect to declare conformity with FDA Consensus Standards to meet certain FDA