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 Comm on Anaesthetic & Respiratory Equipment) SC 3 for approval of the project with a closing date for voting set for 11-Mar-2011. To vote and comment on this proposal you must be a active member of your National Committee for SC62A. Each countries National Committee may have different requirements for membership and voting. The New Work Proposal is for the IEC 60601-1-xx, Medical Electrical Equipment – Part 1-xx: General requirements for basic safety and essential performance – Collateral Standard: Requirements for medical electrical equipment and medical electrical systems used in the emergency medical services environment. Refer to our recent post on this draft standard posted on 25-Oct-2010 for additional information about this proposed standard.
As Eisner Safety Consultants will be joining this Working Group that will be developing the IEC/ISO International Standard we are able to support the electro-medical device manufacturers of emergency medical services equipment prepare for when this standard becomes a regulatory requirement within specific countries in the future. Please feel free to contact us on this matter if you would like some assistance in learning more about this proposed standard as it applies to your product lines.