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 Standard IEC 60601-1-11 Medical Equipment and Medical Systems for Home Use that was published April 2010. Even though this proposed standard follows the structure of 60601-1-11 there are differences such as the environmental exposure of the device (temperature, liquid & particulate exposure, etc.) and the type of operators (professional use – EMT’s vs non-professional use – patients), among other issues. Note, that both of the Collateral Standards (Proposed & 60601-1-11) are aligned with 3rd ed. of IEC 60601-1 (published in 2005). So, if a device has an intended use that is for air &/or land ambulances and you have only tested to 2nd ed. of IEC 60601-1 you will have to move up to 3rd ed. to add this new standard when it is published. As this is not a published standard and will probably take about 3 years to publish the final document may not include all these items but it is likely to follow the IEC 60601-1-11 formatting as these two types of medical products have some similarities as well.
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 products.