IEC 60601-1-12:2014 constitutes a collateral standard to IEC 60601-1: Medical electrical equipment – Part 1: General requirements for basic safety and essential performance hereafter referred to as the general standard. This standard can be used in part to show compliance for Medical Devices and Equipment for U.S.-FDA, Canada-Health Canada and the European Medical Device Directive 93/42/EEC.
Medical practice is increasingly using medical electrical equipment and medical electrical systems for monitoring, treatment or diagnosis of patients in the emergency medical services environment. The safety of medical electrical equipment in this uncontrolled, rough environment is a cause for concern. This collateral standard was developed with contributions from clinicians, engineers and regulators. It can also refer to those devices used in a transport mode, located in vehicles and other transportation equipment.
The terminology, requirements, general recommendations and guidance of this collateral standard are intended to be useful for manufacturers of medical electrical equipment and medical electrical systems and for technical committees responsible for the development of particular standards.
IEC/EN 60601-1-12 is an International Standard that applies to the basic safety and essential performance of medical electrical equipment and medical electrical systems, hereafter referred to as ME equipment and ME systems, which are intended, as indicated in the instructions for use by their manufacturer, for use in the EMS (Emergency Medical Services) environment.
The object of this collateral standard is to provide general requirements for ME equipment and ME systems carried to the scene of an emergency and used there, as well as in transport, in situations where the ambient conditions differ from indoor conditions.
The object of this collateral standard is to specify general requirements that are in addition to those of the general standard and to serve as the basis for particular standards. Usually this intended use of MEDICAL EQUIPMENT OR MEDICAL SYSTEMS will require additional and more stringent testing parameters. Additional information regarding Electromagnetic Capability requirements for emergency medical environments can be found at IEC 60601-1-2.
To find out more about the requirements for emergency medical services environments, and to determine if the standard is applicable to your system or equipment, contact the D.L.S. team for a detailed analysis.