BS EN 60601-2-27:2006 Medical electrical equipment. Particular requirements for the safety, including essential performance, of electrocardiographic monitoring equipment
BS EN 60601-2-27 concerns the safety of electrocardiographic monitoring equipment. It introduces general guidance and rationale for the essential performance of equipment such as defibrillator protection, performance requirements and alarming.
Contents include:
- protection against electric shock hazards
- separation
- dielectric strength
- protection against mechanical hazards
- protection against hazards from unwanted or excessive radiation
- electromagnetic compatibility
- protection against hazards of ignition of flammable anaesthetic mixtures
- protection against excessive temperatures and other safety hazards
- overflow, spillage, leakage, humidity, ingress of liquids, cleaning, sterilization and disinfection
- interruption of the power supply
- accuracy of operating data
- protection against hazardous output
- abnormal and fault conditions
- environmental tests
- constructional requirements
- components and general assembly
BS EN 60601-2-27:2006 supersedes BS EN 6061-2-27:1995 which has been withdrawn.