BS EN 60601-2-27:2006 - Page 3

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BS EN 60601-2-27:2006 supersedes BS EN 6061-2-27:1995 which has been withdrawn.