The document specifies the particular safety requirements for external pacemakers powered by an internal electrical power source and should make easier the interpretation and apllication of the Particular requirements from 1994 by adation to the requirements of IEC 60601-1, Amendment 2, through adaptation to the requirements of the Collateral Standard IEC 60601-1-2 and by include of amendments edition for better comprehensibility of Particular requirements.
Số hiệu tiêu chuẩn
DIN EN 60601-2-31/A1*VDE 0750-2-31/A1
Tên tiêu chuẩn
Medical electrical equipment - Part 2-31: Particular requirements for the safety of external cardiac pacemakers with internal power source; Amendment A1 (IEC 60601-2-31/A1:1998); German version EN 60601-2-31:1996/A1:1998
Ngày phát hành
1999-05-00
Thay thế cho
DIN IEC 62D/206/CDV (1996-12)
Từ khóa
Adjusting equipment * Assembling * Canals * Circuits * Cleaning * Combustible * Components * Conglomerates * Connections * Connectored joints * Continuous current * Defects * Definitions * Determinations * Discharge * Disinfection * Electric power systems * Electric shock * Electrical appliances * Electrical engineering * Electrical safety * Electromagnetic compatibility * Electromedicine * Electronic power supplies * EMC * Environmental conditions * Environmental testing * External * Frequencies * Heat protection * Ignition * Input current * Instructions for use * Internal * Interruptions * Liquids * Marking * Measurement * Measuring uncertainty * Medical equipment * Medical technology * Moisture * Oscilloscopes * Outlets * Overflows * Pacemakers * Paper * Patient auxiliary current * Power consumption * Precision * Radiation * Radiation protection * Safety * Safety requirements * Specification (approval) * Sterilization (hygiene) * Telltales * Temperature * Testing * Working data * Ducts * Sewers * Lines * Protection against electric shocks * Channels