JIS T 1001:1992
Withdrawn
A Withdrawn Standard is one, which is removed from sale, and its unique number can no longer be used. The Standard can be withdrawn and not replaced, or it can be withdrawn and replaced by a Standard with a different number.
A Withdrawn Standard is one, which is removed from sale, and its unique number can no longer be used. The Standard can be withdrawn and not replaced, or it can be withdrawn and replaced by a Standard with a different number.
General requirements for safety of medical electrical equipment
Hardcopy , PDF
11-25-2006
Japanese, English
05-15-1992
1 Scope2 Definitions 2.1 Equipment parts, auxiliaries and accessories 2.2 Equipment types (classification) 2.3 Insulation 2.4 Voltages 2.5 Currents 2.6 Earth terminals and conductors 2.7 Electrical connection (devices) 2.8 Transformers 2.9 Controls and limiting devices 2.10 Operation of equipment 2.11 Mechanical safety 2.12 Miscellaneous3 Environmental conditions and power supply 3.1 Environmental conditions 3.2 Power supply4 Classification of equipment5 Requirements for safety 5.1 General requirements 5.2 Single fault conditions6 Power input7 Protection against electric shock 7.1 Requirements related to classification 7.2 Limitation of voltage and/or energy 7.3 Enclosures and protective covers 7.4 Separation 7.5 Protective earthing, functional earthing and potential equalization 7.6 Continuous leakage currents and patients auxiliary currents 7.7 Insulation and dielectric voltage8 Protection against mechanical hazards 8.1 Mechanical strength 8.2 Moving parts 8.3 Surfaces, corners and edges 8.4 Stability in normal use 8.5 Grips and other handling devices 8.6 Expelled parts 8.7 Suspended masses9 X-radiation10 Protection against hazards of ignition of flammable anesthetic mixtures 10.1 Classification 10.2 Category AP equipment and category APG equipment11 Protection against excessive temperatures and other safety hazards 11.1 Excessive temperatures 11.2 Fire prevention 11.3 Overflow, spillage, leakage, humidity, ingress of liquids, cleaning, sterilization and disinfection 11.4 Pressure vessels and parts subject to pressure 11.5 Interruption of power supply12 Protection against hazardous output 12.1 Intentional exceeding of safety limits 12.2 Indication of parameters relevant to safety 12.3 Accidental selection of excessive output values13 Abnormal operation and fault conditions 13.1 General 13.2 Safety hazard 13.3 Fault condition14 Constructional requirements 14.1 General 14.2 Components and general assembly 14.3 Mains parts, components and layout 14.4 Mains supply transformers 14.5 Creepage distance and air clearances 14.6 Protective earthing - Terminals and connections 14.7 Construction and layout15 Marking 15.1 General 15.2 Marking on the outside of equipment and equipment parts 15.3 Marking on the inside of equipment and equipment parts 15.4 Marking of controls and instruments 15.5 Colors of the insulation of conductors 15.6 Identification of compressed-gas cylinders and connections 15.7 Indicator lights and push-buttons16 Instructions for useAttached Figures
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