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Withdrawn
A Withdrawn Standard is one, which is removed from sale, and its unique number can no longer be used. The Standard can be withdrawn and not replaced, or it can be withdrawn and replaced by a Standard with a different number.
View Superseded by
General requirements for safety of medical electrical equipment
Hardcopy , PDF
25-11-2006
Japanese, English
15-05-1992
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
Standard applies to the safety of electrical equipment (hereafter referred to as the "equipment"). Standard is primarily concerned with safety, however, it does contain some requirements regarding reliable operation where this is connected with safety. Safety hazards resulting from physiological reaction of patient owing to the intended function of equipment are not considered. A requirement of a Particular Standard takes priority over the corresponding requirement of this General Standard.
DocumentType |
Standard
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Pages |
0
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PublisherName |
Japanese Standards Association
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Status |
Withdrawn
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SupersededBy |
92 [15/05/1992]83
JIS T 1006:1992 | Graphical symbols for medical electrical equipment |
JIS T 1021:1997 | 'Hospital grade' outlet-sockets and plugs |
JIS T 1021:2008 | Hospital grade"" outlet-sockets and plu |
JIS T 1002:1992 | General rules of testing methods for safety of medical electrical equipment |
JIS B 8241:1989 | Seamless steel gas cylinders |
JIS T 1011:1988 | Glossary of terms used in medical electrical equipment (general terms) |
JIS C 4003:1998 | Thermal evaluation and classification of electrical insulation |
JIS C 0602:1984 | General Rules Of Colour Identification For Protective Conductor And Neutral Conductor And Terminal Marking For Apparatus |
JIS T 1005:1983 | Style manual for instruction manuals |
JIS T 1204:1988 | Laser photocoagulators |
JIS Z 4703:1995 | General Rules Of Mechanical Units For Medical X-ray Apparatus |
JIS T 1011:1988 | Glossary of terms used in medical electrical equipment (general terms) |
JIS T 1301:1991 | General requirements for patient monitors |
JIS T 7306:1988 | Ophthalmoscopes |
JIS T 1171:1988 | Rhinomanometers |
JIS T 1356:1989 | External cardiac pacemaker |
JIS T 1021:1997 | 'Hospital grade' outlet-sockets and plugs |
JIS T 1353:1984 | Microwave Therapy Equipment |
JIS T 7325:1989 | Ethylene oxide gas sterilizers for medical use (small size) |
JIS T 1308:1988 | Neonatal monitors |
JIS Z 4702:1999 | General Rules Of High Potential Generators Of Medical X-ray Apparatus |
JIS B 9951:1993 | Pressure Swing Adsorption Apparatus - Test Methods |
JIS T 1503:1984 | A-mode Ultrasonic Diagnostic Equipment |
JIS T 1161:1986 | Electroretinographs |
JIS T 7203:1989 | Oxygen analyzers for medical use |
JIS T 1005:1983 | Style manual for instruction manuals |
JIS T 1203:1998 | Electroencephalographs |
JIS T 1002:1992 | General rules of testing methods for safety of medical electrical equipment |
JIS T 7204:1989 | Lung ventilators for medical use |
JIS T 7327:1989 | Electric suction equipment for medical use |
JIS T 7320:1988 | Fundus cameras |
JIS T 1702:1997 | Incubator |
JIS T 1006:1992 | Graphical symbols for medical electrical equipment |
JIS T 1150:1986 | Electromyographs |
JIS T 1117:1988 | Ambulatory ECG recording system (holter system) |
JIS T 1202:1998 | Electrocardiographs |
JIS T 1505:1984 | M-mode Ultrasonic Diagnostic Equipment |
JIS T 1305:1985 | Direct Blood-pressure Monitors |
JIS T 1453:1998 | Electrosurgical Units |
JIS T 1304:1998 | Electrocardiographic monitoring equipment |
JIS T 1170:1987 | Clinical Electronic Spirometers |
JIS T 1603:1995 | Electric Motor Driven Blood Pump For Cardiopulmonary Bypass |
JIS Z 4714:2001 | Medical Electron Accelerators - Functional Performance Characteristics |
JIS T 1206:1992 | Computer-aided perimeters |
JIS T 1190:1987 | Stabilometers |
JIS T 7317:1988 | Operation microscopes |
JIS T 1201-1:2000 | Audiometers Part 1: Pure-tone audiometers |
JIS Z 4701:1997 | General rules for medical X-ray equipment |
JIS T 1507:1989 | Electronic linear scanning ultrasonic diagnostic equipment |
JIS T 7202:1989 | Oxygen tents |
JIS T 1306:1989 | Continuous measuring clinical electrical thermometers |
JIS T 1309:1986 | Polygraphs for clinical use |
JIS T 7201-1:1999 | Inhalational Anaesthesia Systems - Part 1: Anaesthetic Machines For Use With Humans |
JIS T 1114:1985 | Vectorcardiographs |
JIS T 1116:1985 | Direct blood-pressure meters for clinical use |
JIS C 6310:1986 | Low frequency therapy equipment |
JIS T 1504:1984 | Manual Scanning B-mode Ultrasonic Diagnostic Equipment |
JIS T 7316:1988 | Slit-lamp microscopes |
JIS T 7319:1988 | Refractometers |
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