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JIS T 1001:1992

Withdrawn

Withdrawn

A Withdrawn Standard is one, which is removed from sale, and its unique number can no longer be used. The Standard can be withdrawn and not replaced, or it can be withdrawn and replaced by a Standard with a different number.

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withdrawn

A Withdrawn Standard is one, which is removed from sale, and its unique number can no longer be used. The Standard can be withdrawn and not replaced, or it can be withdrawn and replaced by a Standard with a different number.

General requirements for safety of medical electrical equipment

Available format(s)

Hardcopy , PDF

Withdrawn date

11-25-2006

Language(s)

Japanese, English

Published date

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

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
Pages
0
PublisherName
Japanese Standards Association
Status
Withdrawn
SupersededBy

92 [15/05/1992]83

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JIS C 4003:1998 Thermal evaluation and classification of electrical insulation
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JIS T 1005:1983 Style manual for instruction manuals

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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
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JIS T 1503:1984 A-mode Ultrasonic Diagnostic Equipment
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JIS T 1005:1983 Style manual for instruction manuals
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JIS T 7320:1988 Fundus cameras
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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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