This International Standard applies to the basic safety and essential performance of medical electrical equipment and medical electrical systems. Electrical equipment/systems provide a connection to a particular supply main. These equipment/systems is intended for use of diagnose, treat, or monitor the patient and makes physical or electrical contact with the patient and/or transfers energy to or from the patient and/or detects such energy transfer to or from the patient. The object of this standard specifies general requirements for the safety and essential performance of medical electrical equipment and serves as the basis for the safety requirements of particualar standards. Hazards inherent in the intended physiological function of medical electrical equipment and systems within the scope of this standard are basicly not covered by specific requirements in this standard. This standard can also be applied to equipment used for compensation or alleviation of disease, injury, or disability. It does not apply to in vitro diagnostic equipment or to the implantable parts of active implantable medical devices.
Số hiệu tiêu chuẩn
DIN EN 60601-1*VDE 0750-1
Tên tiêu chuẩn
Medical electrical equipment - Part 1: General requirements for basic safety and essential performance (IEC 60601-1:2005); German version EN 60601-1:2006
Ngày phát hành
2007-07-00
Tiêu chuẩn liên quan
DIN EN 60073*VDE 0199 (2003-05) *
DIN EN 60730-1/A11*VDE 0631-1/A11 (2002-09) *
DIN EN ISO 407 (2005-02) *
DIN EN ISO 780 (1999-04) *
DIN EN ISO 10993-2 (2006-10) *
EN 60068-2-2 (1993-03) *
EN 60068-2-2/A1 (1993-03) *
EN 60068-2-2/A2 (1994-07) *
EN 60085 (2004-10) *
EN 60086-4 (2000-08) *
EN 60112 (2003-03) *
EN 60127-1 (2006-07) *
EN 60445 (2000-02) *
EN 60447 (2004-04) *
EN 60529 (1991-10) *
EN 60601-1-2 (2001-11) *
EN 60601-1-3 (1994-09) *
EN 60601-1-6 (2004-11) *
EN 60601-1-8 (2004-01) *
EN 60664-1 (2003-04) *
EN 60695-11-10 (1999-04) *
EN 60825-1/A1 (2002-07) *
EN 60825-1/A2 (2001-03) *
EN 60851-3 (1996-12) *
EN 60851-3/A1 (1997-10) * DIN 820-120 (2001-10) * DIN 4844-1 (2005-05) * DIN EN 563 (2000-01) * DIN EN 60065 (2006-12) * DIN EN 60068-2-2 (1994-08) * DIN EN 60068-2-2/A2 (1995-01) * DIN EN 60079-0 (2007-05) * DIN EN 60079-2 (2005-02) * DIN EN 60079-2 Berichtigung 1 (2006-09) * DIN EN 60085 (2005-05) * DIN EN 60086-1 (2006-01) * DIN EN 60086-4 (2001-03) * DIN EN 60112 (2003-11) * DIN EN 60112 Berichtigung 2 (2004-02) * DIN EN 60127-1 (2007-02) * DIN EN 60127-6 (2003-10) * DIN EN 60252-1 (2002-05) * DIN EN 60309-1 (2000-05) * DIN EN 60309-1/A11 (2004-11) * DIN EN 60317-43 (1997-10) * DIN EN 60320-1 (2002-06) * DIN EN 60335-1 (2007-02) * DIN EN 60384-14 (2006-04) * DIN EN 60445 (2000-08) * DIN EN 60447 (2004-12) * DIN EN 60529 (2000-09) * DIN EN 60601-1-2 (2006-12) * DIN EN 60601-1-3 (2007-03) * DIN EN 60601-1-6 (2006-05) * DIN EN 60601-1-8 (2007-02) * DIN EN 60664-1 (2003-11) * DIN EN 60695-1-1 (2000-10) * DIN EN 60695-11-10 (2004-05) * DIN EN 60721-1 (1997-02) * DIN EN 60721-3-0 (1994-06) * DIN EN 60721-3-1 (1998-03) * DIN EN 60721-3-2 (1998-03) * DIN EN 60721-3-3 (1995-09) * DIN EN 60721-3-3/A2 (1997-07) * DIN EN 60721-3-4 (1995-09) * DIN EN 60721-3-4/A1 (1997-07) * DIN EN 60721-3-5 (1998-06) * DIN EN 60721-3-6 (1994-06) * DIN EN 60721-3-6/A2 (1997-07) * DIN EN 60721-3-7 (1995-09) * DIN EN 60721-3-7/A1 (1997-07) * DIN EN 60721-3-9 (1995-01) * DIN EN 60721-3-9/A1 (1995-08) * DIN EN 60730-1 (2005-12) * DIN EN 60825-1 (2006-11) * DIN EN 60825-1 Berichtigung 1 (2004-06) * DIN EN 60851-3 (2004-07) * DIN EN 60851-5 (2005-04) * DIN EN 60851-6 (2004-10) * DIN EN 60950-1 (2006-11) * DIN EN 60990 (2000-10) * DIN EN 61000-4-11 (2005-02) * DIN EN 61010-1 (2002-08) * DIN EN 61010-1 Berichtigung 1 (2002-11) * DIN EN 61010-1 Berichtigung 2 (2004-01) * DIN EN 61058-1 (2003-03) * DIN EN 61140 (2007-03) * DIN EN 61558-1 (2006-07) * DIN EN 61558-1/A1 (1998-11) * DIN EN 61558-1/A11 (2003-10) * DIN EN 61558-2-1 (1998-07) * DIN EN 61672-1 (2003-10) * DIN EN 61672-2 (2004-08) * DIN EN 61965 (2004-06) * DIN EN 62079 (2001-11) * DIN EN 62304 (2007-03) * DIN EN ISO 3746 (2006-03) * DIN EN ISO 5349-1 (2001-12) * DIN EN ISO 8041 (2006-06) * DIN EN ISO 9614-1 (1995-06) * DIN EN ISO 10993-1 (2003-12) * DIN EN ISO 10993-3 (2004-02) * DIN EN ISO 10993-4 (2007-06) * DIN EN ISO 10993-5 (1999-11) * DIN EN ISO 10993-7 (1995-11) * DIN EN ISO 10993-9 (1999-10) * DIN EN ISO 10993-10 (2007-06) * DIN EN ISO 10993-11 (2006-11) * DIN EN ISO 10993-12 (2005-03) * DIN EN ISO 10993-13 (1999-04) * DIN EN ISO 10993-14 (2002-05) * DIN EN ISO 10993-15 (2001-11) * DIN EN ISO 10993-16 (1997-11) * DIN EN ISO 10993-17 (2003-06) * DIN EN ISO 10993-18 (2005-10) * DIN EN ISO 11137-1 (2006-07) * DIN EN ISO 11137-2 (2007-04) * DIN EN ISO 11137-3 (2006-07) * DIN EN ISO 13732-1 (2006-12) * DIN EN ISO 14971 (2001-03) * DIN EN ISO 14971/A1 (2003-10) * DIN EN ISO 17665-1 (2006-11) * DIN ISO 23529 (2007-01) * EN 60065 (2002-05) * EN 60079-0 (2006-07) * EN 60079-2 (2004-06) * prEN 60079-5 (2006-12) * prEN 60079-6 (2006-12) * EN 60252-1 (2001-10) * EN 60320-1 (2001-08) * EN 60384-14 (2005-08) * EN 60825-1 (1994-03) * HD 60364-4-41 (2007-01) * IEC 60065 (2001-12) * IEC 60079-0 (2004-01) * IEC 60079-2 (2001-02) * IEC 60079-5 (1997-04) * IEC 60079-6 (1995-05) * IEC 60086-4 (2000-03) * IEC 60227-1 (1993-02) * IEC 60252-1 (2001-02) * IEC 60320-1 (2001-06) * IEC 60384-14 (2005-07) * IEC 60445 (1999-10) * IEC 60601-1-3 (1994-07) * IEC 60664-1 (1992-10) * IEC 60851-3 (1996-10) * IEC 60851-5 (1996-08) * IEC 60851-6 (1996-10) * IEC 60950-1 (2001-10) * IEC 61058-1 (2000-07) * IEC 61558-1 (1997-02) * IEC 61558-2-1 (1997-02) * IEC 61672-1 (2002-05) * IEC 61672-2 (2003-04) * IEV 151 (2002-03) * IEV 195 (2002-12) * IEV 441 (1990)
Thay thế bằng
DIN EN 60601-1 (2013-12)
Từ khóa
Accident prevention * Adjusting equipment * Alpha radiation * Anaesthesiology * Annunciators * Applications * Assembling * Ball compression test * Batteries * Bending * Beta radiation * Biocompatibility * Bodies * Chargings * Circuits * Clamps * Classes * Classes of protection * Classification * Classification systems * Cleaning * Clearances * Colour * Colour codes * Combustible * Compatibility * Components * Condensates * Conglomerates * Connections * Continuous current * Corners * Corona * Covers * Defects * Definitions * Design * Determinations * Dictionaries * Dielectric strength * Dimensions * Disinfection * Earth conductors * Earthing * Earthing conductor terminations * Edge * Electric appliances * Electric contact protection * Electric enclosures * Electric mains * Electric power systems * Electric shock * Electric shocks * Electrical accidents * Electrical appliances * Electrical engineering * Electrical equipment * Electrical medical equipment * Electrical protection equipment * Electrical safety * Electrically-operated devices * Electromagnetic compatibility * Electromedicine * Electrostatics * EMC * Enclosure * Enclosures * Energy * Environmental conditions * Environmental testing * Equipment * Equipment safety * Explosion protection * Fire prevention * Fire safety * Forced ventilation * Frequencies * Gamma-radiation * General conditions * Graphic symbols * Height of fall * Hot-mandrel * Humidity * Hydraulics * Ignition * Impact testers * Indications * Infrared radiation * Input current * Inspection * Instructions for use * Insulating enclosures * Insulations * Interruptions * Laser beams * Layout * Leakage paths * Letterings * Limits (mathematics) * Liquids * Lists * Luminous radiation * Marking * Mass * Measurement * Measurement circuits * Measuring circuit * Measuring instruments * Measuring techniques * Mechanical safety * Medical equipment * Medical radiology * Medical sciences * Medical technology * Metal casings * Microwave radiation * Moisture resistance * Motors * Neutron radiation * Noise * Occupational safety * Oil containers * Operation * Operational instructions * Outlets * Overflows * Overheating * Overload * Overload relays * Overvoltage * Paper * Patient auxiliary current * Pneumatics * Potential equalization * Power consumption * Precision * Pressure * Pressure overload * Pressure vessels * Programmable * Protection * Protection against electric shocks * Protection coverings * Protection devices * Protective devices * Qualification tests * Radiation * Radiation protection * Safety * Safety devices * Safety engineering * Safety of products * Safety regulations * Safety requirements * Safety signs * Separation * Set value * Short circuits * Sound energy * Specification (approval) * Stability * Sterilization (hygiene) * Strain relief * Strength of materials * Stress * Surfaces * Surveys * Symbols * System earthing * Temperature * Tensile force * Terms * Test atmospheres * Test equipment * Test sequence * Testing * Testing conditions * Testing voltages * Torque * Transformers * Ultrasonics * Ultraviolet radiation * Use * Values * Vibrations * Voltage * Windings * Working data * X-rays * Junctions * Directories * Registers * Compounds * Implementation * Joints * Tractive force * Lines
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DIN EN 60601-1*VDE 0750-1
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