The document specifies requirements for the safety of pulse oximeters, as defined in point 3.12 of this standard, intended for use in the approximate measurement of the saturation of human arterial heamoglobin, non-invasively. The field of application includes, but is not limited to perioperative use, adult critical care application, paediatric and neonatal applications, general determination of saturation on hospitalised and non-hospitalised patients. Pulse oximeters intended for use in laboratory research applications and "bench" type oximeters that require a blood sample from the patient are outside the scope of this document.
Số hiệu tiêu chuẩn
DIN EN 865
Tên tiêu chuẩn
Pulse oximeters - Particular requirements; German version EN 865:1997
Ngày phát hành
1997-05-00
Tiêu chuẩn tương đương
EN 865 (1997-02), IDT * SN EN 865 (1997), IDT * TS EN 865 (2003-01-20), IDT
Thay thế cho
DIN EN 865 (1993-02)
Từ khóa
Alarm * Alpha radiation * Anaesthetic equipment * Assembling * Beta radiation * Biocompatibility * Bodies * Breathing equipment * Chargings * Clamps * Cleaning * Compatibility * Components * Continuous current * Corners * Covers * Defects * Definitions * Determinations * Dielectric strength * Discharge * Disinfection * Earth conductors * Earthing conductor terminations * Edge * Electric power systems * Electrical * Electrical medical equipment * Electromagnetic compatibility * Electromedicine * Electrostatics * EMC * Enclosures * Energy * Environmental conditions * Environmental testing * Equipment safety * Fire prevention * Gamma-radiation * Haemoglobin * Haemoglobin content * Hydraulics * Infrared radiation * Input current * Interruptions * Laser beams * Layout * Limitations * Liquids * Luminous radiation * Mass * Measuring instruments * Mechanics * Medical equipment * Medical sciences * Moisture * Neutron radiation * Noise * Outlets * Overflows * Oximetry * Paper * Patient auxiliary current * Pneumatics * Potential equalization * Power consumption * Precision * Pressure * Pressure vessels * Protection coverings * Protective devices * Pulse * Pulse oximeters * Safety * Safety requirements * Saturation * Separation * Signals * Sound energy * Specification (approval) * Stability * Sterilization (hygiene) * Strength of materials * Stress * Surfaces * System earthing * Temperature * Testing * Ultrasonics * Ultraviolet radiation * Use * Vibrations * Working data * X-rays * Design * Voltage