- Abstract:This part of the standard series describes safety requirements for pulse oximeter intended for use on humans. This includes pulse oximeter monitor, pulse oximeter probe and probe cable extender.
- Document number:DIN EN ISO 80601-2-61
- Issuing date:2019-09-01
- Document type:Norm
- Title:Medical electrical equipment - Part 2-61: Particular requirements for basic safety and essential performance of pulse oximeter equipment (ISO 80601-2-61:2017, Corrected version 2018-02); German version EN ISO 80601-2-61:2019
- Replaces:DIN EN ISO 80601-2-61(2012-01); DIN EN ISO 80601-2-61(2016-12)
- Author:Rescue Services and Hospital Standards Committee
- Search term:Alarm; Alpha radiation; Anaesthetic equipment; Assembling; Beta radiation; Biocompatibility; Blood counts; Bodies; Breathing equipment; Chargings; Chemical analysis and testing; Clamps; Cleaning; Compatibility; Components; Connections; Continuous current; Corners; Covers; Defects; Definitions; Determinations; Dielectric strength; Discharge; Disinfection; Earth conductors; Earthing conductor terminations; Edge; Electric power systems; Electrical; Electrical engineering; Electrical hazards; Electrical medical equipment; Electrical safety; Electromagnetic compatibility; Electromedicine; Electrostatics; EMC; Enclosures; Energy; Environmental conditions; Environmental testing; Equipment safety; Extension cables; Features; Fire prevention; Gamma-radiation; Haemoglobin; Haemoglobin content; Human errors; Hydraulics; Infrared radiation; Input current; Interruptions; Laser beams; Layout; Limitations; Liquids; Luminous radiation; Mass; Measuring instruments; Mechanical hazards; Mechanics; Medical devices; Medical equipment; Medical sciences; Medical technology; Moisture; Monitors; Neutron radiation; Noise; Outlets; Overflows; Oximeters; Oximetry; Oxygen saturation; Paper; Patient auxiliary current; Performance requirements; Pneumatics; Potential equalization; Power consumption; Precision; Pressure; Pressure vessels; Protection against electric shocks; Protection coverings; Protective devices; Pulse; Pulse oximeters; Radiation protection; Safety; Safety engineering; Safety of products; Safety requirements; Saturation; Sensors; Separation; Signals; Sound energy; Specification (approval); Stability; Sterilization (hygiene); Strength of materials; Stress; Surfaces; System earthing; Temperature; Testing; Thermal hazards; Ultrasonics; Ultraviolet radiation; Use; Vibrations; Working data; X-rays
- Application areas:09.05 Medizinische Geräte und Instrumente
- Hazards:AB Terminologische Festlegungen in Normen mit Arbeitsschutzbezug; GI Ionisierende Strahlungen (Röntgenstrahlungen, radioaktive Strahlung / Alpha-, Beta- und Gamma-Strahlung); GL Kontakt mit heißen oder kalten Medien (Oberflächen, Umgebungen); HG Physische Belastungen (schwere Arbeit, einseitige Arbeit, Haltarbeit, Zwangshaltung, Heben, Tragen u. Ä.); KF Belastungen durch Störungen, Ausfall und Fehlen von Sicherheitseinrichtungen
- ICS:11.040.55 Diagnostic equipment
- Price:251,30 EUR
- Cross references:IEC 60068-2-27 (2008-02)<S>; IEC 60068-2-31 (2008-05)<S>; IEC 60068-2-64 (2008-04)<S>; IEC 60825-2 (2004-06){historisch}<S>; ISO 3744 (2010-10)<S>; ISO 4135 (2001-08){historisch}<S>; ISO 14155 (2011-02){historisch}<S>; ISO 14937 (2009-10)<S>; ISO 15223-1 (2016-11){historisch}<S>; IEC 60601-1-11 (2015-01)<S>; IEC 60601-1-12 (2014-06)<S>; ISO 7000 (2019-07)<G>; IEC 62366-1 (2015-02)<G>; ISO 7010 (2019-07)<G>; DIN EN 60068-2-27 (2010-02); DIN EN 60068-2-31 (2009-04); DIN EN 60529 (2014-09); DIN EN 60721-3-7 (1995-09); DIN EN 60825-2 (2011-06); DIN EN ISO 3744 (2011-02); DIN EN ISO 9000 (2015-11); DIN EN ISO 13732-1 (2008-12); DIN EN ISO 14937 (2010-03); DIN ISO 3534-2 (2013-12); DIN ISO 7000 (2008-12); IEC 60601-1-3 (2008-01); IEC 60601-1-3 AMD 1 (2013-04); IEC 60601-1-10 (2007-11); IEC 60601-1-10 AMD 1 (2013-11); IEC 60721-3-7 (1995-01); IEC 60721-3-7 Edition 2.1 (2002-10); IEC/TR 60721-4-7 (2001-03); IEC/TR 60721-4-7 AMD 1 (2003-05); ISO/IEC Guide 98-3 (2008-09); ISO/IEC Guide 99 (2007-12); ISO 3534-2 (2006-09); ISO 9000 (2015-09); ISO 13732-1 (2006-09); ISO 16142-1 (2016-03); DIN 40046-721-7 (2004-11); DIN EN 60068-2-64 (2020-09); DIN EN 60601-1-2 (2022-01); DIN EN 60601-1-3 (2021-10); DIN EN 60601-1-6 (2021-11); DIN EN 60601-1-8 (2021-12); DIN EN 60601-1-10 (2021-11); DIN EN 60601-1-11 (2021-12); DIN EN 60601-1-12 (2022-02); DIN EN 60825-1 (2022-07); DIN EN 62366-1 (2021-08); DIN EN 62366-1 (2021-08); DIN EN ISO 4135 (2022-06); DIN EN ISO 7010 (2020-07); DIN EN ISO/IEEE 11073-10404 (2023-04); DIN EN ISO 14155 (2021-05); DIN EN ISO 15223-1 (2022-02); DIN EN ISO 80601-2-61 (2019-09); ASTM E 456a (2013); ASTM F 2761 (2009); IEC/TR 60878 (2022-11); IEC 62366-1 (2015-02); ISO/IEEE 11073-10404 (2022-12); IEC 62366-1 (2015-02); ISO 80601-2-61 (2017-12)
- Cited in:DIN EN 60601-1-2 (2022-01); DIN EN IEC 80601-2-30 (2020-03); DIN EN ISO 18778 (2023-02); DIN EN ISO 80601-2-85 (2022-01)
- Identical with:EN ISO 80601-2-61(2019-01)<IDT>; ISO 80601-2-61(2017-12)<IDT>
- Update flag:Unchanged