DIN EN ISO 80601-2-56:2018
Medical electrical equipment - Part 2-56: Particular requirements for basic safety and essential performance of clinical thermometers for body temperature measurement (ISO 80601-2-56:2017); German version EN ISO 80601-2-56:2017
- Standard No.
- DIN EN ISO 80601-2-56:2018
- Release Date
- 2018
- Published By
- German Institute for Standardization
- Status
- Replace By
- DIN EN ISO 80601-2-56 A1 E:2018-04
- Latest
- DIN EN ISO 80601-2-56:2020-08
- Replace
- DIN EN ISO 80601-2-56:2013 DIN EN ISO/IEC 80601-2-56:2015
- Scope
- This standard specifies the general, metrological and technical requirements for electrical clinical thermometers. This standard applies to all electrical clinical thermometers that are used for measuring the body temperature of patients. The clinical thermometers can be equipped with interfaces to accommodate secondary indicators, printing equipment, and other auxiliary equipment to create medical electrical systems. This standard does not apply to such accessories. Medical electrical equipment that measures a temperature as a secondary function is outside the scope of this standard. Requirements for medical electrical equipment intended to be used for non-invasive human febrile temperature screening of groups of individuals under indoor environmental conditions are given in IEC 80601-2-59.
DIN EN ISO 80601-2-56:2018 Referenced Document
- ASTM E1965-98 Standard Specification for Infrared Thermometers for Intermittent Determination of Patient Temperature
- DIN EN 60601-1-11:2016 Medical electrical equipment - Part 1-11: General requirements for basic safety and essential performance - Collateral Standard: Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment (IEC 6060
- DIN EN 60601-1-12:2016 Medical electrical equipment - Part 1-12: General requirements for basic safety and essential performance - Collateral Standard: Requirements for medical electrical equipment and medical electrical systems intended for use in the emergency medical service
- DIN EN 60601-1-2:2016 Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral standard: Electromagnetic disturbances - Requirements and tests (IEC 60601-1-2:2014); German version EN 60601-1-2:2015
- DIN EN 60601-1-3:2014 Medical electrical equipment - Part 1-3: General requirements for basic safety and essential performance - Collateral Standard: Radiation protection in diagnostic X-ray equipment (IEC 60601-1-3:2008 + A1:2013); German version EN 60601-1-3:2008 + Cor.:2010
- DIN EN 60601-1-6:2016 Medical electrical equipment - Part 1-6: General requirements for basic safety and essential performance - Collateral standard: Usability (IEC 60601-1-6:2010 + A1:2013); German version EN 60601-1-6:2010 + A1:2015
- DIN EN 60601-1-8:2014 Medical electrical equipment - Part 1-8: General requirements for basic safety and essential performance - Collateral Standard: General requirements, tests and guidance for alarm systems in medical electrical equipment and medical electrical systems (IEC
- DIN EN 60601-1:2013 Medical electrical equipment.Part 1: General requirements for basic safety and essential performance (IEC 60601-1:2005 + Cor. :2006 + Cor. :2007 + A1:2012); German version EN 60601-1:2006 + Cor. :2010 + A1:2013
- DIN EN 60601-2-19:2017 Medical electrical equipment - Part 2-19: Particular requirements for the basic safety and essential performance of infant incubators (IEC 60601-2-19:2009 + Cor.:2012 + A1:2016); German version EN 60601-2-19:2009 + A11:2011 + A1:2016
- DIN EN 62366-1:2017 Medical devices - Part 1: Application of usability engineering to medical devices (IEC 62366-1:2015 + COR1:2016); German version EN 62366-1:2015 + AC:2015
- DIN EN 80601-2-59:2010 Medical electrical equipment - Part 2-59: Particular requirements for the basic safety and essential performance of screening thermographs for human febrile temperature screening (IEC 80601-2-59:2008 + corrigendum 2009); German version EN 80601-2-59:2009
- DIN EN ISO 14155:2012 Clinical investigation of medical devices for human subjects - Good clinical practice (ISO 14155:2011 + Cor. 1:2011); German version EN ISO 14155:2011 + AC:2011
- DIN EN ISO 14159:2008 Safety of machinery - Hygiene requirements for the design of machinery (ISO 14159:2002); English version of DIN EN ISO 14159:2008-07
- DIN EN ISO 14937:2010 Sterilization of health care products - General requirements for characterization of a sterilizing agent and the development, validation and routine control of a sterilization process for medical devices (ISO 14937:2009); German version EN ISO 14937:2009
- DIN EN ISO 15223-1:2017 Medical devices - Symbols to be used with medical device labels, labelling and information to be supplied - Part 1: General requirements (ISO 15223-1:2016, Corrected version 2017-03); German version EN ISO 15223-1:2016, with CD-ROM
- DIN EN ISO 17664:2004 Sterilization of medical devices - Information to be provided by the manufacturer for the processing of resterilizable medical devices (ISO 17664:2004); German version EN ISO 17664:2004
- DIN EN ISO 9000:2015 Quality management systems - Fundamentals and vocabulary (ISO 9000:2015); German and English version EN ISO 9000:2015
- EN 12470-5:2003 Clinical thermometers - Part 5: Performance of infra-red ear thermometers (with maximum device)
- IEC 60601-1-2:2014 Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral standard: Electromagnetic disturbances - Requirements and tests
- IEC 60601-1-3:2008 Medical electrical equipment - Part 1-3: General requirements for basic safety and essential performance - Collateral standard: Radiation protection in diagnostic X-ray equipment
- IEC 60601-1-6:2010 Medical electrical equipment - General requirements for basic safety and essential performance - Collateral Standard: Usability
- IEC 60601-1-9:2007 Medical electrical equipment - Part 1-9: General requirements for basic safety and essential performance - Collateral Standard: Requirements for environmentally conscious design
- IEC 60601-1:2005 Medical electrical equipment - Part 1: General requirements for basic safety and essential performance
- IEC 60601-2-19:2009 Medical electrical equipment - Part 2-19: Particular requirements for the basic safety and essential performance of infant incubators
DIN EN ISO 80601-2-56:2018 history
- 2020 DIN EN ISO 80601-2-56:2020-08 Medical electrical equipment - Part 2-56: Particular requirements for basic safety and essential performance of clinical thermometers for body temperature measurement (ISO 80601-2-56:2017 + Amd1:2018); German version EN ISO 80601-2-56:2017 + A1:2020
- 2020 DIN EN ISO 80601-2-56:2020 Medical electrical equipment - Part 2-56: Particular requirements for basic safety and essential performance of clinical thermometers for body temperature measurement (ISO 80601-2-56:2017 + Amd1:2018) (includes Amendment 56:2020)
- 1970 DIN EN ISO 80601-2-56 A1 E:2018-04
- 2018 DIN EN ISO 80601-2-56:2018 Medical electrical equipment - Part 2-56: Particular requirements for basic safety and essential performance of clinical thermometers for body temperature measurement (ISO 80601-2-56:2017); German version EN ISO 80601-2-56:2017
- 2013 DIN EN ISO 80601-2-56:2013 Medical electrical equipment - Part 2-56: Particular requirements for basic safety and essential performance of clinical thermometers for body temperature measurement (ISO 80601-2-56:2009); German version EN ISO 80601-2-56:2012
- 1970 DIN EN ISO 80601-2-56 E:2012-04 Medical electrical equipment Part 2-56: Special requirements for basic safety and essential performance of clinical thermometers used for body temperature measurement (draft)
- 2012 DIN EN ISO 80601-2-56 E:2012 Draft Document - Medical electrical equipment - Part 2-56: Particular requirements for basic safety and essential performance of clinical thermometers for body temperature measurement (ISO 80601-2-56:2009); German version FprEN ISO 80601-2-56:2012
- 2009 DIN EN 12470-4:2009 Clinical thermometers - Part 4: Performance of electrical thermometers for continuous measurement(includes Amendment A1:2009); English version of DIN EN 12470-4:2009-11
- 0000 DIN EN 12470-5:2003
