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99.60 Withdrawal effective Jul 26, 2017
CEN
CEN/TC 205 Non-active medical devices
European Norm
11.040.55 Diagnostic equipment
Withdrawn
ISO 80601-2-56:2009 applies to the basic safety and essential performance of a clinical thermometer in combination with its accessories, referred to as ME equipment. ISO 80601-2-56:2009 specifies the general and technical requirements for electrical clinical thermometers. ISO 80601-2-56:2009 applies to all electrical clinical thermometers that are used for measuring the body temperature of patients.
Clinical thermometers can be equipped with interfaces to accommodate secondary indicators, printing equipment, and other auxiliary equipment to create ME systems. ISO 80601-2-56:2009 does not apply to auxiliary equipment.
ME equipment that measures a temperature not as a primary purpose, but as a secondary function, is outside the scope of ISO 80601-2-56:2009.
Requirements for ME equipment intended to be used for non-invasive human febrile temperature screening of groups of individuals under indoor environmental conditions are given in IEC 80601‑2‑59:2008 and such ME equipment is not covered by ISO 80601-2-56:2009.
Legislation related to this standard
WITHDRAWN
EN 12470-3:2000+A1:2009
WITHDRAWN
EN 12470-4:2000+A1:2009
WITHDRAWN
EN 12470-5:2003
WITHDRAWN
EN ISO 80601-2-56:2012
99.60
Withdrawal effective
Jul 26, 2017
PUBLISHED
EN ISO 80601-2-56:2017