Standard Svensk standard · SS-EN ISO 80601-2-56:2012

Elektrisk utrustning för medicinskt bruk - Del 2-56: Särskilda krav för grundläggande säkerhet och väsentliga prestanda för medicinska termometrar för mätning av kroppstemperatur (ISO 80601-2-56:2009)

Status: Upphävd · Ersätts av: SS-EN ISO 80601-2-56:2017

Omfattning
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.

Ämnesområden

Utrustning för diagnostik (11.040.55) Instrument för temperaturmätning (17.200.20)


Produktinformation

Språk: Engelska

Framtagen av: Anestesi- och respiratorutrustning, SIS/TK 329

Internationell titel: 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)

Artikelnummer: STD-87797

Utgåva: 1

Fastställd: 2012-10-20

Antal sidor: 68

Ersätter: SS-EN 12470-5 , SS-EN 12470-3+A1:2009 , SS-EN 12470-4+A1:2009

Ersätts av: SS-EN ISO 80601-2-56:2017