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ÖNORM EN ISO 80601-2-56:2020-08

Действует
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 + Amd 1:2018) (consolidated version)
ОписаниеИзмененияСсылкиВерсии

Ссылочные документы

IEC 60601-1-2:2014 ed4.0
Действует
Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests — 188 стр.
IEC 60601-1-6:2010 ed3.0
Действует
Medical electrical equipment - Part 1-6: General requirements for basic safety and essential performance - Collateral standard: Usability — 51 стр.
IEC 60601-1-8:2006 ed2.0
Действует
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 — 157 стр.
ISO 14155:2011
Действует
Clinical investigation of medical devices for human subjects -- Good clinical practice — 66 стр.
ISO 14937:2009
Действует
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 — 46 стр.
ISO 15223-1:2016
Действует
Medical devices -- Symbols to be used with medical device labels, labelling and information to be supplied -- Part 1: General requirements — 32 стр.
ISO 17664:2004
Заменен
Sterilization of medical devices -- Information to be provided by the manufacturer for the processing of resterilizable medical devices — 26 стр.
IEC 60601-1:2005 ed3.0
Действует
Medical electrical equipment - Part 1: General requirements for basic safety and essential performance — 777 стр.
IEC 60601-1-11:2015 ed2.0
Действует
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 — 125 стр.
IEC 60601-1-12:2014 ed1.0
Действует
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 services environment — 101 стр.
IEC 62366-1:2015 ed1.0
Действует
Medical devices - Part 1: Application of usability engineering to medical devices — 110 стр.
ÖNORM EN ISO 80601-2-56:2018-01
Заменен
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)

На этот документ ссылаются

ÖNORM EN ISO 80601-2-56:2018-01
Заменен
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)