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DIN EN ISO 80601-2-56

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)

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Organization: DIN
Publication Date: 1 August 2020
Status: active
Page Count: 69
ICS Code (Temperature-measuring instruments): 17.200.20

Document History

DIN EN ISO 80601-2-56
August 1, 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)
A description is not available for this item.
DIN EN ISO 80601-2-56/A1
April 1, 2018
Medical electrical equipment - Part 2-56: Particular requirements for basic safety and essential performance of clinical thermometers for body temperature measurement - Amendment 1 (ISO 80601-2-56:2017/DAM 1:2018); German and English version EN ISO 80601-2-56:2017/prA1:2018
A description is not available for this item.
DIN EN ISO 80601-2-56
February 1, 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)
This document applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of a CLINICAL THERMOMETER in combination with its ACCESSORIES, hereafter referred to as ME EQUIPMENT. This document specifies the...
DIN EN ISO 80601-2-56
February 1, 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)
This International Standard applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of a CLINICAL THERMOMETER in combination with its ACCESSORIES, hereafter referred to as ME EQUIPMENT. This standard...

References

This document references:
15223-1 - Medical devices - Symbols to be used with information to be supplied by the manufacturer - Part 1: General requirements
Published by ISO on July 1, 2021
This document specifies symbols used to express information supplied for a medical device. This document is applicable to symbols used in a broad spectrum of medical devices, that are available...
This document references:
ISO 16142-1 - Medical devices - Recognized essential principles of safety and performance of medical devices - Part 1: General essential principles and additional specific essential principles for all non‐IVD medical devices and guidance on the selection of standards
Published by ISO on March 1, 2016
This part of ISO 16142, which includes the essential principles of safety and performance, identifies significant standards and guides that can be used in the assessment of conformity of a medical...
This document references:
ISO 14159 - Safety of Machinery - Hygiene Requirements for the Design of Machinery
Published by ISO on April 1, 2002
A description is not available for this item.
This document references:
ISO 14937 - 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
Published by ISO on October 15, 2009
Inclusions This International Standard specifies general requirements for the characterization of a sterilizing agent and for the development, validation and routine monitoring and control of a...
This document references:
ISO 17664 - Processing of health care products - Information to be provided by the medical device manufacturer for the processing of medical devices
Published by ISO on October 1, 2017
This document specifies requirements for the information to be provided by the medical device manufacturer for the processing of a medical device that requires cleaning followed by disinfection...
This document references:
ISO 9000 - Quality management systems — Fundamentals and vocabulary
Published by ISO on September 15, 2015
This International Standard describes the fundamental concepts and principles of quality management which are universally applicable to the following: — organizations seeking sustained success...
This document references:
ISO/IEC GUIDE 99 - International vocabulary of metrology - Basic and general concepts and associated terms (VIM)
Published by ISO on January 1, 2007
In this Vocabulary, a set of definitions and associated terms is given, in English and French, for a system of basic and general concepts used in metrology, together with concept diagrams to...
This document references:
JIS T 4207 - Infrared ear thermometers
Published by JSA on July 1, 2012
A description is not available for this item.
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