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DIN EN ISO 80601-2-55

Medical electrical equipment - Part 2-55: Particular requirements for the basic safety and essential performance of respiratory gas monitors (ISO 80601-2-55:2018)

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Organization: DIN
Publication Date: 1 March 2019
Status: active
Page Count: 77
ICS Code (Anaesthetic, respiratory and reanimation equipment): 11.040.10

Document History

DIN EN ISO 80601-2-55/A1
March 1, 2023
Medical electrical equipment - Part 2-55: Particular requirements for the basic safety and essential performance of respiratory gas monitors - Amendment 1 (ISO 80601-2-55:2018/DAM 1:2023); German and English version EN ISO 80601-2-55:2018/prA1:2023
A description is not available for this item.
DIN EN ISO 80601-2-55
March 1, 2019
Medical electrical equipment - Part 2-55: Particular requirements for the basic safety and essential performance of respiratory gas monitors (ISO 80601-2-55:2018)
A description is not available for this item.
DIN EN ISO 80601-2-55
July 1, 2018
Medical electrical equipment - Part 2-55: Particular requirements for the basic safety and essential performance of respiratory gas monitors (ISO 80601-2-55:2018)
IEC 60601‐1:2005+Amd 1:2012, 1.1 is replaced by: This document specifies particular requirements for the BASIC SAFETY and ESSENTIAL PERFORMANCE of a RESPIRATORY GAS MONITOR (RGM), hereafter referred...
DIN EN ISO 80601-2-55
November 1, 2016
Medical electrical equipment - Part 2-55: Particular requirements for the basic safety and essential performance of respiratory gas monitors (ISO/DIS 80601-2-55:2016); German and English version prEN ISO 80601-2-55:2016
A description is not available for this item.

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 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 23328-1 - Breathing system filters for anaesthetic and respiratory use - Part 1: Salt test method to assess filtration performance
Published by ISO on August 15, 2003
This part of ISO 23328 gives a short-term airborne sodium chloride particle challenge test method for assessing the filtration performance of breathing system filters (BSF) intended for the...
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