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ÖNORM EN ISO 80601-2-55

Issue date: 2018 12 15

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

Document Number Title
Document Number
ÖNORM EN ISO 80601-2-55/A1
Title
Medical electrical equipment - Part 2-55: Particular requirements for the basic safety and essential performance of respiratory gas monitors (ISO 80601-2-55:2018/Amd 1:2023) (Amendment)
IEC 60601-1:2005+Amd 1:2012, Clause 1 applies, except as follows: 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 to as ME EQUIPMENT, intended for CONTINUOUS OPERATION for use with a PATIENT. This document specifies requirements for — anaesthetic gas monitoring, — carbon dioxide monitoring, and — oxygen monitoring. This document is not applicable to an RGM intended for use with flammable anaesthetic agents. If a clause or subclause is specifically intended to be applicable to ME EQUIPMENT only or to ME SYSTEMS only, the title and content of that clause or subclause will say so. If that is not the case, the clause or subclause applies both to ME EQUIPMENT and to ME SYSTEMS, as relevant. HAZARDS inherent in the intended physiological function of ME EQUIPMENT or ME SYSTEMS within the scope of this document are not covered by specific requirements in this document except in IEC 60601-1:2005+Amd 1:2012, 7.2.13 and 8.4.1.
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General information on ÖNORM EN ISO 80601-2-55

Format
Digital | 74 Pages
Language
German | English | Download GER/ENG
Publisher
Austrian Standards International
Committee 179 Medical technology

Timeline

An overview of the development of ÖNORM EN ISO 80601-2-55 from 1997 til today.

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Normative References

Here you will find an extract of the normative references. Please refer to the document itself for the full list.

Dokumentnummer Titel Ausgabedatum Art
Dokumentnummer
ISO 14937:2009
Titel
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
Ausgabedatum
2009 10 14
Art
Standard
Zur Produktseite
Dokumentnummer
ISO 15223-1:2021
Titel
Medical devices — Symbols to be used with information to be supplied by the manufacturer — Part 1: General requirements (Corrected version 2021-07)
Ausgabedatum
2021 07 06
Art
Standard
Zur Produktseite
Dokumentnummer
ISO 17664:2004
Titel
Sterilization of medical devices — Information to be provided by the manufacturer for the processing of resterilizable medical devices
Ausgabedatum
2004 02 25
Art
Standard
Zur Produktseite
Dokumentnummer
ISO 7000:2014
Titel
Graphical symbols for use on equipment — Registered symbols
Ausgabedatum
2014 01 20
Art
Standard
Zur Produktseite
Dokumentnummer
ISO 7010:2011
Titel
Graphical symbols — Safety colours and safety signs — Registered safety signs
Ausgabedatum
2011 05 27
Art
Standard
Zur Produktseite

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