Jetzt auswählen und bestellen
232,70 €
exkl. USt.
In den Warenkorb
Norm

ÖVE/ÖNORM EN ISO 80601-2-55

Ausgabedatum: 2012 04 01

Medical electrical equipment - Part 2-55: Particular requirements for the basic safety and essential performance of respiratory gas monitors (ISO 80601-2-55:2011) (english version)

This International Standard specifies particular requirements for the BASIC SAFETY and ESSENTIAL PERFORMANCE of a RESPIRATORY GAS MONITOR (RGM), hereafter referred to as...
ZURÜCKGEZOGEN: 2018 12 15
Herausgeber:
Austrian Standards International
Format:
Digital | 72 Seiten
Sprache:
Englisch
This International Standard 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 International Standard specifies requirements for - anaesthetic gas monitoring, - carbon dioxide monitoring, and - oxygen monitoring. This International Standard is not applicable to an RGM intended for use with flammable anaesthetic agents. Environmental aspects are addressed in Annex BB. 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 standard are not covered by specific requirements in this particular standard, except in 7.2.13 and 8.4.1 of the general standard (IEC 60601-1). The object of this particular standard is to establish particular BASIC SAFETY and ESSENTIAL PERFORMANCE requirements for an RGM (as defined in 201.3.210) and its ACCESSORIES.
ÖNORM EN ISO 80601-2-55
2018 12 15
Medizinische elektrische Geräte - Teil 2-55: Besondere Festlegungen für die Sicherheit einschließlic...
Norm
ÖVE/ÖNORM EN ISO 80601-2-55
2012 04 01
Medical electrical equipment - Part 2-55: Particular requirements for the basic safety and essential...
Norm
ÖNORM EN ISO 21647
2009 09 15
Medizinische elektrische Geräte - Besondere Festlegungen für die grundlegende Sicherheit und grundle...
Norm
ÖNORM EN ISO 21647
2006 04 01
Medizinische elektrische Geräte - Besondere Festlegungen für die grundlegende Sicherheit und grundle...
Norm
ÖNORM EN ISO 21647
2005 07 01
Medizinische elektrische Geräte - Besondere Festlegungen für die grundlegende Sicherheit und grundle...
Norm
ÖNORM EN 12598
1999 07 01
Überwachungsgeräte für Sauerstoff in Atemgasgemischen von Patienten - Besondere Festlegungen
Norm
ÖNORM EN ISO 11196
1998 02 01
Überwachungsgeräte für Anästhesiegase (ISO 11196:1995 einschließlich Technisches Korrigendum 1:1997)...
Norm
ÖNORM EN 865
1997 09 01
Pulsoximeter - Besondere Anforderungen
Norm
Historie aufklappen
Norm
ISO 14937:2009
Ausgabedatum : 2009 10 14
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
Norm
ISO 15223-1:2007
Ausgabedatum : 2007 04 04
Medical devices — Symbols to be used with medical device labels, labelling and information to be supplied — Part 1: General requirements
Schlussentwurf
ISO/FDIS 15223-1
Ausgabedatum : 2012 02 23
Medical devices — Symbols to be used with medical device labels, labelling and information to be supplied — Part 1: General requirements
Norm
ISO 17664:2004
Ausgabedatum : 2004 02 25
Sterilization of medical devices — Information to be provided by the manufacturer for the processing of resterilizable medical devices
Norm
ISO 7000:2004
Ausgabedatum : 2004 01 12
Graphical symbols for use on equipment — Index and synopsis
Norm
ISO 7010:2011
Ausgabedatum : 2011 05 27
Graphical symbols — Safety colours and safety signs — Registered safety signs
Norm
ISO 14937:2009
Ausgabedatum : 2009 10 14
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
Norm
ISO 15223-1:2021
Ausgabedatum : 2021 07 06
Medical devices — Symbols to be used with information to be supplied by the manufacturer — Part 1: General requirements (Corrected version 2021-07)
Norm
ISO 17664:2017
Ausgabedatum : 2017 10 25
Processing of health care products — Information to be provided by the medical device manufacturer for the processing of medical devices
Norm
ISO 80369-1:2010
Ausgabedatum : 2010 12 08
Small-bore connectors for liquids and gases in healthcare applications — Part 1: General requirements
Norm
ÖNORM EN ISO 80601-2-55
Ausgabedatum : 2018 12 15
Medizinische elektrische Geräte - Teil 2-55: Besondere Festlegungen für die Sicherheit einschließlich der wesentlichen Leistungsmerkmale von Überwachungsgeräten für Atemgase (ISO 80601-2-55:2018)