NF EN ISO 80601-2-55

NF EN ISO 80601-2-55

February 2012
Standard Cancelled

Medical electrical equipment - Part 2-55 : particular requirements for the basic safety and essential performance of respiratory gas monitors

ISO 80601-2-55:2011 specifies particular requirements for the basic safety and essential performance of a respiratory gas monitor (RGM) intended for continuous operation for use with a patient.ISO 80601-2-55:2011 specifies requirements for: anaesthetic gas monitoring, carbon dioxide monitoring, and oxygen monitoring.ISO 80601-2-55:2011 is not applicable to an RGM intended for use with flammable anaesthetic agents.

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Main informations

Collections

National standards and national normative documents

Publication date

February 2012

Number of pages

71 p.

Reference

NF EN ISO 80601-2-55

ICS Codes

11.040.10   Anaesthetic, respiratory and reanimation equipment

Classification index

S95-190

Print number

1 - 10/02/2012

International kinship

ISO 80601-2-55:2011

European kinship

EN ISO 80601-2-55:2011
Sumary
Medical electrical equipment - Part 2-55 : particular requirements for the basic safety and essential performance of respiratory gas monitors

ISO 80601-2-55:2011 specifies particular requirements for the basic safety and essential performance of a respiratory gas monitor (RGM) intended for continuous operation for use with a patient.

ISO 80601-2-55:2011 specifies requirements for:

  • anaesthetic gas monitoring,
  • carbon dioxide monitoring, and
  • oxygen monitoring.

ISO 80601-2-55:2011 is not applicable to an RGM intended for use with flammable anaesthetic agents.

Replaced standards (1)
NF EN ISO 21647
August 2009
Standard Cancelled
Medical electrical equipment - Particular requirements for the basic safety and essential performance of respiratory gas monitors

ISO 21647:2004 specifies particular requirements for the basic safety and essential performance of respiratory gas monitors (RGM) (as defined in 3.15) intended for continuous operation for use with humans. It supplements the requirements of IEC 60601-1:1988. ISO 21647:2004 specifies requirements for anaesthetic gas monitoring, carbon dioxide monitoring and oxygen monitoring. ISO 21647:2004 is not applicable to monitors intended for use with flammable anaesthetic agents. The requirements of ISO 21647:2004 which replace or modify the requirements of IEC 60601-1:1988 and its Amendments 1 (1991) and 2 (1995) are intended to take precedence over the corresponding general requirements. Environmental aspects are addressed in Annex CC. Additional aspects of environmental impact are addressed in ISO 14971.

Standard replaced by (1)
NF EN ISO 22476-2
July 2005
Standard Current
Geotechnical investigation and testing - Field testing - Part 2 : dynamic probing

ISO 22476-2:2005 specifies requirements for indirect investigations of soil by dynamic probing within the scope of the geotechnical investigations according to prEN 1997.

Table of contents
  • Avant-propos
    vi
  • Introduction
    vii
  • 1 Domaine d'application
    1
  • 201.1 Domaine d'application, objet et normes collatérales
    1
  • 201.2 Références normatives
    3
  • 201.3 Termes et définitions
    4
  • 201.4 Exigences générales
    6
  • 201.5 Exigences générales relatives aux essais des APPAREILS EM
    7
  • 201.6 Classification des APPAREILS EM et des SYSTEMES EM
    7
  • 201.7 Identification, marquage et documentation des APPAREILS EM
    7
  • 201.8 Protection contre les DANGERS d'origine électrique provenant des APPAREILS EM
    12
  • 201.9 Protection contre les DANGERS mécaniques des APPAREILS EM et SYSTEMES EM
    12
  • 201.10 Protection contre les DANGERS dus aux rayonnements indésirables ou excessifs
    12
  • 201.11 Protection contre les températures excessives et les autres DANGERS
    12
  • 201.12 Précision des commandes, des instruments et de la protection contre les caractéristiques de sortie présentant des RISQUES
    15
  • 201.13 SITUATIONS DANGEREUSES et conditions de défaut
    20
  • 201.14 SYSTEMES ELECTROMEDICAUX PROGRAMMABLES (SEMP)
    20
  • 201.15 Construction de l'APPAREIL EM
    20
  • 201.15. 101 Mode de fonctionnement
    22
  • 201.16 SYSTEMES EM
    22
  • 201.17 Compatibilité électromagnétique des APPAREILS EM et des SYSTEMES EM
    22
  • 201.101 Effets des gaz et vapeurs parasites
    23
  • 201.102 Fuite de gaz
    23
  • 201.103 Raccord de sortie d'Un MGR PAR ASPIRATION
    24
  • 201.104 Débit de prélèvement minimal
    24
  • 201.105 Contamination des systèmes respiratoires
    24
  • 202 Compatibilité électromagnétique - Exigences et essais
    24
  • 206 Aptitude à l'utilisation
    25
  • 208 Exigences générales, essais et guide pour les SYSTEMES D'ALARME des appareils et des systèmes électromédicaux
    25
  • 209 Exigences pour une conception éco-responsable
    27
  • 210 Exigences pour le développement de régulateurs physiologiques en boucle fermée
    27
  • 211 Exigences relatives à l'EQUIPEMENT MEDICAL ELECTRIQUE et aux SYSTEMES MEDICAUX ELECTRIQUES utilisés dans les applications de SOINS A DOMICILE
    28
  • Annexe C (informative) Lignes directrices relatives aux exigences de marquage et étiquetage pour les APPAREILS EM et SYSTEMES EM
    29
  • Annexe D (informative) Symboles de marquage
    33
  • Annexe AA (informative) Lignes directrices particulières et justifications
    35
  • Annexe BB (informative) Aspects environnementaux
    47
  • Annexe CC (informative) Mélanges de gaz d'essai pour étalonnage
    49
  • Annexe DD (informative) Référence aux principes essentiels
    50
  • Bibliographie
    52
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