EN ISO 80601-2-55:2011

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

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.

Medizinische elektrische Geräte - Teil 2-55: Besondere Festlegungen für die Sicherheit einschließlich der wesentlichen Leistungsmerkmale von Überwachungsgeräten für Atemgase (ISO 80601-2-55:2011)

Ersatz:
Diese Internationale Norm gilt für die BASISSICHERHEIT einschließlich der WESENTLICHEN LEISTUNGSMERKMALE von ÜBERWACHUNGSGERÄTEN FÜR ATEMGASE, RGM (en: respiratory gas monitor), nachfolgend als ME GERÄTE bezeichnet, die für die ununterbrochene Anwendung am Menschen bestimmt sind.
Diese Internationale Norm legt Anforderungen fest für:
–   Überwachungsgeräte für Anästhesiegase;
–   Überwachungsgeräte für Kohlendioxid;
–   Überwachungsgeräte für Sauerstoff.
ANMERKUNG 1   Ein RGM kann entweder ein einzelnes ME-GERÄT sein oder integriert in/mit anderen Geräten wie z. B. Anästhesie-Arbeitsplätzen oder Beatmungsgeräten.
RGM, die für die Verwendung mit brennbaren Anästhesiemitteln bestimmt sind, liegen außerhalb des Anwendungsbereichs dieser Internationalen Norm.
Umwelteinflüsse werden im Anhang BB beschrieben.
ANMERKUNG 2   Weitere Aspekte von Umwelteinflüssen werden in ISO 14971 und IEC 60601-1-9 behandelt.
Ist ein Abschnitt oder Unterabschnitt nur speziell für die Anwendung auf ME GERÄTE oder ME SYSTEME vorge¬sehen, ist dies aus Überschrift und Inhalt des Abschnittes oder Unterabschnittes ersichtlich. Ist das nicht der Fall, trifft der Abschnitt oder Unterabschnitt, wo anwendbar, auf das ME GERÄT und das ME SYSTEM zu.
GEFÄHRDUNGEN, die sich aus der vorgesehenen physio¬logischen Wirkungsweise von ME GERÄTEN oder ME SYSTEMEN im Anwendungsbereich diesen Besonderen Festlegungen ergeben, sind nicht durch besondere Anforderungen in dieser Norm erfasst, ausgenommen bei 7.2.13 und 8.4.1 der Allgemeinen Festlegungen (IEC 60601-1).
ANMERKUNG 3   Siehe auch 4.2 der Allgemeinen Festlegungen.

Appareils électromédicaux - Partie 2-55: Exigences particulières relatives à la sécurité de base et aux performances essentielles des moniteurs de gaz respiratoires (ISO 80601-2-55:2011)

L'ISO 80601-2-55:2011 spécifie les exigences particulières relatives à la sécurité et aux performances essentielles des moniteurs de gaz respiratoire (MGR) destinés à être utilisés en fonctionnement permanent sur un patient.
L'ISO 80601-2-55:2011 définit les exigences relatives au
contrôle des gaz d'anesthésie,
contrôle du dioxyde de carbone, et
contrôle de l'oxygène.
Les MGR destinés à être utilisés avec des agents anesthésiques inflammables ne font pas partie du domaine d'application de l'ISO 80601-2-55:2011.

Medicinska električna oprema - 2-55. del: Posebne zahteve za osnovno varnost in bistvene lastnosti monitorjev dihalnih plinov (ISO 80601-2-55:2011)

Ta mednarodni standard določa posebne zahteve za OSNOVNO VARNOST in BISTVENE LASTNOSTI MONITORJEV DIHALNIH PLINOV (RGM), v nadaljnjem besedilu ELEKTROMEDICINSKA OPREMA, namenjenih za NEPREKINJENO DELOVANJE za uporabo pri BOLNIKU. Ta mednarodni standard določa zahteve za – spremljanje anestezijskih plinov, – spremljanje ogljikovega dioksida in – spremljanje kisika. Če je poglavje ali podpoglavje namenjeno samo obravnavi ELEKTROMEDICINSKE OPREME ali ELEKTROMEDICINSKIH SISTEMOV, bo to zapisano v naslovu in vsebini poglavja ali podpoglavja. Če ni zapisano, poglavje ali podpoglavje obravnava ELEKTROMEDICINSKO OPREMO in ELEKTROMEDICINSKE SISTEME. Posebne zahteve tega standarda ne vključujejo temeljnih NEVARNOSTI pri nameravani fiziološki funkciji ELEKTROMEDICINSKE OPREME in SISTEMOV, ki spadajo v področje uporabe tega standarda, razen v točkah 7.2.13 in 8.4.1 splošnega standarda (IEC 60601-1).

General Information

• Status: Withdrawn
• Publication Date: 14-Dec-2011
• Withdrawal Date: 27-Feb-2018
• ICS: 11.040.10 - Anaesthetic, respiratory and reanimation equipment
• Technical Committee: CEN/TC 215 - Respiratory and anaesthetic equipment
• Drafting Committee: CEN/TC 215 - Respiratory and anaesthetic equipment
• Current Stage: 9960 - Withdrawal effective - Withdrawal
• Completion Date: 28-Feb-2018
• Directive: 93/42/EEC - Council Directive 93/42/EEC of 14 June 1993 concerning medical devices
• Mandate: M/023 - Standardization mandate to CEN/CENELEC concerning the development of European standards relating to medical devices
• Ref Project: SIST EN ISO 80601-2-55:2013 - Medical electrical equipment - Part 2-55: Particular requirements for the basic safety and essential performance of respiratory gas monitors (ISO 80601-2-55:2011)

Relations

• Replaces: EN ISO 21647:2009 - Medical electrical equipment - Particular requirements for the basic safety and essential performance of respiratory gas monitors (ISO 21647:2004, including Cor 1:2005)
• Effective Date: 01-Feb-2012
• Replaces: EN ISO 21647:2004/AC:2006 - Medical electrical equipment - Particular requirements for the basic safety and essential performance of respiratory gas monitors (ISO 21647:2004)
• Effective Date: 28-Dec-2011
• Replaced By: EN ISO 80601-2-55:2018 - Medical electrical equipment - Part 2-55: Particular requirements for the basic safety and essential performance of respiratory gas monitors (ISO 80601-2-55:2018)
• Effective Date: 07-Mar-2018

Standards Content (Sample)

SLOVENSKI STANDARD
01-november-2013
1DGRPHãþD
SIST EN ISO 21647:2009
0HGLFLQVNDHOHNWULþQDRSUHPDGHO3RVHEQH]DKWHYH]DRVQRYQRYDUQRVWLQ
ELVWYHQHODVWQRVWLPRQLWRUMHYGLKDOQLKSOLQRY,62
Medical electrical equipment - Part 2-55: Particular requirements for the basic safety and
essential performance of respiratory gas monitors (ISO 80601-2-55:2011)
Medizinische elektrische Geräte - Teil 2-55: Besondere Festlegungen für die Sicherheit
einschließlich der wesentlichen Leistungsmerkmale von Überwachungsgeräten für
Atemgase (ISO 80601-2-55:2011)
Appareils électromédicaux - Partie 2-55: Exigences particulières relatives à la sécurité de
base et aux performances essentielles des moniteurs de gaz respiratoires (ISO 80601-2-
55:2011)
Ta slovenski standard je istoveten z: EN ISO 80601-2-55:2011
ICS:
11.040.10 Anestezijska, respiratorna in Anaesthetic, respiratory and
reanimacijska oprema reanimation equipment
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

EUROPEAN STANDARD
EN ISO 80601-2-55
NORME EUROPÉENNE
EUROPÄISCHE NORM
December 2011
ICS 11.040.10 Supersedes EN ISO 21647:2009
English Version
Medical electrical equipment - Part 2-55: Particular requirements
for the basic safety and essential performance of respiratory gas
monitors (ISO 80601-2-55:2011)
Appareils électromédicaux - Partie 2-55: Exigences Medizinische elektrische Geräte - Teil 2-55: Besondere
particulières relatives à la sécurité de base et aux Festlegungen für die Sicherheit einschließlich der
performances essentielles des moniteurs de gaz wesentlichen Leistungsmerkmale von
respiratoires (ISO 80601-2-55:2011) Überwachungsgeräten für Atemgase (ISO 80601-2-
55:2011)
This European Standard was approved by CEN on 2 December 2011.

CEN members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for giving this European
Standard the status of a national standard without any alteration. Up-to-date lists and bibliographical references concerning such national
standards may be obtained on application to the CEN-CENELEC Management Centre or to any CEN member.

This European Standard exists in three official versions (English, French, German). A version in any other language made by translation
under the responsibility of a CEN member into its own language and notified to the CEN-CENELEC Management Centre has the same
status as the official versions.

CEN members are the national standards bodies of Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia,
Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland,
Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and United Kingdom.

EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION

EUROPÄISCHES KOMITEE FÜR NORMUNG

Management Centre: Avenue Marnix 17, B-1000 Brussels
© 2011 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 80601-2-55:2011: E
worldwide for CEN national Members.

Contents Page
Foreword .3
Annex ZA (informative) Relationship between this European Standard and the Essential
Requirements of EU Directive 93/42/EEC .4

Foreword
This document (EN ISO 80601-2-55:2011) has been prepared by Technical Committee ISO/TC 121
"Anaesthetic and respiratory equipment" in collaboration with Technical Committee CEN/TC 215 “Respiratory
and anaesthetic equipment” the secretariat of which is held by BSI.
This European Standard shall be given the status of a national standard, either by publication of an identical
text or by endorsement, at the latest by June 2012, and conflicting national standards shall be withdrawn at
the latest by December 2014.
Attention is drawn to the possibility that some of the elements of this document may be the subject of patent
rights. CEN [and/or CENELEC] shall not be held responsible for identifying any or all such patent rights.
This document supersedes EN ISO 21647:2009.
This document has been prepared under a mandate given to CEN by the European Commission and the
European Free Trade Association, and supports essential requirements of EU Directive.
For relationship with EU Directive, see informative Annex ZA, which is an integral part of this document.
According to the CEN/CENELEC Internal Regulations, the national standards organizations of the following
countries are bound to implement this European Standard: Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech
Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia,
Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain,
Sweden, Switzerland and the United Kingdom.
Endorsement notice
The text of ISO 80601-2-55:2011 has been approved by CEN as a EN ISO 80601-2-55:2011 without any
modification.
Annex ZA
(informative)
Relationship between this European Standard and the Essential
Requirements of EU Directive 93/42/EEC
This International Standard has been prepared under a mandate given to CEN by the European Commission
and the European Free Trade Association to provide a means to conforming to Essential Requirements of the
New Approach Directive 93/42/EEC, Council Directive of 14 June 1993 on the approximation of the laws of
the Member States concerning medical devices” (Medical Device Directive).
Once this standard is cited in the Official Journal of the European Union under that Directive and has been
implemented as a national standard in at least one Member State, compliance with the clauses of this
standard given in Table ZA.1 confers, within the limits of the scope of this standard, a presumption of
conformity with the corresponding Essential Requirements of that Directive and associated EFTA regulations.
Table ZA.1 — Correspondence between this European Standard
and Directive 93/42/EEC
Clause(s)/subclause(s) of this Essential requirements (ERs) Qualifying remarks/Notes
European Standard of EU Directive 93/42/EEC
201.11.6.4 to 201.11.6.6 7.2 Only the parts of ER 7.2 relating to
safety in use for the patient are
addressed
201.11.6.4, 201.11.6.8 7.3 Only the part of the first sentence
relating to design is addressed
201.11.6.4 7.5
201.11.6.5, 201.101 7.6
201.11.6.6, 201.11.6.7 , 201.105 8.1 The part of ER 8.1 relating to easy
handling is not addressed
201.11.6.7 8.4 Validated processes for
sterilization are required via the
normative references to
ISO 11134, ISO 11135, ISO 11137
201.7.2.17.101 8.7
201.7.2.101, 201.7.2.4.101, 201.7.2.13.101, 9.1
201.7.2.17.101, 201.12.1.102, 201.102,
201.103, 208
th
201.9, 201.101, 202, 206 9.2 The 4 indent of ER 9.2 is not
addressed
Table ZA.1 (continued)
Clause(s)/subclause(s) of this Essential requirements (ERs) Qualifying remarks/Notes
European Standard of EU Directive 93/42/EEC
201.11 9.3
201.12.1, 201.101 10.1
201.7, 201.12.1.103, 201.12.1.104, 206, 10.2
201.7.4.3 10.3
201.10 11.1.1
202 11.3.1
201.14 12.1
201.14 12.1 a)
201.11.8.101, 208 12.2
201.11.8.101, 208 12.3
208 12.4
202 12.5
201.8 12.6
201.9 12.7.1
201.9 12.7.2
201.9 12.7.3
201.8, 201.15, 201.103 12.7.4
201.11 12.7.5
201.104 12.8.2 Only the first sentence of ER
12.8.2 is covered
201.7, 201.12.1, 206 12.9
201.7, 201.7.2.4.101, 201.7.2.13.101, 13.1
201.7.2.17.101, 201.7.2.101
201.7, 201.7.2.3, 201.7.2.13.101, 13.2
201.7.2.17.101, 201.7.2.101
201.7.9.1 13.3 a)
201.7, 201.7.2.17.101, 201.7.2.101 13.3 b)
201.7, 201.7.2.17.101 13.3 c)
201.7.2.17.101, 201.7.2.101 13.3 d) Is only covered if the batch
number is preceded by the word
LOT
201.7.2.101 13.3 e)
201.7.2.4.101, 201.7.2.17.101 b) 13.3 f) Distinction between “single use“
and “single-patient use” taken into
account
201.7.2.101 a) 13.3 i)
201.7, 201.7.2 13.3 j)
Table ZA.1 (continued)
Clause(s)/subclause(s) of this Essential requirements (ERs) Qualifying remarks/Notes
European Standard of EU Directive 93/42/EEC
201.7, 201.7.9.2.2.101 13.3 k)
201.7, 201.7.2.17 a) 13.3 m) Presumption of conformity is only
provided if symbols 5.21 to 5.24
are utilized
201.7.9.2.1.101 a), 201.7.2.17.101, 13.4
201.7.2.101
201.7.2.17.101 a), 201.7.2.101 b) 13.5 Is only covered if the batch
number is preceded by the word
LOT
201.7, 201.7.9.1, 201.7.9.2.1.101, 13.6 a)
201.7.9.2.2.101
201.7, 201.7.9.2.1.101, 201.7.9.2.2.101, 13.6 b)
201.7.9.2.9.101 c), 201.7.9.2.9.101 d)
201.7, 201.7.9.2.2.101, 201.7.9.2.5.101, 13.6 c)
201.7.9.2.9.101 e)
201.7, 201.7.9.2.13.101 13.6 d)
201.7, 201.7.9.2.9.101 g), , 13.6 f)
201.7.9.2.9.101 k)
201.7.9.2.14.101 b) 13.6 g)
201.7, 201.7.9.2.9.101 l) , 13.6 h)
201.7.9.2.14.101 b)
201.7 13.6 i)
201.7.9.2.1.101 c) 13.6 j)
201.7 13.6 k)
201.7 13.6 l)
201.7, 201.7.9.2.14.101 c), 13.6 n)
201.7.9.2.15.101
201.12.1.101.1 13.6 p)
201.7.9.2.9.101 m) 13.6 q)
For devices which are also machinery within the meaning of Article 2(a) of Directive 2006/42/EC on
Machinery, in accordance with Article 3 of Directive 93/42/EEC, the following Table ZA.2 details the relevant
essential health and safety requirements of Directive 2006/42/EC on Machinery to the extent to which they are
more specific than essential requirements of Directive 93/42/EEC along with the corresponding clauses of this
International Standard. Table ZA.2, however, does not imply any citation in the OJEU under the machinery
directive and thus does not provide presumption of conformity for the machinery directive.
Table ZA.2 — Relevant Essential Requirements from Directive 2006/42/EC on machinery that
are addressed by this European Standard
(according to article 3 of amended Directive 93/42/EEC)
Clause(s)/subclause(s) of this Essential health and safety Qualifying remarks/Notes
European Standard requirements (ERs)
of EU Directive 2006/42/EC
201.7, 201.12.1 1.1.4 Only the first sentence of EHSR
1.1.4 is addressed
201.12.1, 201.12.1.104, 206, 208.6.5.1, 1.2.2 Only the parts of EHST 1.2.2
208.6.6.2.101 relevant to the RGM are
addressed
201.7.2.101 d), 201.7.2.101 e), 1.5.4
201.7.2.101 f), 201.7.2.101 g)
201.7.2.101 h), 201.103, 201.105
201.7 1.6.2
201.8 1.6.3
201.7, 201.7.2.101 i) 3.6.2
WARNING: Other requirements and other EU Directives may be applicable to the products falling within the
scope of this standard.
INTERNATIONAL ISO
STANDARD 80601-2-55
First edition
2011-12-15
Medical electrical equipment —
Part 2-55:
Particular requirements for the basic
safety and essential performance of
respiratory gas monitors
Appareils électromédicaux —
Partie 2-55: Exigences particulières relatives à la sécurité de base et
aux performances essentielles des moniteurs de gaz respiratoires

Reference number
ISO 80601-2-55:2011(E)
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ISO 80601-2-55:2011(E)
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ISO 80601-2-55:2011(E)
Contents Page
Foreword . vi
Introduction . vii
1  Scope . 1
201.1 Scope, object and related standards . 1
201.1. 1  * Scope . 1
201.1. 2  Object . 2
201.1. 3  Collateral standards . 2
201.1. 4  Particular standards . 2
201.2 Normative references . 3
201.3 Terms and definitions . 4
201.4 General requirements . 6
201.4. 3  ESSENTIAL PERFORMANCE .
...