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)

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. 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).

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
• Public Enquiry End Date: 14-Feb-2010
• Publication Date: 08-Oct-2013
• Withdrawal Date: 11-Apr-2018
• ICS: 11.040.10 - Anaesthetic, respiratory and reanimation equipment
• Technical Committee: VAZ - Healthcare
• Current Stage: 9900 - Withdrawal (Adopted Project)
• Start Date: 10-Apr-2018
• Due Date: 03-May-2018
• Completion Date: 12-Apr-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: 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)

Relations

• Replaced By: SIST 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: 01-May-2018
• Replaces: SIST 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-Nov-2013

Standards Content (Sample)

SLOVENSKI STANDARD
SIST EN ISO 80601-2-55:2013
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
SIST EN ISO 80601-2-55:2013 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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SIST EN ISO 80601-2-55:2013

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SIST EN ISO 80601-2-55:2013


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.

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SIST EN ISO 80601-2-55:2013
EN ISO 80601-2-55:2011 (E)
Contents Page
Foreword .3
Annex ZA (informative) Relationship between this European Standard and the Essential
Requirements of EU Directive 93/42/EEC .4

2

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SIST EN ISO 80601-2-55:2013
EN ISO 80601-2-55:2011 (E)
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.
3

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SIST EN ISO 80601-2-55:2013
EN ISO 80601-2-55:2011 (E)
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

4

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SIST EN ISO 80601-2-55:2013
EN ISO 80601-2-55:2011 (E)
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
208
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)
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SIST EN ISO 80601-2-55:2013
EN ISO 80601-2-55:2011 (E)
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)

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SIST EN ISO 80601-2-55:2013
EN ISO 80601-2-55:2011 (E)

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.


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SIST EN ISO 80601-2-55:2013

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SIST EN ISO 80601-2-55:2013

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)
©
ISO 2011

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SIST EN ISO 80601-2-55:2013
ISO 80601-2-55:2011(E)

COPYRIGHT PROTECTED DOCUMENT


©  ISO 2011
All rights reserved. Unless otherwise specified, no part of this publication may be reproduced or utilized in any form or by any means,
electronic or mechanical, including photocopying and microfilm, without permission in writing from either ISO at the address below or
ISO's member body in the country of the requester.
ISO copyright office
Case postale 56  CH-1211 Geneva 20
Tel. + 41 22 749 01 11
Fax + 41 22 749 09 47
E-mail [e-mail]
Web www.iso.org
Published in Switzerland

ii © ISO 2011 – All rights reserved

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SIST EN ISO 80601-2-55:2013
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 . 6
201.4. 3.101  * Additional requirements for ESSENTIAL PERFORMANCE . 6
201.4. 3.102  Additional requirements for acceptance criteria . 6
201.4. 6  * ME EQUIPMENT or ME SYSTEM parts that contact the PATIENT . 6
201.4.10.2.101  * Additional requirements for SUPPLY MAINS for ME EQUIPMENT and ME SYSTEMS . 6
201.5 General requirements for testing ME EQUIPMENT . 7
201.6 Classification of ME EQUIPMENT and ME SYSTEMS . 7
201.7 ME EQUIPMENT identification, marking and documents . 7
201.7. 2.3  * Consult ACCOMPANYING DOCUMENTS . 7
201.7. 2.101  * Additional requirements for marking on the outside of ME EQUIPMENT or
ME EQUIPMENT parts . 7
201.7. 2.4.101  Additional requirements for ACCESSORIES . 8
201.7. 2.13.101  * Additional requirements for physiological effects (safety signs and warning
statements) . 8
201.7. 2.17.101  Additional requirements for protective packaging . 8
201.7. 4.3  Unit of measure . 8
201.7. 9.1  General requirements . 9
201.7. 9.2.1.101  * Additional general requirements . 9
201.7. 9.2.2.101  * Additional requirements for warnings and safety notices . 9
201.7. 9.2.5.101  Additional requirements for ME EQUIPMENT description . 10
201.7. 9.2.8.101  * Additional requirements for start-up procedure . 10
201.7. 9.2.9.101* Additional requirements for operating instructions . 10
201.7. 9.2.13.101  * Additional requirements for maintenance . 11
201.7. 9.2.14.101  * Additional requirements for ACCESSORIES, supplementary equipment, used
material 11
201.7. 9.2.15.101* Additional requirements for environmental protection . 11
201.7. 9.3.101  * Additional requirements for technical description. 12
201.8 Protection against electrical HAZARDS from ME EQUIPMENT . 12
201.9 Protection against mechanical HAZARDS of ME EQUIPMENT and ME SYSTEMS . 12
201.10 Protection against unwanted and excessive radiation HAZARDS . 12
201.11 Protection against excessive temperatures and other HAZARDS . 12
201.11. 6.4  Leakage . 12
201.11. 6.5  * Ingress of water or particulate matter into ME EQUIPMENT or ME SYSTEMS . 13
201.11. 6.6  * Cleaning and disinfection of ME EQUIPMENT or ME SYSTEMS . 13
201.11. 6.7  Sterilization of ME EQUIPMENT or ME SYSTEMS . 13
© ISO 2011 – All rights reserved iii

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SIST EN ISO 80601-2-55:2013
ISO 80601-2-55:2011(E)
201.11. 6.8  Compatibility with substances used with ME EQUIPMENT .13
201.11. 8.101  Additional requirements for interruption of the power supply/SUPPLY MAINS to
ME EQUIPMENT .14
201.11. 8.101.1  * Supply failure TECHNICAL ALARM CONDITION .14
201.11. 8.101.2  * Settings and data storage following short interruptions or automatic
switchover .14
201.11. 8.101.3  * Operation following long interruptions .14
201.11. 8.101.4  * RESERVE ELECTRICAL POWER SOURCE .14
201.11. 8.101.5  * RESERVE ELECTRICAL POWER SOURCE for transport outside a healthcare facility .15
201.12 Accuracy of controls and instruments and protection against hazardous outputs .15
201.12. 1  Accuracy of controls and instruments .15
201.12. 1.101  * Measurement accuracy .15
201.12. 1.101.1  General .15
201.12. 1.101.2  * DRIFT of MEASUREMENT ACCURACY .16
201.12. 1.101.3  * MEASUREMENT ACCURACY of GAS READINGS for gas mixtures .17
201.12. 1.102  * TOTAL SYSTEM RESPONSE TIME and rise time .17
201.12. 1.103  * Indication of units of measure for GAS READINGS .18
201.12. 1.104  * Indication of operating mode .19
201.13 HAZARDOUS SITUATIONS and fault conditions .19
201.14 PROGRAMMABLE ELECTRICAL MEDICAL SYSTEMS (PEMS) .19
201.15 Construction of ME EQUIPMENT.19
201.15. 3.5.101  * Additional requirements for rough handling .19
201.15. 3.5.101.1  * Shock and vibration .19
201.15. 3.5.101.2  * Shock and vibration for professional transportation .20
201.15. 101  * Mode of operation .21
201.16 ME SYSTEMS .21
201.17 Electromagnetic compatibility of ME EQUIPMENT and ME SYSTEMS .21
201.101 * Interfering gas and vapour effects .22
201.102 * Gas leakage.22
201.103 * Port connector for DIVERTING RGM .22
201.104 * Minimum sampling flowrate .23
201.105 * Contamination of breathing systems .23
201.105. 1  Sampling tube .23
201.105. 2  Exhaust tube .23
202  Electromagnetic compatibility — Requirements and tests .23
202.6.2.1.7  * PATIENT simulation .23
202.6.2.1.10  Compliance criteria .23
202.6.2.3.1  * Requirements.24
206  Usability .24
206.6.2.2.2  Primary operating functions .24
208  General requirements, tests and guidance for alarm systems in medical electrical
equipment and medical electrical systems .24
208.6.1.2  * ALARM CONDITION priority .24
208.6.5.1  * General requirements .26
208.6.6.2.101  * Additional requirements for adjustable ALARM LIMIT .26
208.6.8.5.101  * Additional requirements for ALARM SIGNAL deactivation states, indication and
access 26
209  Requirements for environmentally conscious design .26
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SIST EN ISO 80601-2-55:2013
ISO 80601-2-55:2011(E)
210  Requirements for the development of physiologic closed-loop controllers . 26
211  Requirements for MEDICAL ELECTRICAL EQUIPMENT and MEDICAL ELECTRICAL SYSTEMS used in
the home healthcare environment . 27
Annex C (informative) Guide to marking and labelling requirements for ME EQUIPMENT and
ME SYSTEMS . 28
201.C.1 Marking on the outside of ME EQUIPMENT, ME SYSTEMS or their parts . 28
201.C.4 ACCOMPANYING DOCUMENTS, general . 28
201.C.5 ACCOMPANYING DOCUMENTS, instructions for use . 29
201.C.6 ACCOMPANYING DOCUMENTS, technical description . 30
Annex D (informative) Symbols on marking . 31
Annex AA (informative) Particular guidance and rationale . 33
Annex BB (informative) Environmental aspects . 43
Annex CC (informative) Test gas mixtures for calibration . 45
Annex DD (informative) Reference to the essential principles . 46
Bibliography . 48

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SIST EN ISO 80601-2-55:2013
ISO 80601-2-55:2011(E)
Foreword
ISO (the International Organization for Standardization) is a worldwide federation of national standards bodies
(ISO member bodies). The work of preparing International Standards is normally carried out through ISO
technical committees. Each member body interested in a subject for which a technical committee has been
established has the right to be represented on that committee. International organizations, governmental and
non-governmental, in liaison with ISO, also take part in the work. ISO collaborates closely with the
International Electrotechnical Commission (IEC) on all matters of electrotechnical standardization.
International Standards are drafted in accordance with the rules given in the ISO/IEC Directives, Part 2.
The main task of technical committees is to prepare International Standards. Draft International Standards
adopted by the technical committees are circulated to the member bodies for voting. Publication as an
International Standard requires approval by at least 75 % of the member bodies casting a vote.
Attention is drawn to the possibility that some of the elements of this document may be the subject of patent
rights. ISO shall not be held responsible for identifying any or all such patent rights.
ISO 80601-2-55 was prepared by Technical Committee ISO/TC 121, Anaesthetic and respiratory equipment,
Subcommittee SC 1, Breathing attachments and anaesthetic machines and IEC/TC 62, Electrical equipment
in medical practice, Subcommittee SC 62D, Electromedical equipment.
This first edition cancels and replaces ISO 21647:2004 and ISO 21647:2004/Cor.1:2005. This edition
constitutes a minor technical revision and alignment with the third edition of IEC
...