SIST EN ISO 80601-2-13:2013
(Main)Medical electrical equipment - Part 2-13: Particular requirements for basic safety and essential performance of an anaesthetic workstation (ISO 80601-2-13:2011)
Medical electrical equipment - Part 2-13: Particular requirements for basic safety and essential performance of an anaesthetic workstation (ISO 80601-2-13:2011)
This International Standard is applicable to the BASIC SAFETY and ESSENTIAL PERFORMANCE of an ANAESTHETIC WORKSTATION for administering inhalational anaesthesia whilst continuously attended by a professional OPERATOR. This International Standard specifies particular requirements for a complete ANAESTHETIC WORKSTATION and the following ANAESTHETIC WORKSTATION components which, although considered as individual devices in their own right, may be utilized, in conjunction with other relevant ANAESTHETIC WORKSTATION components, to form an ANAESTHETIC WORKSTATION to a given specification: - ANAESTHETIC GAS DELIVERY SYSTEM; - ANAESTHETIC BREATHING SYSTEM; - ANAESTHETIC GAS SCAVENGING SYSTEM; - ANAESTHETIC VAPOUR DELIVERY SYSTEM; - ANAESTHETIC VENTILATOR; - MONITORING EQUIPMENT; - ALARM SYSTEM; An ANAESTHETIC WORKSTATION supplied complete and its individual components are considered as ME EQUIPMENT or ME SYSTEMS with regard to the general standard. This International Standard is also applicable to those ACCESSORIES intended by their MANUFACTURER to be connected to an ANAESTHETIC WORKSTATION where the characteristics of those ACCESSORIES can affect theIf a clause or subclause is specifically intended to be applicable to ANAESTHETIC WORKSTATION components 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 an ANAESTHETIC WORKSTATION and its individual components, as relevant. HAZARDS inherent in the intended physiological function of an ANAESTHETIC WORKSTATION and its individual components within the scope of this International Standard are not covered by specific requirements in this International Standard except in 7.2.13 and 8.4.1 of the general standard. This International Standard is not applicable to any ANAESTHETIC WORKSTATION intended for use with flammable anaesthetic agents, as determined by Annex BB. BASIC SAFETY and ESSENTIAL PERFORMANCE of the ANAESTHETIC WORKSTATION.
Medizinische elektrische Geräte - Teil 2-13: Besondere Festlegungen für die Sicherheit einschließlich der wesentlichen Leistungsmerkmale von Anästhesie-Arbeitsplätzen (ISO 80601-2-13:2011)
Diese Internationale Norm gilt für die BASISSICHERHEIT und einschließlich der WESENTLICHEN LEISTUNGS-MERKMALE eines ANÄSTHESIE-ARBEITSPLATZES für die Applikation einer Inhalationsanästhesie unter ständiger Aufsicht eines fachlich ausgebildeten BEDIENERS.
Diese Internationale Norm legt die besonderen Anforderungen an einen vollständigen ANÄSTHESIE-ARBEITSPLATZ und an nachfolgend angeführte Bauteile von ANÄSTHESIE-ARBEITSPLÄTZEN fest, die, obwohl sie als einzelne „selbstständige“ Geräte zu betrachten sind, auch in Verbindung mit anderen relevanten ANÄSTHESIE-ARBEITSPLATZ-Bauteilen unter Bildung eines entsprechend festgelegten ANÄSTHESIE-ARBEITS-PLATZES eingesetzt werden können:
- ANÄSTHESIEGAS-ABGABESYSTEM;
- ANÄSTHESIE-ATEMSYSTEM;
- ANÄSTHESIEGAS-FORTLEITUNGSSYSTEM;
- ANÄSTHESIEMITTELDAMPF-ABGABESYSTEM;
- ANÄSTHESIE-BEATMUNGSGERÄT;
- ÜBERWACHUNGSGERÄT;
- ALARMSYSTEM;
- SCHUTZVORRICHTUNG.
ANMERKUNG 1 Die ÜBERWACHUNGSGERÄTE, ALARMSYSTEME und SCHUTZVORRICHTUNGEN sind in Tabelle AA.1 zusam-mengefasst.
Ein als Ganzes bereitgestellter ANÄSTHESIE-ARBEITSPLATZ und dessen einzelne Bauteile werden in Bezug auf die Allgemeinen Festlegungen als ME GERÄTE oder ME SYSTEME betrachtet.
ANMERKUNG 2 Die Gültigkeit dieser Internationalen Norm ist in Tabelle AA.2 wiedergegeben.
Diese Internationale Norm gilt auch für das ZUBEHÖR, das vom HERSTELLER für den Anschluss an einen ANÄSTHESIE-ARBEITSPLATZ vorgesehen ist, wenn die Eigenschaften dieses ZUBEHÖRS die BASISSICHERHEIT und die WESENTLICHEN LEISTUNGSMERKMALE eines ANÄSTHESIE-ARBEITSPLATZES beeinträchtigen können.
Ist ein Abschnitt oder Unterabschnitt nur speziell für die Anwendung auf ANÄSTHESIE-ARBEITSPLATZ-Bauteile vorgesehen, ist dies aus Überschrift und Inhalt des Abschnittes oder Unterabschnittes ersichtlich. Ist das nicht der Fall, trifft der Abschnitt oder Unterabschnitt, wo anwendbar, auf den ANÄSTHESIE-ARBEITSPLATZ und auf dessen Bauteile zu.
Die mit der vorgesehenen physiologischen Funktion des ANÄSTHESIE-ARBEITSPLATZES oder seiner Bauteile innerhalb des Anwendungsbereiches dieser Internationalen Norm direkt verbundenen GEFÄHRDUNGEN bleiben von den spezifischen Anforderungen (Festlegungen) dieser Internationalen Norm unberücksichtigt, mit Ausnahme von 7.2.13 und 8.4.1 der Allgemeinen Festlegungen.
ANMERKUNG 3 Siehe auch 4.2 der Allgemeinen Festlegungen.
Diese Internationale Norm gilt nicht für einen ANÄSTHESIE-ARBEITSPLATZ, der für die Verwendung mit ent-flammbaren Anästhesiemitteln (Narkosemitteln) entsprechend Anhang BB vorgesehen ist.
Appareils électromédicaux - Partie 2-13: Exigences particulières de sécurité de base et de performance essentielle pour les systèmes d'anesthésie (ISO 80601-2-13:2011)
L'ISO/CEI 80601-2-13:2011 s'applique à la sécurité de base et aux performances essentielles d'un poste de travail d'anesthésie pour l'administration d'un anesthésiant par inhalation tout en étant assisté en continu par un opérateur professionnel.
L'ISO/CEI 80601-2-13:2011 spécifie les exigences particulières pour un poste de travail d'anesthésie complet et les composants suivants d'un poste de travail d'anesthésie qui, bien qu'ils soient considérés comme des dispositifs individuels à part entière, peuvent être utilisés en association avec d'autres composants appropriés d'un poste de travail d'anesthésie afin de former un poste de travail d'anesthésie selon une spécification donnée:
système d'administration de gaz anesthesique,
système d'anesthesie par voie respiratoire,
système d'évacuation des gaz anesthesiques,
système d'administration de vapeur anesthesique
ventilateur d'anesthesie,
appareil de surveillance,
système d'alarme,
dispositif de protection.
L'ISO/CEI 80601-2-13:2011 s'applique également aux accessoires destinés selon leur fabricant à être raccordés à un poste de travail d'anesthésie lorsque les caractéristiques de ces accessoires peuvent affecter la sécurité de base et les performances essentielles du poste de travail d'anesthésie.
Si un article ou un paragraphe est destiné en particulier à être appliqué aux composants d'un poste de travail d'anesthésie uniquement, le titre et le contenu de cet article ou de ce paragraphe le mentionneront. Si cela n'est pas le cas, l'article ou le paragraphe s'applique à la fois à un poste de travail d'anesthésie et à ses composants individuels, comme il se doit.
Les dangers inhérents à la fonction physiologique prévue d'un poste de travail d'anesthésie et de ses composants individuels dans le cadre du domaine d'application de l'ISO/CEI 80601-2-13:2011 ne sont pas couverts par les exigences particulières contenues dans l'ISO/CEI 80601-2-13:2011, à l'exception des paragraphes 7.2.13 et 8.4.1 de la CEI 60601-1:2005.
L'ISO/CEI 80601-2-13:2011 ne s'applique pas aux postes de travail d'anesthésie destinés à être utilisés avec des agents anesthésiques inflammables, comme déterminé par l'Annexe BB.
Medicinska električna oprema - 2-13: del: Posebne zahteve za osnovno varnost in bistvene lastnosti delovnega mesta za anestezijo (ISO 80601-2-13:2011)
Ta mednarodni standard se uporablja za OSNOVNO VARNOST in BISTVENE LASTNOSTI DELOVNEGA MESTA ZA ANESTEZIJO za dajanje inhalacijske anestezije, ki ga vedno upravlja profesionalni UPRAVLJAVEC. Ta mednarodni standard določa posebne zahteve za celotno DELOVNO MESTO ZA ANESTEZIJO in naslednje sestavne dele DELOVNEGA MESTA ZA ANESTEZIJO, ki se lahko kljub temu, da so samostojne naprave, uporabljajo skupaj z drugimi ustreznimi sestavnimi deli DELOVNEGA MESTA ZA ANESTEZIJO in z njimi sestavljajo DELOVNO MESTO ZA ANESTEZIJO za določeno specifikacijo: – SISTEM ZA DOSTAVO ANESTETIČNIH PLINOV; – SISTEM ZA VDIHAVANJE ANESTETIKA; – SISTEM ZA POVRATNI ANESTETIČNI PLIN; – SISTEM ZA DOSTAVO ANESTETIČNIH HLAPOV; – ANESTETIČNI VENTILATOR; – OPREMA ZA NADZOR; – SISTEM ALARMOV. Celotno DELOVNO MESTO ZA ANESTEZIJO in njegovi posamezni sestavni deli se glede na splošen standard štejejo kot ELEKTROMEDICINSKA OPREMA ali ELEKTROMEDICINSKI SISTEMI. Ta mednarodni standard se uporablja tudi za tiste PRIPOMOČKE, ki jih je PROIZVAJALEC izdelal za povezavo z DELOVNIM MESTOM ZA ANESTEZIJO, če lastnosti PRIPOMOČKOV vplivajo na DELOVNO MESTO ZA ANESTEZIJO. Če se točka ali podtočka posebej uporablja samo za sestavne dele DELOVNEGA MESTA ZA ANESTEZIJO, je to zapisano v naslovu in vsebini točke ali podtočke. Če ni zapisano, točka ali podtočka obravnava DELOVNO MESTO ZA ANESTEZIJO in njegove posamezne sestavne dele. Temeljnih TVEGANJ pri nameravani fiziološki funkciji DELOVNEGA MESTA ZA ANESTEZIJO in njegovih sestavnih delov, ki spadajo na področje uporabe tega mednarodnega standarda, posebne zahteve tega mednarodnega standarda ne vključujejo, razen v točkah 7.2.13 in 8.4.1 splošnega standarda. Ta mednarodni standard se ne uporablja za DELOVNA MESTA ZA ANESTEZIJO, ki se uporabljajo z vnetljivimi anestetičnimi snovmi, kot je določeno v dodatku BB. OSNOVNA VARNOST in BISTVENE LASTNOSTI DELOVNEGA MESTA ZA ANESTEZIJO.
General Information
Relations
Standards Content (Sample)
SLOVENSKI STANDARD
SIST EN ISO 80601-2-13:2013
01-marec-2013
1DGRPHãþD
SIST EN ISO 8835-2:2009
SIST EN ISO 8835-3:2009
SIST EN ISO 8835-3:2009/A1:2011
SIST EN ISO 8835-4:2009
SIST EN ISO 8835-5:2009
0HGLFLQVNDHOHNWULþQDRSUHPD GHO 3RVHEQH]DKWHYH]DRVQRYQRYDUQRVWLQ
ELVWYHQHODVWQRVWLGHORYQHJDPHVWD]DDQHVWH]LMR ,62
Medical electrical equipment - Part 2-13: Particular requirements for basic safety and
essential performance of an anaesthetic workstation (ISO 80601-2-13:2011)
Medizinische elektrische Geräte - Teil 2-13: Besondere Festlegungen für die Sicherheit
einschließlich der wesentlichen Leistungsmerkmale von Anästhesie-Arbeitsplätzen (ISO
80601-2-13:2011)
Appareils électromédicaux - Partie 2-13: Exigences particulières de sécurité de base et
de performance essentielle pour les systèmes d'anesthésie (ISO 80601-2-13:2011)
Ta slovenski standard je istoveten z: EN ISO 80601-2-13:2012
ICS:
11.040.10 Anestezijska, respiratorna in Anaesthetic, respiratory and
reanimacijska oprema reanimation equipment
SIST EN ISO 80601-2-13:2013 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
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SIST EN ISO 80601-2-13:2013
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SIST EN ISO 80601-2-13:2013
EUROPEAN STANDARD
EN ISO 80601-2-13
NORME EUROPÉENNE
EUROPÄISCHE NORM
December 2012
ICS 11.040.10 Supersedes EN ISO 8835-2:2009, EN ISO 8835-3:2009,
EN ISO 8835-4:2009, EN ISO 8835-5:2009,
EN 60601-2-13:2006
English Version
Medical electrical equipment - Part 2-13: Particular requirements
for basic safety and essential performance of an anaesthetic
workstation (ISO 80601-2-13:2011)
Appareils électromédicaux - Partie 2-13: Exigences Medizinische elektrische Geräte - Teil 2-13: Besondere
particulières de sécurité de base et de performance Festlegungen für die Sicherheit einschließlich der
essentielle pour les systèmes d'anesthésie (ISO 80601-2- wesentlichen Leistungsmerkmale von Anästhesie-
13:2011) Arbeitsplätzen (ISO 80601-2-13:2011)
This European Standard was approved by CEN on 18 November 2012.
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,
Former Yugoslav Republic of Macedonia, 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 NORMALISATIO N
EUROPÄISCHES KOMITEE FÜR NORMUN G
Management Centre: Avenue Marnix 17, B-1000 Brussels
© 2012 CEN All rights of exploitation in any form and by any means reserved worldwide Ref. No. EN ISO 80601-2-13:2012: E
for CEN national Members.
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SIST EN ISO 80601-2-13:2013
EN ISO 80601-2-13:2012 (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 80601-2-13:2013
EN ISO 80601-2-13:2012 (E)
Foreword
The text of ISO 80601-2-13:2011 has been prepared by Technical Committee ISO/TC 121 “Anaesthetic and
respiratory equipment” of the International Organization for Standardization (ISO) and has been taken over as
EN ISO 80601-2-13:2012 by 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 2013, and conflicting national standards shall be withdrawn at
the latest by December 2015.
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 8835-2:2009, EN ISO 8835-3:2009, EN ISO 8835-4:2009,
EN ISO 8835-5:2009, EN 60601-2-13:2006.
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 organisations of the following
countries are bound to implement this European Standard: Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech
Republic, Denmark, Estonia, Finland, Former Yugoslav Republic of Macedonia, France, Germany, Greece,
Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal,
Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and the United Kingdom.
Endorsement notice
The text of ISO 80601-2-13:2011 has been approved by CEN as a EN ISO 80601-2-13:2012 without any
modification.
3
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SIST EN ISO 80601-2-13:2013
EN ISO 80601-2-13:2012 (E)
Annex ZA
(informative)
Relationship between this European Standard and the Essential Requirements
of EU Directive 93/42/EEC
This European 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
Corresponding essential
Clause(s)/subclause(s) of this EN Qualifying remarks/ynotes
requirements of Directive
93/42/EEC
201.11.6.8; 201.102.3; 201.104.7 7.2 only the risks to patients during
NORMAL USE are addressed
201.11.6.3; 201.11.6.8 7.3
nd rd
201.7.2.105, 201.7.9.2.14 7.5, 2 and 3 paragraph
201.101.4.1.2; 201.11.6.3 7.6 IP classification according
IEC 60529 is governed by
EN 60601-1:2006
201.11.101; 201.104.7 8.1 Easy handling and contamination
by the patients are not addressed.
201.11.101 8.6
201.16.9.2.1; 201.16.101; 9.1
201.101.3; 201.101.4.1
201.101.4.2; 201.101.9;
201.102.5; 201.102.9;
201.103.4 to 201.103.7;
201.104.4; 201.104.5, 201.104.6;
201.105.4; 201.105.6
201.9.4; 201.9.4.2.4.3; 201.105.7, Clause 202 refers to EN 60601-1-
9.2 (First and second indents)
202; 209 2:2007,
Clause 209 refers to EN 60601-1-
9:2008
201.11; 201.102.4 9.3
201.12.4.104.1; 10.1
201.101.6.1; 201.104.2.2
4
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SIST EN ISO 80601-2-13:2013
EN ISO 80601-2-13:2012 (E)
Clause(s)/subclause(s) of this EN Corresponding essential Qualifying remarks/ynotes
requirements of Directive
93/42/EEC
201.7.4.2; 10.2
201.7.4.3 10.3
201.14 12.1 EN 62304:2006, 1.4
201.14, 201.14.101 12.1 a) EN 62304:2006, 1.4
201.11.8.102; 201.11.8.103 12.2
201.11.8.102 12.3
201.12.4.104.2; 201.12.4.105; 12.4 Clause 208 refers to
201.12.4.106; 208
EN 60601-1-8:2006
202 12.5 Clause 202 refers to EN 60601-1-
2:2007
201.9 12.7.1
201.9, 201.9.2.103 12.7.2
201.9, 201.11.8.102 12.7.3
201.15, 201.16, 201.101.4.2.1 12.7.4 Covered by compliance with
EN 60601-1:2006, 15.4.1 and 16.9
201.11 12.7.5 EN 60601-1:2006, Clause 11
201.101.4.1.3; 201.101.6.2; 12.8.1
201.101.6.3; 201.102.2.1;
201.102.2.2; 201.102.10.4;
201.104.2.1; 201.104.5;
201.105.2.1; 201.105.2.2;
201.12.4.104.2; 201.12.4.106; 12.8.2
201.12.4.107.1; 201.12.4.107.2;
201.12.4.107.3; 201.12.4.109;
201.101.2; 201.101.4.3;
201.102.10: 201.102.10.4;
201.104.5; 201.105.5; 201.105.8;
208
201.101.6.1; 201.104.2.1; 12.9
201.7, 201.7.2.104; 201.7.9.1; 13.1
201.102.1.1.1
201.7, 201.7.2.3; 201.7.2.101; 13.2
201.7.2.103; 201.7.2.107;
201.7.4.2
201.7.9.1 13.3 a)
201.7.2.101 13.3 e)
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SIST EN ISO 80601-2-13:2013
EN ISO 80601-2-13:2012 (E)
Clause(s)/subclause(s) of this EN Corresponding essential Qualifying remarks/ynotes
requirements of Directive
93/42/EEC
201.7, 201.7.2.101 13.3 f) The indication that the device is for
single use must be consistent
across the Community is not
addressed in a requirement.
201.7, 201.7.9.3.102 13.3 i)
201.7,
13.3 j)
201.7.2
201.7.2.102, 201.7.2.103,
201.7.2.104
201.7.2.107
201.7.4.2
201.101.6.1
201.102.1.1.2
201.102.1.1.3
201.102.1.1.4
201.102.5.2
201.102.5.3
201.102.5.4
201.102.5.7
201.103.1.1
201.104.1.1
201.104.2.1
201.104.6
201.105.6
201.7, 13.3 k)
201.7.2.3
201.104.1.1
201.7.2.101 13.3.l)
201.7.2.102; 201.102.5.2; 13.5
201.102.5.4; 201.102.5.5;
201.102.5.6; 201.103.5;
201.103.6; 201.104.4
201.7 13.6 a) Covered by compliance with
EN 60601-1:2006, 7.9.2
201.7 13.6 b) Covered by compliance with
EN 60601-1:2006, 7.9.2
201.7.9.2.1 13.6 c)
201.7.9.2.14
201.11.8
201.11.8.101
201.11.8.103
201.12.4.102
201.12.4.103.3
201.12.4.106
201.12.4.107.2
201.12.4.108
201.101.1.1
201.101.1.2
201.102.1.2
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SIST EN ISO 80601-2-13:2013
EN ISO 80601-2-13:2012 (E)
Clause(s)/subclause(s) of this EN Corresponding essential Qualifying remarks/ynotes
requirements of Directive
93/42/EEC
201.102.7
201.102.8.2
201.102.9.2
201.102.9.3
201.102.10.3
201.103.1.2
201.104.1.2
201.104.2.1
201.104.6
201.105.1
201.105.2.2
201.105.5
201.7, 201.102.10.1 13.6 d) maintenance and frequency
covered by compliance with
201.103.3.1.5
EN 60601-1:2006, 7.9.2.13
208.5.2.2
201.7.9.2.14 13.6 f)
201.7 13.6 h), first paragraph only Covered by compliance with
EN 60601-1:2006, 7.9.2
201.7.9.2.14
201.7 13.6 i) Covered by compliance with
EN 60601-1:2006, 7.9
201.7.9.2.1
201.7.9.2.8
201.7.9.2.2 13.6 k)
201.7.9.2.14
201.12.4.103 ; 13.6 p)
201.12.4.104.1,
201.12.4.109; 201.101.6.1;
201.104.2.2;
201.7.9.2.1 13.6 q)
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SIST EN ISO 80601-2-13:2013
EN ISO 80601-2-13:2012 (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.102 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
European Standard. Table ZA.102, 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.102 — 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 EHSR of Directive 2006/42/EC Qualifying remarks/notes
EN
201.9.2.102 1.1.4
201.9.2.103
1.1.8
201.7.4.2
1.2.2
201.9.2
201.9.2.104
201.101.6.1
201.102.1.1.2
201.102.1.1.3
201.102.9.2
201.104.1.1
201.104.2.1
206
208
1.5.4
201.101.3
201.101.4.1.1
201.101.4.1.2
201.101.9
201.102.5
201.102.8.1
201.102.9.1
201.103.4,
201.103.5;
201.103.6
201.103.7
201.104.4
201.105.4
201.105.6
201.9.2.101
1.6.2
201.8 1.6.3
Covered by compliance with
201.7 3.6.2
EN 60601-1:2006, 7.2
201.7.2.106
WARNING: Other requirements and other EU Directives may be applicable to the products falling within the
scope of this European Standard.
8
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SIST EN ISO 80601-2-13:2013
INTERNATIONAL ISO
STANDARD 80601-2-13
First edition
2011-08-01
Medical electrical equipment —
Part 2-13:
Particular requirements for basic safety
and essential performance of an
anaesthetic workstation
Appareils électromédicaux —
Partie 2-13: Exigences particulières de sécurité de base et de
performance essentielle pour les systèmes d'anesthésie
Reference number
ISO 80601-2-13:2011(E)
©
ISO 2011
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SIST EN ISO 80601-2-13:2013
ISO 80601-2-13:2011(E)
COPYRIGHT PROTECTED DOCUMENT
© ISO/IEC 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 copyright@iso.org
Web www.iso.org
Published in Switzerland
ii © ISO 2011 – All rights reserved
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SIST EN ISO 80601-2-13:2013
ISO 80601-2-13:2011(E)
Contents Page
Foreword .v
Introduction.vi
201.1 Scope, object and related standards.1
201.2 Normative references.3
201.3 Terms and definitions .5
201.4 General requirements.9
201.5 General requirements for testing ME EQUIPMENT .11
201.6 Classification of ME EQUIPMENT and ME SYSTEMS .11
201.7 ME EQUIPMENT identification, marking and documents .11
201.8 Protection against electrical HAZARDS from ME EQUIPMENT.15
201.9 Protection against mechanical HAZARDS of ME EQUIPMENT and ME SYSTEMS.16
201.10 Protection against unwanted and excessive radiation HAZARDS .17
201.11 Protection against excessive temperatures and other HAZARDS .17
201.12 Accuracy of controls and instruments and protection against hazardous outputs .19
201.13 HAZARDOUS SITUATIONS and fault conditions.24
201.14 PROGRAMMABLE ELECTRICAL MEDICAL SYSTEMS (PEMS) .24
201.15 Construction of ME EQUIPMENT.25
201.16 ME SYSTEMS .25
201.17 Electromagnetic compatibility of ME EQUIPMENT AND ME SYSTEMS.26
201.101 Additional requirements for ANAESTHETIC GAS DELIVERY SYSTEMS.26
201.102 Additional requirements for an ANAESTHETIC BREATHING SYSTEM .32
201.103 Additional requirements for an ANAESTHETIC GAS SCAVENGING SYSTEM.39
201.104 Additional requirements for an ANAESTHETIC VAPOUR DELIVERY SYSTEM.43
201.105 Additional requirements for an ANAESTHETIC VENTILATOR.47
201.105.7 * Timed ventilatory pause .50
201.105.7.1 Expiratory pause .50
201.105.7.2 Inspiratory pause.50
201.106 Display loops.53
201.107 Clinical evaluation .53
202 Electromagnetic compatibility — Requirements and tests.54
203 General requirements for radiation protection in diagnostic X-ray equipment.54
206 Usability.54
208 General requirements, tests and guidance for ALARM SYSTEMS in MEDICAL ELECTRICAL
EQUIPMENT and MEDICAL ELECTRICAL SYSTEMS .55
209 Requirements for environmentally conscious design .55
© ISO 2011 – All rights reserved iii
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SIST EN ISO 80601-2-13:2013
ISO 80601-2-13:2011(E)
210 PROCESS requirements for the development of physiologic closed-loop controllers .56
211 Requirements for MEDICAL ELECTRICAL EQUIPMENT and MEDICAL ELECTRICAL SYSTEMS used in
the home healthcare.56
Annex C (informative) Guide to marking and labelling requirements for ME EQUIPMENT and ME
SYSTEMS or their parts .57
Annex D (informative) Symbols on marking.67
Annex AA (informative) Particular guidance and rationale.69
Annex BB (normative) Test for flammability of anaesthetic agent .84
Annex CC (informative) Environmental aspects .85
Annex DD (informative) Reference to the essential principles.87
Bibliography .94
Alphabetized index of defined terms used in this particular standard .96
iv © ISO 2011 – All rights reserved
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SIST EN ISO 80601-2-13:2013
ISO 80601-2-13:2011(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 80601-2-13 was prepared by a joint working group of Technical Committee ISO/TC 121, Anaesthetic and
respiratory equipment, Subcommittee SC 1, Breathing attachments and anaesthetic machines and Technical
Committee IEC/TC 62, Electrical equipment in medical practice, Subcommittee SC D, Electromedical
equipment. The draft was circulated for voting to the national bodies of both ISO and IEC.
This first edition of ISO 80601-2-13 cancels and replaces the following:
⎯ ISO 8835-2:2007, Inhalational anaesthesia systems — Part 2: Anaesthetic breathing systems
⎯ ISO 8835-3:2007, Inhalational anaesthesia systems — Part 3: Transfer and receiving systems of active
anaesthetic gas scavenging systems
⎯ ISO 8835-4:2004, Inhalational anaesthesia systems — Part 4: Anaesthetic vapour delivery devices
⎯ ISO 8835-5:2004, Inhalational anaesthesia systems — Part 5: Anaesthetic ventilators
⎯ IEC 60601-2-13:2003, Medical electrical equipment — Part 2-13: Particular requirements for the safety
and essential performance of anaesthetic systems
This edition constitutes a major technical revision of the material that was contained in the previous standards
by consolidating it into a single document, removing duplications and inconsistencies as well as harmonization
with the third edition of IEC 60601-1.
© ISO 2011 – All rights reserved v
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SIST EN ISO 80601-2-13:2013
ISO 80601-2-13:2011(E)
Introduction
In this International Standard, the following print types are used:
⎯ Requirements and definitions: roman type.
⎯ Test specifications: italic type.
⎯ Informative material appearing outside of tables, such as notes, examples and references: in smaller
type. Normative text of tables is also in a smaller type.
⎯ Terms defined in Clause 3 of the general standard, in this particular standard or as noted: small capitals.
In referring to the structure of this standard, the term
⎯ “clause” means one of the seventeen numbered divisions within the table of contents, inclusive of all
subdivisions (e.g. Clause 7 includes subclauses 7.1, 7.2, etc.);
⎯ “subclause” means a numbered subdivision of a clause (e.g. 201.7.1, 201.7.2 and 201.7.2.1 are all
subclauses of Clause 201.7).
References to clauses within this standard are preceded by the term “Clause” followed by the clause number.
References to subclauses within this particular standard are by number only.
In this International Standard, the conjunctive “or” is used as an “inclusive or” so a statement is true if any
combination of the conditions is true.
The verbal forms used in this International Standard conform to usage described in Annex H of the
ISO/IEC Directives, Part 2. For the purposes of this standard, the auxiliary verb:
⎯ “shall” means that compliance with a requirement or a test is mandatory for compliance with this
standard;
⎯ “should” means that compliance with a requirement or a test is recommended but is not mandatory for
compliance with this standard;
⎯ “may” is used to describe a permissible way to achieve compliance with a requirement or test.
An asterisk (*) as the first character of a title or at the beginning of a paragraph or table title indicates that
there is guidance or rationale related to that item in Annex AA.
The attention of Member Bodies and National Committees is drawn to the fact that equipment
MANUFACTURERS and testing organizations may need a transitional period following publication of a new,
amended or revised ISO or IEC publication in which to make products in accordance with the new
requirements and to equip themselves for conducting new or revised tests. It is the recommendation of the
committee that the content of this publication not be adopted for mandatory implementation nationally earlier
than 3 years from the date of publication for equipment newly designed and not earlier than 5 years from the
date of publication for equipment already in production.
This International Standard considers both an ANAESTHETIC WORKSTATION supplied complete and its individual
components. It has been structured to allow RESPONSIBLE ORGANIZATIONS to configure an ANAESTHETIC
WORKSTATION from individual components in conformance with professional guidelines and to meet the needs
of their clinical practice. In order to achieve this aim, this International Standard identifies particular
vi © ISO 2011 – All rights reserved
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SIST EN ISO 80601-2-13:2013
ISO 80601-2-13:2011(E)
requirements pertinent to specific ANAESTHETIC WORKSTATION components, and to their associated MONITORING
EQUIPMENT, ALARM SYSTEM(S) and PROTECTION DEVICE(S), and defines the interfaces.
Figure 201.101 is a graphical representation of the structure of this International Standard and is provided for
informational purposes only.
ANAESTHETIC WORKSTATION
General requirements
Clauses 201.1 – 201.17, 201.106,
201.107, 202-211
MONITORING EQUIPMENT,
Mandatory elements;
ALARM SYSTEMS and
ANAESTHETIC GAS DELIVERY SYSTEM
see also Table AA.1
Clause 201.101 PROTECTION DEVICES
ANAESTHETIC BREATHING SYSTEM
Clause 201.102
ANAESTHETIC GAS SCAVENGING SYSTEM
Clause 201.103
MONITORING EQUIPMENT,
ANAESTHETIC VAPOUR DELIVERY SYSTEM Optionally present;
ALARM SYSTEMS and
see also Table AA.1
Clause 201.104
PROTECTION DEVICES
ANAESTHETIC VENTILATOR
Clause 201.105
Figure 201.101 — Configuration of an ANAESTHETIC WORKSTATION and corresponding organization of
this International Standard
© ISO 2011 – All rights reserved vii
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SIST EN ISO 80601-2-13:2013
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SIST EN ISO 80601-2-13:2013
INTERNATIONAL STANDARD ISO 80601-2-13:2011(E)
Medical electrical equipment —
Part 2-13:
Particular requirements for basic safety and essential
performance of an anaesthetic workstation
201.1 Scope, object and related standards
IEC 60601-1:2005, Clause 1 applies, except as follows:
201.1.1 * Scope
Replacement:
This International Standard is applicable to the BASIC SAFETY and ESSENTIAL PERFORMANCE of an ANAESTHETIC
WORKSTATION for administering inhalational anaesthesia whilst continuously attended by a professional
.
OPERATOR
This International Standard specifies particular requirements for a complete ANAESTHETIC WORKSTATION and the
following ANAESTHETIC WORKSTATION components which, although considered as individual devices in their
own right, may be utilized, in conjunction with other relevant ANAESTHETIC WORKSTATION components, to form
an ANAESTHETIC WORKSTATION to a given specification:
⎯ ANAESTHETIC GAS DELIVERY SYSTEM;
⎯ ANAESTHETIC BREATHING SYSTEM;
⎯ ANAESTHETIC GAS SCAVENGING SYSTEM;
⎯ ANAESTHETIC VAPOUR DELIVERY SYSTEM;
⎯ ANAESTHETIC VENTILATOR;
⎯ MONITORING EQUIPMENT;
⎯ ALARM SYSTEM;
⎯ PROTECTION DEVICE.
NOTE 1 MONITORING EQUIPMENT, ALARM SYSTEMS and PROTECTION DEVICES are summarized in Table AA.1.
An ANAESTHETIC WORKSTATION supplied complete and its individual components are considered as ME
EQUIPMENT or ME SYSTEMS with regard to the general standard.
NOTE 2 The applicability of this International Standard is indicated in Table AA.2.
This International Standard is also applicable to those ACCESSORIES intended by their MANUFACTURER to be
connected to an ANAESTHETIC WORKSTATION where the characteristics of those ACCESSORIES can affect the
BASIC SAFETY and ESSENTIAL PERFORMANCE
...
SLOVENSKI STANDARD
kSIST FprEN ISO 80601-2-13:2012
01-julij-2012
Elektromedicinska oprema - 2-13: del: Posebne zahteve za osnovno varnost in
bistvene lastnosti delovnega mesta za anestezijo (ISO 80601-2-13:2011)
Medical electrical equipment - Part 2-13: Particular requirements for basic safety and
essential performance of an anaesthetic workstation (ISO 80601-2-13:2011)
Appareils électromédicaux - Partie 2-13: Exigences particulières de sécurité de base et
de performance essentielle pour les systèmes d'anesthésie (ISO 80601-2-13:2011)
Ta slovenski standard je istoveten z: FprEN ISO 80601-2-13
ICS:
11.040.10 Anestezijska, respiratorna in Anaesthetic, respiratory and
reanimacijska oprema reanimation equipment
kSIST FprEN ISO 80601-2-13:2012 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
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kSIST FprEN ISO 80601-2-13:2012
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kSIST FprEN ISO 80601-2-13:2012
EUROPEAN STANDARD
FINAL DRAFT
FprEN ISO 80601-2-13
NORME EUROPÉENNE
EUROPÄISCHE NORM
May 2012
ICS 11.040.10
English Version
Medical electrical equipment - Part 2-13: Particular requirements
for basic safety and essential performance of an anaesthetic
workstation (ISO 80601-2-13:2011)
Appareils électromédicaux - Partie 2-13: Exigences Medizinische elektrische Geräte - Teil 2-13: Besondere
particulières de sécurité de base et de performance
Festlegungen für die Sicherheit einschließlich der
essentielle pour les systèmes d'anesthésie (ISO 80601-2- wesentlichen Leistungsmerkmale von Anästhesie-
13:2011) Arbeitsplätzen (ISO 80601-2-13:2011)
This draft European Standard is submitted to CEN members for unique acceptance procedure. It has been drawn up by the Technical
Committee CEN/TC 215.
If this draft becomes a European Standard, 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.
This draft European Standard was established by CEN 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.
Recipients of this draft are invited to submit, with their comments, notification of any relevant patent rights of which they are aware and to
provide supporting documentation.
Warning : This document is not a European Standard. It is distributed for review and comments. It is subject to change without notice and
shall not be referred to as a European Standard.
EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION
EUROPÄISCHES KOMITEE FÜR NORMUNG
Management Centre: Avenue Marnix 17, B-1000 Brussels
© 2012 CEN All rights of exploitation in any form and by any means reserved Ref. No. FprEN ISO 80601-2-13:2012: E
worldwide for CEN national Members.
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kSIST FprEN ISO 80601-2-13:2012
FprEN ISO 80601-2-13:2012 (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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kSIST FprEN ISO 80601-2-13:2012
FprEN ISO 80601-2-13:2012 (E)
Foreword
The text of ISO 80601-2-13:2011 has been prepared by Technical Committee ISO/TC 121 “Anaesthetic and
respiratory equipment” of the International Organization for Standardization (ISO) and has been taken over as
FprEN ISO 80601-2-13:2012 by Technical Committee CEN/TC 215 “Respiratory and anaesthetic equipment”
the secretariat of which is held by BSI.
This document is currently submitted to the Unique Acceptance Procedure.
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.
Endorsement notice
The text of ISO 80601-2-13:2011 has been approved by CEN as a FprEN ISO 80601-2-13:2012 without any
modification.
3
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kSIST FprEN ISO 80601-2-13:2012
FprEN ISO 80601-2-13:2012 (E)
Annex ZA
(informative)
Relationship between this European Standard and the Essential Requirements
of EU Directive 93/42/EEC
This European 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 EN Corresponding essential Qualifying remarks/ynotes
requirements of Directive 3/42/EEC
201.11.6.8; 201.102.3; 201.104.7 7.2 only the risks to patients during
NORMAL USE are addressed
201.11.6.3; 201.11.6.8 7.3
nd rd
201.7.2.105, 201.7.9.2.14 7.5, 2 and 3 paragraph
201.101.4.1.2; 201.11.6.3 7.6 IP classification according
IEC 60529 is governed by
EN 60601-1:2006
201.11.101; 201.104.7 8.1 Easy handling and contamination
by the patients are not addressed.
201.11.101 8.6
201.16.9.2.1; 201.16.101; 9.1
201.101.3; 201.101.4.1
201.101.4.2; 201.101.9;
201.102.5; 201.102.9;
201.103.4 to 201.103.7;
201.104.4; 201.104.5, 201.104.6;
201.105.4; 201.105.6
201.9.4; 201.9.4.2.4.3; 201.105.7, 9.2 (First and second indents) Clause 202 refers to EN 60601-1-
202; 209 2:2007,
Clause 209 refers to EN 60601-1-
9:2008
201.11; 201.102.4 9.3
201.12.4.104.1; 10.1
201.101.6.1; 201.104.2.2
4
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kSIST FprEN ISO 80601-2-13:2012
FprEN ISO 80601-2-13:2012 (E)
Clause(s)/subclause(s) of this EN Corresponding essential Qualifying remarks/ynotes
requirements of Directive 3/42/EEC
201.7.4.2; 10.2
201.7.4.3 10.3
201.14 12.1 EN 62304:2006, 1.4
201.14, 201.14.101 12.1 a) EN 62304:2006, 1.4
201.11.8.102; 201.11.8.103 12.2
201.11.8.102 12.3
201.12.4.104.2; 201.12.4.105; 12.4 Clause 208 refers to
201.12.4.106; 208
EN 60601-1-8:2006
202 12.5 Clause 202 refers to EN 60601-1-
2:2007
201.9 12.7.1
201.9, 201.9.2.103 12.7.2
201.9, 201.11.8.102 12.7.3
201.15, 201.16, 201.101.4.2.1 12.7.4 Covered by compliance with
EN 60601-1:2006, 15.4.1 and 16.9
201.11 12.7.5 EN 60601-1:2006, Clause 11
201.101.4.1.3; 201.101.6.2; 12.8.1
201.101.6.3; 201.102.2.1;
201.102.2.2; 201.102.10.4;
201.104.2.1; 201.104.5;
201.105.2.1; 201.105.2.2;
201.12.4.104.2; 201.12.4.106; 12.8.2
201.12.4.107.1; 201.12.4.107.2;
201.12.4.107.3; 201.12.4.109;
201.101.2; 201.101.4.3;
201.102.10: 201.102.10.4;
201.104.5; 201.105.5; 201.105.8;
208
201.101.6.1; 201.104.2.1; 12.9
201.7, 201.7.2.104; 201.7.9.1; 13.1
201.102.1.1.1
201.7, 201.7.2.3; 201.7.2.101; 13.2
201.7.2.103; 201.7.2.107;
201.7.4.2
201.7.9.1 13.3 a)
201.7.2.101 13.3 e)
5
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kSIST FprEN ISO 80601-2-13:2012
FprEN ISO 80601-2-13:2012 (E)
Clause(s)/subclause(s) of this EN Corresponding essential Qualifying remarks/ynotes
requirements of Directive 3/42/EEC
201.7, 201.7.2.101 13.3 f) The indication that the device is for
single use must be consistent
across the Community is not
addressed in a requirement.
201.7, 201.7.9.3.102 13.3 i)
201.7, 13.3 j)
201.7.2
201.7.2.102, 201.7.2.103,
201.7.2.104
201.7.2.107
201.7.4.2
201.101.6.1
201.102.1.1.2
201.102.1.1.3
201.102.1.1.4
201.102.5.2
201.102.5.3
201.102.5.4
201.102.5.7
201.103.1.1
201.104.1.1
201.104.2.1
201.104.6
201.105.6
201.7, 13.3 k)
201.7.2.3
201.104.1.1
201.7.2.101 13.3.l)
201.7.2.102; 201.102.5.2; 13.5
201.102.5.4; 201.102.5.5;
201.102.5.6; 201.103.5;
201.103.6; 201.104.4
201.7 13.6 a) Covered by compliance with
EN 60601-1:2006, 7.9.2
201.7 13.6 b) Covered by compliance with
EN 60601-1:2006, 7.9.2
201.7.9.2.1 13.6 c)
201.7.9.2.14
201.11.8
201.11.8.101
201.11.8.103
201.12.4.102
201.12.4.103.3
201.12.4.106
201.12.4.107.2
201.12.4.108
201.101.1.1
201.101.1.2
201.102.1.2
201.102.7
6
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kSIST FprEN ISO 80601-2-13:2012
FprEN ISO 80601-2-13:2012 (E)
Clause(s)/subclause(s) of this EN Corresponding essential Qualifying remarks/ynotes
requirements of Directive 3/42/EEC
201.102.8.2
201.102.9.2
201.102.9.3
201.102.10.3
201.103.1.2
201.104.1.2
201.104.2.1
201.104.6
201.105.1
201.105.2.2
201.105.5
201.7, 201.102.10.1 13.6 d) maintenance and frequency
covered by compliance with
201.103.3.1.5
EN 60601-1:2006, 7.9.2.13
208.5.2.2
201.7.9.2.14 13.6 f)
201.7 13.6 h), first paragraph only Covered by compliance with
EN 60601-1:2006, 7.9.2
201.7.9.2.14
201.7 13.6 i) Covered by compliance with
EN 60601-1:2006, 7.9
201.7.9.2.1
201.7.9.2.8
201.7.9.2.2 13.6 k)
201.7.9.2.14
201.12.4.103 ; 13.6 p)
201.12.4.104.1,
201.12.4.109; 201.101.6.1;
201.104.2.2;
201.7.9.2.1 13.6 q)
7
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kSIST FprEN ISO 80601-2-13:2012
FprEN ISO 80601-2-13:2012 (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.102 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
European Standard. Table ZA.102, 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.102 — 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 EHSR of Directive 2006/42/EC Qualifying remarks/notes
EN
201.9.2.102 1.1.4
201.9.2.103 1.1.8
201.7.4.2
1.2.2
201.9.2
201.9.2.104
201.101.6.1
201.102.1.1.2
201.102.1.1.3
201.102.9.2
201.104.1.1
201.104.2.1
206
208
1.5.4
201.101.3
201.101.4.1.1
201.101.4.1.2
201.101.9
201.102.5
201.102.8.1
201.102.9.1
201.103.4,
201.103.5;
201.103.6
201.103.7
201.104.4
201.105.4
201.105.6
201.9.2.101
1.6.2
201.8 1.6.3
201.7 Covered by compliance with
3.6.2
EN 60601-1:2006, 7.2
201.7.2.106
WARNING: Other requirements and other EU Directives may be applicable to the products falling within the
scope of this International Standard.
8
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kSIST FprEN ISO 80601-2-13:2012
INTERNATIONAL ISO
STANDARD 80601-2-13
First edition
2011-08-01
Medical electrical equipment —
Part 2-13:
Particular requirements for basic safety
and essential performance of an
anaesthetic workstation
Appareils électromédicaux —
Partie 2-13: Exigences particulières de sécurité de base et de
performance essentielle pour les systèmes d'anesthésie
Reference number
ISO 80601-2-13:2011(E)
©
ISO 2011
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kSIST FprEN ISO 80601-2-13:2012
ISO 80601-2-13:2011(E)
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ii © ISO 2011 – All rights reserved
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kSIST FprEN ISO 80601-2-13:2012
ISO 80601-2-13:2011(E)
Contents Page
Foreword .v
Introduction.vi
201.1 Scope, object and related standards.1
201.2 Normative references.3
201.3 Terms and definitions .5
201.4 General requirements.9
201.5 General requirements for testing ME EQUIPMENT .11
201.6 Classification of ME EQUIPMENT and ME SYSTEMS .11
201.7 ME EQUIPMENT identification, marking and documents .11
201.8 Protection against electrical HAZARDS from ME EQUIPMENT.15
201.9 Protection against mechanical HAZARDS of ME EQUIPMENT and ME SYSTEMS.16
201.10 Protection against unwanted and excessive radiation HAZARDS .17
201.11 Protection against excessive temperatures and other HAZARDS .17
201.12 Accuracy of controls and instruments and protection against hazardous outputs .19
201.13 HAZARDOUS SITUATIONS and fault conditions.24
201.14 PROGRAMMABLE ELECTRICAL MEDICAL SYSTEMS (PEMS) .24
201.15 Construction of ME EQUIPMENT.25
201.16 ME SYSTEMS .25
201.17 Electromagnetic compatibility of ME EQUIPMENT AND ME SYSTEMS.26
201.101 Additional requirements for ANAESTHETIC GAS DELIVERY SYSTEMS.26
201.102 Additional requirements for an ANAESTHETIC BREATHING SYSTEM .32
201.103 Additional requirements for an ANAESTHETIC GAS SCAVENGING SYSTEM.39
201.104 Additional requirements for an ANAESTHETIC VAPOUR DELIVERY SYSTEM.43
201.105 Additional requirements for an ANAESTHETIC VENTILATOR.47
201.105.7 * Timed ventilatory pause .50
201.105.7.1 Expiratory pause .50
201.105.7.2 Inspiratory pause.50
201.106 Display loops.53
201.107 Clinical evaluation .53
202 Electromagnetic compatibility — Requirements and tests.54
203 General requirements for radiation protection in diagnostic X-ray equipment.54
206 Usability.54
208 General requirements, tests and guidance for ALARM SYSTEMS in MEDICAL ELECTRICAL
EQUIPMENT and MEDICAL ELECTRICAL SYSTEMS .55
209 Requirements for environmentally conscious design .55
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kSIST FprEN ISO 80601-2-13:2012
ISO 80601-2-13:2011(E)
210 PROCESS requirements for the development of physiologic closed-loop controllers .56
211 Requirements for MEDICAL ELECTRICAL EQUIPMENT and MEDICAL ELECTRICAL SYSTEMS used in
the home healthcare.56
Annex C (informative) Guide to marking and labelling requirements for ME EQUIPMENT and ME
SYSTEMS or their parts .57
Annex D (informative) Symbols on marking.67
Annex AA (informative) Particular guidance and rationale.69
Annex BB (normative) Test for flammability of anaesthetic agent .84
Annex CC (informative) Environmental aspects .85
Annex DD (informative) Reference to the essential principles.87
Bibliography .94
Alphabetized index of defined terms used in this particular standard .96
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kSIST FprEN ISO 80601-2-13:2012
ISO 80601-2-13:2011(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 80601-2-13 was prepared by a joint working group of Technical Committee ISO/TC 121, Anaesthetic and
respiratory equipment, Subcommittee SC 1, Breathing attachments and anaesthetic machines and Technical
Committee IEC/TC 62, Electrical equipment in medical practice, Subcommittee SC D, Electromedical
equipment. The draft was circulated for voting to the national bodies of both ISO and IEC.
This first edition of ISO 80601-2-13 cancels and replaces the following:
⎯ ISO 8835-2:2007, Inhalational anaesthesia systems — Part 2: Anaesthetic breathing systems
⎯ ISO 8835-3:2007, Inhalational anaesthesia systems — Part 3: Transfer and receiving systems of active
anaesthetic gas scavenging systems
⎯ ISO 8835-4:2004, Inhalational anaesthesia systems — Part 4: Anaesthetic vapour delivery devices
⎯ ISO 8835-5:2004, Inhalational anaesthesia systems — Part 5: Anaesthetic ventilators
⎯ IEC 60601-2-13:2003, Medical electrical equipment — Part 2-13: Particular requirements for the safety
and essential performance of anaesthetic systems
This edition constitutes a major technical revision of the material that was contained in the previous standards
by consolidating it into a single document, removing duplications and inconsistencies as well as harmonization
with the third edition of IEC 60601-1.
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kSIST FprEN ISO 80601-2-13:2012
ISO 80601-2-13:2011(E)
Introduction
In this International Standard, the following print types are used:
⎯ Requirements and definitions: roman type.
⎯ Test specifications: italic type.
⎯ Informative material appearing outside of tables, such as notes, examples and references: in smaller
type. Normative text of tables is also in a smaller type.
⎯ Terms defined in Clause 3 of the general standard, in this particular standard or as noted: small capitals.
In referring to the structure of this standard, the term
⎯ “clause” means one of the seventeen numbered divisions within the table of contents, inclusive of all
subdivisions (e.g. Clause 7 includes subclauses 7.1, 7.2, etc.);
⎯ “subclause” means a numbered subdivision of a clause (e.g. 201.7.1, 201.7.2 and 201.7.2.1 are all
subclauses of Clause 201.7).
References to clauses within this standard are preceded by the term “Clause” followed by the clause number.
References to subclauses within this particular standard are by number only.
In this International Standard, the conjunctive “or” is used as an “inclusive or” so a statement is true if any
combination of the conditions is true.
The verbal forms used in this International Standard conform to usage described in Annex H of the
ISO/IEC Directives, Part 2. For the purposes of this standard, the auxiliary verb:
⎯ “shall” means that compliance with a requirement or a test is mandatory for compliance with this
standard;
⎯ “should” means that compliance with a requirement or a test is recommended but is not mandatory for
compliance with this standard;
⎯ “may” is used to describe a permissible way to achieve compliance with a requirement or test.
An asterisk (*) as the first character of a title or at the beginning of a paragraph or table title indicates that
there is guidance or rationale related to that item in Annex AA.
The attention of Member Bodies and National Committees is drawn to the fact that equipment
MANUFACTURERS and testing organizations may need a transitional period following publication of a new,
amended or revised ISO or IEC publication in which to make products in accordance with the new
requirements and to equip themselves for conducting new or revised tests. It is the recommendation of the
committee that the content of this publication not be adopted for mandatory implementation nationally earlier
than 3 years from the date of publication for equipment newly designed and not earlier than 5 years from the
date of publication for equipment already in production.
This International Standard considers both an ANAESTHETIC WORKSTATION supplied complete and its individual
components. It has been structured to allow RESPONSIBLE ORGANIZATIONS to configure an ANAESTHETIC
WORKSTATION from individual components in conformance with professional guidelines and to meet the needs
of their clinical practice. In order to achieve this aim, this International Standard identifies particular
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kSIST FprEN ISO 80601-2-13:2012
ISO 80601-2-13:2011(E)
requirements pertinent to specific ANAESTHETIC WORKSTATION components, and to their associated MONITORING
EQUIPMENT, ALARM SYSTEM(S) and PROTECTION DEVICE(S), and defines the interfaces.
Figure 201.101 is a graphical representation of the structure of this International Standard and is provided for
informational purposes only.
ANAESTHETIC WORKSTATION
General requirements
Clauses 201.1 – 201.17, 201.106,
201.107, 202-211
MONITORING EQUIPMENT,
Mandatory elements;
ALARM SYSTEMS and
ANAESTHETIC GAS DELIVERY SYSTEM
see also Table AA.1
Clause 201.101 PROTECTION DEVICES
ANAESTHETIC BREATHING SYSTEM
Clause 201.102
ANAESTHETIC GAS SCAVENGING SYSTEM
Clause 201.103
MONITORING EQUIPMENT,
ANAESTHETIC VAPOUR DELIVERY SYSTEM Optionally present;
ALARM SYSTEMS and
see also Table AA.1
Clause 201.104
PROTECTION DEVICES
ANAESTHETIC VENTILATOR
Clause 201.105
Figure 201.101 — Configuration of an ANAESTHETIC WORKSTATION and corresponding organization of
this International Standard
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kSIST FprEN ISO 80601-2-13:2012
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kSIST FprEN ISO 80601-2-13:2012
INTERNATIONAL STANDARD ISO 80601-2-13:2011(E)
Medical electrical equipment —
Part 2-13:
Particular requirements for basic safety and essential
performance of an anaesthetic workstation
201.1 Scope, object and related standards
IEC 60601-1:2005, Clause 1 applies, except as follows:
201.1.1 * Scope
Replacement:
This International Standard is applicable to the BASIC SAFETY and ESSENTIAL PERFORMANCE of an ANAESTHETIC
WORKSTATION for administering inhalational anaesthesia whilst continuously attended by a professional
.
OPERATOR
This International Standard specifies particular requirements for a complete ANAESTHETIC WORKSTATION and the
following ANAESTHETIC WORKSTATION components which, although considered as individual devices in their
own right, may be utilized, in conjunction with other relevant ANAESTHETIC WORKSTATION components, to form
an ANAESTHETIC WORKSTATION to a given specification:
⎯ ANAESTHETIC GAS DELIVERY SYSTEM;
⎯ ANAESTHETIC BREATHING SYSTEM;
⎯ ANAESTHETIC GAS SCAVENGING SYSTEM;
⎯ ANAESTHETIC VAPOUR DELIVERY SYSTEM;
⎯ ANAESTHETIC VENTILATOR;
⎯ MONITORING EQUIPMENT;
⎯ ALARM SYSTEM;
⎯ PROTECTION DEVICE.
NOTE 1 MONITORING EQUIPMENT, ALARM SYSTEMS and PROTECTION DEVICES are summarized in Table AA.1.
An ANAESTHETIC WORKSTATION supplied complete and its individual components are considered as ME
EQUIPMENT or ME SYSTEMS with regard to the general standard.
NOTE 2 The applicability of this International Standard is indicated in Table AA.2.
This International Standard is also applicable to those ACCESSORIES intended by their MANUFACTURER to be
connected to an ANAESTHETIC WORKSTATION where the characteristics of those ACCESSORIES can affect the
BASIC SAFETY and ESSENTIAL PERFORMANCE of the ANAESTHETIC WORKSTATION.
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ISO 80601-2-13:2011(E)
If a clause or subclause is specifically intended to be applicable to ANAESTHETIC WORKSTATION components
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 an ANAESTHETIC WORKSTATION and its individual components, as relevant.
HAZARDS inherent in the intended physiological function of an ANAESTHETIC WORKSTATION and its individual
components within the scope of this International Standard are not covered by specific requirements in this
International Standard except in 7.2.13 and 8.4.1 of the general standard.
NOTE 3 See also 4.2 of the general standard.
This International Standard is not applicable to any ANAESTHETIC WORKSTATION intended for use with
flammable anaesthetic agents, as determined by Annex BB.
201.1.2 Object
Replacement:
The object of this particular standard is to establish particular BASIC SAFETY and ESSENTIAL PER
...
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