EN ISO 80601-2-13:2012

Medical electrical equipment - Part 2-13: Particular requirements for basic safety and essential performance of an anaesthetic workstation (ISO 80601-2-13:2011)

ISO/IEC 80601-2-13:2011 is applicable to the basic safety and essential performance of an anaesthetic workstation for administering inhalational anaesthesia whilst continuously attended by a professional operator.
ISO/IEC 80601-2-13:2011 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.
ISO/IEC 80601-2-13:2011 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.
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 ISO/IEC 80601-2-13:2011 are not covered by specific requirements in ISO/IEC 80601-2-13:2011 except in 7.2.13 and 8.4.1 of IEC 60601-1:2005.
ISO/IEC 80601-2-13:2011 is not applicable to any anaesthetic workstation intended for use with flammable anaesthetic agents, as determined by Annex BB.

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

• Status: Withdrawn
• Publication Date: 11-Dec-2012
• Withdrawal Date: 14-Jun-2022
• ICS: 11.040.10 - Anaesthetic, respiratory and reanimation equipment
• Technical Committee: CEN/TC 215 - Respiratory and anaesthetic equipment
• Drafting Committee: CEN/TC 215/WG 1 - Anaesthetic machines, medical breathing systems and anaesthetic gas scavenging systems
• Current Stage: 9960 - Withdrawal effective - Withdrawal
• Completion Date: 15-Jun-2022
• Directive: 2007/47/EC - Directive 2007/47/EC of the European Parliament and of the council of 5 September 2007 amending Council Directive 90/385/EEC on the approximation of the laws of the Member States relating to active implantable medical devices, Council Directive 93/42/EEC concerning medical devices and Directive 98/8/EC concerning the placing of biocidal products on the market
• 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 80601-2-13:2013 - Medical electrical equipment - Part 2-13: Particular requirements for basic safety and essential performance of an anaesthetic workstation (ISO 80601-2-13:2011)

Relations

• Replaces: EN ISO 8835-4:2009 - Inhalational anaesthesia systems - Part 4: Anaesthetic vapour delivery devices (ISO 8835-4:2004)
• Effective Date: 26-Dec-2012
• Replaces: EN ISO 8835-3:2009/A1:2010 - Inhalational anaesthesia systems - Part 3: Transfer and receiving systems of active anaesthetic gas scavenging systems (ISO 8835-3:2007/AMD 1:2010)
• Effective Date: 26-Dec-2012
• Replaces: EN ISO 8835-3:2009 - Inhalational anaesthesia systems - Part 3: Transfer and receiving systems of active anaesthetic gas scavenging systems (ISO 8835-3:2007)
• Effective Date: 26-Dec-2012
• Replaces: EN ISO 8835-2:2009 - Inhalational anaesthesia systems - Part 2: Anaesthetic breathing systems (ISO 8835-2:2007)
• Effective Date: 26-Dec-2012
• Replaces: EN ISO 8835-5:2009 - Inhalational anaesthesia systems - Part 5: Anaesthetic ventilators (ISO 8835-5:2004)
• Effective Date: 26-Dec-2012
• Replaced By: EN ISO 80601-2-13:2022 - Medical electrical equipment - Part 2-13: Particular requirements for basic safety and essential performance of an anaesthetic workstation (ISO 80601-2-13:2022)
• Effective Date: 22-Jun-2022
• Amended By: EN ISO 80601-2-13:2012/A1:2019 - Medical electrical equipment - Part 2-13: Particular requirements for basic safety and essential performance of an anaesthetic workstation - Amendment 1 (ISO 80601-2-13:2011/Amd 1:2015)
• Effective Date: 26-Dec-2018
• Amended By: EN ISO 80601-2-13:2012/A2:2019 - Medical electrical equipment - Part 2-13: Particular requirements for basic safety and essential performance of an anaesthetic workstation - Amendment 2 (ISO 80601-2-13:2011/Amd 2:2018)
• Effective Date: 27-Jul-2016

Standards Content (Sample)

SLOVENSKI STANDARD
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
0HGLFLQVNDHOHNWULþQDRSUHPDGHO3RVHEQH]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
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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

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
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.
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
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;
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)
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
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)
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
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.
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
ISO 80601-2-13:2011(E)
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ISO 80601-2-13:2011(E)
Contents Page
Foreword .v
Introduction.vi
201.1 Scope, object and related
...