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)

Medicinska električna oprema - 2-13: del: Posebne zahteve za osnovno varnost in bistvene lastnosti delovnega mesta za anestezijo (ISO 80601-2-13:2011)

General Information

• Status: Published
• Technical Committee: COVID 19 - COVID 19 - ISO
• Directive: standardi COVID-19 - UPDATE ON THE AVAILABILITY OF CEN, CENELEC, ISO, IEC STANDARDS AND THEIR NATIONAL ADOPTIONS IN RESPONSE TO THE COVID-19 OUTBREAK

Standards Content (Sample)

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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.

Posebna objava SIST z dovoljenjem CEN, CENELEC, ISO in IEC: Za potrebe zagotavljanja brezplačnega dostopa do vsebin standardov v času epidemije COVID-19.
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Posebna objava SIST z dovoljenjem CEN, CENELEC, ISO in IEC: Za potrebe zagotavljanja brezplačnega dostopa do vsebin standardov v času epidemije COVID-19.
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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.
Posebna objava SIST z dovoljenjem CEN, CENELEC, ISO in IEC: Za potrebe zagotavljanja brezplačnega dostopa do vsebin standardov v času epidemije COVID-19.
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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

Posebna objava SIST z dovoljenjem CEN, CENELEC, ISO in IEC: Za potrebe zagotavljanja brezplačnega dostopa do vsebin standardov v času epidemije COVID-19.
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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.
Posebna objava SIST z dovoljenjem CEN, CENELEC, ISO in IEC: Za potrebe zagotavljanja brezplačnega dostopa do vsebin standardov v času epidemije COVID-19.
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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
Posebna objava SIST z dovoljenjem CEN, CENELEC, ISO in IEC: Za potrebe zagotavljanja brezplačnega dostopa do vsebin standardov v času epidemije COVID-19.
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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;
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)
Posebna objava SIST z dovoljenjem CEN, CENELEC, ISO in IEC: Za potrebe zagotavljanja brezplačnega dostopa do vsebin standardov v času epidemije COVID-19.
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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
Posebna objava SIST z dovoljenjem CEN, CENELEC, ISO in IEC: Za potrebe zagotavljanja brezplačnega dostopa do vsebin standardov v času epidemije COVID-19.
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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)
Posebna objava SIST z dovoljenjem CEN, CENELEC, ISO in IEC: Za potrebe zagotavljanja brezplačnega dostopa do vsebin standardov v času epidemije COVID-19.
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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.
...