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)

2019-10-07: CEN/BT 169/2019: remove link to MDD + MDR & publish without delay
2019-10-09 - JO- BT decision - BT N 11739 - remove link to MDD
20180720 - TAN - Consultant assessment rejected
CEN/BT C082/2011:  DOW = DAV + 36 months

Medizinische elektrische Geräte - Teil 2-13: Besondere Festlegungen für die Sicherheit einschließlich der wesentlichen Leistungsmerkmale für Anästhesie-Arbeitsplätzen - Änderung 2 (ISO 80601-2-13:2011/Amd 2:2018)

Appareils électromédicaux - Partie 2-13: Exigences particulières de sécurité de base et de performances essentielles pour les postes de travail d'anesthésie - Amendement 2 (ISO 80601-2-13:2011/Amd 2:2018)

Medicinska električna oprema - 2-13: del: Posebne zahteve za osnovno varnost in bistvene lastnosti delovnega mesta za anestezijo - Dopolnilo A2 (ISO 80601-2-13:2011/Amd 2:2018)

General Information

Status
Published
Public Enquiry End Date
19-Jun-2017
Publication Date
12-Jan-2020
Technical Committee
Current Stage
6060 - National Implementation/Publication (Adopted Project)
Start Date
11-Dec-2019
Due Date
15-Feb-2020
Completion Date
13-Jan-2020

Relations

Buy Standard

Amendment
EN ISO 80601-2-13:2013/A2:2020
English language
8 pages
sale 10% off
Preview
sale 10% off
Preview
e-Library read for
1 day
Draft
EN ISO 80601-2-13:2013/oprA2:2017
English language
6 pages
sale 10% off
Preview
sale 10% off
Preview
e-Library read for
1 day

Standards Content (Sample)

SLOVENSKI STANDARD
SIST EN ISO 80601-2-13:2013/A2:2020
01-februar-2020
Medicinska električna oprema - 2-13: del: Posebne zahteve za osnovno varnost in
bistvene lastnosti delovnega mesta za anestezijo - Dopolnilo A2 (ISO 80601-2-
13:2011/Amd 2:2018)
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)
Medizinische elektrische Geräte - Teil 2-13: Besondere Festlegungen für die Sicherheit
einschließlich der wesentlichen Leistungsmerkmale für Anästhesie-Arbeitsplätzen -
Änderung 2 (ISO 80601-2-13:2011/Amd 2:2018)
Appareils électromédicaux - Partie 2-13: Exigences particulières de sécurité de base et
de performances essentielles pour les postes de travail d'anesthésie - Amendement 2
(ISO 80601-2-13:2011/Amd 2:2018)
Ta slovenski standard je istoveten z: EN ISO 80601-2-13:2012/A2:2019
ICS:
11.040.10 Anestezijska, respiratorna in Anaesthetic, respiratory and
reanimacijska oprema reanimation equipment
SIST EN ISO 80601-2-13:2013/A2:2020 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

---------------------- Page: 1 ----------------------
SIST EN ISO 80601-2-13:2013/A2:2020

---------------------- Page: 2 ----------------------
SIST EN ISO 80601-2-13:2013/A2:2020


EN ISO 80601-2-
EUROPEAN STANDARD
13:2012/A2
NORME EUROPÉENNE

EUROPÄISCHE NORM

November 2019
ICS 11.040.10
English Version

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)
Appareils électromédicaux - Partie 2-13: Exigences Medizinische elektrische Geräte - Teil 2-13: Besondere
particulières de sécurité de base et de performances Festlegungen für die Sicherheit einschließlich der
essentielles pour les postes de travail d'anesthésie - wesentlichen Leistungsmerkmale für Anästhesie-
Amendement 2 (ISO 80601-2-13:2011/Amd 2:2018) Arbeitsplätzen - Änderung 2 (ISO 80601-2-
13:2011/Amd 2:2018)
This amendment A2 modifies the European Standard EN ISO 80601-2-13:2012; it was approved by CEN on 4 November 2019.

CEN members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for inclusion of
this amendment into the relevant 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 amendment exists in three official versions (English, French, German). A version in any other language made by translation
under the responsibility of a CEN member into its own language and notified to the CEN-CENELEC Management Centre has the
same status as the official versions.

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





EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION

EUROPÄISCHES KOMITEE FÜR NORMUNG

CEN-CENELEC Management Centre: Rue de la Science 23, B-1040 Brussels
© 2019 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 80601-2-13:2012/A2:2019 E
worldwide for CEN national Members.

---------------------- Page: 3 ----------------------
SIST EN ISO 80601-2-13:2013/A2:2020
EN ISO 80601-2-13:2012/A2:2019 (E)
Contents Page
European foreword . 3

2

---------------------- Page: 4 ----------------------
SIST EN ISO 80601-2-13:2013/A2:2020
EN ISO 80601-2-13:2012/A2:2019 (E)
European foreword
This document (EN ISO 80601-2-13:2012/A2:2019) has been prepared by Technical Committee ISO/TC
121 "Anaesthetic and respiratory equipment" in collaboration with Technical Committee CEN/TC 215
“Respiratory and anaesthetic equipment” the secretariat of which is held by BSI.
This Amendment to the European Standard EN ISO 80601-2-13:2012 shall be given the status of a
national standard, either by publication of an identical text or by endorsement, at the latest by May
2020, and conflicting national standards shall be withdrawn at the latest by May 2020.
Attention is drawn to the possibility that some of the elements of this document may be the subject of
patent rights. CEN shall not be held responsible for identifying any or all such patent rights.
According to the CEN-CENELEC Internal Regulations, the national standards organizations o
...

SLOVENSKI STANDARD
SIST EN ISO 80601-2-13:2013/oprA2:2017
01-junij-2017
0HGLFLQVNDHOHNWULþQDRSUHPDGHO3RVHEQH]DKWHYH]DRVQRYQRYDUQRVWLQ
ELVWYHQHODVWQRVWLGHORYQHJDPHVWD]DDQHVWH]LMR'RSROQLOR$ ,62
'$0
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/DAM 2:2017)
Medizinische elektrische Geräte - Teil 2-13: Besondere Festlegungen für die Sicherheit
einschließlich der wesentlichen Leistungsmerkmale für Anästhesie-Arbeitsplätzen -
Änderung 2 (ISO 80601-2-13:2011/DAM 2:2017)
Appareils électromédicaux - Partie 2-13: Exigences particulières de sécurité de base et
de performances essentielles pour les postes de travail d'anesthésie - Amendement 2
(ISO 80601-2-13:2011/DAM 2:2017)
Ta slovenski standard je istoveten z: EN ISO 80601-2-13:2012/prA2
ICS:
11.040.10 Anestezijska, respiratorna in Anaesthetic, respiratory and
reanimacijska oprema reanimation equipment
SIST EN ISO 80601-2- en,fr,de
13:2013/oprA2:2017
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

---------------------- Page: 1 ----------------------

SIST EN ISO 80601-2-13:2013/oprA2:2017

---------------------- Page: 2 ----------------------

SIST EN ISO 80601-2-13:2013/oprA2:2017
DRAFT AMENDMENT
ISO 80601-2-13:2011/DAM 2
ISO/TC 121/SC 1 Secretariat: DIN
Voting begins on: Voting terminates on:
2017-04-10 2017-07-02
Medical electrical equipment —
Part 2-13:
Particular requirements for basic safety and essential
performance of an anaesthetic workstation
AMENDMENT 2
Appareils électromédicaux —
Partie 2-13: Exigences particulières de sécurité de base et de performances essentielles pour les postes de
travail d’anesthésie
AMENDEMENT 2
ICS: 11.040.10
Member bodies are requested to consult relevant national interests in IEC/SC
62D before casting their ballot to the e-Balloting application.
THIS DOCUMENT IS A DRAFT CIRCULATED
This document is circulated as received from the committee secretariat.
FOR COMMENT AND APPROVAL. IT IS
THEREFORE SUBJECT TO CHANGE AND MAY
NOT BE REFERRED TO AS AN INTERNATIONAL
STANDARD UNTIL PUBLISHED AS SUCH.
IN ADDITION TO THEIR EVALUATION AS
ISO/CEN PARALLEL PROCESSING
BEING ACCEPTABLE FOR INDUSTRIAL,
TECHNOLOGICAL, COMMERCIAL AND
USER PURPOSES, DRAFT INTERNATIONAL
STANDARDS MAY ON OCCASION HAVE TO
BE CONSIDERED IN THE LIGHT OF THEIR
POTENTIAL TO BECOME STANDARDS TO
WHICH REFERENCE MAY BE MADE IN
Reference number
NATIONAL REGULATIONS.
ISO 80601-2-13:2011/DAM 2:2017(E)
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. ISO 2017

---------------------- Page: 3 ----------------------

SIST EN ISO 80601-2-13:2013/oprA2:2017
ISO 80601-2-13:2011/DAM 2:2017(E)

COPYRIGHT PROTECTED DOCUMENT
© ISO 2017, Published in Switzerland
All rights reserved. Unless otherwise specified, no part of this publication may be reproduced or utilized otherwise in any form
or by any means, electronic or mechanical, including photocopying, or posting on the internet or an intranet, without prior
written permission. Permission can be requested from either ISO at the address below or ISO’s member body in the country of
the requester.
ISO copyright office
Ch. de Blandonnet 8 • CP 401
CH-1214 Vernier, Geneva, Switzerland
Tel. +41 22 749 01 11
Fax +41 22 749 09 47
copyright@iso.org
www.iso.org
ii © ISO 2017 – All rights reserved

---------------------- Page: 4 ----------------------

SIST EN ISO 80601-2-13:2013/oprA2:2017
ISO 80601-2-13:2011/DAM 2:2017(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
...

Questions, Comments and Discussion

Ask us and Technical Secretary will try to provide an answer. You can facilitate discussion about the standard in here.