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SIST

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

(Amendment)

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)

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
ICS
11.040.10 - Anaesthetic, respiratory and reanimation equipment
Technical Committee
VAZ - Healthcare
Current Stage
6060 - National Implementation/Publication (Adopted Project)
Start Date
11-Dec-2019
Due Date
15-Feb-2020
Completion Date
13-Jan-2020
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
93/42/EEC - Council Directive 93/42/EEC of 14 June 1993 concerning medical devices
Mandate
M/023 - Standardization mandate to CEN/CENELEC concerning the development of European standards relating to medical devices
Ref Project
EN ISO 80601-2-13:2012/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)

Relations

Replaced By
SIST 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
01-Sep-2022
Amends
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)
Effective Date
01-Feb-2020

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EN ISO 80601-2-13:2013/A2:2020EN ISO 80601-2-13:2013/A2:2020
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EN ISO 80601-2-13:2013/A2:2020
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Standards Content (Sample)


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

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.

Contents Page
European foreword . 3

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 of the
following countries are bound to implement this European Standard: Austria, Belgium, Bulgaria,
Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland,
Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Republic of
North Macedonia, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and the
United Kingdom.
Endorsement notice
The text of ISO 80601-2-13:2011/Amd 2:2018 has been approved by CEN as EN ISO 80601-2-
13:2012/A2:2019 without any modification.
...

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 ventilators or accessories intended for ventilator-dependent patients in the home healthcare
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Medical electrical equipment - Part 2-84: Particular requirements for the basic safety and essential performance of ventilators for the emergency medical services environment (ISO 80601-2-84:2023)
EN ISO 80601-2-84:2023

This document applies to the basic safety and essential performance of an EMS ventilator in combination with its accessories, hereafter also referred to as ME equipment:
–   intended for patients who need differing levels of support from artificial ventilation including ventilator-dependent patients;
–   intended to be operated by a healthcare professional operator;
–   intended for use in the EMS environment; and
–   intended for invasive or non-invasive ventilation.
NOTE 1 An EMS ventilator can also be used for transport within a professional healthcare facility.
* An EMS ventilator is not considered to utilize physiologic closed loop-control system unless it uses a physiological patient variable to adjust the ventilation therapy settings.
This document is also applicable to those accessories intended by their manufacturer to be connected to the ventilator breathing system, or to an EMS ventilator, where the characteristics of those accessories can affect the basic safety or essential performance of the EMS ventilator.
NOTE 2 If a clause or subclause is specifically intended to be applicable to ME equipment only, or to ME systems only, the title and content of that clause or subclause will say so. If that is not the case, the clause or subclause applies both to ME equipment and to ME systems, as relevant.
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NOTE 3 Additional information can be found in IEC 60601-1:2005+AMD1:2012, 4.2.
This document does not specify the requirements for the following:
–   ventilators or accessories intended for ventilator-dependent patients in critical care applications, which are given in ISO 80601-2-12.
–   ventilators or accessories intended for ventilator-dependent patients in the home healthcare environment, which are given in ISO 80601-2-72[3].
–   ventilators or accessories intended for anaesthetic applications, which are given in ISO 80601‐2‐13[4].
–   ventilators or accessories intended for ventilatory support equipment (intended only to augment the ventilation of spontaneously breathing patients), which are given in ISO 80601-2-79[5] and ISO 80601-2-80[6] 1.
–   obstructive sleep apnoea therapy ME equipment, which are given in ISO 80601‐2‐70[7].
–   operator-powered resuscitators, which are given in ISO 10651‐4[8].
–   gas-powered emergency resuscitators, which are given in ISO 10651‐5[9].
–   continuous positive airway pressure (CPAP) ME equipment .
–   high‐frequency jet ventilators (HFJVs), which are given ISO 80601-2-87[11].
–   high‐frequency oscillatory ventilators (HFOVs)[10], which are given ISO 80601-2-87[11].
–   NOTE 4 An EMS ventilator can incorporate high-frequency jet or high-frequency oscillatory ventilation-modes.
–   cuirass or “iron‐lung” ventilators.

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