Norsk Standard NS-EN ISO 80601-2-13:2012/A2:2019

Publisert: 2020-02-01

Språk: Engelsk

Endring 2 Medisinsk elektrisk utstyr Del 2-13: Spesielle krav til grunnleggende sikkerhet og vesentlig ytelse for anestesiapparater (ISO 80601-2-13:2011/Amd 2:2018)

Amendment 2 Medical electrical equipment Part 2-13: Particular requirements for basic safety and essential performance of an anaesthetic workstation (ISO 80601-2-13:2011/Amd 2:2018)

Referansenummer: NS-EN ISO 80601-2-13:2012/A2:2019 (en)

© Standard Norge 2020

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Norsk forord

Den engelskspråklige versjonen av europeisk standard EN ISO 80601-2-13:2012/A2:2019 ble fastsatt som Norsk Standard NS-EN ISO 80601-2-13:2012/A2:2019 i februar 2020.

ICS: 11.040.10

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EUROPEAN STANDARD

NORME EUROPÉENNE

EUROPÄISCHE NORM

EN ISO 80601-2-13:2012/A2

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

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)

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)

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 C O M I T É E U R O P É E N D E N O R M A L I S A T I O N E U R O P Ä I S C H E S K O M I T E E F Ü R N O R M U N G

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 worldwide for CEN national Members.

Ref. No. EN ISO 80601-2-13:2012/A2:2019 E

NS-EN ISO 80601-2-13:2012/A2:2019

© Standard Norge 2020

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EN ISO 80601-2-13:2012/A2:2019 (E)

2

Contents Page

European foreword ....................................................................................................................................................... 3

NS-EN ISO 80601-2-13:2012/A2:2019

© Standard Norge 2020

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EN ISO 80601-2-13:2012/A2:2019 (E)

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.

NS-EN ISO 80601-2-13:2012/A2:2019

© Standard Norge 2020

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Medical electrical equipment —Part 2-13: Particular requirements for basic safety and essential performance of an anaesthetic workstationAMENDMENT 2Appareils électromédicaux —Partie 2-13: Exigences particulières de sécurité de base et de performances essentielles pour les postes de travail d'anesthésieAMENDEMENT 2

INTERNATIONAL STANDARD

ISO80601-2-13

First edition2011-08-01

Reference numberISO 80601-2-13:2011/Amd.2:2018(E)

AMENDMENT 22018-07

© ISO 2018

NS-EN ISO 80601-2-13:2012/A2:2019

© Standard Norge 2020

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ISO 80601-2-13:2011/Amd.2:2018(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.

The procedures used to develop this document and those intended for its further maintenance are described in the ISO/IEC Directives, Part 1. In particular the different approval criteria needed for the different types of ISO documents should be noted. This document was drafted in accordance with the editorial rules of the ISO/IEC Directives, Part 2 (see www .iso .org/directives).

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. Details of any patent rights identified during the development of the document will be in the Introduction and/or on the ISO list of patent declarations received (see www .iso .org/patents).

Any trade name used in this document is information given for the convenience of users and does not constitute an endorsement.

For an explanation on the voluntary nature of standards, the meaning of ISO specific terms and expressions related to conformity assessment, as well as information about ISO's adherence to the World Trade Organization (WTO) principles in the Technical Barriers to Trade (TBT) see the following URL: www .iso .org/iso/foreword .html

This document was prepared by 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 62 D, Electromedical equipment.

© ISO 2018 – All rights reserved iii

NS-EN ISO 80601-2-13:2012/A2:2019

© Standard Norge 2020

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Medical electrical equipment —

Part 2-13: Particular requirements for basic safety and essential performance of an anaesthetic workstation

AMENDMENT 2 201.1.3 Collateral standards

Replace the second paragraph with the following:

IEC 60601-1-3:2008, IEC 60601-1-9:2007+AMD1: 2013 and IEC 60601-1-11:2010 do not apply.

201.2 Normative references

Delete IEC 60601-1-9:2007, Medical electrical equipment — Part 1-9: General requirements for basic safety and essential performance — Collateral Standard: Requirements for environmentally conscious design.

201.15 Construction of me equipment

Add the following subclause:

201.15.3.5 Rough handling test

Addition:

For an anaest het ic wor kst at ion with a weight exceeding 125 kg in its nominal configuration and only movable manually, the speed in c) frame-door-shock shall be reduced from 0,8 m/s to 0,4 m/s.

201.101.4.2.1 Inlet connector

Replace list item a) by the following text:

a) female non-interchangeable screw-threaded (NIST) connector, or

209 Requirements for environmentally conscious design

Replace the existing text by:

IEC 60601-1-9 does not apply.

ISO 80601-2-13:2011/Amd.2:2018(E)

© ISO 2018 – All rights reserved 1

NS-EN ISO 80601-2-13:2012/A2:2019

© Standard Norge 2020

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ISO 80601-2-13:2011/Amd.2:2018(E)

Bibliography

Add:

[16] IEC 60601-1-9, Medical electrical equipment — Part 1-9: General requirements for basic safety and essential performance — Collateral standard: Requirements for environmentally conscious design

Renumber subsequent references.

2 © ISO 2018 – All rights reserved

NS-EN ISO 80601-2-13:2012/A2:2019

© Standard Norge 2020

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