General Information

Abstract

Status
Published
Publication Date
18-Jul-2018
Drafting Committee
JWG 2 - TC 62/SC 62D/JWG 2
Current Stage
DELPUB - Deleted Publication
Start Date
03-May-2022
Completion Date
28-Aug-2026

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ISO 80601-2-13:2011/AMD2:2018 - Amendment 2 - Medical electrical equipment - Part 2-13: Particular requirements for basic safety and essential performance of an anaesthetic workstation

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ISO 80601-2-13:2011/AMD2:2018 - Amendment 2 - Medical electrical equipment - Part 2-13: Particular requirements for basic safety and essential performance of an anaesthetic workstation

Release Date:19-Jul-2018
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ISO 80601-2-13:2011/AMD2:2018 - Amendement 2 - Appareils électromédicaux - Partie 2-13: Exigences particulieres de sécurité de base et de performances essentielles pour les postes de travail d'anesthésie Released:7/19/2018

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Overview

ISO 80601-2-13:2011/AMD2:2018 is an important amendment to the international standard for medical electrical equipment, specifically focusing on anaesthetic workstations. Developed through collaboration between the International Organization for Standardization (ISO) and the International Electrotechnical Commission (IEC), this amendment addresses particular requirements for the basic safety and essential performance of anaesthetic workstations. By updating guidelines related to component construction, inlet connectors, and performance under physical stress, this amendment enhances patient safety, operational reliability, and regulatory compliance in healthcare environments.

Key Topics

  • Basic Safety and Essential Performance: The amendment strengthens requirements for the foundational safety and essential performance features that anaesthetic workstations must meet in clinical use.
  • Construction and Handling: It introduces updated test procedures, notably a modified rough handling test for workstations with higher nominal weights, better reflecting real-world hospital settings.
  • Connectors and Interface Requirements: Changes ensure that inlet connectors use specified female non-interchangeable screw-threaded (NIST) designs, helping prevent misconnections and increasing compatibility across equipment.
  • Collateral Standards: The amendment revises the applicability of certain collateral IEC standards, specifically clarifying that IEC 60601-1-9 does not apply to this context.
  • Environmental Considerations: The removal of environmental design requirements from this standard aligns with specialized collateral standards, clarifying manufacturer obligations.

Applications

ISO 80601-2-13:2011/AMD2:2018 is critical for manufacturers, engineers, and regulatory professionals involved with the design, production, and certification of anaesthetic workstations. Key applications include:

  • Medical Device Manufacturing: Ensures new anaesthetic workstation designs meet updated safety and performance requirements, reducing the risk of malfunction or misuse during surgical procedures.
  • Hospital Procurement and Maintenance: Assists healthcare facilities in choosing compliant anaesthetic workstations and maintaining their equipment according to the latest safety benchmarks.
  • Product Testing and Certification: Guides testing laboratories and notified bodies in assessing compliance with current international requirements, streamlining the conformity assessment process.
  • Regulatory Submissions: Provides documented evidence of adherence to up-to-date safety and performance standards for market approvals in different regions.

By mandating specific features for rough handling, connector design, and updates to referenced standards, the amendment helps promote a safer clinical environment, minimize user error, and improve equipment interoperability.

Related Standards

Implementing and understanding ISO 80601-2-13:2011/AMD2:2018 often involves reference to other key standards, including:

  • IEC 60601-1: General requirements for basic safety and essential performance of medical electrical equipment.
  • IEC 60601-1-3: Collateral standard for radiation protection in diagnostic X-ray equipment, which is clarified not to apply for anaesthetic workstations.
  • IEC 60601-1-9: Environmental requirements for medical devices-explicitly excluded from this amendment’s scope to avoid overlap and improve clarity.
  • IEC 60601-1-11: Requirements for medical electrical equipment and systems used in the home healthcare environment, also clarified as not applicable here.

Conclusion

ISO 80601-2-13:2011/AMD2:2018 delivers targeted updates to the requirements for anaesthetic workstations, resulting in safer, more reliable equipment for healthcare settings. Compliance with this amendment ensures continued alignment with international best practices, maximizes patient safety, and streamlines regulatory processes for medical electrical equipment.

Relations

Effective Date
05-Sep-2023
Effective Date
05-Sep-2023

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ISO 80601-2-13:2011/AMD2:2018 - Amendment 2 - Medical electrical equipment - Part 2-13: Particular requirements for basic safety and essential performance of an anaesthetic workstation

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Standard

ISO 80601-2-13:2011/AMD2:2018 - Amendment 2 - Medical electrical equipment - Part 2-13: Particular requirements for basic safety and essential performance of an anaesthetic workstation

Release Date:19-Jul-2018
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Standard

ISO 80601-2-13:2011/AMD2:2018 - Amendement 2 - Appareils électromédicaux - Partie 2-13: Exigences particulieres de sécurité de base et de performances essentielles pour les postes de travail d'anesthésie Released:7/19/2018

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Frequently Asked Questions

ISO 80601-2-13:2011/AMD2:2018 is a standard published by the International Electrotechnical Commission (IEC). Its full title is "Amendment 2 - Medical electrical equipment - Part 2-13: Particular requirements for basic safety and essential performance of an anaesthetic workstation". This standard covers: Amendment 2 - Medical electrical equipment - Part 2-13: Particular requirements for basic safety and essential performance of an anaesthetic workstation

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/AMD2:2018 is classified under the following ICS (International Classification for Standards) categories: 11.040.10 - Anaesthetic, respiratory and reanimation equipment. The ICS classification helps identify the subject area and facilitates finding related standards.

ISO 80601-2-13:2011/AMD2:2018 has the following relationships with other standards: It is inter standard links to ISO 80601-2-13:2011, ISO 80601-2-13:2022. Understanding these relationships helps ensure you are using the most current and applicable version of the standard.

ISO 80601-2-13:2011/AMD2:2018 is available in PDF format for immediate download after purchase. The document can be added to your cart and obtained through the secure checkout process. Digital delivery ensures instant access to the complete standard document.

Standards Content (Sample)


INTERNATIONAL ISO
STANDARD 80601-2-13
First edition
2011-08-01
AMENDMENT 2
2018-07
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
Reference number
ISO 80601-2-13:2011/Amd.2:2018(E)
©
ISO 2018
ISO 80601-2-13:2011/Amd.2:2018(E)

© ISO 2018
All rights reserved. Unless otherwise specified, or required in the context of its implementation, 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
CP 401 • Ch. de Blandonnet 8
CH-1214 Vernier, Geneva
Phone: +41 22 749 01 11
Fax: +41 22 749 09 47
Email: copyright@iso.org
Website: www.iso.org
Published in Switzerland
ii © ISO 2018 – All rights reserved

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
...


INTERNATIONAL ISO
STANDARD 80601-2-13
First edition
2011-08-01
AMENDMENT 2
2018-07
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
Reference number
ISO 80601-2-13:2011/Amd.2:2018(E)
©
ISO 2018
ISO 80601-2-13:2011/Amd.2:2018(E)

© ISO 2018
All rights reserved. Unless otherwise specified, or required in the context of its implementation, 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
CP 401 • Ch. de Blandonnet 8
CH-1214 Vernier, Geneva
Phone: +41 22 749 01 11
Fax: +41 22 749 09 47
Email: copyright@iso.org
Website: www.iso.org
Published in Switzerland
ii © ISO 2018 – All rights reserved

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
o
...


NORME ISO
INTERNATIONALE 80601-2-13
Première édition
2011-08-01
AMENDEMENT 2
2018-07
Appareils électromédicaux —
Partie 2-13:
Exigences particulières de sécurité de
base et de performances essentielles
pour les postes de travail d'anesthésie
AMENDEMENT 2
Medical electrical equipment —
Part 2-13: Particular requirements for basic safety and essential
performance of an anaesthetic workstation
AMENDMENT 2
Numéro de référence
ISO 80601-2-13:2011/Amd.2:2018(F)
©
ISO 2018
ISO 80601-2-13:2011/Amd.2:2018(F)

DOCUMENT PROTÉGÉ PAR COPYRIGHT
© ISO 2018
Tous droits réservés. Sauf prescription différente ou nécessité dans le contexte de sa mise en œuvre, aucune partie de cette
publication ne peut être reproduite ni utilisée sous quelque forme que ce soit et par aucun procédé, électronique ou mécanique,
y compris la photocopie, ou la diffusion sur l’internet ou sur un intranet, sans autorisation écrite préalable. Une autorisation peut
être demandée à l’ISO à l’adresse ci-après ou au comité membre de l’ISO dans le pays du demandeur.
ISO copyright office
Case postale 401 • Ch. de Blandonnet 8
CH-1214 Vernier, Genève
Tél.: +41 22 749 01 11
Fax: +41 22 749 09 47
E-mail: copyright@iso.org
Web: www.iso.org
Publié en Suisse
ii © ISO 2018 – Tous droits réservés

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

Avant-propos
L'ISO (Organisation internationale de normalisation) est une fédération mondiale d'organismes

nationaux de normalisation (comités membres de l'ISO). L'élaboration des Normes internationales est

en général confiée aux comités techniques de l'ISO. Chaque comité membre intéressé par une étude

a le droit de faire partie du comité technique créé à cet effet. Les organisations internationales,
gouvernementales et non gouvernementales, en liaison avec l'ISO participent également aux travaux.
L'ISO collabore étroitement avec la Commission électrotechnique internationale (IEC) en ce qui
concerne la normalisation électrotechnique.

Les procédures utilisées pour élaborer le présent document et celles destinées à sa mise à jour sont

décrites dans les Directives ISO/IEC, Partie 1. Il convient, en particulier de prendre note des différents
critères d'approbation requis pour les différents types de documents ISO. Le présent document a été
rédigé conformément aux règles de rédaction données dans les Directives ISO/IEC, Partie 2 (voir www
.iso .org/directives).
L'attention est attirée sur le fait que certains des éléments du présent document peuvent faire l'objet de
droits de propriété intellectuelle ou de droits analogues. L'ISO ne saurait être tenue pour responsable
de ne pas avoir identifié de tels droits de propriété et averti de leur existence. Les détails concernant
les références aux droits de propriété intellectuelle ou autres droits analogues identifiés lors de
l'él
...