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IEC 60601-1-8:2006

(Main)

Medical electrical equipment — Part 1-8: General requirements for basic safety and essential performance — Collateral standard: General requirements, tests and guidance for alarm systems in medical electrical equipment and medical electrical systems

Medical electrical equipment — Part 1-8: General requirements for basic safety and essential performance — Collateral standard: General requirements, tests and guidance for alarm systems in medical electrical equipment and medical electrical systems

Specifies basic safety and essential performance requirements and tests for alarm systems in medical electrical equipment and medical electrical systems and to provide guidance for their application. This is accomplished by defining alarm categories (priorities) by degree of urgency, consistent alarm signals and consistent control states and their marking for all alarm systems.

Appareils électromédicaux — Partie 1-8: Exigences générales pour la sécurité de base et les performances essentielles — Norme collatérale: Exigences générales, essais et guides pour les systèmes d'alarme des appareils et des systèmes électromédicaux

Spécifie les exigences de sécurité de base et les exigences en matière de performances essentielles ainsi que les essais des systèmes d'alarme des appareils et des systèmes électromédicaux et de donner des lignes directrices pour leur application. Cela est réalisé en définissant des catégories d'alarmes (priorités) par degré d'urgence, des signaux d'alarme et des états de commande cohérents et leur marquage pour tous les systèmes d'alarme.

General Information

Status
Published
Publication Date
12-Nov-2006
ICS
11.040.10 - Anaesthetic, respiratory and reanimation equipment
Technical Committee
ISO/TC 121/SC 3 - Respiratory devices and related equipment used for patient care
Drafting Committee
ISO/TC 121/SC 3 - Respiratory devices and related equipment used for patient care
Current Stage
9020 - International Standard under periodical review
Start Date
15-Oct-2025
Completion Date
15-Oct-2025
Ref Project

Relations

Amended By
IEC 60601-1-8:2006/Amd 2:2020 - Medical electrical equipment — Part 1-8: General requirements for basic safety and essential performance — Collateral standard: General requirements, tests and guidance for alarm systems in medical electrical equipment and medical electrical systems — Amendment 2
Effective Date
14-Jul-2018
Amended By
IEC 60601-1-8:2006/Amd 1:2012 - Medical electrical equipment — Part 1-8: General requirements for basic safety and essential performance — Collateral standard: General requirements, tests and guidance for alarm systems in medical electrical equipment and medical electrical systems — Amendment 1
Effective Date
14-Jul-2018
Revises
IEC 60601-1-8:2003/Amd 1:2006 - Medical electrical equipment — Part 1-8: General requirements for safety — Collateral standard: General requirements, tests and guidance for alarm systems in medical electrical equipment and medical electrical systems — Amendment 1
Effective Date
27-Apr-2013
Revises
IEC 60601-1-8:2003 - Medical electrical equipment — Part 1-8: General requirements for safety — Collateral standard: General requirements, tests and guidance for alarm systems in medical electrical equipment and medical electrical systems
Effective Date
15-Apr-2008
IEC 60601-1-8:2006IEC 60601-1-8:2006
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IEC 60601-1-8:2006
English language
160 pages
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NORME CEI
INTERNATIONALE
IEC
60601-1-8
INTERNATIONAL
Deuxième édition
STANDARD
Second edition
2006-10
Appareils électromédicaux –
Partie 1-8:
Exigences générales pour la sécurité
de base et les performances essentielles –
Norme collatérale: Exigences générales, essais
et guide pour les systèmes d’alarme des appareils
et des systèmes électromédicaux

Medical electrical equipment –
Part 1-8:
General requirements for basic
safety and essential performance –
Collateral Standard: General requirements,
tests and guidance for alarm systems in
medical electrical equipment and medical
electrical systems
Numéro de référence
Reference number
CEI/IEC 60601-1-8:2006
Numérotation des publications Publication numbering
Depuis le 1er janvier 1997, les publications de la CEI As from 1 January 1997 all IEC publications are
sont numérotées à partir de 60000. Ainsi, la CEI 34-1 issued with a designation in the 60000 series. For
devient la CEI 60034-1. example, IEC 34-1 is now referred to as IEC 60034-1.
Editions consolidées Consolidated editions
Les versions consolidées de certaines publications de la The IEC is now publishing consolidated versions of its
CEI incorporant les amendements sont disponibles. Par publications. For example, edition numbers 1.0, 1.1
exemple, les numéros d’édition 1.0, 1.1 et 1.2 indiquent and 1.2 refer, respectively, to the base publication,
respectivement la publication de base, la publication de the base publication incorporating amendment 1 and
base incorporant l’amendement 1, et la publication de the base publication incorporating amendments 1
base incorporant les amendements 1 et 2. and 2.
Informations supplémentaires Further information on IEC publications
sur les publications de la CEI
Le contenu technique des publications de la CEI est The technical content of IEC publications is kept
constamment revu par la CEI afin qu'il reflète l'état under constant review by the IEC, thus ensuring that
actuel de la technique. Des renseignements relatifs à the content reflects current technology. Information
cette publication, y compris sa validité, sont dispo- relating to this publication, including its validity, is
nibles dans le Catalogue des publications de la CEI available in the IEC Catalogue of publications
(voir ci-dessous) en plus des nouvelles éditions, (see below) in addition to new editions, amendments
amendements et corrigenda. Des informations sur les and corrigenda. Information on the subjects under
sujets à l’étude et l’avancement des travaux entrepris consideration and work in progress undertaken by the
par le comité d’études qui a élaboré cette publication, technical committee which has prepared this
ainsi que la liste des publications parues, sont publication, as well as the list of publications issued,
également disponibles par l’intermédiaire de: is also available from the following:
• Site web de la CEI (www.iec.ch) • IEC Web Site (www.iec.ch)
• Catalogue des publications de la CEI • Catalogue of IEC publications
Le catalogue en ligne sur le site web de la CEI The on-line catalogue on the IEC web site
(www.iec.ch/searchpub) vous permet de faire des (www.iec.ch/searchpub) enables you to search by a
recherches en utilisant de nombreux critères, variety of criteria including text searches,
comprenant des recherches textuelles, par comité technical committees and date of publication. On-
d’études ou date de publication. Des informations en line information is also available on recently
ligne sont également disponibles sur les nouvelles issued publications, withdrawn and replaced
publications, les publications remplacées ou retirées, publications, as well as corrigenda.
ainsi que sur les corrigenda.
• IEC Just Published • IEC Just Published
Ce résumé des dernières publications parues This summary of recently issued publications
(www.iec.ch/online_news/justpub) est aussi dispo- (www.iec.ch/online_news/justpub) is also available
nible par courrier électronique. Veuillez prendre by email. Please contact the Customer Service
contact avec le Service client (voir ci-dessous) Centre (see below) for further information.
pour plus d’informations.
• Service clients • Customer Service Centre
Si vous avez des questions au sujet de cette If you have any questions regarding this
publication ou avez besoin de renseignements publication or need further assistance, please
supplémentaires, prenez contact avec le Service contact the Customer Service Centre:
clients:
Email: custserv@iec.ch Email: custserv@iec.ch
Tél: +41 22 919 02 11 Tel: +41 22 919 02 11
Fax: +41 22 919 03 00 Fax: +41 22 919 03 00
.
NORME CEI
INTERNATIONALE
IEC
60601-1-8
INTERNATIONAL
Deuxième édition
STANDARD
Second edition
2006-10
Appareils électromédicaux –
Partie 1-8:
Exigences générales pour la sécurité
de base et les performances essentielles –
Norme collatérale: Exigences générales, essais
et guide pour les systèmes d’alarme des appareils
et des systèmes électromédicaux

Medical electrical equipment –
Part 1-8:
General requirements for basic
safety and essential performance –
Collateral Standard: General requirements,
tests and guidance for alarm systems in
medical electrical equipment and medical
electrical systems
© IEC 2006 Droits de reproduction réservés ⎯ Copyright - all rights reserved
Aucune partie de cette publication ne peut être reproduite ni No part of this publication may be reproduced or utilized in any
utilisée sous quelque forme que ce soit et par aucun procédé, form or by any means, electronic or mechanical, including
électronique ou mécanique, y compris la photocopie et les photocopying and microfilm, without permission in writing from
microfilms, sans l'accord écrit de l'éditeur. the publisher.
International Electrotechnical Commission, 3, rue de Varembé, PO Box 131, CH-1211 Geneva 20, Switzerland
Telephone: +41 22 919 02 11 Telefax: +41 22 919 03 00 E-mail: inmail@iec.ch Web: www.iec.ch
CODE PRIX
XC
PRICE CODE
Pour prix, voir catalogue en vigueur
For price, see current catalogue

– 2 – 60601-1-8 © CEI:2006
SOMMAIRE
AVANT-PROPOS.6
INTRODUCTION.12

1 * Domaine d'application, objet et normes connexes .14
1.1 Domaine d’application .14
1.2 Objet .14
1.3 Normes connexes.14
2 Références normatives.16
3 Termes et définitions .16
4 Exigences générales .24
5 Identification, marquage et documentation des APPAREILS EM.26
5.1 Voyants lumineux et organes de commande.26
5.2 Documents d'accompagnement .26
6 Systèmes d'alarme .26
6.1 Condition d'alarme .26
6.2 * Indications pour les systèmes d'alarme intelligents .28
6.3 Génération des signaux d'alarme .30
6.4 * Indication des délais .40
6.5 PRÉRÉGLAGES D’ALARME .40
6.6 LIMITE D'ALARME .46
6.7 * Sécurité du SYSTÈME D'ALARME .48
6.8 * Etats de désactivation du SIGNAL D'ALARME .48
6.9 * RÉINITIALISATION DE L'ALARME.52
6.10 * SIGNAUX D'ALARME AVEC ET SANS VERROUILLAGE.52
6.11 * SYSTÈME D'ALARME RÉPARTI.54
6.12 * Constitution d'un journal de CONDITION D'ALARME .56

Annexe A (informative) Guide général et justifications .58
Annexe B (informative) Guide pour le marquage et exigences d'étiquetage pour les
APPAREILS EM et les SYSTÈMES EM .126
Annexe C (normative) Symboles sur le marquage.132
Annexe D (informative) Lignes directrices concernant les SIGNAUX D’ALARME sonores.140
Annexe E (informative) SIGNAUX D’ALARME vocaux.142
Annexe F (normative) * Mélodies réservées pour les SIGNAUX D'ALARME .148

Bibliographie.150

Index des termes définis dans la présente norme collatérale .154

Figure 1 – Illustration des caractéristiques temporelles des SIGNAUX D'ALARME sonores.36
Figure A.1 – Représentation graphique des composantes du délai du SYSTÈME D'ALARME.96

60601-1-8 © IEC:2006 – 3 –
CONTENTS
FOREWORD.7
INTRODUCTION.13

1 * Scope, object and related standards .15
1.1 Scope.15
1.2 Object .15
1.3 Related standards .15
2 Normative references .17
3 Terms and definitions .17
4 General requirements .25
5 ME EQUIPMENT identification marking and documents.27
5.1 Indicator lights and controls.27
5.2 ACCOMPANYING DOCUMENTS.27
6 ALARM SYSTEMS.27
6.1 ALARM CONDITION .27
6.2 * Disclosures for INTELLIGENT ALARM SYSTEM .29
6.3 Generation of ALARM SIGNALS .31
6.4 * Disclosure of delays.41
6.5 ALARM PRESETS.41
6.6 ALARM LIMIT .47
6.7 * ALARM SYSTEM security.49
6.8 * ALARM SIGNAL inactivation states .49
6.9 * ALARM RESET .53
6.10 * NON-LATCHING and LATCHING ALARM SIGNALS .53
6.11 * DISTRIBUTED ALARM SYSTEM .55
6.12 * ALARM CONDITION logging .57

Annex A (informative) General guidance and rationale.59
Annex B (informative) Guide to marking and labelling requirements for ME EQUIPMENT
and ME SYSTEMS.127
Annex C (normative) Symbols on marking.133
ANNEX D (informative) Guidance for auditory ALARM SIGNALS .141
ANNEX E (informative) Verbal ALARM SIGNALS.143
ANNEX F (normative) * Reserved melodies for ALARM SIGNALS.149

Bibliography.151

Index of defined terms used in this collateral standard.155

Figure 1 – Illustration of temporal characteristics of auditory ALARM SIGNALS .37
Figure A.1 – Graphical representation of components of ALARM SYSTEM delay .97

– 4 – 60601-1-8 ©
...

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ISO 18562-4:2024(Main)
Biocompatibility evaluation of breathing gas pathways in healthcare applications — Part 4: Tests for leachables in condensate

This document specifies tests for substances leached by liquid water condensing in gas pathways of a medical device, its parts or accessories, which are intended to provide respiratory care or supply substances via the respiratory tract to a patient in all environments. The chemical characterization methods described in this document apply to chemical substances that could leach from the medical device, its parts or accessories into the condensate. This document establishes verifiable acceptance criteria for these tests. The identity and quantity of each chemical released is intended for toxicological risk assessment as described in ISO 18562-1:2024. This document addresses potential contamination of the gas stream arising from the gas pathways, which deliver breathing gas to the patient. This document applies over the expected lifetime of the medical device in normal use and takes into account the effects of any intended processing. This document does not address biological evaluation of the surfaces of gas pathways that have direct contact with the patient. The requirements for direct contact surfaces are found in the ISO 10993 series. Medical devices, parts or accessories containing gas pathways that are addressed by this document include, but are not limited to, ventilators, anaesthesia workstations (including gas mixers), breathing systems, oxygen conserving devices, oxygen concentrators, nebulizers, low-pressure hose assemblies, humidifiers, heat and moisture exchangers, respiratory gas monitors, respiration monitors, masks, medical respiratory personal protective equipment, mouth pieces, resuscitators, breathing tubes, breathing systems filters, Y-pieces and any breathing accessories intended to be used with such devices. The enclosed chamber of an incubator, including the mattress, and the inner surface of an oxygen hood are considered to be gas pathways and are also addressed by this document. This document does not address contamination already present in the gas supplied from the gas sources while medical devices are in normal use. EXAMPLE Contamination arriving at the medical device from gas sources such as medical gas pipeline systems (including the non-return valves in the pipeline outlets), outlets of pressure regulators connected or integral to a medical gas cylinder, or room air taken into the medical device. This document does not address contact with drugs or anaesthetic agents. If a medical device or accessory is intended to be used with anaesthetic agents or drugs, then additional testing can be required. This document is intended to quantify hazardous water-soluble substances that are leached from the medical device, its parts or accessories by condensate and then conveyed by that liquid to the patient.

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ISO
ISO 80601-2-84:2023(Main)
Medical electrical equipment — Part 2-84: Particular requirements for the basic safety and essential performance of ventilators for the emergency medical services environment

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: ¾ intended for patients who need differing levels of support from artificial ventilation including ventilator-dependent patients; ¾ intended to be operated by a healthcare professional operator; ¾ intended for use in the EMS environment; and ¾ intended for invasive or non-invasive ventilation. NOTE 2 An EMS ventilator can also be used for transport within a professional healthcare facility. An EMS ventilator is not considered to use a physiologic closed loop-control system unless it uses a physiological patient variable to adjust the artificial 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 3 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. Hazards inherent in the intended physiological function of ME equipment or ME systems within the scope of this document are not covered by specific requirements in this document except in IEC 60601‑1:2005+AMD1:2012+AMD2:2020, 7.2.13 and 8.4.1. NOTE 4 Additional information can be found in IEC 60601-1:2005+AMD1:2012+AMD2:2020, 4.2. This document does not specify the requirements for the following: NOTE 5 See ISO/TR 21954 for guidance on the selection of the appropriate ventilator for a given patient. ¾ ventilators or accessories intended for ventilator-dependent patients in critical care applications, which are given in ISO 80601-2-12. ¾ ventilators or accessories intended for ventilator-dependent patients in the home healthcare environment, which are given in ISO 80601-2-72. ¾ ventilators or accessories intended for anaesthetic applications, which are given in ISO 80601‑2‑13. ¾ 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 and ISO 80601-2-80. ¾ obstructive sleep apnoea therapy ME equipment, which are given in ISO 80601‐2‐70. ¾ user-powered resuscitators, which are given in ISO 10651‐4. ¾ gas-powered emergency resuscitators, which are given in ISO 10651‐5. ¾ continuous positive airway pressure (CPAP) ME equipment. ¾ high‐frequency jet ventilators (HFJVs), which are given in ISO 80601-2-87. ¾ high‐frequency oscillatory ventilators (HFOVs) REF _Ref69393406 \r \h \* MERGEFORMAT [44] 08D0C9EA79F9BACE118C8200AA004BA90B02000000080000000D0000005F00520065006600360039003300390033003400300036000000 , which are given in ISO 80601-2-87. NOTE 6 An EMS ventilator can incorporate high-frequency jet or high-frequency oscillatory ventilation-modes. ¾ respiratory high-flow therapy equipment, which are given in ISO 80601-2-90. NOTE 7 An EMS ventilator can incorporate high-flow therapy operational mode, but such a mode is only for spontaneously breathing patients. ¾ oxygen therapy constant flow ME equipment. ¾ cuirass or “iron‐lung” ventilators.

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ISO
ISO 80601-2-12:2023(Main)
Medical electrical equipment — Part 2-12: Particular requirements for basic safety and essential performance of critical care ventilators

This document applies to the basic safety and essential performance of a critical care ventilator in combination with its accessories, hereafter referred to as ME equipment: ¾ intended for use in an environment that provides specialized care for patients whose conditions can be life-threatening and who can require comprehensive care and constant monitoring in a professional healthcare facility; NOTE 2 For the purposes of this document, such an environment is referred to as a critical care environment. Ventilators for this environment are considered life-sustaining. NOTE 3 For the purposes of this document, such a critical care ventilator can provide ventilation during transport within a professional healthcare facility (i.e. be a transit-operable ventilator). NOTE 4 A critical care ventilator intended for use in transport within a professional healthcare facility is not considered as an emergency medical services environment ventilator. ¾ intended to be operated by a healthcare professional operator; and ¾ intended for those patients who need differing levels of support from artificial ventilation including for ventilator-dependent patients. A critical care ventilator is not considered to use a physiologic closed-loop-control system unless it uses a physiological patient variable to adjust the artificial ventilation therapy settings. This document is also applicable to those accessories intended by their manufacturer to be connected to a ventilator breathing system, or to a ventilator, where the characteristics of those accessories can affect the basic safety or essential performance of the ventilator. NOTE 5 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. Hazards inherent in the intended physiological function of ME equipment or ME systems within the scope of this document are not covered by specific requirements in this document except in IEC 60601-1:2005+AMD1:2012+AMD2:2020, 7.2.13 and 8.4.1. NOTE 6 Additional information can be found in IEC 60601-1:2005+AMD1:2012+AMD2:2020, 4.2. This document is not applicable to ME equipment or an ME system operating in a ventilator-operational mode solely intended for patients who are not dependent on artificial ventilation. NOTE 7 A critical care ventilator, when operating in such a ventilator-operational mode, is not considered life-sustaining. This document is not applicable to ME equipment that is intended solely to augment the ventilation of spontaneously breathing patients within a professional healthcare facility. This document does not specify the requirements for: NOTE 8 See ISO/TR 21954 for guidance on the selection of the appropriate ventilator for a given patient. ¾ ventilators or accessories intended for anaesthetic applications, which are given in ISO 80601‑2‑13; ¾ ventilators or accessories intended for the emergency medical services environment, which are given in ISO 80601-2-84; ¾ ventilators or accessories intended for ventilator-dependent patients in the home healthcare environment, which are given in ISO 80601‑2-72; ¾ ventilators or accessories intended for home-care ventilatory support devices, which are given in ISO 80601-2-79 and ISO 80601-2-80; ¾ obstructive sleep apnoea therapy ME equipment, which are given in ISO 80601‑2‑70; ¾ continuous positive airway pressure (CPAP) ME equipment. ¾ high-frequency ventilators, which are given in ISO 80601‑2‑87; NOTE 9 A critical care ventilator can incorporate high-frequency jet or high-frequency oscillatory ventilator-operational modes. ¾ respiratory high-flow therapy equipment, which are given in ISO 80601‑2‑90; NOTE 10 A critical care ventilator can incorporate high-flow therapy operational mode, but such a mode is only for spontaneously breathing p

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ISO
ISO 80601-2-72:2023(Main)
Medical electrical equipment — Part 2-72: Particular requirements for basic safety and essential performance of home healthcare environment ventilators for ventilator-dependent patients

This document applies to the basic safety and essential performance of a ventilator in combination with its accessories, hereafter referred to as ME equipment: — intended for use in the home healthcare environment; — intended for use by a lay operator; and — intended for those patients who need differing levels of support from artificial ventilation including for ventilator-dependent patients. This document is also applicable to those accessories intended by their manufacturer to be connected to a ventilator breathing system or to a ventilator where the characteristics of those accessories can affect the basic safety or essential performance of the ventilator.

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