SIST EN ISO 10651-4:2023
(Main)Lung ventilators - Part 4: Particular requirements for user-powered resuscitators (ISO 10651-4:2023)
Lung ventilators - Part 4: Particular requirements for user-powered resuscitators (ISO 10651-4:2023)
This document specifies requirements for user-powered resuscitators intended for use with all age groups and which are intended to provide lung ventilation to patients whose breathing is inadequate. User-powered resuscitators are designated according to ideal body mass range.
Example user-powered resuscitators include:
— self-inflating bag resuscitators intended to be squeezed by the user’s hand and refilled by elastic recoil; and
NOTE 1 Self-inflating bag resuscitators are generally transit-operable and can be used in a wide range of environmental and emergency situations.
— flow-inflating bag resuscitators intended to be squeezed by the user’s hand and refilled by a flow from a medical gas source.
This document is also applicable to those accessories that are intended for use with resuscitators where the characteristics of those accessories can affect the safety of the user-powered resuscitator.
Examples of such accessories include face masks, PEEP valves, capnometric indicators, manometers, metronomes, flow restrictors, filters, gas refill valves, oxygen gas mixers, connectors, electronic feedback devices, electronic sensors and transmission of data to other equipment.
This document is also applicable to point-of-use packaging.
This document does not specify the requirements for:
— gas-powered emergency resuscitators, which are given in ISO 10651-5;
— electrically-powered resuscitators;
— gas powered resuscitators for professional healthcare facilities; and
— anaesthetic reservoir bags, which are given in ISO 5362.
NOTE 2 This document has been prepared to address the relevant essential principles[24] and labelling[25] guidances of the International Medical Devices Regulators Forum (IMDRF) as indicated in Annex D.
NOTE 3 This document has been prepared to address the relevant essential principles of safety and performance of ISO 16142-1:2016 as indicated in Annex E.
NOTE 4 This document has been prepared to address the relevant general safety and performance requirements of European regulation (EU) 2017/745[23] as indicated in Annex F.
Beatmungsgeräte - Teil 4: Anforderungen an anwenderbetriebene Wiederbelebungsgeräte (Handbeatmungsgeräte) (ISO 10651-4:2023)
Dieses Dokument legt Anforderungen an anwenderbetriebene tragbare Wiederbelebungsgeräte (Handbeatmungsgeräte) fest, die zur Anwendung an Menschen aller Altersstufen und zur Lungenbeatmung bei Patienten mit unzureichender Atemtätigkeit vorgesehen sind. Anwenderbetriebene Wiederbelebungsgeräte werden entsprechend dem idealen Körpergewichtsbereich festgelegt.
ANMERKUNG 1 Patienten, die mit einem Wiederbelebungsgerät behandelt werden, können beatmungsabhängig sein.
Beispiele für anwenderbetriebene Wiederbelebungsgeräte sind:
- selbstaufblasende Beutel-Wiederbelebungsgeräte, die dafür vorgesehen sind, von dem Anwender gedrückt zu werden und durch elastischen Rückstoß neu befüllt werden; und
ANMERKUNG 2 Selbstaufblasende Beutel-Wiederbelebungsgeräte sind im Allgemeinen während des Transports verwendbar.
- durchfluss-aufblasbare Beutel-Wiederbelebungsgeräte, die dafür vorgesehen sind, von dem Anwender mit der Hand gedrückt zu werden, und durch den Durchfluss aus einer medizinischen Gasquelle wieder gefüllt werden.
Dieses Dokument gilt außerdem für Zubehör, das für die Anwendung mit Wiederbelebungsgeräten vorgesehen ist und wo die Eigenschaften dieses Zubehörs die Sicherheit des anwenderbetriebenen Wiederbelebungsgeräts beeinflussen kann.
Beispiele für solches Zubehör sind Masken, PEEP-Ventile, kapnometrische Anzeigegeräte, Manometer, Metronome, Durchflussbegrenzer, Filter, Gasnachfüllventile, Sauerstoff-Gasmischer, Verbindungsstücke, Gebrauchsverpackungen, elektronische Rückmeldeeinrichtungen, elektronische Sensoren und die Übertragung von Daten an andere Geräte.
Dieses Dokument legt keine Anforderungen fest für:
- gasbetriebene Notwiederbelebungsgeräte, die in ISO 10651-5 [8] aufgeführt sind;
- elektrisch betriebene Wiederbelebungsgeräte;
- gasbetriebene Wiederbelebungsgeräte für professionelle Gesundheitseinrichtungen; und
- Anästhesie-Reservoirbeutel, die in ISO 5362 [4] aufgeführt sind.
ANMERKUNG 3 Dieses Dokument wurde erstellt, um die relevanten grundsätzlichen Prinzipien [22] und Kennzeichnungsrichtlinien [23] des Internationalen Forums der Aufsichtsbehörden für Medizinprodukte (en: International Medical Devices Regulators Forum, IMDRF) zu behandeln, wie in Anhang D angegeben.
ANMERKUNG 4 Dieses Dokument wurde erstellt, um die relevanten grundsätzlichen Prinzipien der Sicherheit und Leistung nach ISO 16142-1:2016 [11] zu behandeln, wie in Anhang E angegeben.
ANMERKUNG 5 Dieses Dokument wurde erstellt, um die relevanten grundlegenden Sicherheits- und Leistungsanforderungen der europäischen Verordnung (EU) 2017/745 [21] zu behandeln, wie in Anhang F angegeben.
Ventilateurs pulmonaires - Partie 4 : Exigences relatives aux ressuscitateurs actionnés par l’utilisateur (ISO 10651-4:2023)
Le présent document spécifie les exigences relatives aux ressuscitateurs actionnés par l’utilisateur destinés à être utilisés pour tous les groupes d’âge et conçus pour assurer la ventilation pulmonaire de patients dont la respiration est insuffisante. Les ressuscitateurs actionnés par l’utilisateur sont conçus en fonction d’une gamme de poids corporel idéal.
Voici quelques exemples de ressuscitateurs actionnés par l’utilisateur:
— ressuscitateurs à ballon autoremplisseur destinés à être pressés manuellement par l’utilisateur et remplis à nouveau par un retour élastique; et
NOTE 1 Les ressuscitateurs à ballon autoremplisseur sont généralement opérationnels en déplacement et peuvent être utilisés dans une multitude de situations environnementales et d’urgence.
— ressuscitateurs à ballon gonflé par un débit (dit «flow-inflating bag») destinés à être pressés manuellement par l’utilisateur et remplis à nouveau au moyen d’un débit provenant d’une source de gaz médical.
Le présent document est également applicable aux accessoires destinés à être utilisés avec des ressuscitateurs lorsque les caractéristiques de ces accessoires peuvent affecter la sécurité du ressuscitateur actionné par l’utilisateur.
Les masques faciaux, les valves PEEP, les indicateurs capnométriques, les manomètres, les métronomes, les réducteurs de débit, les filtres, les valves de remplissage de gaz, les mélangeurs d’oxygène gazeux, les raccords, les dispositifs de rétroaction électroniques, les capteurs électroniques et la transmission de données à d’autres équipements sont des exemples d’accessoires de ce type.
Le présent document est également applicable aux emballages au point d’utilisation.
Le présent document ne spécifie pas les exigences relatives aux:
— appareils de réanimation d’urgence alimentés par gaz, qui sont présentés dans l’ISO 10651‑5;
— ressuscitateurs électriques;
— ressuscitateurs alimentés par gaz pour établissements de soins professionnels; et
— ballons réservoirs d’anesthésie, qui sont présentés dans l’ISO 5362.
NOTE 2 Le présent document a été élaboré afin de couvrir les principes essentiels[24] et les recommandations relatives à l’étiquetage[25] de l’International Medical Devices Regulators Forum (IMDRF) comme indiqué à l’Annexe D.
NOTE 3 Le présent document a été élaboré pour traiter des principes essentiels de sécurité et de performances pertinents de l’ISO 16142‑1:2016, tels qu’indiqués dans l’Annexe E.
NOTE 4 Le présent document a été élaboré pour traiter des exigences générales pertinentes en matière de sécurité et de performances du Règlement européen (UE) 2017/745,[23] telles qu’indiquées dans l’Annexe F.
Pljučni ventilatorji - 4. del: Posebne zahteve za naprave za oživljanje, ki jih upravlja uporabnik (ISO 10651-4:2023)
Ta dokument določa zahteve za naprave za oživljanje, ki jih upravlja uporabnik in so namenjene za uporabo pri vseh starostnih skupinah ter zagotavljajo ventilacijo pljuč bolnikov, katerih dihanje je nezadostno. Naprave za oživljanje, ki jih upravlja uporabnik, so zasnovane glede na območje idealne telesne mase.
Primeri naprav za oživljanje, ki jih upravlja uporabnik, so naslednji:
– naprave za oživljanje s samonapihljivo vrečo, ki jih uporabnik stisne z roko in se polnijo z elastičnim povratnim delovanjem; in
OPOMBA 1: Naprave za oživljanje s samonapihljivo vrečo se običajno uporablja na terenu v številnih okoljih in nujnih primerih.
– naprave za oživljanje s tokovnim napihovanjem, ki jih uporabnik stisne z roko in se polnijo s tokom iz vira medicinskega plina.
Ta dokument se uporablja tudi za tisto dodatno opremo, ki je namenjena za uporabo z napravami za oživljanje, kjer lahko lastnosti te dodatne opreme vplivajo na varnost naprave za oživljanje, ki jo upravlja uporabnik.
Primeri te dodatne opreme so obrazne maske, ventili PEEP, kapnometrični indikatorji, manometri, metronomi, omejevalniki pretoka, filtri, ventili za polnjenje plina, mešalniki kisikovih plinov, priključki, elektronske naprave s povratnim odzivom, elektronski senzorji in prenos podatkov na drugo opremo.
Ta dokument se uporablja tudi za embalažo na mestu uporabe.
Ta dokument ne določa zahtev za:
– naprave za oživljanje v sili na plin, ki so navedene v standardu ISO 10651-5;
– električne naprave za oživljanje;
– naprave za oživljanje na plin za strokovne zdravstvene ustanove; in
– vrečke z anestetikom, ki so navedene v standardu ISO 5362.
OPOMBA 2: Ta dokument je pripravljen za obravnavo pomembnih smernic za bistvena načela[24] in označevanje[25] mednarodnega foruma regulativnih organov na področju medicinskih pripomočkov (IMDRF), kot je navedeno v dodatku D.
OPOMBA 3: Ta dokument je pripravljen za obravnavo pomembnih bistvenih načel varnosti in učinkovitosti iz standarda ISO 16142-1:2016, kot je navedeno v dodatku E.
OPOMBA 4: Ta dokument je pripravljen za obravnavo pomembnih splošnih zahtev glede varnosti in učinkovitosti evropske uredbe (EU) 2017/745[23], kot je navedeno v dodatku F.
General Information
Relations
Standards Content (Sample)
SLOVENSKI STANDARD
SIST EN ISO 10651-4:2023
01-junij-2023
Nadomešča:
SIST EN ISO 10651-4:2009
Pljučni ventilatorji - 4. del: Posebne zahteve za naprave za oživljanje, ki jih upravlja
uporabnik (ISO 10651-4:2023)
Lung ventilators - Part 4: Particular requirements for user-powered resuscitators (ISO
10651-4:2023)
Beatmungsgeräte - Teil 4: Anforderungen an anwenderbetriebene
Wiederbelebungsgeräte (Handbeatmungsgeräte) (ISO 10651-4:2023)
Ventilateurs pulmonaires - Partie 4 : Exigences relatives aux ressuscitateurs actionnés
par l’utilisateur (ISO 10651-4:2023)
Ta slovenski standard je istoveten z: EN ISO 10651-4:2023
ICS:
11.040.10 Anestezijska, respiratorna in Anaesthetic, respiratory and
reanimacijska oprema reanimation equipment
SIST EN ISO 10651-4:2023 en,fr,de
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
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SIST EN ISO 10651-4:2023
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SIST EN ISO 10651-4:2023
EN ISO 10651-4
EUROPEAN STANDARD
NORME EUROPÉENNE
April 2023
EUROPÄISCHE NORM
ICS 11.040.10 Supersedes EN ISO 10651-4:2009
English Version
Lung ventilators - Part 4: Particular requirements for user-
powered resuscitators (ISO 10651-4:2023)
Ventilateurs pulmonaires - Partie 4 : Exigences Beatmungsgeräte - Teil 4: Anforderungen an
relatives aux ressuscitateurs actionnés par l'utilisateur anwenderbetriebene Wiederbelebungsgeräte
(ISO 10651-4:2023) (Handbeatmungsgeräte) (ISO 10651-4:2023)
This European Standard was approved by CEN on 17 February 2023.
CEN members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for giving this
European Standard the status of a 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 European Standard 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, Türkiye 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
© 2023 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 10651-4:2023 E
worldwide for CEN national Members.
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SIST EN ISO 10651-4:2023
EN ISO 10651-4:2023 (E)
Contents Page
European foreword . 3
2
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SIST EN ISO 10651-4:2023
EN ISO 10651-4:2023 (E)
European foreword
This document (EN ISO 10651-4:2023) 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 European Standard shall be given the status of a national standard, either by publication of an
identical text or by endorsement, at the latest by October 2023, and conflicting national standards shall
be withdrawn at the latest by October 2023.
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.
This document supersedes EN ISO 10651-4:2009.
Any feedback and questions on this document should be directed to the users’ national standards
body/national committee. A complete listing of these bodies can be found on the CEN website.
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, Türkiye and the
United Kingdom.
Endorsement notice
The text of ISO 10651-4:2023 has been approved by CEN as EN ISO 10651-4:2023 without any
modification.
3
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SIST EN ISO 10651-4:2023
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SIST EN ISO 10651-4:2023
INTERNATIONAL ISO
STANDARD 10651-4
Second edition
2023-03
Lung ventilators —
Part 4:
Particular requirements for user-
powered resuscitators
Ventilateurs pulmonaires —
Partie 4: Exigences relatives aux ressuscitateurs actionnés par
l’utilisateur
Reference number
ISO 10651-4:2023(E)
© ISO 2023
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SIST EN ISO 10651-4:2023
ISO 10651-4:2023(E)
COPYRIGHT PROTECTED DOCUMENT
© ISO 2023
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
Email: copyright@iso.org
Website: www.iso.org
Published in Switzerland
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SIST EN ISO 10651-4:2023
ISO 10651-4:2023(E)
Contents Page
Foreword .v
Introduction .vii
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 2
4 General requirements for testing of a resuscitator.15
4.1 Risk management process . .15
4.2 Type tests . 16
4.3 Test conditions . 16
4.4 Gas flowrate, volume and leakage specifications . 17
4.5 Testing errors . 17
4.6 Environmental conditions in the end user environment . 18
4.6.1 Transport and storage conditions . 18
4.6.2 Operating conditions . 19
4.6.3 Shelf-life . 20
4.6.4 Expected lifetime. 20
5 Information supplied by the manufacturer .21
5.1 General . 21
5.2 Additional marking requirements . 22
5.3 Additional instructions for use requirements . 22
6 Connectors and ports .23
6.1 General .23
6.2 Patient-connection port .23
6.3 Expiratory port connector for breathing gases . 23
6.4 Face mask connectors . 24
6.5 Intake connectors . 24
6.6 Bag refill valve connector. 24
6.7 Oxygen inlet connection . . .25
6.8 Pressure monitor connector . 26
7 Operational requirements .26
7.1 Dismantling and reassembly .26
7.2 Resuscitator performance after contamination with vomitus . 26
7.3 Mechanical strength . 27
7.4 Resistance to separation from an axial load . 27
7.4.1 Multiple patient multiple use resuscitators .28
7.4.2 Single use and single patient multiple use resuscitators .28
7.5 Immersion in water .29
7.6 Bag refill valve .29
7.7 Compatibility with substances .29
8 Ventilatory requirements .30
8.1 Delivered oxygen concentration .30
8.1.1 Non-spontaneously breathing patient .30
8.1.2 Spontaneously breathing patient . 31
8.2 Expiratory resistance .33
8.3 Inspiratory resistance .34
8.4 Gas source excessive flow .34
8.5 Resuscitator deadspace . 35
8.6 Ventilation performance . 35
8.6.1 Minimum guaranteed tidal volume (V ) — one hand . 35
T
8.6.2 Minimum guaranteed tidal volume for B < 2,5 kg .36
8.6.3 Maximum deliverable tidal volume — two hands . 37
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SIST EN ISO 10651-4:2023
ISO 10651-4:2023(E)
8.6.4 Maximum limited pressure .38
9 Additional requirements for resuscitator parts and accessories .39
9.1 General .39
9.2 Labelling .40
9.3 Breathing system filters .40
9.4 Stand-alone gas mixer .40
10 Processing requirements for a resuscitator and its accessories that are reusable .40
11 Biocompatibility .41
12 Usability .41
Annex A (informative) Particular guidance and rationale .43
Annex B (informative) Guide to marking and labelling requirements for resuscitators and
their accessories .49
Annex C (informative) Symbols on marking .52
Annex D (informative) Reference to the IMDRF essential principles and labelling guidances .55
Annex E (informative) Reference to the essential principles .58
Annex F (informative) Reference to the general safety and performance requirements .60
Bibliography .63
Terminology — Alphabetized index of defined terms .65
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SIST EN ISO 10651-4:2023
ISO 10651-4:2023(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 of 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
www.iso.org/iso/foreword.html.
This document was prepared by Technical Committee ISO/TC 121, Anaesthetic and respiratory equipment,
Subcommittee SC 3, Respiratory devices and related equipment used for patient care, in collaboration with
the European Committee for Standardization (CEN) Technical Committee CEN/TC 215, Respiratory and
anaesthetic equipment, in accordance with the Agreement on technical cooperation between ISO and
CEN (Vienna Agreement).
This second edition cancels and replaces the first edition (ISO 10651-4:2002), which has been
technically revised.
The main changes are as follows:
— clarified scope to include flow-inflating bag and self-inflating bag resuscitators and also indicated
that the requirements include specified accessories;
— updated normative references and defined terms;
— specified test conditions;
— specified calculation and disclosure of measurement uncertainty;
— harmonized storage and operating environmental conditions;
— added requirements for shelf-life and expected lifetime;
— harmonized information supplied by the manufacturer with ISO 20417 and ISO 15223-1;
— added requirements for the oxygen inlet connector;
— clarified ventilatory testing requirements;
— clarified delivered oxygen concentration performance requirements;
— added processing requirements;
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SIST EN ISO 10651-4:2023
ISO 10651-4:2023(E)
— added biocompatibility requirements; and
— added usability requirements.
A list of all parts in the ISO 10651 series can be found on the ISO website.
Any feedback or questions on this document should be directed to the user’s national standards body. A
complete listing of these bodies can be found at www.iso.org/members.html.
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SIST EN ISO 10651-4:2023
ISO 10651-4:2023(E)
Introduction
In this document, the conjunctive “or” is used as an “inclusive or” so a statement is true if any
combination of the conditions is true.
In this document, the following print types are used:
— requirements and definitions: roman type;
— terms defined in this document: italic type;
— informative material appearing outside of tables, such as notes, examples and references: in smaller
type. Normative text of tables is also in a smaller type.
In this document, the following verbal forms are used:
— “shall” indicates a requirement;
— “should” indicates a recommendation;
— “may” indicates a permission;
— "can" indicates a possibility or a capability;
— "must" indicates an external constraint.
Annex A contains rationale or guidance to some of the requirements in this document.
Annex B contains a guide to the marking and labelling requirements in this document.
Annex C contains a summary of the symbols referenced in this document.
Requirements in this document have been decomposed so that each requirement is uniquely delineated.
This is done to support automated requirements tracking.
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SIST EN ISO 10651-4:2023
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SIST EN ISO 10651-4:2023
INTERNATIONAL STANDARD ISO 10651-4:2023(E)
Lung ventilators —
Part 4:
Particular requirements for user-powered resuscitators
1 Scope
This document specifies requirements for user-powered resuscitators intended for use with all age
groups and which are intended to provide lung ventilation to patients whose breathing is inadequate.
User-powered resuscitators are designated according to ideal body mass range.
Example user-powered resuscitators include:
— self-inflating bag resuscitators intended to be squeezed by the user’s hand and refilled by elastic
recoil; and
NOTE 1 Self-inflating bag resuscitators are generally transit-operable and can be used in a wide range of
environmental and emergency situations.
— flow-inflating bag resuscitators intended to be squeezed by the user’s hand and refilled by a flow
from a medical gas source.
This document is also applicable to those accessories that are intended for use with resuscitators where
the characteristics of those accessories can affect the safety of the user-powered resuscitator.
Examples of such accessories include face masks, PEEP valves, capnometric indicators, manometers,
metronomes, flow restrictors, filters, gas refill valves, oxygen gas mixers, connectors, electronic
feedback devices, electronic sensors and transmission of data to other equipment.
This document is also applicable to point-of-use packaging.
This document does not specify the requirements for:
— gas-powered emergency resuscitators, which are given in ISO 10651-5;
— electrically-powered resuscitators;
— gas powered resuscitators for professional healthcare facilities; and
— anaesthetic reservoir bags, which are given in ISO 5362.
[24] [25]
NOTE 2 This document has been prepared to address the relevant essential principles and labelling
guidances of the International Medical Devices Regulators Forum (IMDRF) as indicated in Annex D.
NOTE 3 This document has been prepared to address the relevant essential principles of safety and performance
of ISO 16142-1:2016 as indicated in Annex E.
NOTE 4 This document has been prepared to address the relevant general safety and performance
[23]
requirements of European regulation (EU) 2017/745 as indicated in Annex F.
2 Normative references
The following documents are referred to in the text in such a way that some or all of their content
constitutes requirements of this document. For dated references, only the edition cited applies. For
undated references, the latest edition of the referenced document (including any amendments) applies.
1
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SIST EN ISO 10651-4:2023
ISO 10651-4:2023(E)
ISO 5356-1:2015, Anaesthetic and respiratory equipment — Conical connectors — Part 1: Cones and
sockets
ISO 10993-1:2018, Biological evaluation of medical devices — Part 1: Evaluation and testing within a risk
management process
ISO 11195:2018, Gas mixers for medical use — Stand-alone gas mixers
ISO 14937:2009, Sterilization of health care products — General requirements for characterization of a
sterilizing agent and the development, validation and routine control of a sterilization process for medical
devices
ISO 14971:2019, Medical devices — Application of risk management to medical devices
ISO 17664-1:2021, Processing of health care products — Information to be provided by the medical device
manufacturer for the processing of medical devices — Part 1: Critical and semi-critical medical devices
ISO 17664-2:2021, Processing of health care products — Information to be provided by the medical device
manufacturer for the processing of medical devices — Part 2: Non-critical medical devices
ISO 18562-1:2017, Biocompatibility evaluation of breathing gas pathways in healthcare applications —
Part 1: Evaluation and testing within a risk management process
ISO 20417:2021, Medical devices — Information to be supplied by the manufacturer
ISO 23328-1:2003, Breathing system filters for anaesthetic and respiratory use — Part 1: Salt test method
to assess filtration performance
ISO 23328-2:2002, Breathing system filters for anaesthetic and respiratory use — Part 2: Non-filtration
aspects
1)
ISO 80369-2:—, Small-bore connectors for liquids and gases in healthcare applications — Part 2:
Connectors for breathing systems and driving gases applications
IEC 60068-2-31:2008, Environmental testing — Part 2-31: Tests — Test Ec: Rough handling shocks,
primarily for equipment-type specimens
IEC 62366-1:2015+AMD1: 2020, Medical devices — Part 1: Application of usability engineering to medical
devices
IEC 62570:2014, Standard practice for marking medical devices and other items for safety in the magnetic
resonance environment
IEC Guide 115:2021, Application of uncertainty of measurement to conformity assessment activities in the
electrotechnical sector
EN 13544-2:2002+AMD1: 2009, Respiratory therapy equipment - Part 2: Tubing and connectors
3 Terms and definitions
For the purposes of this document, the following terms and definitions apply.
ISO and IEC maintain terminology databases for use in standardization at the following addresses:
— ISO Online browsing platform: available at https:// www .iso .org/ obp
— IEC Electropedia: available at https:// www .electropedia .org/
NOTE For convenience, an alphabetized index of terms and their sources used in this document is found at
the end of this document.
1) Under preparation. Stage at the time of publication: ISO/DIS 80369-2:2021.
2
© ISO 2023 – All rights reserved
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SIST EN ISO 10651-4:2023
ISO 10651-4:2023(E)
3.1
accessory
item, intended specifically by its manufacturer, to be used together with one
...
SLOVENSKI STANDARD
oSIST prEN ISO 10651-4:2021
01-september-2021
Pljučni ventilatorji - 4. del: Posebne zahteve za naprave za oživljanje, ki jih upravlja
uporabnik (ISO/DIS 10651-4:2021)
Lung ventilators - Part 4: Particular requirements for user-powered resuscitators
(ISO/DIS 10651-4:2021)
Beatmungsgeräte - Teil 4: Anforderungen an anwenderbetriebene
Wiederbelebungsgeräte (Handbeatmungsgeräte) (ISO/DIS 10651-4:2021)
Ventilateurs pulmonaires - Partie 4 : Exigences relatives aux ressuscitateurs à puissance
motrice manuelle (ISO/DIS 10651-4:2021)
Ta slovenski standard je istoveten z: prEN ISO 10651-4
ICS:
11.040.10 Anestezijska, respiratorna in Anaesthetic, respiratory and
reanimacijska oprema reanimation equipment
oSIST prEN ISO 10651-4:2021 en,fr,de
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
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oSIST prEN ISO 10651-4:2021
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oSIST prEN ISO 10651-4:2021
DRAFT INTERNATIONAL STANDARD
ISO/DIS 10651-4
ISO/TC 121/SC 3 Secretariat: ANSI
Voting begins on: Voting terminates on:
2021-07-07 2021-09-29
Lung ventilators —
Part 4:
Particular requirements for user-powered resuscitators
Ventilateurs pulmonaires —
Partie 4: Exigences relatives aux ressuscitateurs à puissance motrice manuelle
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/DIS 10651-4:2021(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 2021
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oSIST prEN ISO 10651-4:2021
ISO 10651-4:2021(E)
ISO/DIS 10651-4:2021(E)
1 Contents
2 Foreword . vi
3 Introduction. viii
4 1 Scope . 1
5 2 Normative references . 1
6 3 Terms and definitions . 2
7 4 General requirements for testing of a resuscitator . 16
8 4.1 Type tests . 16
9 4.2 Test conditions . 17
10 4.3 Gas flowrate, volume and leakage specifications . 17
11 4.4 Testing errors . 18
12 4.5 Ambient temperature, humidity, atmospheric pressure . 18
13 4.5.1 Storage conditions . 18
14 4.5.2 Continuous operating conditions . 19
15 4.5.3 Shelf-life . 21
16 4.5.4 Expected lifetime . 21
17 5 Information supplied by the manufacturer . 22
18 5.1 General . 22
19 5.2 Additional marking requirements . 23
20 5.3 Additional instructions for use requirements . 23
21 6 Connectors and ports . 24
22 6.1 General . 24
23 6.2 Patient-connection port . 25
24 6.3 Expiratory port connector for breathing gases . 25
25 6.4 Mask connectors . 25
26 6.5 Bag inlet valve . 25
27 6.6 Bag refill valve connector. 26
28 6.7 Oxygen inlet connection . 26
29 6.8 Pressure gauge (manometer) connector . 27
30 7 Operational requirements . 27
31 7.1 Dismantling and reassembly . 27
32 7.2 Resuscitator performance after contamination with vomitus . 27
33 7.3 Mechanical shock-drop test . 28
34 7.4 Resistance to separation from an axial load . 29
35 7.4.1 Multiple patient multiple use resuscitators. 29
36 7.4.2 Single use and single patient multiple use resuscitators . 29
37 7.5 Immersion in water . 30
38 7.6 Bag refill valve . 31
39 7.7 Materials of construction . 31
40 8 Ventilatory requirements . 31
41 8.1 Supplementary oxygen and delivered oxygen concentration . 31
42 8.1.1 Non-spontaneously breathing patient . 31
COPYRIGHT PROTECTED DOCUMENT
43 8.1.2 Spontaneously breathing patient . 34
44 8.2 Expiratory resistance . 36
© ISO 2021
45 8.2.1 Expiratory resistance-without BSF . 36
All rights reserved. Unless otherwise specified, or required in the context of its implementation, no part of this publication may
46 8.2.2 Expiratory resistance-with BSF . 37
be reproduced or utilized otherwise in any form or by any means, electronic or mechanical, including photocopying, or posting
47 8.3 Inspiratory resistance . 37
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.
48 8.3.1 Inspiratory resistance-without BSF . 37
ISO copyright office 49 8.3.2 Inspiratory resistance-with BSF . 38
CP 401 • Ch. de Blandonnet 8
CH-1214 Vernier, Geneva
Phone: +41 22 749 01 11
© ISO 2021 – All rights reserved iii
Fax: +41 22 749 09 47
Email: copyright@iso.org
Website: www.iso.org
Published in Switzerland
ii © ISO 2021 – All rights reserved
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oSIST prEN ISO 10651-4:2021
ISO 10651-4:2021(E)
1 Contents
2 Foreword . vi
3 Introduction. viii
4 1 Scope . 1
5 2 Normative references . 1
6 3 Terms and definitions . 2
7 4 General requirements for testing of a resuscitator . 16
8 4.1 Type tests . 16
9 4.2 Test conditions . 17
10 4.3 Gas flowrate, volume and leakage specifications . 17
11 4.4 Testing errors . 18
12 4.5 Ambient temperature, humidity, atmospheric pressure . 18
13 4.5.1 Storage conditions . 18
14 4.5.2 Continuous operating conditions . 19
15 4.5.3 Shelf-life . 21
16 4.5.4 Expected lifetime . 21
17 5 Information supplied by the manufacturer . 22
18 5.1 General . 22
19 5.2 Additional marking requirements . 23
20 5.3 Additional instructions for use requirements . 23
21 6 Connectors and ports . 24
22 6.1 General . 24
23 6.2 Patient-connection port . 25
24 6.3 Expiratory port connector for breathing gases . 25
25 6.4 Mask connectors . 25
26 6.5 Bag inlet valve . 25
27 6.6 Bag refill valve connector. 26
28 6.7 Oxygen inlet connection . 26
29 6.8 Pressure gauge (manometer) connector . 27
30 7 Operational requirements . 27
31 7.1 Dismantling and reassembly . 27
32 7.2 Resuscitator performance after contamination with vomitus . 27
33 7.3 Mechanical shock-drop test . 28
34 7.4 Resistance to separation from an axial load . 29
35 7.4.1 Multiple patient multiple use resuscitators. 29
36 7.4.2 Single use and single patient multiple use resuscitators . 29
37 7.5 Immersion in water . 30
38 7.6 Bag refill valve . 31
39 7.7 Materials of construction . 31
40 8 Ventilatory requirements . 31
41 8.1 Supplementary oxygen and delivered oxygen concentration . 31
42 8.1.1 Non-spontaneously breathing patient . 31
43 8.1.2 Spontaneously breathing patient . 34
44 8.2 Expiratory resistance . 36
45 8.2.1 Expiratory resistance-without BSF . 36
46 8.2.2 Expiratory resistance-with BSF . 37
47 8.3 Inspiratory resistance . 37
48 8.3.1 Inspiratory resistance-without BSF . 37
49 8.3.2 Inspiratory resistance-with BSF . 38
© ISO 2021 – All rights reserved iii
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oSIST prEN ISO 10651-4:2021
ISO 10651-4:2021(E)
50 8.4 Gas source excessive flow protection device . 38
51 8.5 Resuscitator deadspace and rebreathing . 38
52 8.6 Ventilation performance . 39
53 8.6.1 Minimum guaranteed tidal volume (V ) . 39
T
54 8.6.2 Minimum guaranteed tidal volume (V ) at 30 mm compression . 40
T
55 8.6.3 Maximum guaranteed tidal volume (V ) . 41
T
56 8.6.4 Maximum limited pressure protection device . 42
57 9 Requirements for additional resuscitator functions or accessories . 43
58 9.1 General . 43
59 9.2 Labelling. 43
60 9.3 Breathing system filters . 44
61 9.4 Stand-alone gas mixer . 44
62 10 Processing requirements for a resuscitator and its accessories that are reusable . 44
63 11 Biocompatibility . 45
64 12 Usability . 45
65 Annex A (informative) Particular guidance and rationale . 47
66 A.1 General guidance . 47
67 A.2 Rationale for particular clauses and subclauses . 47
68 Annex B (informative) Guide to marking and labelling requirements for resuscitators
69 and their accessories . 54
70 B.1 Marking on the outside of a resuscitator and its accessories . 54
71 B.2 Accompanying information of a resuscitator and its accessories . 54
72 B.3 Instructions for use of a resuscitator and its accessories . 54
73 B.4 Technical description of a resuscitator and its accessories . 55
74 Annex C (informative) Symbols on marking . 57
75 Annex D (informative) Reference to the IMDRF essential principles and labelling guidances . 60
76 Annex E (informative) Reference to the essential principles . 62
77 Annex F (informative) Reference to the general safety and performance requirements . 64
78 Bibliography . 66
79 Terminology — Alphabetized index of defined terms . 69
80
81 Figures
82 Figure 1 — 32 mm ring and plug gauges . 26
83 Figure 2 — Example non-spontaneous breathing ventilatory performance
84 test setup . 33
85 Figure 3 — Spontaneous breathing ventilatory performance test setup . 35
86 Figure 4 — Maximum hand dimensions . 40
87
iv © ISO 2021 – All rights reserved
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oSIST prEN ISO 10651-4:2021
ISO 10651-4:2021(E)
88 Tables
89 Table 1 — Test conditions for ventilatory performance . 22
90 Table 2 — Example test conditions for spontaneous breathing ventilatory performance . 36
91 Table 3 — Test conditions for maximum guaranteed tidal volume . 42
92 Table B.1 — Marking on the of a resuscitator and its accessories . 54
93 Table B.2 — Accompanying information of the resuscitator and its accessories . 54
94 Table B.3 — Instructions for use of the resuscitator and its accessories . 55
95 Table B.4 — Technical description of a resuscitator and its accessories . 56
96 Table C.1 —Symbols on marking . 57
97 Table D.1 — Correspondence between this document and the IMDRF
98 essential principles . 60
99 Table E.1 — Correspondence between this document and the essential
100 principles . 62
101 Table F.1 — Correspondence between this document and the general safety
102 and performance requirements . 64
103
© ISO 2021 – All rights reserved v
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oSIST prEN ISO 10651-4:2021
ISO 10651-4:2021(E)
104 Foreword
105 ISO (the International Organization for Standardization) is a worldwide federation of national standards
106 bodies (ISO member bodies). The work of preparing International Standards is normally carried out
107 through ISO technical committees. Each member body interested in a subject for which a technical
108 committee has been established has the right to be represented on that committee. International
109 organizations, governmental and non-governmental, in liaison with ISO, also take part in the work. ISO
110 collaborates closely with the International Electrotechnical Commission (IEC) on all matters of
111 electrotechnical standardization.
112 The procedures used to develop this document and those intended for its further maintenance are
113 described in the ISO/IEC Directives, Part 1. In particular, the different approval criteria needed for the
114 different types of ISO documents should be noted. This document was drafted in accordance with the
115 editorial rules of the ISO/IEC Directives, Part 2 (see www.iso.org/directives).
116 Attention is drawn to the possibility that some of the elements of this document may be the subject of
117 patent rights. ISO shall not be held responsible for identifying any or all such patent rights. Details of any
118 patent rights identified during the development of the document will be in the Introduction and/or on
119 the ISO list of patent declarations received (see www.iso.org/patents).
120 Any trade name used in this document is information given for the convenience of users and does not
121 constitute an endorsement.
122 For an explanation of the voluntary nature of standards, the meaning of ISO specific terms and
123 expressions related to conformity assessment, as well as information about ISO's adherence to the World
124 Trade Organization (WTO) principles in the Technical Barriers to Trade (TBT), see
125 www.iso.org/iso/foreword.html.
126 This document was prepared by Technical Committee ISO/TC 121, Anaesthetic and respiratory
127 equipment, Subcommittee SC 3, Respiratory devices and related equipment used for patient care.
1
[7]
128 This second edition cancels and replaces the first edition (ISO 10651-4:2002 ), which has been
129 technically revised.
130 The main changes compared to the previous edition are as follows:
131 — clarified scope and indicated that the requirements include specified accessories;
132 — normative references updated from ENs to current ISO standards;
133 — updated defined terms to be consistent with current ISO standards;
134 — specified test conditions;
135 — specified calculation and disclosure of measurement uncertainty;
136 — harmonized storage and operating environmental conditions with current ISO standards;
137 — added requirements for shelf-life and expected lifetime;
138 — harmonized information supplied by the manufacturer with ISO 20417 and ISO 15223-1;
1
Figures in square brackets refer to the Bibliography.
vi © ISO 2021 – All rights reserved
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oSIST prEN ISO 10651-4:2021
ISO 10651-4:2021(E)
139 — added requirements for the oxygen inlet connector;
140 — clarified ventilatory testing requirements;
141 — clarified delivered oxygen concentration performance requirements;
142 — added processing requirements;
143 — added biocompatibility requirements;
144 — added usability requirements;
145 A list of all parts in the ISO 10651 series can be found on the ISO website.
146 Any feedback or questions on this document should be directed to the user’s national standards body. A
147 complete listing of these bodies can be found at www.iso.org/members.html.
© ISO 2021 – All rights reserved vii
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oSIST prEN ISO 10651-4:2021
ISO 10
...
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