Lung ventilators for medical use - Particular requirements for basic safety and essential performance - Part 5: Gas-powered emergency resuscitators (ISO 10651-5:2006)

ISO 10651-5:2006 specifies the basic safety and essential performance requirements for gas-powered emergency resuscitators intended for use with humans by first responders. This equipment is intended for emergency field use and is intended to be continuously operator attended in normal use.
ISO 10651-5:2006 also specifies the requirements for resuscitator sets.
ISO 10651-5:2006 is not applicable to electrically-powered resuscitators.

Beatmungsgeräte für die medizinische Anwendung - Besondere Festlegungen für die grundlegende Sicherheit einschließlich der wesentlichen Leistungsmerkmale - Teil 5: Gasbetriebene Notfall-Wiederbelebungsgeräte (ISO 10651-5:2006)

Dieser Teil von ISO 10651 legt die grundlegenden Sicherheits- und Leistungsanforderungen für gasbetriebene Notfall-Wiederbelebungsgeräte (3.10) fest, die für die Verwendung am Menschen durch Ersthelfer vorgesehen sind. Das Gerät ist für den Notfalleinsatz im Freien vorgesehen und sollte beim bestimmungsgemäßen Gebrauch ständig vom Bediener betrieben werden.
Dieser Teil von ISO 10651 legt außerdem die Anforderungen an Wiederbelebungsgeräte-Sätze (3.22) fest.
Dieser Teil von ISO 10651 ist nicht für elektrisch betriebene Wiederbelebungsgeräte anwendbar.
ANMERKUNG   ISO 10651 3 deckt Notfall- und Transportbeatmungsgeräte ab.

Ventilateurs pulmonaires à usage médical - Exigences particulières pour la sécurité de base et les performances essentielles - Partie 5: Appareils de réanimation d'urgence alimentés par gaz (ISO 10651-5:2006)

La présente partie de l’ISO 10651 spécifie les exigences particulières pour la sécurité de base et les performances essentielles applicables aux ressuscitateurs d’urgence alimentés par gaz (3.10) destinés à être utilisés sur les personnes par les premiers intervenants. Cet appareil est destiné à une utilisation d’urgence sur le terrain et est destiné à être surveillé en permanence par un opérateur en utilisation normale.
La présente partie de l’ISO 10651 spécifie également les exigences applicables aux ensembles ressuscitateurs (3.22).
La présente partie de l’ISO 10651 ne s’applique pas aux ressuscitateurs alimentés électriquement.
NOTE            L’ISO 10651‑3 couvre les ventilateurs de secours et de transport.

Pljučni ventilatorji za uporabo v medicini - Posebne zahteve za osnovno varnost in bistvene lastnosti - 5. del: Naprave na plin za oživljanje za nujne primere (ISO 10651-5:2006)

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04-Aug-2021
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04-Aug-2021

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SLOVENSKI STANDARD
SIST EN ISO 10651-5:2021
01-september-2021

Pljučni ventilatorji za uporabo v medicini - Posebne zahteve za osnovno varnost in

bistvene lastnosti - 5. del: Naprave na plin za oživljanje za nujne primere (ISO
10651-5:2006)

Lung ventilators for medical use - Particular requirements for basic safety and essential

performance - Part 5: Gas-powered emergency resuscitators (ISO 10651-5:2006)
Beatmungsgeräte für die medizinische Anwendung - Besondere Festlegungen für die

grundlegende Sicherheit einschließlich der wesentlichen Leistungsmerkmale - Teil 5:

Gasbetriebene Notfall-Wiederbelebungsgeräte (ISO 10651 5:2006)

Ventilateurs pulmonaires à usage médical - Exigences particulières pour la sécurité de

base et les performances essentielles - Partie 5: Appareils de réanimation d'urgence

alimentés par gaz (ISO 10651-5:2006)
Ta slovenski standard je istoveten z: EN ISO 10651-5:2021
ICS:
11.040.10 Anestezijska, respiratorna in Anaesthetic, respiratory and
reanimacijska oprema reanimation equipment
SIST EN ISO 10651-5:2021 en,fr,de

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

---------------------- Page: 1 ----------------------
SIST EN ISO 10651-5:2021
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SIST EN ISO 10651-5:2021
EN ISO 10651-5
EUROPEAN STANDARD
NORME EUROPÉENNE
August 2021
EUROPÄISCHE NORM
ICS 11.040.10
English Version
Lung ventilators for medical use - Particular requirements
for basic safety and essential performance - Part 5: Gas-
powered emergency resuscitators (ISO 10651-5:2006)

Ventilateurs pulmonaires à usage médical - Exigences Beatmungsgeräte für die medizinische Anwendung -

particulières pour la sécurité de base et les Besondere Festlegungen für die grundlegende

performances essentielles - Partie 5: Appareils de Sicherheit einschließlich der wesentlichen

réanimation d'urgence alimentés par gaz (ISO 10651- Leistungsmerkmale - Teil 5: Gasbetriebene Notfall-

5:2006) Wiederbelebungsgeräte (ISO 10651 5:2006)
This European Standard was approved by CEN on 18 July 2021.

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, Turkey and

United Kingdom.
EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION
EUROPÄISCHES KOMITEE FÜR NORMUNG
CEN-CENELEC Management Centre: Rue de la Science 23, B-1040 Brussels

© 2021 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 10651-5:2021 E

worldwide for CEN national Members.
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SIST EN ISO 10651-5:2021
EN ISO 10651-5:2021 (E)
Contents Page

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

---------------------- Page: 4 ----------------------
SIST EN ISO 10651-5:2021
EN ISO 10651-5:2021 (E)
European foreword

The text of ISO 10651-5:2006 has been prepared by Technical Committee ISO/TC 121 "Anaesthetic and

respiratory equipment” of the International Organization for Standardization (ISO) and has been taken

over as EN ISO 10651-5:2021 by 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 February 2022, and conflicting national standards

shall be withdrawn at the latest by February 2022.

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.

Any feedback and questions on this document should be directed to the users’ national standards body.

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, Turkey and the

United Kingdom.
Endorsement notice

The text of ISO 10651-5:2006 has been approved by CEN as EN ISO 10651-5:2021 without any

modification.
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SIST EN ISO 10651-5:2021
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SIST EN ISO 10651-5:2021
INTERNATIONAL ISO
STANDARD 10651-5
First edition
2006-02-01
Lung ventilators for medical use —
Particular requirements for basic safety
and essential performance —
Part 5:
Gas-powered emergency resuscitators
Ventilateurs pulmonaires à usage médical — Exigences particulières
pour la sécurité de base et les performances essentielles —
Partie 5: Appareils de réanimation d'urgence alimentés par gaz
Reference number
ISO 10651-5:2006(E)
ISO 2006
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SIST EN ISO 10651-5:2021
ISO 10651-5:2006(E)
PDF disclaimer

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© ISO 2006

All rights reserved. Unless otherwise specified, no part of this publication may be reproduced or utilized in any form or by any means,

electronic or mechanical, including photocopying and microfilm, without permission in writing from either ISO at the address below or

ISO's member body in the country of the requester.
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Published in Switzerland
ii © ISO 2006 – All rights reserved
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SIST EN ISO 10651-5:2021
ISO 10651-5:2006(E)
Contents Page

Foreword............................................................................................................................................................ iv

Introduction ........................................................................................................................................................ v

1 * Scope.................................................................................................................................................. 1

2 Normative references ........................................................................................................................... 1

3 Terms and definitions........................................................................................................................... 2

4 General requirements........................................................................................................................... 4

4.1 General................................................................................................................................................... 4

4.2 Other test methods............................................................................................................................... 5

4.3 Acceptance criteria............................................................................................................................... 5

5 Constructional requirements............................................................................................................... 6

5.1 General................................................................................................................................................... 6

5.2 Connectors ............................................................................................................................................ 7

6 Operational requirements .................................................................................................................... 9

6.1 General................................................................................................................................................... 9

6.2 Resistance to environmental influences..........................................................................................10

6.3 Resistance to typical use................................................................................................................... 10

6.4 Size and mass ..................................................................................................................................... 11

6.5 Gas supply........................................................................................................................................... 11

7 Performance ........................................................................................................................................ 12

7.1 Ventilatory requirements ................................................................................................................... 12

7.2 * Ventilation performance ................................................................................................................. 14

8 Identification, marking and documents............................................................................................ 17

8.1 General................................................................................................................................................. 17

8.2 Marking ................................................................................................................................................ 18

8.3 Information provided by the manufacturer for operation and maintenance ................................ 19

Annex A (informative) Rationale ..................................................................................................................... 23

Annex B (normative) Test methods................................................................................................................ 28

Annex C (informative) Relationship between this part of ISO 10651 and cardiopulmonary

resuscitation guidelines..................................................................................................................... 40

Annex D (informative) Clauses of this part of ISO 10651 addressing the essential principles................ 41

Annex E (informative) Terminology — Index of defined terms.................................................................... 43

Bibliography ..................................................................................................................................................... 45

© ISO 2006 – All rights reserved iii
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SIST EN ISO 10651-5:2021
ISO 10651-5:2006(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.

International Standards are drafted in accordance with the rules given in the ISO/IEC Directives, Part 2.

The main task of technical committees is to prepare International Standards. Draft International Standards

adopted by the technical committees are circulated to the member bodies for voting. Publication as an

International Standard requires approval by at least 75 % of the member bodies casting a vote.

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.

ISO 10651-5 was prepared by Technical Committee ISO/TC 121, Anaesthetic and respiratory equipment,

Subcommittee SC 3, Lung ventilators and related equipment.

This first edition of ISO 10651-5, together with ISO 10651-4:2002, cancels and replaces ISO 8382:1988,

which has been technically revised.

ISO 10651 consists of the following parts, under the general title Lung ventilators for medical use — Particular

requirements for basic safety and essential performance:
⎯ Part 2: Home care ventilators for ventilator-dependent patients
⎯ Part 3: Particular requirements for emergency and transport ventilators
⎯ Part 4: Particular requirements for operator-powered resuscitators
⎯ Part 5: Gas-powered emergency resuscitators
⎯ Part 6: Home-care ventilatory support devices

NOTE ISO 10651-1:1993, Lung ventilators for medical use — Part 1: Requirements, was withdrawn in 2001 and has

been revised as IEC 60601-2-12:2001, Medical electrical equipment — Part 2-12: Particular requirements for the safety of

lung ventilators — Critical care ventilators.
iv © ISO 2006 – All rights reserved
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SIST EN ISO 10651-5:2021
ISO 10651-5:2006(E)
Introduction

For victims whose lives are at risk from respiratory failure, in particular during cardiac arrest, resuscitation

councils and associations teach that the best ultimate outcome will be achieved if there is a continuous chain

of care starting with earliest possible bystander cardiopulmonary resuscitation and continuing until the

victim can be put under professional medical care. In order to improve the care possible at the early stages of

this chain, authorities and organizations are training non-specialized personnel in key situations, such as

where people congregate or where there are increased risks, so that they can be available to provide a higher

level of care with a minimum of delay.

There is a growing realization that the effectiveness of such intervention can be greatly enhanced by the use

of certain basic equipment, such as that which provides ventilation whilst avoiding mouth-to-mouth contact.

Simple, gas-powered emergency resuscitators can deliver controlled ventilation for this purpose and this

document specifies the criteria they are required to satisfy.
In this part of ISO 10651, the following symbols and notations are used:

⎯ requirements, compliance with which can be tested, and definitions: roman type;

⎯ notes, explanations, advice, introductions, general statements and references: smaller roman type;

⎯ test specifications: italic type;

⎯ terms defined in ISO 4135:2001, IEC 60601-1:1988 or in this part of ISO 10651: bold type.

Throughout this part of ISO 10651, text for which a rationale is provided in Annex A is indicated by an

asterisk (*).
© ISO 2006 – All rights reserved v
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SIST EN ISO 10651-5:2021
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SIST EN ISO 10651-5:2021
INTERNATIONAL STANDARD ISO 10651-5:2006(E)
Lung ventilators for medical use — Particular requirements for
basic safety and essential performance —
Part 5:
Gas-powered emergency resuscitators
1 * Scope

This part of ISO 10651 specifies the basic safety and essential performance requirements for gas-powered

emergency resuscitators (3.10) intended for use with humans by first responders. This equipment is

intended for emergency field use and is intended to be continuously operator attended in normal use.

This part of ISO 10651 also specifies the requirements for resuscitator sets (3.22).

This part of ISO 10651 is not applicable to electrically-powered resuscitators.
NOTE ISO 10651-3 covers emergency and transport ventilators.
2 Normative references

The following referenced documents are indispensable for the application 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.
ISO 31 (all parts), Quantities and units
ISO 32, Gas cylinders for medical use — Marking for identification of content

ISO 1000, SI units and recommendations for the use of their multiples and of certain other units

ISO 4135:2001, Anaesthetic and respiratory equipment — Vocabulary

ISO 5356-1, Anaesthetic and respiratory equipment — Conical connectors — Part 1: Cones and sockets

ISO 5356-2, Anaesthetic and respiratory equipment — Conical connectors — Part 2: Screw-threaded weight-

bearing connectors
ISO 5359, Low-pressure hose assemblies for use with medical gases

ISO 5367, Breathing tubes intended for use with anaesthetic apparatus and ventilators

ISO 9170-1, Terminal units for medical gas pipeline systems — Part 1: Terminal units for use with

compressed medical gases and vacuum

ISO 10297, Gas cylinders — Refillable gas cylinder valves — Specification and type testing

ISO 10524-1, Pressure regulators for use with medical gases — Part 1: Pressure regulators and pressure

regulators with flow-metering devices
© ISO 2006 – All rights reserved 1
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SIST EN ISO 10651-5:2021
ISO 10651-5:2006(E)

ISO 10524-3, Pressure regulators for use with medical gases — Part 3: Pressure regulators integrated with

cylinder valves
ISO 11607, Packaging for terminally sterilized medical devices

ISO 14971, Medical devices — Application of risk management to medical devices and Amendment 1:2003

ISO 15223:2000, Medical devices — Symbols to be used with medical device labels, labelling and information

to be supplied and Amendment 1:2002 and Amendment 2:2004

ISO 17664, Sterilization of medical devices — Information to be provided by the manufacturer for the

processing of resterilizable medical devices

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
IEC 60529:2001, Degrees of protection provided by enclosures (IP code)

IEC 60601-1:1988, Medical electrical equipment — Part 1: General requirements for safety and

Amendment 1:1991 and Amendment 2:1995
3 Terms and definitions

For the purposes of this document, the terms and definitions given in ISO 4135:2001, IEC 60601-1:1988 and

the following apply. For convenience, the sources of all defined terms used in this document are given in

Annex E.
3.1
accompanying documents

documents accompanying resuscitator or resuscitator sets and containing all important information for the

user, operator, installer or assembler of the resuscitator, particularly regarding safety

NOTE Adapted from IEC 60601-1:1988, definition 2.1.4.
3.2
automatic pressure-cycled resuscitator

resuscitator in which the cycling from the inspiratory phase to the expiratory phase occurs after attaining a

pressure determined by the control setting
3.3
automatic time-cycled resuscitator

resuscitator in which the cycling between the inspiratory phase and expiratory phase is controlled

automatically at time intervals determined by the control setting
3.4
automatic volume-cycled resuscitator

resuscitator in which the cycling from the inspiratory phase to the expiratory phase occurs after the

delivery of a delivered volume determined by the control setting
3.5
cardiopulmonary resuscitation

combination of rescue breathing and chest compressions delivered to victims thought to be in cardiac arrest

[AHA Guidelines for Cardiopulmonary Resuscitation and Emergency Care]
2 © ISO 2006 – All rights reserved
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SIST EN ISO 10651-5:2021
ISO 10651-5:2006(E)
3.6
clearly legible

capable of being read by the operator or other relevant person with normal vision

NOTE See also 8.2.1.
3.7
* delivered volume
del

volume of gas delivered through the patient connection port during an inspiratory phase

3.8
demand valve

part of the resuscitator that delivers a flow of gas related to a reduction of pressure generated by the patient

at the patient connection port
3.9
first responder

individual who has been trained to provide primary response to a respiratory emergency

EXAMPLE 1 Fire fighter.
EXAMPLE 2 Emergency medical technician.
3.10
gas-powered emergency resuscitator
resuscitator

portable equipment, powered by compressed gas, intended for immediate use to provide lung ventilation in

the resuscitation of individuals who have sudden breathing difficulties
3.11
inadvertent positive end-expiratory pressure
inadvertent PEEP

unintended positive pressure at the patient connection port at the end of the expiratory phase

3.12
intermediate hose
hose that conducts gas between parts of the resuscitator
3.13
manually-cycled resuscitator

resuscitator in which the inspiratory phase and expiratory phase are controlled by a repeated manual

action of the operator

NOTE A demand valve that can be overridden with a manual trigger is, for the purposes of this document, classified

as a 'manually-cycled resuscitator incorporating a demand valve' and not as a 'demand valve' as they are commonly

termed in some countries.
3.14
minute volume
volume of gas per minute entering or leaving the patient’s lungs
3.15
operator
person handling the resuscitator
NOTE Adapted from IEC 60601-1:1988, definition 2.12.17.
© ISO 2006 – All rights reserved 3
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SIST EN ISO 10651-5:2021
ISO 10651-5:2006(E)
3.16
patient-triggered resuscitator

resuscitator in which the cycling from the expiratory phase to the inspiratory phase is triggered by an

inspiratory effort of the patient
3.17
patient-triggering

mode of operation in which a reduction of pressure generated by the patient at the patient connection port

initiates the set inspiratory phase
3.18
patient valve

valve in the resuscitator breathing system that directs gas into the lungs during the inspiratory phase and

from the lungs into the atmosphere during the expiratory phase
3.19
pressure-limiting device
means for limiting the maximum pressure within the resuscitator breathing system
3.20
resuscitator breathing system

breathing system bounded by the low-pressure gas input port(s), the gas intake port(s) and the patient

connection port, together with the fresh gas intake port and exhaust port(s), if these are provided

3.21
resuscitator dead space

volume of previously exhaled gas within the resuscitator breathing system that is delivered to the patient in

the succeeding inspiratory phase
3.22
resuscitator set

pack of all the necessary components that enable the resuscitator to be carried to the site of a resuscitation

emergency and that enable the resuscitator to be made ready for immediate use
3.23
safety hazard

potentially detrimental effect on the patient, other persons, animals, or the surroundings, arising directly from

the resuscitator
NOTE Adapted from IEC 60601-1:1988, definition 2.12.18.
3.24
single fault condition

condition in which a single means for protection against a safety hazard in the resuscitator is defective or a

single external abnormal condition is present
NOTE Adapted from IEC 60601-1:1988, definition 2.10.11.
4 General requirements
4.1 General

The resuscitator shall, when transported, stored, installed, operated in normal use, and maintained

according to the accompanying documents, cause no safety hazard that could reasonably be foreseen and

that is not connected with its intended application, in normal condition and in single fault condition.

A risk management process complying with ISO 14971 shall be performed.
4 © ISO 2006 – All rights reserved
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SIST EN ISO 10651-5:2021
ISO 10651-5:2006(E)
In applying ISO 14971:
a) the term “medical device” shall assume the same meaning as resuscitator;

b) the term “fault conditions” referred to in ISO 14971 shall include, but shall not be limited to, single fault

conditions identified in this part of ISO 10651;

c) where this part of ISO 10651 specifies measurable requirements addressing particular risks, and these

requirements are complied with, the residual risks of these requirements shall be presumed to be

acceptable unless there is objective evidence to the contrary.

This part of ISO 10651 specifies requirements that are generally applicable to risks associated with

resuscitators, and is intended to serve as a tool during the risk management process. The risk

management process identifies not only those safety hazards addressed by this part of ISO 10651, but also

all safety hazards, their associated risks and risk control measures.

Conditions or faults that can give rise to safety hazards are identified in the clauses of this part of ISO 10651.

In these cases, it will often be necessary to carry out a risk management process to determine what the

actual safety hazards are and the tests that need to be done to show that the identified safety hazards do

not arise in the specified circumstance.

It is recognized that the manufacturer might not be able to follow all the processes identified in this part of

ISO 10651 for each constituent component of the resuscitator, such as proprietary components, subsystems

of non-medical origin, and legacy parts. In this case, the manufacturer should take special account of the need

for additional risk control measures.

Where requirements of this part of ISO 10651 refer to freedom from unacceptable risk, the manufacturer, in

accordance with the manufacturer’s policy for determining acceptable risk, determines the acceptability or

unacceptability of this risk.

Check compliance by inspection of the risk management file. The requirements of this clause and all

requirements of this part of ISO 10651 referring to inspection of the risk management file are considered to

be satisfied if the manufacturer has
⎯ established a risk management process,
⎯ established acceptable levels of risk, and

⎯ demonstrated that the residual risk is acceptable (in accordance with the policy for determining

acceptable risk).
4.2 Other test methods

The manufacturer may use type tests different from those detailed within this part of ISO 10651 if an

equivalent degree of safety is obtained. However, in the event of dispute, the methods specified herein shall

be used as the reference methods.
4.3 Acceptance criteria

Many of the test clauses within this part of ISO 10651 establish acceptance criteria for performance aspects.

These acceptance criteria shall always be met.

When the manufacturer chooses to specify in the accompanying documents higher performance levels than

those specified within this part of ISO 10651, these manufacturer-specified levels become the acceptance

levels and shall also be met.
© ISO 2006 – All rights reserved 5
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SIST EN ISO 10651-5:2021
ISO 10651-5:2006(E)
5 Constructional requirements
5.1 General
5.1.1 Materials of construction

All gas conducting parts shall be constructed from materials selected to take into account the chemical and

physical properties of any substances that the accompanying documents indicate:
⎯ can be administered through the resuscitator, and
⎯ can be used to clean and disinfect or sterilize the resuscitator.
Check compliance by inspection of the risk management file.
5.1.2 Surfaces, corners and edges

Rough surfaces, sharp corners, open ends of tubular components and edges that can cause injury or damage

shall be avoided or covered. Particular attention shall be paid to the removal of burrs.

Check compliance by inspection.
5.1.3 Leaching of substances
The resuscitator and parts thereof
...

SLOVENSKI STANDARD
oSIST prEN ISO 10651-5:2021
01-junij-2021

Pljučni ventilatorji za uporabo v medicini - Posebne zahteve za osnovno varnost in

bistvene lastnosti - 5. del: Naprave na plin za oživljanje za nujne primere (ISO
10651-5:2006)

Lung ventilators for medical use - Particular requirements for basic safety and essential

performance - Part 5: Gas-powered emergency resuscitators (ISO 10651-5:2006)
Beatmungsgeräte für die medizinische Anwendung - Besondere Festlegungen für die

grundlegende Sicherheit einschließlich der wesentlichen Leistungsmerkmale - Teil 5:

Gasbetriebene Notfall-Wiederbelebungsgeräte (ISO 10651 5:2006)

Ventilateurs pulmonaires à usage médical - Exigences particulières pour la sécurité de

base et les performances essentielles - Partie 5: Appareils de réanimation d'urgence

alimentés par gaz (ISO 10651-5:2006)
Ta slovenski standard je istoveten z: prEN ISO 10651-5
ICS:
11.040.10 Anestezijska, respiratorna in Anaesthetic, respiratory and
reanimacijska oprema reanimation equipment
oSIST prEN ISO 10651-5:2021 en,fr,de

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

---------------------- Page: 1 ----------------------
oSIST prEN ISO 10651-5:2021
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oSIST prEN ISO 10651-5:2021
INTERNATIONAL ISO
STANDARD 10651-5
First edition
2006-02-01
Lung ventilators for medical use —
Particular requirements for basic safety
and essential performance —
Part 5:
Gas-powered emergency resuscitators
Ventilateurs pulmonaires à usage médical — Exigences particulières
pour la sécurité de base et les performances essentielles —
Partie 5: Appareils de réanimation d'urgence alimentés par gaz
Reference number
ISO 10651-5:2006(E)
ISO 2006
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oSIST prEN ISO 10651-5:2021
ISO 10651-5:2006(E)
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© ISO 2006

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ii © ISO 2006 – All rights reserved
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oSIST prEN ISO 10651-5:2021
ISO 10651-5:2006(E)
Contents Page

Foreword............................................................................................................................................................ iv

Introduction ........................................................................................................................................................ v

1 * Scope.................................................................................................................................................. 1

2 Normative references ........................................................................................................................... 1

3 Terms and definitions........................................................................................................................... 2

4 General requirements........................................................................................................................... 4

4.1 General................................................................................................................................................... 4

4.2 Other test methods............................................................................................................................... 5

4.3 Acceptance criteria............................................................................................................................... 5

5 Constructional requirements............................................................................................................... 6

5.1 General................................................................................................................................................... 6

5.2 Connectors ............................................................................................................................................ 7

6 Operational requirements .................................................................................................................... 9

6.1 General................................................................................................................................................... 9

6.2 Resistance to environmental influences..........................................................................................10

6.3 Resistance to typical use................................................................................................................... 10

6.4 Size and mass ..................................................................................................................................... 11

6.5 Gas supply........................................................................................................................................... 11

7 Performance ........................................................................................................................................ 12

7.1 Ventilatory requirements ................................................................................................................... 12

7.2 * Ventilation performance ................................................................................................................. 14

8 Identification, marking and documents............................................................................................ 17

8.1 General................................................................................................................................................. 17

8.2 Marking ................................................................................................................................................ 18

8.3 Information provided by the manufacturer for operation and maintenance ................................ 19

Annex A (informative) Rationale ..................................................................................................................... 23

Annex B (normative) Test methods................................................................................................................ 28

Annex C (informative) Relationship between this part of ISO 10651 and cardiopulmonary

resuscitation guidelines..................................................................................................................... 40

Annex D (informative) Clauses of this part of ISO 10651 addressing the essential principles................ 41

Annex E (informative) Terminology — Index of defined terms.................................................................... 43

Bibliography ..................................................................................................................................................... 45

© ISO 2006 – All rights reserved iii
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oSIST prEN ISO 10651-5:2021
ISO 10651-5:2006(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.

International Standards are drafted in accordance with the rules given in the ISO/IEC Directives, Part 2.

The main task of technical committees is to prepare International Standards. Draft International Standards

adopted by the technical committees are circulated to the member bodies for voting. Publication as an

International Standard requires approval by at least 75 % of the member bodies casting a vote.

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.

ISO 10651-5 was prepared by Technical Committee ISO/TC 121, Anaesthetic and respiratory equipment,

Subcommittee SC 3, Lung ventilators and related equipment.

This first edition of ISO 10651-5, together with ISO 10651-4:2002, cancels and replaces ISO 8382:1988,

which has been technically revised.

ISO 10651 consists of the following parts, under the general title Lung ventilators for medical use — Particular

requirements for basic safety and essential performance:
⎯ Part 2: Home care ventilators for ventilator-dependent patients
⎯ Part 3: Particular requirements for emergency and transport ventilators
⎯ Part 4: Particular requirements for operator-powered resuscitators
⎯ Part 5: Gas-powered emergency resuscitators
⎯ Part 6: Home-care ventilatory support devices

NOTE ISO 10651-1:1993, Lung ventilators for medical use — Part 1: Requirements, was withdrawn in 2001 and has

been revised as IEC 60601-2-12:2001, Medical electrical equipment — Part 2-12: Particular requirements for the safety of

lung ventilators — Critical care ventilators.
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oSIST prEN ISO 10651-5:2021
ISO 10651-5:2006(E)
Introduction

For victims whose lives are at risk from respiratory failure, in particular during cardiac arrest, resuscitation

councils and associations teach that the best ultimate outcome will be achieved if there is a continuous chain

of care starting with earliest possible bystander cardiopulmonary resuscitation and continuing until the

victim can be put under professional medical care. In order to improve the care possible at the early stages of

this chain, authorities and organizations are training non-specialized personnel in key situations, such as

where people congregate or where there are increased risks, so that they can be available to provide a higher

level of care with a minimum of delay.

There is a growing realization that the effectiveness of such intervention can be greatly enhanced by the use

of certain basic equipment, such as that which provides ventilation whilst avoiding mouth-to-mouth contact.

Simple, gas-powered emergency resuscitators can deliver controlled ventilation for this purpose and this

document specifies the criteria they are required to satisfy.
In this part of ISO 10651, the following symbols and notations are used:

⎯ requirements, compliance with which can be tested, and definitions: roman type;

⎯ notes, explanations, advice, introductions, general statements and references: smaller roman type;

⎯ test specifications: italic type;

⎯ terms defined in ISO 4135:2001, IEC 60601-1:1988 or in this part of ISO 10651: bold type.

Throughout this part of ISO 10651, text for which a rationale is provided in Annex A is indicated by an

asterisk (*).
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oSIST prEN ISO 10651-5:2021
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oSIST prEN ISO 10651-5:2021
INTERNATIONAL STANDARD ISO 10651-5:2006(E)
Lung ventilators for medical use — Particular requirements for
basic safety and essential performance —
Part 5:
Gas-powered emergency resuscitators
1 * Scope

This part of ISO 10651 specifies the basic safety and essential performance requirements for gas-powered

emergency resuscitators (3.10) intended for use with humans by first responders. This equipment is

intended for emergency field use and is intended to be continuously operator attended in normal use.

This part of ISO 10651 also specifies the requirements for resuscitator sets (3.22).

This part of ISO 10651 is not applicable to electrically-powered resuscitators.
NOTE ISO 10651-3 covers emergency and transport ventilators.
2 Normative references

The following referenced documents are indispensable for the application 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.
ISO 31 (all parts), Quantities and units
ISO 32, Gas cylinders for medical use — Marking for identification of content

ISO 1000, SI units and recommendations for the use of their multiples and of certain other units

ISO 4135:2001, Anaesthetic and respiratory equipment — Vocabulary

ISO 5356-1, Anaesthetic and respiratory equipment — Conical connectors — Part 1: Cones and sockets

ISO 5356-2, Anaesthetic and respiratory equipment — Conical connectors — Part 2: Screw-threaded weight-

bearing connectors
ISO 5359, Low-pressure hose assemblies for use with medical gases

ISO 5367, Breathing tubes intended for use with anaesthetic apparatus and ventilators

ISO 9170-1, Terminal units for medical gas pipeline systems — Part 1: Terminal units for use with

compressed medical gases and vacuum

ISO 10297, Gas cylinders — Refillable gas cylinder valves — Specification and type testing

ISO 10524-1, Pressure regulators for use with medical gases — Part 1: Pressure regulators and pressure

regulators with flow-metering devices
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ISO 10651-5:2006(E)

ISO 10524-3, Pressure regulators for use with medical gases — Part 3: Pressure regulators integrated with

cylinder valves
ISO 11607, Packaging for terminally sterilized medical devices

ISO 14971, Medical devices — Application of risk management to medical devices and Amendment 1:2003

ISO 15223:2000, Medical devices — Symbols to be used with medical device labels, labelling and information

to be supplied and Amendment 1:2002 and Amendment 2:2004

ISO 17664, Sterilization of medical devices — Information to be provided by the manufacturer for the

processing of resterilizable medical devices

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
IEC 60529:2001, Degrees of protection provided by enclosures (IP code)

IEC 60601-1:1988, Medical electrical equipment — Part 1: General requirements for safety and

Amendment 1:1991 and Amendment 2:1995
3 Terms and definitions

For the purposes of this document, the terms and definitions given in ISO 4135:2001, IEC 60601-1:1988 and

the following apply. For convenience, the sources of all defined terms used in this document are given in

Annex E.
3.1
accompanying documents

documents accompanying resuscitator or resuscitator sets and containing all important information for the

user, operator, installer or assembler of the resuscitator, particularly regarding safety

NOTE Adapted from IEC 60601-1:1988, definition 2.1.4.
3.2
automatic pressure-cycled resuscitator

resuscitator in which the cycling from the inspiratory phase to the expiratory phase occurs after attaining a

pressure determined by the control setting
3.3
automatic time-cycled resuscitator

resuscitator in which the cycling between the inspiratory phase and expiratory phase is controlled

automatically at time intervals determined by the control setting
3.4
automatic volume-cycled resuscitator

resuscitator in which the cycling from the inspiratory phase to the expiratory phase occurs after the

delivery of a delivered volume determined by the control setting
3.5
cardiopulmonary resuscitation

combination of rescue breathing and chest compressions delivered to victims thought to be in cardiac arrest

[AHA Guidelines for Cardiopulmonary Resuscitation and Emergency Care]
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3.6
clearly legible

capable of being read by the operator or other relevant person with normal vision

NOTE See also 8.2.1.
3.7
* delivered volume
del

volume of gas delivered through the patient connection port during an inspiratory phase

3.8
demand valve

part of the resuscitator that delivers a flow of gas related to a reduction of pressure generated by the patient

at the patient connection port
3.9
first responder

individual who has been trained to provide primary response to a respiratory emergency

EXAMPLE 1 Fire fighter.
EXAMPLE 2 Emergency medical technician.
3.10
gas-powered emergency resuscitator
resuscitator

portable equipment, powered by compressed gas, intended for immediate use to provide lung ventilation in

the resuscitation of individuals who have sudden breathing difficulties
3.11
inadvertent positive end-expiratory pressure
inadvertent PEEP

unintended positive pressure at the patient connection port at the end of the expiratory phase

3.12
intermediate hose
hose that conducts gas between parts of the resuscitator
3.13
manually-cycled resuscitator

resuscitator in which the inspiratory phase and expiratory phase are controlled by a repeated manual

action of the operator

NOTE A demand valve that can be overridden with a manual trigger is, for the purposes of this document, classified

as a 'manually-cycled resuscitator incorporating a demand valve' and not as a 'demand valve' as they are commonly

termed in some countries.
3.14
minute volume
volume of gas per minute entering or leaving the patient’s lungs
3.15
operator
person handling the resuscitator
NOTE Adapted from IEC 60601-1:1988, definition 2.12.17.
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ISO 10651-5:2006(E)
3.16
patient-triggered resuscitator

resuscitator in which the cycling from the expiratory phase to the inspiratory phase is triggered by an

inspiratory effort of the patient
3.17
patient-triggering

mode of operation in which a reduction of pressure generated by the patient at the patient connection port

initiates the set inspiratory phase
3.18
patient valve

valve in the resuscitator breathing system that directs gas into the lungs during the inspiratory phase and

from the lungs into the atmosphere during the expiratory phase
3.19
pressure-limiting device
means for limiting the maximum pressure within the resuscitator breathing system
3.20
resuscitator breathing system

breathing system bounded by the low-pressure gas input port(s), the gas intake port(s) and the patient

connection port, together with the fresh gas intake port and exhaust port(s), if these are provided

3.21
resuscitator dead space

volume of previously exhaled gas within the resuscitator breathing system that is delivered to the patient in

the succeeding inspiratory phase
3.22
resuscitator set

pack of all the necessary components that enable the resuscitator to be carried to the site of a resuscitation

emergency and that enable the resuscitator to be made ready for immediate use
3.23
safety hazard

potentially detrimental effect on the patient, other persons, animals, or the surroundings, arising directly from

the resuscitator
NOTE Adapted from IEC 60601-1:1988, definition 2.12.18.
3.24
single fault condition

condition in which a single means for protection against a safety hazard in the resuscitator is defective or a

single external abnormal condition is present
NOTE Adapted from IEC 60601-1:1988, definition 2.10.11.
4 General requirements
4.1 General

The resuscitator shall, when transported, stored, installed, operated in normal use, and maintained

according to the accompanying documents, cause no safety hazard that could reasonably be foreseen and

that is not connected with its intended application, in normal condition and in single fault condition.

A risk management process complying with ISO 14971 shall be performed.
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ISO 10651-5:2006(E)
In applying ISO 14971:
a) the term “medical device” shall assume the same meaning as resuscitator;

b) the term “fault conditions” referred to in ISO 14971 shall include, but shall not be limited to, single fault

conditions identified in this part of ISO 10651;

c) where this part of ISO 10651 specifies measurable requirements addressing particular risks, and these

requirements are complied with, the residual risks of these requirements shall be presumed to be

acceptable unless there is objective evidence to the contrary.

This part of ISO 10651 specifies requirements that are generally applicable to risks associated with

resuscitators, and is intended to serve as a tool during the risk management process. The risk

management process identifies not only those safety hazards addressed by this part of ISO 10651, but also

all safety hazards, their associated risks and risk control measures.

Conditions or faults that can give rise to safety hazards are identified in the clauses of this part of ISO 10651.

In these cases, it will often be necessary to carry out a risk management process to determine what the

actual safety hazards are and the tests that need to be done to show that the identified safety hazards do

not arise in the specified circumstance.

It is recognized that the manufacturer might not be able to follow all the processes identified in this part of

ISO 10651 for each constituent component of the resuscitator, such as proprietary components, subsystems

of non-medical origin, and legacy parts. In this case, the manufacturer should take special account of the need

for additional risk control measures.

Where requirements of this part of ISO 10651 refer to freedom from unacceptable risk, the manufacturer, in

accordance with the manufacturer’s policy for determining acceptable risk, determines the acceptability or

unacceptability of this risk.

Check compliance by inspection of the risk management file. The requirements of this clause and all

requirements of this part of ISO 10651 referring to inspection of the risk management file are considered to

be satisfied if the manufacturer has
⎯ established a risk management process,
⎯ established acceptable levels of risk, and

⎯ demonstrated that the residual risk is acceptable (in accordance with the policy for determining

acceptable risk).
4.2 Other test methods

The manufacturer may use type tests different from those detailed within this part of ISO 10651 if an

equivalent degree of safety is obtained. However, in the event of dispute, the methods specified herein shall

be used as the reference methods.
4.3 Acceptance criteria

Many of the test clauses within this part of ISO 10651 establish acceptance criteria for performance aspects.

These acceptance criteria shall always be met.

When the manufacturer chooses to specify in the accompanying documents higher performance levels than

those specified within this part of ISO 10651, these manufacturer-specified levels become the acceptance

levels and shall also be met.
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ISO 10651-5:2006(E)
5 Constructional requirements
5.1 General
5.1.1 Materials of construction

All gas conducting parts shall be constructed from materials selected to take into account the chemical and

physical properties of any substances that the accompanying documents indicate:
⎯ can be administered through the resuscitator, and
⎯ can be used to clean and disinfect or sterilize the resuscitator.
Check compliance by inspection of the risk management file.
5.1.2 Surfaces, corners and edges

Rough surfaces, sharp corners, open ends of tubular components and edges that can cause injury or damage

shall be avoided or covered. Particular attention shall be paid to the removal of burrs.

Check compliance by inspection.
5.1.3 Leaching of substances

The resuscitator and parts thereof shall be designed and manufactured to minimize health risks due to

substances leached from the resuscitator or its components during use. Particular attention shall be paid to

the toxicity of materials and their compatibility with substances and gases with which they enter into contact

during normal use.
Check compliance by inspection of the risk management file.
5.1.4 Breathing tubes

Breathing tubes with an internal diameter of more than 18 mm, intended for use in the resuscitator breathing

system, shall comply with ISO 5367.
Check compliance by application of the requirements of ISO 5367.
5.1.5 Supply of sterile components

If a claim is made in the labelling that a product is sterile, it shall have been sterilized using an appropriate,

validated method, as described in ISO 11134, ISO 11135, ISO 11137, ISO 11138, or ISO 14937.

The packaging for resuscitators or parts supplied sterile shall meet the requirements of ISO 11607. Such

packaging shall not be capable of re-closure without clearly revealing that it has been opened.

Non-sterile packaging systems shall be designed to maintain products that are intended to be sterilized before

use at their intended level of cleanliness and shall be designed to minimize the risk of microbial contamination.

Check compliance by a review of the accompanying documents for methods of sterilization and disinfection

and by inspection of the relevant validation reports.
5.1.6 * Breathing system filter

Any breathing system filter, either incorporated into the resuscitator or indicated in the accompanying

documents for use with the resuscitator, shall comply with the applicable parts of ISO 23328-1 and

ISO 23328-2.

Check compliance by application of the requirements of ISO 23328-1 and ISO 23328-2.

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5.1.7 Arrangement of functions

Any single fault condition shall not cause any monitoring or alarm system function, as specified in this part

of ISO 10651, and the corresponding ventilation control function to fail in such a way that the monitoring or

alarm system function becomes simultaneously ineffective, and thus fails to detect the loss of the monitored

resuscitator function.

Check compliance by simulation of a single fault condition and visual inspection.

5.1.8 Protection against accidental adjustments

Means of protection against accidental alteration of control settings, including the “on-off” switch, shall be

provided. Mechanical techniques such as locks, shielding, friction-loading and detents may be used.

Check compliance by visual inspection following the instructions for use.
5.1.9 Selector switches/controls

For controls that are not continuously variable, means shall be provided that prevent the selector from

remaining in an intermediate position.
EXAMPLE 1 An “on-off” switch.
EXAMPLE 2 An oxygen concentration selector.

EXAMPLE 3 A selector for preset, discrete values of delivered volume or frequency.

Check compliance by inspection.
5.1.10 Accuracy of operating data

While the resuscitator is in normal use, it shall deliver ventilation accuracy as indicated in the instructions for

use. See also 8.3.2.2.

Verify compliance, by means of the appropriate test methods described in this part of ISO 10651.

5.1.11 * Resuscitator set

The resuscitator shall be supplied with or the accompanying documents shall recommend a resuscitator

set, including a medical gas supply system that complies with the relevant requirements of this part of

ISO 10651.
Check compliance by inspection.
5.2 Connectors
5.2.1 Connection to the medical gas supply system

If a detachable hose assembly is provided for connection between the resuscitator and the medical gas

supply system, it shall comply with ISO 5359. If a hose assembly is permanently connected to the

resuscitator, the connection to the medical gas supply system shall be by means of:

⎯ either a probe complying with ISO 9170-1, or
⎯ a permanent connector.
NOTE A permanent connector is one that can be separated only by use of a tool.
Check compliance by inspection.
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ISO 10651-5:2006(E)
5.2.2 Connection to the high-pressure gas input port
The
...

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