SIST EN ISO 10651-5:2021
(Main)Lung ventilators for medical use - Particular requirements for basic safety and essential performance - Part 5: Gas-powered emergency resuscitators (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)
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.
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)
General Information
Standards Content (Sample)
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.
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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
2
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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.
3
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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)
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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
V
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
V
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
---------------------- Page: 2 ----------------------
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)
PDF disclaimer
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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
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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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oSIST prEN 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]
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oSIST prEN 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
V
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
V
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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oSIST prEN 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.
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oSIST prEN 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.
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oSIST prEN 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 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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oSIST prEN ISO 10651-5:2021
ISO 10651-5:2006(E)
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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oSIST prEN ISO 10651-5:2021
ISO 10651-5:2006(E)
5.2.2 Connection to the high-pressure gas input port
The
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