SIST EN ISO 10651-4:2009

Lung ventilators - Part 4: Particular requirements for operator-powered resuscitators (ISO 10651-4:2002)

Pljučni ventilatorji - 4. del: Posebne zahteve za naprave za oživljanje, ki jih upravlja operater (ISO 10651-4:2002)

General Information

• Status: Published
• Technical Committee: COVID 19 - COVID 19 - ISO
• Directive: standardi COVID-19 - UPDATE ON THE AVAILABILITY OF CEN, CENELEC, ISO, IEC STANDARDS AND THEIR NATIONAL ADOPTIONS IN RESPONSE TO THE COVID-19 OUTBREAK

Standards Content (Sample)

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SLOVENSKI STANDARD
01-julij-2009
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SIST EN ISO 10651-4:2002
SIST EN ISO 10651-4:2002/AC:2006
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RSHUDWHU,62
Lung ventilators - Part 4: Particular requirements for operator-powered resuscitators (ISO
10651-4:2002)
Lungenbeatmungsgeräte - Teil 4: Anforderungen an anwenderbetriebene
Wiederbelebungsgeräte (Handbeatmungsgeräte) (ISO 10651-4:2002)
Ventilateurs pulmonaires - Partie 4: Exigences relatives aux ressuscitateurs à puissance
motrice manuelle (ISO 10651-4:2002)
Ta slovenski standard je istoveten z: EN ISO 10651-4:2009
ICS:
11.040.10 Anestezijska, respiratorna in Anaesthetic, respiratory and
reanimacijska oprema reanimation equipment
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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EUROPEAN STANDARD
EN ISO 10651-4
NORME EUROPÉENNE
EUROPÄISCHE NORM
April 2009
ICS 11.040.10 Supersedes EN ISO 10651-4:2002
English Version
Lung ventilators - Part 4: Particular requirements for operator-
powered resuscitators (ISO 10651-4:2002)
Ventilateurs pulmonaires - Partie 4: Exigences relatives aux Lungenbeatmungsgeräte - Teil 4: Anforderungen an
ressuscitateurs à puissance motrice manuelle (ISO 10651- anwenderbetriebene Wiederbelebungsgeräte
4:2002) (Handbeatmungsgeräte) (ISO 10651-4:2002)
This European Standard was approved by CEN on 21 March 2009.
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 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 Management Centre has the same status as the
official versions.
CEN members are the national standards bodies of Austria, Belgium, Bulgaria, Cyprus, Czech Republic, Denmark, Estonia, Finland,
France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal,
Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland and United Kingdom.
EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION
EUROPÄISCHES KOMITEE FÜR NORMUNG
Management Centre: Avenue Marnix 17, B-1000 Brussels
© 2009 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 10651-4:2009: E
worldwide for CEN national Members.

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EN ISO 10651-4:2009 (E)
Contents Page
Foreword .3
Annex ZA (Informative) Relationship between this European Standard and the Essential
Requirements of EU Directive 93/42/EEC .4

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EN ISO 10651-4:2009 (E)
Foreword
The text of ISO 10651-4:2002 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 10651-4:2009 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 October 2009, and conflicting national standards shall be withdrawn at
the latest by March 2010.
Attention is drawn to the possibility that some of the elements of this document may be the subject of patent
rights. CEN [and/or CENELEC] shall not be held responsible for identifying any or all such patent rights.
This document supersedes EN ISO 10651-4:2002.
This document has been prepared under a mandate given to CEN by the European Commission and the
European Free Trade Association, and supports essential requirements of EC Directive.
For relationship with EC Directive, see informative Annex ZA, which is an integral part of this document.
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, Cyprus, Czech
Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia,
Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain,
Sweden, Switzerland and the United Kingdom.
Endorsement notice
The text of ISO 10651-4:2002 has been approved by CEN as a EN ISO 10651-4:2009 without any
modification.
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EN ISO 10651-4:2009 (E)
Annex ZA
(Informative)
Relationship between this European Standard and the Essential
Requirements of EU Directive 93/42/EEC
This European Standard has been prepared under a mandate given to CEN by the European Commission
and the European Free Trade Association to provide a means of conforming to Essential Requirements of the
New Approach Directive 93/42/EEC on medical devices.
Once this standard is cited in the Official Journal of the European Communities under that Directive and has
been implemented as a national standard in at least one Member State, compliance with the clauses of this
standard given in Table ZA.1 confers, within the limits of the scope of this standard, a presumption of
conformity with the corresponding Essential Requirements of that Directive and associated EFTA regulations.

Table ZA.1 – Correspondence between this European Standard and EU Directives

Clause(s)/sub-clause(s) of this Essential Requirements (ERs) of Qualifying remarks/Notes
EN Directive 93/42/EEC
All 1 (1st paragraph), 2
4.1 3, 9.1
4.2 3, 9.1
4.3 3, 9.1
4.4 9.1
4.5 3, 9.1
4.6 3, 7.1, 7.6, 9.1
4.7 3, 7.3, 9.1
4, 5, 9, 10 1 (2nd paragraph, 1st dash) This relevant Essential
Requirement is not fully
addressed in this European
Standard
4, 5, 9, 10 1 (2nd paragraph, 2nd This relevant Essential
Requirement is not fully
dash)
addressed in this European
Standard
- 6a) This relevant Essential
Requirement is not addressed in

this European Standard
5.1 4, 9.2
5.2 3, 4, 9.2
5.3 3, 4, 7.6
5.4 3, 4, 5
5.5 4, 5
5.7 7.5 (1st paragraph) This relevant Essential
Requirement is not fully
addressed in this European
Standard
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EN ISO 10651-4:2009 (E)
Clause(s)/sub-clause(s) of this Essential Requirements (ERs) of Qualifying remarks/Notes
EN Directive 93/42/EEC
5.7 7.5 (2nd paragraph) This relevant Essential
Requirement is not fully
addressed in this European
Standard
- 7.5 (3rd paragraph) This relevant Essential
Requirement is not addressed in
this European Standard
6.1 3, 9.1
6.2 3, 9.2
6.3 3, 9.2
6.4 3, 9.1,
6.5 3, 7.5, 9.2
6.6 3, 9.2
6.7.1 3
6.7.2 3, 9.2, 12.8.2
7.1 3, 5, 9.2
7.2 3, 9.2
8.1 8.1, 8.3, 8.4, 8.5
8.2 8.1, 8.3, 8.4, 8.5
9 13.3 (a): This relevant Essential
Requirement is not fully
addressed in this European
Standard
9.1 2, 6, 13.1, 13.2
9.2 5, 9.2, 13.1, 13.2
9.3 13.3, 13.4
9, 10 13.3 (f) This relevant Essential
Requirement is not fully
addressed in this European
Standard
9, 10 13.6 (h)(2nd paragraph) This relevant Essential
Requirement is not fully
addressed in this European
Standard
10 9.3, 13.1, 13.2, 13.3, 13.4, 13.6
10 13.6 (q) This relevant Essential
Requirement is not addressed in
this European Standard
All other requirements are not applicable
to this standard
WARNING: Other requirements and other EU Directives may be applicable to the product(s) falling within the
scope of this standard.
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INTERNATIONAL ISO
STANDARD 10651-4
First edition
2002-03-01
Lung ventilators —
Part 4:
Particular requirements for operator-
powered resuscitators
Ventilateurs pulmonaires —
Partie 4 : Exigences relatives aux ressuscitateurs à puissance motrice
manuelle
Reference number
ISO 10651-4:2002(E)
©
ISO 2002
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ISO 10651-4:2002(E)
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ISO 10651-4:2002(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 3.
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 part of ISO 10651 may be the subject of
patent rights. ISO shall not be held responsible for identifying any or all such patent rights.
ISO 10651-4 was prepared by the European Committee for Standardization (CEN) in collaboration with Technical
Committee ISO/TC 121, Anaesthetic and respiratory equipment, Subcommittee SC 3, Lung ventilators and related
equipment, in accordance with the Agreement on technical cooperation between ISO and CEN (Vienna
Agreement).
Throughout the text of this document, read ".this European Standard." to mean ".this International Standard.".
ISO 10651 consists of the following parts, under the general title Lung ventilators:
— Part 1: Requirements
— Part 2: Particular requirements for home care ventilators
— Part 3: Particular requirements for emergency and transport ventilators
— Part 4: Particular requirements for operator-powered resuscitators
Annex A forms a normative part of this part of ISO 10651. Annex B is for information only.
For the purposes of this part of ISO 10651, the CEN annex regarding fulfilment of European Council Directives has
been removed.
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ISO 10651-4:2002(E)
Contents
Page
Foreword.v
1 Scope .1
2 Normative references .1
3 Terms and definitions.1
4 Connectors .3
5 Operational requirements .3
6 Ventilatory requirements.4
7 Storage and operating conditions.6
8 Requirements for resuscitator, or parts, supplied sterile .6
9 Marking .6
10 Information to be provided by the manufacturer in operating and maintenance instructions .7
Annex A (normative) Test methods.9
Annex B (informative) Rationale .19
Bibliography .22
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ISO 10651-4:2002(E)
Foreword
This document (EN ISO 10651-4:2002) has been prepared by Technical Committee CEN/TC 215 "Respiratory and
anaesthetic equipment", the secretariat of which is held by BSI, in collaboration with Technical Committee ISO/TC
121 "Anaesthetic and respiratory equipment".
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 September 2002, and conflicting national standards shall be withdrawn at the
latest by September 2002.
This document has been prepared under a mandate given to CEN by the European Commission and the European
Free Trade Association, and supports essential requirements of EU Directive(s).
Annex A is normative and form part of this European Standard.
Annex B is for information only.
According to the CEN/CENELEC Internal Regulations, the national standards organizations of the following
countries are bound to implement this European Standard : Austria, Belgium, Czech Republic, Denmark, Finland,
France, Germany, Greece, Iceland, Ireland, Italy, Luxembourg, Malta, Netherlands, Norway, Portugal, Spain,
Sweden, Switzerland and the United Kingdom.
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ISO 10651-4:2002(E)
1 Scope
This European Standard specifies requirements for operator-powered resuscitators intended for use with all age
groups and which are portable and intended to provide lung ventilation to individuals whose breathing is
inadequate. Operator-powered resuscitators for infants and children are designated according to body mass range
and approximate age equivalent.
Electrically- and gas-powered resuscitators are not covered by this European Standard.
NOTE Annex B contains rationale statements for this Part of this European Standard. The clauses and subclauses which
have corresponding rationale statements are marked with R) after their number.
2 Normative references
This European Standard incorporates by dated or undated reference, provisions from other publications. These
normative references are cited at the appropriate places in text and the publications are listed hereafter. For dated
references, subsequent amendments to or revisions of any of these publications apply to this European Standard
only when incorporated in it by amendment or revision. For undated references the latest edition of the publication
referred to applies (including amendments).
EN 148-1, Respiratory protective devices - Threads for facepieces –Part 1: Standard thread connection.
EN 556: 1994+A1:1998, Sterilization of medical devices - Requirements for terminally-sterilized medical devices to
be labelled “STERILE”.
EN 737-1, Medical gas pipeline systems - Part 1: Terminal units for compressed medical gases and vacuum.
EN 868-1, Packaging materials and systems for medical devices which are to be sterilized - Part 1: General
requirements and test methods .
EN 1041, Information supplied by the manufacturer with medical devices.
EN 1281-1, Anaesthetic and respiratory equipment - Conical connectors - Part 1: Cones and sockets.
prEN 13544-2:2000, Respiratory therapy equipment – Part 2 : Specifications for tubing and connectors.
EN ISO 4135:1996, Anaesthesiology – Vocabulary (ISO 4135 :1995).
3 Terms and definitions
For the purposes of this part of EN ISO 10651, the terms and definitions given in EN ISO 4135:1996 and the
following terms and definitions apply.
NOTE Some of the definitions have been taken from EN ISO 4135, but they are included in this European Standard for
convenience; other definitions, which are given in EN ISO 4135, for apparatus in general, have been modified slightly for the
purposes of this European Standard as they apply specifically to resuscitators.
3.1
reverse leakage
volume of expired gas which does not pass through the expiratory port but returns to the resuscitator
3.2
bag inlet valve
valve activated by the subatmospheric pressure in the compressible unit of the resuscitator to refill the
compressible unit with gas at ambient pressure
3.3
bag refill valve
valve, with no manual trigger, activated by the sub-atmospheric pressure in the compressible unit of the
resuscitator to refill the compressible unit from a pressurized gas source
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ISO 10651-4:2002(E)
3.4
compressible unit
that part of an operator-powered resuscitator e.g. a bag or bellows that, when compressed by the operator, delivers
a volume of gas
3.5
delivered oxygen concentration
average concentration of oxygen in the gas delivered from the resuscitator
3.6
delivered volume, V
del
volume of gas, expressed in millilitres, leaving the resuscitator through the patient connection port during the
inspiratory phase
3.7
forward leakage
volume of gas produced by the resuscitator during the inspiratory phase which does not pass through the patient
port to the patient but passes to the atmosphere
3.8


minute volume, V
volume of gas per minute entering or leaving the patient’s lungs
3.9
operator-powered resuscitator
resuscitation device in which ventilation of the lungs is produced by the operator compressing the compressible
unit of the device
NOTE Hereinafter called "resuscitator".
3.10
patient connection port
that opening through which gas flows to and from the patient
3.11
patient connection port connector
connector at the patient connection port which connects directly to a face mask or an appropriate mating airway
device
3.12
patient valve
valve in the breathing system that directs gas into the lungs for the inspiratory phase and into the atmosphere
during the expiratory phase
3.13
pressure limiting system
means for limiting the maximum delivery pressure
3.14
resuscitator deadspace, V
D,app
that volume of previously exhaled gas which is delivered from the resuscitator in the succeeding inspiratory phase
3.15
tidal volume, V
T
volume of gas, expressed in millilitres, entering or leaving the patient or the lung model during the inspiratory or
expiratory phase
3.16
ventilatory cycle
ventilation cycle comprising the inspiratory phase plus the expiratory phase of breathing
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ISO 10651-4:2002(E)
4 Connectors
4.1 Patient connection port connector
The patient connection port connector of the resuscitator shall be a 15 mm female and 22 mm male coaxial
connector complying with EN 1281-1.
4.2 ) Expiratory port connector for breathing gases
R
If an expiratory port connector is provided, it shall be one of the following :
a) a 30 mm male conical connector complying with EN 1281-1 or ;
b) a permanent connection or propriatory connector incompatible with EN 1281-1 and EN 737-1 ;
and with a means to prevent connection with internal lumen to any breathing attachment.
4.3 Face mask connectors
If provided with the resuscitator, face masks shall have either a 22 mm female connector or a 15 mm male
connector which shall mate with the corresponding connectors specified in EN 1281-1.
4.4 R) Bag refill valve connectors
If a conical connector is provided for attachment of a bag refill valve, it shall be a unique 32 mm female design. The
dimensions of this connector, when submitted to the test gauge given in Figure A.1, shall fit within the tolerance
steps.
4.5 Bag inlet valve connectors
Bag inlet valve connectors shall not be compatible with connectors dimensioned in accordance with EN 1281-1.
The bag inlet valve should be designed to minimize the risk of unintentional connection of breathing attachments
which might block the valve
4.6 Threaded gas filter connectors
If the resuscitator is fitted with a threaded gas filter connection, it shall comply with EN 148-1.
4.7 Oxygen tube connector and pressure gauge connector
The oxygen tube connector, if provided, shall comply with prEN 13544-2:2000. The pressure gauge connector (if
provided) shall not be compatible with tubing fitting the oxygen tube connector.
5 Operational requirements
5.1 General
All test performance requirements in this European Standard shall be satisfied when the resuscitator is operated by
one person.
5.2 R) Dismantling and reassembly
A resuscitator intended to be dismantled by the user, e.g. for cleaning, etc. should be designed so as to minimize
the risk of incorrect reassembly when all parts are mated.
The manufacturer shall recommend a functional test of operation to be carried out after reassembly (see 10.2d)).
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ISO 10651-4:2002(E)
5.3 R) Patient valve function after contamination with vomitus
After the resuscitator has been tested in accordance with the test described in A.4.3, it shall meet the requirements
specified in 6.2, 6.4, 6.7.1 and 6.7.2.
NOTE It is preferable that the valve housing be constructed so that operation of the mechanism can be observed by the
operator, e.g. through a transparent housing. Observation of the functioning mechanism of the patient valve can assist the
operator in detecting abnormal operation.
5.4 Mechanical shock
5.4.1 R) Drop test
The resuscitator shall meet, at room temperature, the requirements specified in 6.2, 6.4 and 6.7.1, following the
drop test described in A.4.4.
5.5 Immersion in water
After immersion in water by the method described in A.4.5, the resuscitator shall comply with the requirements
specified in 6.2, 6.4, 6.7.1 and 6.7.2.
5.6 R) Bag refill valves
Bag refill valves for use with resuscitators shall not have provision for manual operation.
5.7 Materials of construction
All gas conducting parts shall be from materials selected to take into account the chemical and physical properties
of any substances that the manufacturer declares can be administered by the resuscitator
6 Ventilatory requirements
6.1 R) Supplementary oxygen and delivered oxygen concentration
When tested by the method described in A.4.6 in accordance with the requirements of its classification (see 6.7.1)
V/V) when connected to an
a resuscitator shall provide a minimum delivered oxygen concentration of at least 35 % (
oxygen source supplying not more than 15 l/min and, in addition, shall be capable of providing an oxygen
/V
concentration of at least 85 % (V ) (see note). The manufacturer shall state the range of delivered oxygen
concentrations at representative flows, i.e. 2 l/min, 4 l/min, 6 l/min, 8 l/min, etc.
NOTE The 85 % (V/V) requirement can be accomplished with the use of an attachment.
6.2 R) Expiratory resistance
In the absence of positive end-expiratory pressure devices, and when tested by the method described in A.4.7, the
pressure generated at the patient connection port shall not exceed 0,5 kPa (
5 cmH 0). (See also 10.2 c) 8)).
6.3 R) Inspiratory resistance
When tested by the method described in A.4.8, the pressure at the patient connection port shall not exceed 0,5 kPa
(
5 cmH 0) below atmospheric pressure. (See also 10.2 c) 8)).
6.4 R) Patient valve malfunction
When tested by the method described in A.4.9, an inadvertent positive expiratory pressure greater than 0,6 kPa
(
6 cmH O) shall not be created at an added input flow of up to 30 l/min when this flow is added in accordance
with the manufacturer’s instructions.
4 © ISO 2002 – All rights reserved

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ISO 10651-4:2002(E)
6.5 R) Patient valve leakage - Forward leakage
If forward leakage is a design feature, it shall be so stated in the instruction manual.
6.6 R) Resuscitator deadspace and rebreathing
When tested by the method described in A.4.10, the resuscitator deadspace shall not exceed 5 ml + 10 % of the
minimal delivered volume specified for the classification of the resuscitator (see 6.7.1).
Excessive rebreathing should not occur during spontaneous breathing.
6.7 R) Ventilation performance
6.7.1 R) Minimum delivered volume (V )
del
When tested as described in A.4.11 using the compliance, resistance, frequency and I:E ra
...