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)
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)
General Information
Standards Content (Sample)
SLOVENSKI STANDARD
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
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
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.
Contents Page
European foreword . 3
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.
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
ISO 10651-5:2006(E)
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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 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 a
...
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