EN ISO 23747:2007

Anaesthetic and respiratory equipment - Peak expiratory flow meters for the assessment of pulmonary function in spontaneously breathing humans (ISO 23747:2007)

This International Standard specifies requirements for peak expiratory flow meters (PEFMs) intended for the assessment of pulmonary function in spontaneously breathing humans. This International Standard covers all devices that measure peak expiratory flowrate in spontaneously breathing humans either as part of an integrated lung function device or as a stand-alone device. Planning and design of products applying to this International Standard should consider the environmental impact from the product during its life cycle. Environmental aspects are addressed in Annex E.

Anästhesie- und Beatmungsgeräte - Spirometer für den exspiratorischen Spitzenfluss zur Bewertung der Lungenfunktion bei spontan atmenden Menschen (ISO 23747:2007)

Diese Internationale Norm legt Anforderungen für Spirometer für den exspiratorischen Spitzenfluss (PEFM) fest, die zur Beurteilung der Lungenfunktion bei spontan atmenden Menschen bestimmt sind.
Diese Internationale Norm gilt für alle Geräte, die den exspiratorischen Spitzenfluss bei spontan atmenden Menschen als Teil eines kombinierten Geräts zur Messung der Lungenfunktion oder als Einzelgerät messen.
Bei der Planung und Auslegung von Produkten, für die diese Internationale Norm gilt, sollten die Umweltauswirkungen des Produkts während seines Lebenszyklus berücksichtigt werden. Umweltgesichts¬punkte werden in Anhang E behandelt.
ANMERKUNG   Zusätzliche Gesichtspunkte der Umweltauswirkungen werden in ISO 14971 behandelt.

Matériel d'anesthésie et de réanimation respiratoire - Débitmètres à débit de pointe expiratoire pour l'évaluation de la fonction pulmonaire chez les êtres humains respirant spontanément (ISO 23747:2007)

Anestezijska in dihalna oprema - Merilniki največjega pretoka zraka med izdihom za oceno funkcije pljuč pri spontano dihajočih ljudeh (ISO 23747:2007)

General Information

• Status: Withdrawn
• Publication Date: 14-Jul-2007
• Withdrawal Date: 03-Mar-2009
• ICS: 11.040.10 - Anaesthetic, respiratory and reanimation equipment
• Technical Committee: CEN/TC 215 - Respiratory and anaesthetic equipment
• Drafting Committee: CEN/TC 215/WG 2 - Lung ventilators
• Current Stage: 9960 - Withdrawal effective - Withdrawal
• Start Date: 04-Mar-2009
• Completion Date: 04-Mar-2009
• Directive: 93/42/EEC - Council Directive 93/42/EEC of 14 June 1993 concerning medical devices
• Mandate: M/023 - Standardization mandate to CEN/CENELEC concerning the development of European standards relating to medical devices
• Ref Project: SIST EN ISO 23747:2008 - Anaesthetic and respiratory equipment - Peak expiratory flow meters for the assessment of pulmonary function in spontaneously breathing humans (ISO 23747:2007)

Relations

• Replaces: EN 13826:2003 - Peak expiratory flow meters
• Effective Date: 22-Dec-2008
• Replaced By: EN ISO 23747:2009 - Anaesthetic and respiratory equipment - Peak expiratory flow meters for the assessment of pulmonary function in spontaneously breathing humans (ISO 23747:2007)
• Effective Date: 08-Jun-2022

Standards Content (Sample)

SLOVENSKI STANDARD
01-april-2008
1DGRPHãþD
SIST EN 13826:2003
$QHVWH]LMVNDLQGLKDOQDRSUHPD0HULOQLNLQDMYHþMHJDSUHWRND]UDNDPHGL]GLKRP
]DRFHQRIXQNFLMHSOMXþSULVSRQWDQRGLKDMRþLKOMXGHK,62
Anaesthetic and respiratory equipment - Peak expiratory flow meters for the assessment
of pulmonary function in spontaneously breathing humans (ISO 23747:2007)
Anästhesie- und Beatmungsgeräte - Spirometer für den exspiratoischen Spitzenfluss zur
Bewertung der Lungenfunktion bei spontan atmenden Menschen (ISO 23747:2007)
Matériel d'anesthésie et de réanimation respiratoire - Débitmetres de débit expiratoire de
pointe pour l'évaluation de la fonction pulmonaire chez les etres humains respirant
spontanément (ISO 23747:2007)
Ta slovenski standard je istoveten z: EN ISO 23747:2007
ICS:
11.040.10
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

EUROPEAN STANDARD
EN ISO 23747
NORME EUROPÉENNE
EUROPÄISCHE NORM
July 2007
ICS 11.040.10 Supersedes EN 13826:2003
English Version
Anaesthetic and respiratory equipment - Peak expiratory flow
meters for the assessment of pulmonary function in
spontaneously breathing humans (ISO 23747:2007)
Matériel d'anesthésie et de réanimation respiratoire - Anästhesie- und Beatmungsgeräte - Spirometer für den
Débitmètres à débit de pointe expiratoire pour l'évaluation exspiratorischen Spitzenfluss zur Bewertung der
de la fonction pulmonaire chez les êtres humains respirant Lungenfunktion bei spontan atmenden Menschen (ISO
spontanément (ISO 23747:2007) 23747:2007)
This European Standard was approved by CEN on 28 June 2007.
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: rue de Stassart, 36  B-1050 Brussels
© 2007 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 23747:2007: E
worldwide for CEN national Members.

Foreword
This document (EN ISO 23747:2007) has been prepared by Technical Committee ISO/TC 121 "Anaesthetic and
respiratory equipment" in collaboration with Technical Committee CEN/TC 215 "Respiratory and anaesthetic
equipment", the secretariat of which is held by BSI.

This European Standard shall be given the status of a national standard, either by publication of an identical text
or by endorsement, at the latest by January 2008, and conflicting national standards shall be withdrawn at the
latest by January 2008.
This document supersedes EN 13826:2003.

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).

For relationship with EU Directive(s), 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 United Kingdom.

Endorsement notice
The text of ISO 23747:2007 has been approved by CEN as EN ISO 23747:2007 without any modifications.

Annex ZA
(informative)
Relationship between this International Standard and the Essential Requirements
of EU Directive 93/42/EEC
This International Standard has been prepared under a mandate given to CEN by the European Commission and
the European Free Trade Association to provide one means of conforming to Essential Requirements of the New
Approach Directive 93/42/EEC.
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 normative 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 International Standard and EU Directives

a
Clause(s)/Subclause(s) of Corresponding Essential
Comments
this International Standard Requirement of Directive 93/42/EEC
All 1, 2, 3 And via IEC 60601-1
4.1 12.6 And via IEC 60601-1, Clauses 4, 8
4.2 9.2 And via IEC 60601-1, Clauses 4, 5, 9,
and Subclauses 8.9.1.5, 12.2, 15.2
5 5, 13.1 And via IEC 60601-1, Clauses 4, 7
and Subclauses 7.2.17, 7.9.3.1, 15.3.7,16.2
5.1 a) 10.3 And via IEC 60601-1, Subclause 7.4.3
5.1 b) 10.1, 10.2, 12.9 And via IEC 60601-1, Clause 4
and Subclauses 7.4, 7.5, 7.6, 7.8, 12.1, 12.2
5.1 c) 12.9 And via IEC 60601-1, Clause 4,
and Subclauses 7.4, 7.5, 7.6, 7.8, 12.2
5.1 d) 12.9 And via IEC 60601-1, Clause 4,
and Subclauses 7.4, 7.5, 7.6, 7.8, 12.2
5.1 e) 12.9 And via IEC 60601-1, Clause 4,
and Subclauses 7.4, 7.5, 7.6, 7.8, 12.2
5.2.1 a) 9.1, 12.9 And via IEC 60601-1, Clauses 4, 14,
16, and Subclauses 7.4, 7.5, 7.6, 7.8,
8.2, 8.3, 8.5.2, 8.5.5, 8.6.6, 8.10.3,
8.10.4, 9,11.2.2, 11.4, 11.5, 12.2
5.2.1 b) 13.3 a) And via IEC 60601-1, Subclause 7.2.2
5.2.1 c) 13.2, 13.3 d) And via IEC 60601-1, Subclauses 7.2,
7.4, 7.5, 7.6
5.2.1 d) 13.6 n)
5.2.2 a) 13.3 b) And via IEC 60601-1, Subclause 7.2.2
5.2.2 b) 8.3, 8.7, 13.2, 13.3 c) And via IEC 60601-1, Subclauses 7.2,
7.4, 7.5, 7.6, 11.6.7
a
Corresponding Essential Requirement
Clause(s)/Subclause(s) of
Comments
of Directive 93/42/EEC
this International Standard
5.2.2 c) 13.3 e)
5.2.2 d) 13.2, 13.3 f) And via IEC 60601-1,
Subclauses 7.2.1, 7.4, 7.5, 7.6
5.2.2 e) 13.3 i) And via IEC 60601-1,
Subclause 7.2.17
5.2.2 f) 13.4 And via IEC 60601-1,
Subclauses 7.9.2.1, 16.2
5.3 13.6 a) And via IEC 60601-1,
Subclauses 7.9.1, 7.9.2, 16.2
5.3 b) 13.1, 13.3 i), 13.3 j), 13.3 k) And via IEC 60601-1, Clause 7
and Subclause 16.2
5.3 c) 13.6 d) And via IEC 60601-1,
Subclauses 7.9.2.6, 7.9.2.8, 7.9.2.9,
7.9.2.13, 7.9.2.16, 9.8.1, 16.2
5.3 d) 13.6 b), 13.6 k) And via IEC 60601-1,
Subclauses 7.9.2.1, 7.9.2.2 ,7.9.2.9,16.2
5.3 e) 13.6 i)
5.3 f) 7.6, 8.1, 13.6 h) And via IEC 60601-1,
Subclauses 7.9.2.6, 7.9.2.8, 7.9.2.9,
7.9.2.12, 7.9.2.14, 11.3, 11.6.1, 11.6.7,
11.6.8, 13.1.2, 13.2.6, 16.2
5.4 a) 9.1, 13.6 b) And via IEC 60601-1, Clauses 4, 14,
16, and Subclauses 7.9.2.1,
7.9.2.2 ,7.9.2.9, 8.2, 8.3, 8.5.2, 8.5.5,
8.6.6, 8.10.3, 8.10.4, 9,11.2.2, 11.4,
11.5, 16.2
5.4 b) 10.1, 13.6 p) And via IEC 60601-1, Clause 4
and Subclause 12.1
5.4 c) 10.1, 13.6 l) And via IEC 60601-1, Clause 4
and Subclause 12.1
5.4 d) 10.1, 13.6 l) And via IEC 60601-1, Clause 4
and Subclause 12.1
6 10.1, 10.2 And via IEC 60601-1, Clause 4
and Subclauses 12.1, 12.2
7 3, 10.1 And via IEC 60601-1, Clause 4
and Subclauses 11.1, 12.1
8 4, 9.2, 10.1 And via IEC 60601-1, Clauses 4, 5, 9,
15 and Subclauses 7.9, 8.9.1.5, 12.1,
12.2, 15.2
9 4, 9.2, 10.1 And via IEC 60601-1, Clauses 4, 5, 9,
15 and Subclauses 7.9, 8.9.1.5, 12.1, 12.2,
15.2
a
Clause(s)/Subclause(s) of Corresponding Essential Requirement
Comments
this International Standard of Directive 93/42/EEC
10 4, 9.2 And via IEC 60601-1, Clauses 4, 5, 9,
15 and Subclauses 7.9, 8.9.1.5, 12.2, 15.2
11.1 4, 7.3, 8.1, 8.5 And via IEC 60601-1, Clauses 4, 15
and Subclauses 7.9, 11.2, 11.4, 11.5,
11.6, 11.7, 16.2
11.2 8.4 And via IEC 60601-1,
Subclause 11.6.7
12 4, 7.1, 7.3, 7.5 And via IEC 60601-1, Clauses 4, 9, 15,
and Subclauses 7.9, 11.2, 11.3, 11.4,
11.5, 11.6, 11.7, 13.1.2, 13.2.6, 15.2
13 7.1 And via IEC 60601-1, Clause 9,and
Subclauses 11.2, 11.3, 11.4, 11.5,
11.6.8, 11.7, 15.2
— 7.2 Via IEC 60601-1, Subclauses 11.6.6,
11.6.7, 11.7, 15.3.7, 16.2
— 9.3 Via IEC 60601-1, Clause 4, and
Subclauses 8.11.6, 11.2, 11.3, 11.4,
11.5, 13.1.2, 15.4.3.5
— 11.3.1 Via IEC 60601-1, Clauses 4, 10,
and Subclause 12.4.5.1
— 12.5 Via IEC 60601-1, Clauses 4, 17
— 12.7.1 Via IEC 60601-1, Clauses 4, 9,
and Subclause 15.3
— 12.7.2 Via IEC 60601-1, Clause 4
and Subclause 9.6
— 12.7.3 Via IEC 60601-1, Clause 4
and Subclause 9.6
— 12.7.4 Via IEC 60601-1, Clause 4,
and Subclauses 8.10.3, 8.10.4, 8.11
— 12.7.5 Via IEC 60601-1, Clause 4,
and Subclauses 8.11.4, 11.1, 15.4.1,
16.9.1, 16.9.2.1
— 12.8.2 Via IEC 60601-1, Clause 4,
and Subclauses 7.8, 12.3, 12.4
— 13.3 m) Via IEC 60601-1, Subclauses 6.4, 7.2.17
— 13.5 Via IEC 60601-1, Subclauses 7.2.2, 7.2.4
— 13.6 c) Via IEC 60601-1, Subclauses 7.9.2.6,
7.9.2.8, 7.9.2.9, 7.9.2.14, 16.2
— 13.6 f) Via IEC 60601-1, Subclause 7.9.2.2
a The following comments relating to clauses and subclauses of IEC 60601-1:2005 describe the consequences of the general
normative reference to IEC 60601-1:2005 made in the requirement 4.1 of the present standard.
-WARNING: Other requirements and other EU Directives may be applicable to the product(s) falling within the
scope of this standard.
INTERNATIONAL ISO
STANDARD 23747
First edition
2007-07-15
Anaesthetic and respiratory equipment —
Peak expiratory flow meters for the
assessment of pulmonary function in
spontaneously breathing humans
Matériel d'anesthésie et de réanimation respiratoire — Débitmètres à
débit de pointe expiratoire pour l'évaluation de la fonction pulmonaire
chez les êtres humains respirant spontanément

Reference number
ISO 23747:2007(E)
©
ISO 2007
ISO 23747:2007(E)
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ISO 23747:2007(E)
Contents Page
Foreword. iv
Introduction . v
1 Scope . 1
2 Normative references . 1
3 Terms and definitions. 1
4 General requirements. 2
4.1 Safety for PEFMs that utilize electricity. 2
4.2 Mechanical safety for all PEFMs . 2
5 Identification, marking and documents. 2
5.1 Marking of the scale or display . 2
5.2 Marking of PEFM or packaging . 3
5.3 Instructions for use . 3
5.4 Technical description. 4
6 PEFM measurement range. 4
7 Performance requirements . 4
7.1 E
...