SIST EN ISO 23747:2008

SLOVENSKI STANDARD
SIST EN ISO 23747:2008
01-april-2008
1DGRPHãþD
SIST EN 13826:2003
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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
SIST EN ISO 23747:2008 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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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.

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EN ISO 23747:2007 (E)






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.


2

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EN ISO 23747:2007 (E)
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
3

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EN ISO 23747:2007 (E)


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
4

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EN ISO 23747:2007 (E)

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.
5

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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

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ISO 23747:2007(E)
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ii © ISO 2007 – All rights reserved

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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 Error of measurement . 4
7.2 Linearity . 4
7.3 Resistance to flow . 5
7.4 Frequency response. 5
8 Dismantling and reassembly. 5
9 Effects of mechanical ageing . 5
10 Effects of dropping a hand-held PEFM. 5
11 Cleaning, sterilization and disinfection. 5
11.1 Re-usable PEFM and parts . 5
11.2 PEFM and parts delivered sterile . 6
12 Compatibility with substances . 6
13 Biocompatibility. 6
Annex A (informative) Rationale for tests and examples of test apparatus. 7
Annex B (normative) Determination of error, repeatability and resistance to PEFM output . 10
Annex C (normative) Determination of frequency response. 13
Annex D (normative) Test methods for determination of the effects of dismantling, ageing and
dropping . 15
Annex E (informative) Environmental aspects. 17
Annex F (informative) Reference to the essential principals. 19
Bibliography . 22

© ISO 2007 – All rights reserved iii

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ISO 23747:2007(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 23747 was prepared by Technical Committee ISO/TC 121, Anaesthetic and respiratory equipment,
Subcommittee SC 3, Lung ventilators and related equipment.
iv © ISO 2007 – All rights reserved

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ISO 23747:2007(E)
Introduction
The development of a standard for peak expiratory flowrate (PEF) measurement is considered important for
the enhancement of the ability of clinicians to diagnose and monitor lung conditions by ensuring that all
devices for such purposes meet minimum levels for safety and performance. An agreed standard means that
peak expiratory flow meters (PEFM) can be tested to meet the same requirements with the latest accepted
methods. Clinicians and patients can then be confident that these PEFM are fit for the purposes for which they
are intended.
[14]
The American Thoracic Society has been foremost in proposing initial standards for testing PEFM . They
have proposed 26 waveforms for testing PEF, which are deemed suitable for checking that these PEFMs can
correctly measure PEF.
[16]
The work of Miller et al. first showed the problem of PEFM inaccuracy and they have recently defined the
[18]
population characteristics of the PEF profile and demonstrated limitations of pump systems for testing
[17] [18]
PEFM . The European Respiratory Society has published a comprehensive statement on PEF .
This International Standard is based on the best currently available evidence concerning the methods and
[15]
waveforms suited for testing PEFM .
Throughout this International Standard, text for which a rationale is provided in Annex A, is indicated by an
asterisk (*).
© ISO 2007 – All rights reserved v

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INTERNATIONAL STANDARD ISO 23747:2007(E)

Anaesthetic and respiratory equipment — Peak expiratory flow
meters for the assessment of pulmonary function in
spontaneously breathing humans
1 Scope
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.
NOTE Additional aspects of environmental impact are addressed in ISO 14971.
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 10993-1, Biological evaluation of medical devices — Part 1: Evaluation and testing within a risk
management system
ISO 14937, Sterilization of health care products — General requirements for characterization of a sterilizing
agent and the development, validation and routine control of a sterilization process for medical devices
ISO 15223-1:2007, Medical devices — Symbols to be used with medical device labels, labelling and
information to be supplied — Part 1: General requirements
IEC 60601-1:2005, Medical electrical equipment — Part 1: General requirements for basic safety and
essential performance
3 Terms and definitions
For the purposes of this document the following terms and definitions apply.
3.1
BTPS
body temperature (37 °C), at the measured pressure when saturated with water vapour
3.2
dwell time
DT
time for which the expiratory flowrate is in excess of 90 % of the achieved PEF (3.3)
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ISO 23747:2007(E)
3.3
peak expiratory flowrate
PEF
maximum flowrate measured at the mouth during an expiration delivered with maximal force starting
immediately after achieving maximum lung inflation
3.4
peak expiratory flow meter
PEFM
device for measurement of peak expiratory flowrate (3.3)
3.5
rise time
RT
time taken for flowrate to rise from 10 % to 90 % of the achieved PEF (3.3)
4 General requirements
4.1 Safety for PEFMs that utilize electricity
A PEFM that utilizes electrical power shall meet the requirements of IEC 60601-1, in addition to the
requirements in this International Standard.
Check compliance by application of the tests of IEC 60601-1.
4.2 Mechanical safety for all PEFMs
Rough surfaces, sharp corners and edges, which can cause injury or damage shall be avoided or covered.
Particular attention shall be paid to flange or frame edges and the removal of burrs.
Check compliance by inspection.
5 Identification, marking and documents
5.1 Marking of the scale or display
The scale or display of the PEFM shall be marked clearly and legibly as follows.
a) The scale or display shall be marked in units of litres per second or litres per minute.
b) For a PEFM with a graduated scale the increment between adjacent graduations shall represent a
difference in peak flowrate no greater than 10 l/min (0,17 l/s) at flowrates of 700 l/min (11,67 l/s) or below,
and 20 l/min (0,33 l/s) at flowrates above 700 l/min (11,67 l/s). For a PEFM with a digital display, the
incremental steps shall be no greater than 5 l/min or 0,08 l/s.
NOTE Litres per minute and litres per second are not exact equivalents because digital displays do not usually register
to three decimal places.
c) The numbering and graduation lines on a scale or digital display shall be clearly legible with normal vision.
[i.e. visual acuity of 0 on the log minimum angle of resolution (log MAR) scale or 6/6 (20/20), corrected if
necessary, at a distance of 0,5 m and at an ambient luminance in the range 100 lx to 1 500 lx].
d) The numbering on a scale shall appear at intervals no greater than 50 l/min (0,83 l/s) up to 700 l/min
(11,67 l/s) and 100 l/min (1,67 l/s) above 700 l/min (11,67 l/s).
e) The numbering on a scale or digital display shall not exceed the measurement range. (see Clause 6).
Check compliance by inspection and functional testing.
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ISO 23747:2007(E)
5.2 Marking of PEFM or packaging
5.2.1 Marking of the PEFM
The PEFM and/or its components shall be marked clearly and legibly with the following:
a) an arrow showing the direction of flow for any user-detachable components that are flow-direction-
sensitive unless designed in such a way that prevents incorrect assembly;
b) the name or trademark and address of the manufacturer;
c) where appropriate, an identification reference to the batch or serial number, or symbol 5.14 or 5.16 from
ISO 15223-1:2007;
d) indications with regard to proper disposal, as appropriate.
Check compliance by inspection.
5.2.2 Marking of the PEFM packaging
The following shall be marked on the packaging:
a) details to enable the user to identify the PEFM and the contents of the packaging;
b) for a sterile PEFM, the word “STERILE” or the appropriate symbol 5.20. 5.21, 5.22, 5.23 or 5.24 from
ISO 15223-1:2007;
c) for a PEFM with an expiration date, symbol 5.12 from ISO 15223-1:2007;
d) for a single use PEFM, the words “single use only” or “do not re-use” or symbol 5.2 from
ISO 15223-1:2007;
e) any special storage and/or handling instructions;
f) the intended purpose of the PEFM.
Check compliance by inspection.
5.3 Instructions for use
The accompanying documents shall include the following:
a) the intended purpose of the PEFM including any restrictions for its use;
b) a statement, if applicable, that the performance of the PEFM can be affected by the patient spitting or
coughing into the PEFM or by extremes of temperature, humidity and altitude;
c) if the PEFM is intended to be dismantled by the user, the correct method of reassembly;
d) details of what the user should do if unusual readings are obtained;
e) recommended storage conditions;
f) details about cleaning and disinfection or cleaning and sterilization methods that can be used and a list of
the applicable parameters such as temperature, pressure, humidity, time limits and number of cycles that
the PEFM parts can tolerate;
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ISO 23747:2007(E)
g) the highest resistance to flow within the measurement range of the PEFM and the flowrate at which this
occurs;
h) details of the nature and frequency of any maintenance and/or calibration needed to ensure that the
PEFM operates properly and safely;
i) information concerning the disposal of the PEFM and its components (e.g. a battery).
Check compliance by inspection.
5.4 Technical description
The technical description shall include the following:
a) specification of the signal input/output part, if applicable;
b) error of the measured value (see 7.1);
c) a statement to the effect that the values displayed by the instrument are expressed as BTPS values;
d) any correction factors to be applied for changes in ambient conditions.
Check compliance by inspection.
6 PEFM measurement range
The marked measurement range shall be from no greater than 60 l/min (1,00 l/s) to not less than 800 l/min
(13,33 l/s). The marked measurement range shall be expressed at BTPS conditions.
Check compliance by inspection.
7 Performance requirements
7.1 Error of measurement
The maximum permissible error for flowrate in the measurement range shall be ± 10 l/min (± 0,17 l/s) or 10 %
of the reading, whichever is the greater. This applies under the following environmental conditions:
⎯ ambient temperature from 10 °C to 35 °C;
⎯ relative humidity from 30 % RH to 75 % RH;
⎯ altitude from 0 m to 1 400 m (atmospheric pressure range from 1 060 hPa to 850 hPa).
Check compliance by the tests of Annex B.
7.2 Linearity
The difference between the mean error at any two consecutive test flowrates (see Annex B) shall not exceed
5 % of the larger of the two test flowrates.
Under ambient conditions, the PEFM reading at any peak flowrate in the measurement range shall not vary by
more than 10 l/min (0,17 l/s) or 5 % of the mean of the readings, whichever is the greater.
Check compliance by the tests of Annex B.
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ISO 23747:2007(E)
7.3 Resistance to flow
The resistance to flow across the measurement range of the PEFM shall not exceed 0,35 kPa/l/min
(0,006 kPa/l/s).
Check compliance by the tests of Annex B
...