EN ISO 23747:2009

2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.Anästhesie- und Beatmungsgeräte - Spirometer für den exspiratorischen Spitzenfluss zur Bewertung der Lungenfunktion bei spontan atmenden Menschen (ISO 23747:2007)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)Anaesthetic and respiratory equipment - Peak expiratory flow meters for the assessment of pulmonary function in spontaneously breathing humans (ISO 23747:2007)11.040.10Anestezijska, respiratorna in reanimacijska opremaAnaesthetic, respiratory and reanimation equipmentICS:Ta slovenski standard je istoveten z:EN ISO 23747:2009SIST EN ISO 23747:2009en01-julij-2009SIST EN ISO 23747:2009SLOVENSKI
STANDARDSIST EN ISO 23747:20081DGRPHãþD

EUROPEAN STANDARDNORME EUROPÉENNEEUROPÄISCHE NORMEN ISO 23747March 2009ICS 11.040.10Supersedes EN ISO 23747:2007
English VersionAnaesthetic and respiratory equipment - Peak expiratory flowmeters for the assessment of pulmonary function inspontaneously breathing humans (ISO 23747:2007)Matériel d'anesthésie et de réanimation respiratoire -Débitmètres à débit de pointe expiratoire pour l'évaluationde la fonction pulmonaire chez les êtres humains respirantspontanément (ISO 23747:2007)Anästhesie- und Beatmungsgeräte - Spirometer für denexspiratorischen Spitzenfluss zur Bewertung derLungenfunktion bei spontan atmenden Menschen (ISO23747:2007)This European Standard was approved by CEN on 24 February 2009.CEN members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for giving this EuropeanStandard the status of a national standard without any alteration. Up-to-date lists and bibliographical references concerning such nationalstandards 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 translationunder the responsibility of a CEN member into its own language and notified to the CEN Management Centre has the same status as theofficial 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 STANDARDIZATIONCOMITÉ EUROPÉEN DE NORMALISATIONEUROPÄISCHES KOMITEE FÜR NORMUNGManagement Centre:
Avenue Marnix 17,
B-1000 Brussels© 2009 CENAll rights of exploitation in any form and by any means reservedworldwide for CEN national Members.Ref. No. EN ISO 23747:2009: ESIST EN ISO 23747:2009

Relationship between this European Standard and the Essential Requirements of EU Directive 93/42/EEC .4
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. 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. - Relationship between this European Standard and the Essential Requirements of EU Directive 93/42/EEC Clause(s)/sub-clause(s) of this EN
Essential Requirements (ERs) of Directive 93/42/EEC Qualifying remarks/Notes 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 13.3 (a): This relevant Essential Requirement is not fully addressed in this European Standard 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 SIST EN ISO 23747:2009

5.2.1 d) 13.6 n)
5.2.2 7.5 (2nd paragraph) This relevant Essential Requirement is not fully addressed in this European Standard 5.2.2 13.3 (f) This relevant Essential Requirement is not fully addressed in this European Standard 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 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 7.5 (3rd paragraph) This relevant Essential Requirement is not fully addressed in this European Standard 5.3 13.6 a) And via IEC 60601-1, Subclauses 7.9.1, 7.9.2, 16.2 5.3 13.6 (h)(2nd paragraph) This relevant Essential Requirement is not fully addressed in this European Standard
13.6 (q) This relevant Essential Requirement is not addressed in this European Standard 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 SIST EN ISO 23747:2009

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 - 6a)
This relevant Essential Requirement is not addressed in this European Standard 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 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 12, 13 7.5 (1st paragraph) This relevant Essential Requirement is not fully addressed in this European Standard — 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 SIST EN ISO 23747:2009

— 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 products falling within the scope of this International standard.
Reference numberISO 23747:2007(E)© ISO 2007
INTERNATIONAL STANDARD ISO23747First edition2007-07-15Anaesthetic 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
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ii © ISO 2007 – All rights reserved
ISO 23747:2007(E) © ISO 2007 – All rights reserved iiiContents 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 23747:2007(E) iv © ISO 2007 – All rights reserved 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. SIST EN ISO 23747:2009

ISO 23747:2007(E) © ISO 2007 – All rights reserved vIntroduction 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. The American Thoracic Society has been foremost in proposing initial standards for testing PEFM [14]. They have proposed 26 waveforms for testing PEF, which are deemed suitable for checking that these PEFMs can correctly measure PEF. The work of Miller et al. [16] first showed the problem of PEFM inaccuracy and they have recently defined the population characteristics of the PEF profile [18] and demonstrated limitations of pump systems for testing PEFM [17]. The European Respiratory Society has published a comprehensive statement on PEF [18]. This International Standard is based on the best currently available evidence concerning the methods and waveforms suited for testing PEFM [15]. Throughout this International Standard, text for which a rationale is provided in Annex A, is indicated by an asterisk (*). SIST EN ISO 23747:2009

INTERNATIONAL STANDARD ISO 23747:2007(E) © ISO 2007 – All rights reserved 1Anaesthetic 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) SIST EN ISO 23747:2009

ISO 23747:2007(E) 2 © ISO 2007 – All rights reserved 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. SIST EN ISO 23747:2009

ISO 23747:2007(E) © ISO 2007 – All rights reserved 35.2 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; SIST EN ISO 23747:2009

ISO 23747:2007(E) 4 © ISO 2007 – All rights reserved 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. SIST EN ISO 23747:2009

ISO 23747:2007(E) © ISO 2007 – All rights reserved 57.3 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. 7.4 Frequency response The difference between the indicated PEF value of the PEFM for profiles A and B (see B.2.1, C.2.1, C.2.2 and Figure C.1) shall, for an identical reference PEF, not exceed 15 l/min (0,25 l/s) or 12 %, whichever is the greater. Check compliance by the tests of Annex C. 8 Dismantling and reassembly 8.1 If intended for dismantling by the user, the PEFM shall be designed or marked to indicate correct reassembly when all parts are mated. Check compliance by inspection. 8.2 After dismantling and reassembly in accordance with the instructions for use, the PEFM shall meet the requirements of Clause 7 and its
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