SVENSK STANDARD SS-EN ISO 23747:2015

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1 SVENSK STANDARD SS-EN ISO 23747:2015 Fastställd/Approved: Publicerad/Published: Utgåva/Edition: 3 Språk/Language: engelska/english ICS: Anestesi och respiratorutrustning Mätare för maximalt exspirationsflöde för bedömning av lungfunktion hos människor med spontan andning (ISO 23747:2015) Anaesthetic and respiratory equipment Peak expiratory flow meters for the assessment of pulmonary function in spontaneously breathing humans (ISO 23747:2015)

2 Provläsningsexemplar / Preview Standarder får världen att fungera SIS (Swedish Standards Institute) är en fristående ideell förening med medlemmar från både privat och offentlig sektor. Vi är en del av det europeiska och globala nätverk som utarbetar internationella standarder. Standarder är dokumenterad kunskap utvecklad av framstående aktörer inom industri, näringsliv och samhälle och befrämjar handel över gränser, bidrar till att processer och produkter blir säkrare samt effektiviserar din verksamhet. Delta och påverka Som medlem i SIS har du möjlighet att påverka framtida standarder inom ditt område på nationell, europeisk och global nivå. Du får samtidigt tillgång till tidig information om utvecklingen inom din bransch. Ta del av det färdiga arbetet Vi erbjuder våra kunder allt som rör standarder och deras tillämpning. Hos oss kan du köpa alla publikationer du behöver allt från enskilda standarder, tekniska rapporter och standardpaket till handböcker och onlinetjänster. Genom vår webbtjänst e-nav får du tillgång till ett lättnavigerat bibliotek där alla standarder som är aktuella för ditt företag finns tillgängliga. Standarder och handböcker är källor till kunskap. Vi säljer dem. Utveckla din kompetens och lyckas bättre i ditt arbete Hos SIS kan du gå öppna eller företagsinterna utbildningar kring innehåll och tillämpning av standarder. Genom vår närhet till den internationella utvecklingen och ISO får du rätt kunskap i rätt tid, direkt från källan. Med vår kunskap om standarders möjligheter hjälper vi våra kunder att skapa verklig nytta och lönsamhet i sina verksamheter. Vill du veta mer om SIS eller hur standarder kan effektivisera din verksamhet är du välkommen in på eller ta kontakt med oss på tel Standards make the world go round SIS (Swedish Standards Institute) is an independent non-profit organisation with members from both the private and public sectors. We are part of the European and global network that draws up international standards. Standards consist of documented knowledge developed by prominent actors within the industry, business world and society. They promote cross-border trade, they help to make processes and products safer and they streamline your organisation. Take part and have influence As a member of SIS you will have the possibility to participate in standardization activities on national, European and global level. The membership in SIS will give you the opportunity to influence future standards and gain access to early stage information about developments within your field. Get to know the finished work We offer our customers everything in connection with standards and their application. You can purchase all the publications you need from us - everything from individual standards, technical reports and standard packages through to manuals and online services. Our web service e-nav gives you access to an easy-to-navigate library where all standards that are relevant to your company are available. Standards and manuals are sources of knowledge. We sell them. Increase understanding and improve perception With SIS you can undergo either shared or in-house training in the content and application of standards. Thanks to our proximity to international development and ISO you receive the right knowledge at the right time, direct from the source. With our knowledge about the potential of standards, we assist our customers in creating tangible benefit and profitability in their organisations. If you want to know more about SIS, or how standards can streamline your organisation, please visit or contact us on phone +46 (0)

3 Provläsningsexemplar / Preview Europastandarden EN ISO 23747:2015 gäller som svensk standard. Detta dokument innehåller den officiella engelska versionen av EN ISO 23747:2015. Denna standard ersätter SS-EN ISO 23747:2009, utgåva 2. The European Standard EN ISO 23747:2015 has the status of a Swedish Standard. This document contains the official English version of EN ISO 23747:2015. This standard supersedes the Swedish Standard SS-EN ISO 23747:2009, edition 2. Copyright / Upphovsrätten till denna produkt tillhör SIS, Swedish Standards Institute, Stockholm, Sverige. Användningen av denna produkt regleras av slutanvändarlicensen som återfinns i denna produkt, se standardens sista sidor. Copyright SIS, Swedish Standards Institute, Stockholm, Sweden. All rights reserved. The use of this product is governed by the end-user licence for this product. You will find the licence in the end of this document. Upplysningar om sakinnehållet i standarden lämnas av SIS, Swedish Standards Institute, telefon Standarder kan beställas hos SIS Förlag AB som även lämnar allmänna upplysningar om svensk och utländsk standard. Information about the content of the standard is available from the Swedish Standards Institute (SIS), telephone Standards may be ordered from SIS Förlag AB, who can also provide general information about Swedish and foreign standards. Denna standard är framtagen av kommittén för Anestesi- och respiratorutrustning, SIS / TK 329. Har du synpunkter på innehållet i den här standarden, vill du delta i ett kommande revideringsarbete eller vara med och ta fram andra standarder inom området? Gå in på - där hittar du mer information.

4 Provläsningsexemplar / Preview

5 EUROPEAN STANDARD NORME EUROPÉENNE EUROPÄISCHE NORM Provläsningsexemplar / Preview EN ISO August 2015 ICS Supersedes EN ISO 23747:2009 English Version Anaesthetic and respiratory equipment - Peak expiratory flow meters for the assessment of pulmonary function in spontaneously breathing humans (ISO 23747:2015) 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 23747:2015) Anästhesie- und Beatmungsgeräte - Spirometer für den exspiratorischen Spitzenfluss zur Bewertung der Lungenfunktion bei spontan atmenden Menschen (ISO 23747:2015) This European Standard was approved by CEN on 13 June 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, Former Yugoslav Republic of Macedonia, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, 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: Avenue Marnix 17, B-1000 Brussels 2015 CEN All rights of exploitation in any form and by any means reserved worldwide for CEN national Members. Ref. No. EN ISO 23747:2015 E

6 SS-EN ISO 23747:2015 (E) Provläsningsexemplar / Preview Contents Page European foreword... Introduction...v 1 Scope Normative references Terms and definitions General requirements Safety for a pefm that utilizes electricity Mechanical basic safety for all pefms Identification, marking and documents Marking of the scale or display Marking of the pefm or packaging Marking of the pefm Marking of the pefm packaging Instructions for use Technical description pefm measurement range Performance requirements Error of measurement Linearity Resistance to flow Frequency response Dismantling and reassembly Effects of mechanical ageing Effects of dropping a hand-held pefm Cleaning, sterilization, and disinfection Reusable pefm and parts pefm and parts delivered sterile Compatibility with substances Biocompatibility... 7 Annex A (informative) Rationale for tests and examples of test apparatus...8 Annex B (normative) Determination of error, repeatability, and resistance to pefm output...11 Annex C (normative) Determination of frequency response...14 Annex D (normative) Test methods for determination of the effectsof dismantling, ageing and dropping...16 Annex E (informative) Environmental aspects...18 Annex F (informative) Reference to the Essential Principles...20 Annex G (informative) Terminology Alphabetized index of defined terms...24 Annex ZA (informative) Relationship between this Document and the Essential Requirements of EU Directive 93/42/EEC...25 Bibliography...29 iii

7 Provläsningsexemplar / Preview SS-EN ISO 23747:2015 (E) European foreword This document (EN ISO 23747:2015) 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 February 2016, and conflicting national standards shall be withdrawn at the latest by February 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 23747:2009. 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, Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, Former Yugoslav Republic of Macedonia, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and the United Kingdom. Endorsement notice The text of ISO 23747:2015 has been approved by CEN as EN ISO 23747:2015 without any modification. iv

8 SS-EN ISO 23747:2015 (E) Provläsningsexemplar / Preview Introduction The development of a standard for peak expiratory flowrate (pef) measurement is considered important for clinicians to use in diagnosing and monitoring lung and airway conditions by ensuring that all medical devices for such purposes meet minimum levels for safety and performance. An agreed standard means that a peak expiratory flow meter (pefm) can be tested to meet the same requirements with the latest accepted methods. Clinicians and patients can then be confident that a pefm is fit for the purposes for which it is intended. The American Thoracic Society has been foremost in proposing initial standards for testing a pefm (see Reference [15]). They have proposed 26 waveforms suitable for testing pef, which are deemed suitable for checking that a pefm can correctly measure pef. The work of Miller et al. (see Reference [18]) first showed the problem of pefm inaccuracy and they have subsequently defined the population characteristics of the pef profile (see Reference [21]) and demonstrated limitations of pump systems for testing a pefm (see Reference [20]). The European Respiratory Society has published a comprehensive statement on pef (see Reference [21]). This International Standard is based on the best currently available evidence concerning the methods and waveforms suited for testing a pefm (see Reference [17]). Throughout this International Standard, text for which a rationale is provided in Annex A, is indicated by an asterisk (*). In this International Standard, the following print types are used: Requirements and definitions: roman type. Test specifications: italic type. Informative material appearing outside of tables, such as notes, examples and references: in smaller type. Normative text of tables is also in a smaller type. Terms defined in this particular standard or as noted: small capitals type. v

9 Provläsningsexemplar / Preview SS-EN ISO 23747:2015 (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 a peak expiratory flow meter (pefm) intended for the assessment of pulmonary function in spontaneously breathing humans. This International Standard covers all medical devices that measure peak expiratory flowrate in spontaneously breathing humans either as part of an integrated lung function medical device or as a stand-alone medical device. Planning and design of products applying to this International Standard are to 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 Normative references The following documents, in whole or in part, are normatively referenced in this document and are indispensable for its application. For dated references, only the edition cited applies. For undated references, the latest edition of the referenced document (including any amendments) applies. ISO :2009, Biological evaluation of medical devices Part 1: Evaluation and testing within a risk management process ISO 14937:2009, 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 :2012, Medical devices Symbols to be used with medical device labels, labelling and information to be supplied Part 1: General requirements IEC :2005+A1:2012, 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. NOTE An alphabetized index of defined terms is found in Annex G. 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 1

10 SS-EN ISO 23747:2015 (E) Provläsningsexemplar / Preview 3.3 manufacturer natural or legal person with responsibility for the design, manufacture, packaging, or labelling of a medical device, assembling a system, or adapting a medical device before it is placed on the market or put into service, regardless of whether these operations are carried out by that person or on that person s behalf by a third party Note 1 to entry: Attention is drawn to the fact that the provisions of national or regional regulations can apply to the definition of manufacturer. Note 2 to entry: For a definition of labelling, see ISO 13485:2003, definition 3.6. [11] [SOURCE: ISO 14971:2007, definition 2.8] 3.4 medical device any instrument, apparatus, implement, machine, appliance, implant, in vitro reagent or calibrator, software, material, or other similar or related article, intended by the manufacturer (3.3) to be used, alone or in combination, for human beings for one or more of the specific purpose(s) of diagnosis, prevention, monitoring, treatment or alleviation of disease, diagnosis, monitoring, treatment, alleviation of or compensation for an injury, investigation, replacement, modification, or support of the anatomy or of a physiological process, supporting or sustaining life, control of conception, disinfection of medical devices, providing information for medical purposes by means of in vitro examination of specimens derived from the human body, and which does not achieve its primary intended action in or on the human body by pharmacological, immunological, or metabolic means, but which may be assisted in its function by such means. Note 1 to entry: This definition has been developed by the Global Harmonization Task Force (GHTF). See Reference [15]. [SOURCE: ISO 13485:2003, definition 3.7] 3.5 model or type reference combination of figures, letters, or both used to identify a particular model of medical device (3.4)or accessory [SOURCE: IEC :2005, definition 3.66, modified: equipment was replaced by medical device ] 3.6 peak expiratory flowrate pef maximum flowrate measured at the mouth during an expiration delivered with maximal force starting immediately after achieving maximum lung inflation 3.7 peak expiratory flow meter pefm medical device (3.4) for measurement of peak expiratory flowrate (3.6) 2

11 Provläsningsexemplar / Preview SS-EN ISO 23747:2015 (E) 3.8 responsible organization entity accountable for the use and maintenance of a medical device (3.4) Note 1 to entry: The accountable entity can be, for example, a hospital, an individual clinician, or a layperson. In home use applications, the patient, operator, and responsible organization can be one and the same person. Note 2 to entry: Education and training is included in use. [SOURCE: IEC :2005, definition 3.101, modified: an me equipment or an me system was replaced by a medical device.] 3.9 rise time rt time taken for flowrate to rise from 10 % to 90 % of the achieved pef (3.6) 4 General requirements 4.1 Safety for a pefm that utilizes electricity A pefm that utilizes electrical power shall meet the requirements of IEC :2005+A1:2012, in addition to the requirements in this International Standard. NOTE 1 IEC requires a pefm to comply with IEC to control the risks associated with electromagnetic compatibility. NOTE 2 IEC requires a pefm to comply with IEC to control the risks associated with usability. NOTE 3 IEC requires a pefm intended for use in the home healthcare environment to comply with IEC NOTE 4 IEC requires a pefm intended for use in the emergency medical services environment to comply with IEC Check compliance by application of the tests of IEC :2005+A1: Mechanical basic 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. 3

SVENSK STANDARD SS-EN ISO :2006/A1:2014

SVENSK STANDARD SS-EN ISO :2006/A1:2014 SVENSK STANDARD SS-EN ISO 11979-10:2006/A1:2014 Fastställd/Approved: 2014-08-10 Publicerad/Published: 2014-10-01 Utgåva/Edition: 1 Språk/Language: engelska/english ICS: 11.040.70 Ögonimplantat Intraokulära