SIST EN ISO 26782:2009

2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.Anestezijska in dihalna oprema - Merilniki pretoka zraka (spirometri) za merjenje pospešenega volumna izdiha pri ljudeh (ISO 26782:2009)Anästhesie- und Beatmungsgeräte - Spirometer zur Messung des zeitbezogenen forcierten Exspirationsvolumens beim Menschen (ISO 26782:2009)Matériel d'anesthésie et de réanimation respiratoire - Spiromètres destinés au mesurage des volumes expiratoires forcés chronométrés chez les humains (ISO 26782:2009)Anaesthetic and respiratory equipment - Spirometers intended for the measurement of time forced expired volumes in humans (ISO 26782:2009)11.040.10Anestezijska, respiratorna in reanimacijska opremaAnaesthetic, respiratory and reanimation equipmentICS:Ta slovenski standard je istoveten z:EN ISO 26782:2009SIST EN ISO 26782:2009en01-november-2009SIST EN ISO 26782:2009SLOVENSKI
STANDARD
EUROPEAN STANDARDNORME EUROPÉENNEEUROPÄISCHE NORMEN ISO 26782July 2009ICS 11.040.10 English VersionAnaesthetic and respiratory equipment - Spirometers intendedfor the measurement of time forced expired volumes in humans(ISO 26782:2009)Matériel d'anesthésie et de réanimation respiratoire -Spiromètres destinés au mesurage des volumesexpiratoires forcés chronométrés chez les humains (ISO26782:2009)Anästhesie- und Beatmungsgeräte - Spirometer zurMessung des zeitbezogenen forciertenExspirationsvolumens beim Menschen (ISO 26782:2009)This European Standard was approved by CEN on 17 June 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 26782:2009: ESIST EN ISO 26782:2009

Relationship between this standard and the Essential Requirements of EU Directive 93/42/EEC .4 SIST EN ISO 26782:2009

Relationship between this standard and the Essential Requirements of EU Directive 93/42/EEC This standard has been prepared under a mandate given to CEN by the European Commission and the European Free Trade Association to provide a means to conforming to Essential Requirements of the New Approach Directive 93/42/EEC, Council Directive of 29 March 2007 on the approximation of the laws of the Member States concerning medical devices” (Medical Device Directive).
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.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 standard and Directive 93/42/EEC
Clause(s)/sub-clause(s) of this International Standard Essential requirements (ERs) of EU Directive 93/42/EEC Qualifying remarks/NotesAll 1, 2, 3
4.1 12.6, 13.1, 13.2, 13.6 f) And via IEC 60601-1 4.2 9.2
5 13.1 And via IEC 60601-1 5.1 10.1, 10.3 And via IEC 60601-1 5.2 4, 10.2 And via IEC 60601-1 5.3 4 And via IEC 60601-1 5.4 13
5.4.1 a) 13.6 d)
5.4.1 b) 13.3 a)
5.4.1 c) 13.3 b), o)
5.4.1 d) 13.3 d)
5.4.1 e) 13.6 n)
5.4.1 f) 13.3 e)
5.4.2 a) 13.3 b)
5.4.2 b) 13.4
5.4.2 c) 13.2, 13.3 e)
5.4.2 d) 13.3 f)
5.4.2 e) 13.3 f)
5.4.2 f) 5, 13.3 i) And via IEC 60601-1 5.4.2 g) 13.3 j)
5.4.2 h) 13.3 k)
5.4.2 i) 8.7, 13.2, 13.3 m)
5.5.1 9.1 And via IEC 60601-1 SIST EN ISO 26782:2009

5.5.1 b) 13.4
5.5.1 c), d), e) 13.6 b)
5.5.1 f) 13.6 a)
5.5.1 h) 13.6 a)
5.5.1 i) 13.6 a), b), n)
5.5.1 j) 13.6 b), d)
5.5.1 k) 13.6 c)
5.5.1 l) 13.6 i)
5.5.1 m) 13.6 k)
5.5.1 n) 13.3 i)
5.5.1 o) 13.6 d)
5.5.1 p) 13.6 c)
5.5.1 q) 13.3 k), 13.6 n)
5.5.1 r) 13.6 q)
5.5.2 13.6 g), h)
6 10.1 And via IEC 60601-1 7 10.2 And via IEC 60601-1 7 10.3 And via IEC 60601-1 7.1 4, 10.1 And via IEC 60601-1 8 4 And via IEC 60601-1 8.2 4, 9.2 And via IEC 60601-1 9.1, 9.2 8.1, 8.5 And via IEC 60601-1 9.3 7.3, 8.4 And via IEC 60601-1 10 7.1 And via IEC 60601-1 10 7.2 And via IEC 60601-1 10 7.3 And via IEC 60601-1 Annex C 6 a)
- 6, 7.5, 7.6, 9.3, 11.3.1, 12.2, 12.5, 12.7.1, 12.7.2, 12.7.3, 12.7.4, 12.7.5 Via IEC 60601-1 NOTE
ERs 13.3 a) and 13.6 h) are not fully addressed.
WARNING — Other requirements and other EU Directives may be applicable to the products falling within the scope of this standard.
Reference numberISO 26782:2009(E)© ISO 2009
INTERNATIONAL STANDARD ISO26782First edition2009-07-15Anaesthetic and respiratory equipment —Spirometers intended for the measurement of time forced expired volumes in humans Matériel d'anesthésie et de réanimation respiratoire — Spiromètres destinés au mesurage des volumes expiratoires forcés chronométrés chez les humains
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ii © ISO 2009 – All rights reserved
ISO 26782:2009(E) © ISO 2009 – All rights reserved iii Contents Page Foreword.iv Introduction.v 1 *Scope.1 2 Normative references.1 3 Terms and definitions.2 4 General requirements.4 4.1 Electrical safety.4 4.2 Mechanical safety.4 5 Identification, marking and documents.4 5.1 Marking of the scale or display.4 5.2 Legibility of markings.5 5.3 Durability of markings.5 5.4 Marking of the spirometer or its packaging.6 5.5 Instructions for use.6 5.6 Technical description.8 6 *Measurement range.8 7 Performance requirements.8 7.1 Accuracy.8 7.2 Recording time.9 7.3 Graphical display aspect ratios.9 7.4 Volume recording.9 7.5 *Start of forced exhalation.9 7.6 *End of forced exhalation.9 7.7 Linearity.9 7.8 Repeatability.9 7.9 Expiratory impedance.10 8 Constructional requirements.10 8.1 Effects of dropping components of a hand-held spirometer or accessory.10 8.2 Calibration.10 8.3 Dismantling and re-assembly.10 9 Cleaning, sterilization and disinfection.10 9.1 Re-usable spirometer and parts.10 9.2 Spirometer and parts requiring processing before use.11 9.3 Spirometer and parts delivered sterile.11 10 Biocompatibility.11 Annex A (informative)
Rationale.12 Annex B (normative)
Testing accuracy, linearity and impedance of spirometers.16 Annex C (normative)
* Defined test profiles.20 Annex D (informative)
Environmental aspects.23 Annex E (informative)
Reference to the essential principals.24 Bibliography.26 Alphabetized index of defined terms used in this International Standard.27
ISO 26782:2009(E) iv © ISO 2009 – 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 26782 was prepared by Technical Committee ISO/TC 121, Anaesthetic and respiratory equipment, Subcommittee SC 3, Lung ventilators and related equipment.
ISO 26782:2009(E) © ISO 2009 – All rights reserved v Introduction A spirometer is a medical device that records physiological lung ventilation volumes within the range of the vital capacity. The timed volumes that a PATIENT is able to expel after a maximal inspiration give a reliable method of assessing lung function. These spirometric assessments are used, for example, to screen individuals at risk of lung disease, to give objective measures in the presence of lung disease, to evaluate symptoms and pre-operative risk and to record the effect of therapeutic intervention. A SPIROMETER can also be used in evaluating pulmonary disability, public health and clinical trials. The American Thoracic Society (ATS) and the European Respiratory Society (ERS) have been instrumental in developing recommendations for the standardization of lung function testing, including guidelines for spirometry [6], [7]. There is however no recognised international or national standard for SPIROMETERS with reliance for accuracy, repeatability, etc. based on objective test methodology and on meeting defined tolerances when tested with a carefully selected set of defined test profiles such as those published by the ATS. This International Standard addresses this problem by developing a standard for a SPIROMETER to give the clinician the confidence that any SPIROMETER used meets agreed standards of accuracy, repeatability, electrical safety, etc. The minimum safety requirements specified in this particular International Standard are considered to provide a practical degree of safety in the operation of SPIROMETERS. The requirements are followed by specifications for the relevant tests. A “rationale and guidance” section giving some explanatory notes, where appropriate, about the more important requirements is included in Annex A. It is considered that knowledge of the reasons for these requirements will not only facilitate the proper application of this International Standard but will, in due course, expedite any revision necessitated by changes in clinical practice or as a result of developments in technology. However, this annex does not form part of the requirements of this International Standard. In this document, the following print types are used: ⎯ requirements, compliance with which can be verified, and definitions: roman type; ⎯ notes and examples: smaller roman type; ⎯ description of type of document change, and test methods: italic type; ⎯ TERMS DEFINED IN THIS DOCUMENT: SMALL CAPITALS. Throughout this document, text for which a rationale is provided in Annex A is indicated by an asterisk (*).
INTERNATIONAL STANDARD ISO 26782:2009(E) © ISO 2009 – All rights reserved 1 Anaesthetic and respiratory equipment — Spirometers intended for the measurement of time forced expired volumes in humans 1 *Scope This International Standard specifies requirements for SPIROMETERS intended for the assessment of pulmonary function in humans weighing more than 10 kg. This International Standard applies to a SPIROMETER that measure timed forced expired volumes, either as part of an integrated lung function device or as a stand-alone device, irrespective of the measuring method employed. Devices intended for continuously monitoring PATIENTS are outside the scope of this International Standard. 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 10933-11), Biological evaluation of medical devices — Part 1: Evaluation and testing within a risk management process ISO 149372), 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
1) To be published. (Revision of ISO 10993-1:2003) 2) To be published. (Revision of ISO 14937:2000) SIST EN ISO 26782:2009

ISO 26782:2009(E) 2 © ISO 2009 – All rights reserved 3 Terms and definitions For the purposes of this document the following terms and definitions apply. For convenience, the sources of all defined terms used in this International Standard are given in the Alphabetical Index. 3.1 accessory additional part for use with SPIROMETER in order to: ⎯ achieve the INTENDED USE, ⎯ adapt it to some special use, ⎯ facilitate its use, ⎯ enable its functions to be integrated with those of other equipment NOTE Adapted from IEC 60601-1:2005, definition 3.3. 3.2 accompanying document document accompanying a SPIROMETER or ACCESSORY and containing information for those accountable for the installation, use and maintenance of the SPIROMETER or ACCESSORY, the OPERATOR or the RESPONSIBLE ORGANIZATION, particularly regarding safety NOTE Adapted from ISO 14971:2007, definition 2.1. 3.3 body temperature and pressure saturated BTPS body temperature (37 °C), at the ambient pressure and saturated with water vapour 3.4 clearly legible capable of being read by a person with normal vision [IEC 60601-1:2005, definition 3.15] 3.5 expected service life maximum period of useful life as defined by the MANUFACTURER [IEC 60601-1:2005, definition 3.28] 3.6 forced expiratory volume after time t FEVt expiratory volume of a PATIENT under forced conditions at time t in seconds, measured from TIME ZERO 3.7 forced vital capacity FVC maximal volume of air exhaled with a continuous maximum forced expiratory effort from the point of maximal inspiration 3.8 hand-held term referring to equipment intended to be supported by the hand during NORMAL USE NOTE Adapted from IEC 60601-1:2005, definition 3.37. SIST EN ISO 26782:2009

ISO 26782:2009(E) © ISO 2009 – All rights reserved 3 3.9 intended use use of a product, process or service in accordance with the specifications, instructions and information provided by the MANUFACTURER NOTE INTENDED USE is not to be confused with NORMAL USE. While both include the concept of use as intended by the MANUFACTURER, INTENDED USE focuses on the medical purpose while NORMAL USE incorporates not only the medical purpose, but also maintenance, service, transport, etc. [IEC 60601-1:2005, definition 3.44] 3.10 manufacturer natural or legal person with responsibility for the design, manufacture, packaging, or labelling of SPIROMETER, or adapting SPIROMETER, regardless of whether these operations are performed by that person or on that person's behalf by a third party NOTE 1 ISO 13485 [1] defines “labelling” as written, printed or graphic matter ⎯ affixed to a medical device or any of its containers or wrappers or ⎯ accompanying a medical device, related to identification, technical description, and use of the medical device, but excluding shipping documents. In this International Standard, that material is described as markings and the ACCOMPANYING DOCUMENT. NOTE 2 “Adapting” includes making substantial modifications to a SPIROMETER already in use. NOTE 3 In some jurisdictions, the RESPONSIBLE ORGANIZATION can be considered a MANUFACTURER when involved in the activities described. NOTE 4 Adapted from IEC 60601-1:2005, definition 3.55. 3.11 measurement range set of values of measurands for which the error of a measuring instrument is intended to lie within specified limits 3.12 *model or type reference combination of figures, letters or both used to identify a particular model of SPIROMETER or ACCESSORY NOTE Adapted from IEC 60601-1:2005, definition 3.66. 3.13 normal use operation, including routine inspection and adjustments by any OPERATOR, and stand-by, according to the instruction for use NOTE NORMAL USE should not be confused with INTENDED USE. While both include the concept of use as intended by the MANUFACTURER, INTENDED USE focuses on the medical purpose while NORMAL USE incorporates not only the medical purpose, but also maintenance, service, transport, etc. [IEC 60601-1:2005, definition 3.71] 3.14 operator person handling equipment [IEC 60601-1:2005, definition 3.73] SIST EN ISO 26782:2009

ISO 26782:2009(E) 4 © ISO 2009 – All rights reserved 3.15 patient living being (person or animal) undergoing a medical, surgical or dental procedure [IEC 60601-1:2005, definition 3.76] 3.16 responsible organization entity accountable for the use and maintenance of a SPIROMETER NOTE 1 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 Education and training is included in “use.” NOTE 3 Adapted from IEC 60601-1:2005, definition 3.101. 3.17 spirometer device for recording forced expiratory volume over a period of time 3.18 *time zero point of intersection on the time axis of a line drawn on the volume time trace through the point of peak expiratory flow (PEF) with a slope equal to peak expiratory flow 3.19 tool extra-corporeal object that can be used to secure or release fasteners or to make adjustments NOTE Coins and keys are considered TOOLS within the context of this International Standard. [IEC 60601-1:2005, definition 3.127] 4 General requirements 4.1 Electrical safety SPIROMETERS that utilize electrical power shall meet the applicable requirements in 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 Spirometers shall comply with IEC 60601-1:2005, Clause 9. Check compliance by inspection. 5 Identification, marking and documents 5.1 Marking of the scale or display The scale or display of a SPIROMETER shall be marked as follows. a) The scale or display shall be in units of litres. SIST EN ISO 26782:2009

ISO 26782:2009(E) © ISO 2009 – All rights reserved 5 b) The numbering on a scale or digital display shall not exceed the MEASUREMENT RANGE. c) For SPIROMETERS with volume traces as the primary output, the increment between any two adjacent graduation lines shall represent a difference in volume no greater than 0,1 l and the numbering on a scale shall appear at intervals no greater than 1,0 l. d) For SPIROMETERS with a digital display the incremental step shall be no greater than 0,01 l. Check compliance by inspection. 5.2 Legibility of markings The markings required by 5.1 and 5.4 shall be CLEARLY LEGIBLE under the following conditions: a) for warning statements, instructive statements, safety signs and drawings on the outside of the SPIROMETER, from the intended position of the person performing the related function; b) for markings on the inside of the SPIROMETER or SPIROMETER parts, from the intended position of the person performing the related function. Check compliance for a CLEARLY LEGIBLE marking by the following test. 1) Position the SPIROMETER or its part so that the viewpoint is the intended position of the OPERATOR; or the viewpoint is at any point within the base of a cone subtended by an angle of 30° to the axis normal to the centre of the plane of the marking and at a distance of 1 m. 2) Ensure that the ambient illuminance is the least favourable level in the range of 100 lx to 1 500 lx. 3) Ensure that the observer has a visual acuity of 0 on the log minimum angle of resolution (log MAR) scale or 6/6 (20/20), corrected if necessary. 4) The observer correctly reads the marking from the viewpoint. 5.3 Durability of markings The markings required by 5.1 and 5.4 shall be removable only with a TOOL or by appreciable force and shall be sufficiently durable to remain CLEARLY LEGIBLE during the EXPECTED SERVICE LIFE of the SPIROMETER. In considering the durability of the markings, the effect of NORMAL USE shall be taken into account. NOTE Recordings or paper output chards are not considered markings. Check compliance by inspection and the following tests. After all the other tests of this document have been performed: a) rub markings by hand, without undue pressure, first for 15 s with a cloth rag soaked with distilled water, then for 15 s with a cloth rag soaked with methylated spirits and then for 15 s with a cloth rag soaked with isopropyl alcohol; b) test the legibility of markings to the requirements of 5.2; c) ensure that adhesive labels have not worked loose or become curled at the edges. SIST EN ISO 26782:2009

ISO 26782:2009(E) 6 © ISO 2009 – All rights reserved 5.4 Marking of the spirometer or its packaging 5.4.1 The SPIROMETER and, where physically possible, its ACCESSORIES shall be marked with the following: a) a symbol showing the direction of flow for any OPERATOR-detachable components that are flow-direction sensitive unless designed in such a way as to prevent incorrect use or assembly; b) the name and address or trademark and address of the MANUFACTURER; c) MODEL OR TYPE REFERENCE; d) where appropriate, an identification reference to the batch or serial number, or symbol 5.14 or 5.16 from ISO 15223-1:2007; e) method of disposal, as appropriate; f) for a SPIROMETER with an expiration date, symbol 5.12 from ISO 15223-1:2007, or if not practicable, an expiration date may be marked on the packaging. 5.4.2 The packaging of a SPIROMETER, an ACCESSORY or their components shall be marked with the following: a) details to enable the RESPONSIBLE ORGANIZATION to identify the contents of the packaging; b) the INTENDED USE of the SPIROMETER or ACCESSORY; c) for a SPIROMETER or ACCESSORY with an expiration date, symbol 5.12 from ISO 15223-1:2007; d) for a single PATIENT use ACCESSORY the words “single patient use”; e) for a single use SPIROMETER, ACCESSORY or component, the words “single use only” or “do not re-use” or symbol 5.2 from ISO 15223-1:2007; f) any special storage and/or handling instructions; g) any special operating instructions; h) any warnings and/or precautions to take; i) for a sterile SPIROMETER, ACCESSORY or component, the word “STERILE” or symbol 5.20, 5.21, 5.22, 5.23 or 5.24 (as appropriate) from ISO 15223-1:2007. Check compliance by inspection. 5.5 Instructions for use 5.5.1 General The ACCOMPANYING DOCUMENTS shall include the following: a) identity of the SPIROMETER by inclusion of the following: ⎯ name or trade-name of the MANUFACTURER, and an address to which the RESPONSIBLE ORGANIZATION can refer; NOTE In some countries, the name and address of a local authorized representative is required, where the MANUFACTURER does not have a local registered place of business. ⎯ MODEL OR TYPE REFERENCE; SIST EN ISO 26782:2009

ISO 26782:2009(E) © ISO 2009 – All rights reserved 7 b) the INTENDED USE of the SPIROMETER, including any restrictions on its use; c) a brief description of the SPIROMETER, including its significant physical and performance characteristics; d) all information necessary to operate the SPIROMETER in accordance with its specification; EXAMPLE Explanations of the functions of controls, displays and signals, the sequence of operation, connection and disconnection of detachable parts and ACCESSORIES, and replacement of material that is consumed during operation. e) how the SPIROMETER functions;
f) the information required in 5.4; g) a description of all markings on the SPIROMETER; EXAMPLE Figures, symbols, warning statements, abbreviations and indicator lights. h) any special operating instructions; i) any warnings and/or precautions to be taken; j) a statement that the performance of the SPIROMETER can be affected by the PATIENT spitting or coughing into the SPIROMETER during expiration or by extremes of temperature, humidity and altitude if applicable; k) if installation of the SPIROMETER or its parts is required, a reference to where the installation instructions are to be found (e.g. the technical description); l) the correct method of re-assembly, if the SPIROMETER is intended to be dismantled by the OPERATOR; m) details of the SPIROMETER checks that the OPERATOR should consider if unusual readings are obtained; n) recommended storage conditions; o) details of the nature and frequency of any maintenance and/or calibration needed to ensure that the SPIROMETER operates within the requirements specified in this International Standard; p) details of any breathing system filter recommended; q) information concerning the disposal of the SPIROMETER, its ACCESSORIES, detachable parts and material; r) the date of issue of the ACCOMPANYING DOCUMENTS. Check compliance by inspection. 5.5.2 Cleaning, disinfection and sterilization For SPIROMETER parts or ACCESSORIES that can become contaminated through contact with the PATIENT or with body fluids or expired gases during NORMAL USE, the instructions for use shall contain: a) details about cleaning and disinfection or cleaning and sterilization methods that may be used; b) a list of the applicable parameters such as temperature, pressure, humidity, time limits and number of cycles that such SPIROMETER parts or ACCESSORIES can tolerate. See also 9.1 and 9.2. SIST EN ISO 26782:2009

ISO 26782:2009(E) 8 © ISO 2009 – All rights reserved This requirement does not apply to any material, component, ACCESSORY or SPIROMETER that is marked as intended for single use unless the MANUFACTURER specifies that the material, component, ACCESSORY or SPIROMETER is to be cleaned and disinfected or cleaned and sterilized before use (see 9.2). Check compliance by inspection. 5.6 Technical description 5.6.1 The technical description shall include the following: a) specification of the signal input/output part, if applicable; b) limits of accuracy of the measured value (see 7.1); c) the method by which the SPIROMETER determines TIME ZERO; d) the highest expiratory impedance and the flow at which this occurs when using the SPIROMETER within its MEASUREMENT RANGE, including any ACCESSORIES listed in the ACCOMPANYING DOCUMENT. 5.6.2 The technical description shall also include, if applicable, the following: a) any correction factors to be applied for changes in ambient conditions; b) a statement to the effect that the values displayed by the SPIROMETER are expressed as BTPS values or if the volumes are not expressed as BTPS, a warning to describe the deviation and the conditions under which the values are expressed, together with a conversion formula to change the volumes into BTPS. Check compliance by inspection. 6 *Measurement range The MEASUREMENT RANGE shall be from zero to at least 8 l when referenced to BTPS conditions. Check compliance by inspection. 7 Performance requirements 7.1 Accuracy The maximum permissible error for the volume reading in the MEASUREMENT RANGE shall be ± 3,0 % of reading or 0,05 l (whichever is greater). This applies under the following environmental conditions: ⎯ ambient temperature from 17 °C to 35 °C; ⎯ relative humidity from 30 % RH to 75 % RH; ⎯ ambient pressure from 850 hPa to 1 060 hPa. NOTE The maximum permissible errors do not take into account the tolerances of the test apparatus. Check compliance by the tests described in Annex B. SIST EN ISO 26782:2009

ISO 26782:2009(E) © ISO 2009 – All rights reserved 9 7.2 Recording time While measuring FVC, a SPIROMETER shall be capable of recording volume for at least 15 s. Check compliance by functional testing. 7.3 Graphical display aspect ratios If graphically displayed recordings are provided, the following shall be the default aspect ratios: a) for volume vs. time (1 l:1 s) maintained for at least 6 s b) for flow vs. volume (2 l/s:1 l) maintained for the full volume Check compliance by inspection. 7.4 Volume recording FEV1 and FEV6 shall be measured at 1 s and 6 s from TIME ZERO determined by back extrapolation. Check compliance by the tests described in Annex B. 7.5 *Start of forced exhalation The SPIROMETER shall provide a means of indicating that the start of a forced exhalation is acceptable, i.e. when back-extrapolated volume is < 0,15 l or < 5 % of the FVC, whichever is greater. Check compliance by the tests described in Annex B. 7.6 *End of forced exhalation If the SPIROMETER records FVC, it shall have a means of indicating that a satisfactory end-phase of a forced exhalation has been achieved, i.e. when the rate of change of volume is less than 0,025 l/s. See Reference [7]. Check compliance by functional testing. 7.7 Linearity The linearity error of the SPIROMETER, including its ACCESSORIES and detachable parts, shall not exceed 3 % when measured at steps that are between 0,4 l and 0,6 l apart and span the MEASUREMENT RANGE of the SPIROMETER for the defined test profiles of Annex C. Check compliance by the tests described in Annex B. 7.8 Repeatability The span of the SPIROMETER readings within the MEASUREMENT RANGE at each test value shall be within 0,05 l or 3 % of the mean of the readings, whichever is greater, when measured at ambient conditions for the defined test profiles of Annex C (see B.1 in Annex A). NOTE
The tolerances do not take into account the tolerances of the test apparatus.
Check compliance by the tests described in Annex B. SIST EN ISO 26782:2009

ISO 26782:2009(E) 10 © ISO 2009 – All rights reserved 7.9 Expiratory impedance The expiratory impedance of the SPIROMETER, including its ACCESSORIES and detachable parts, shall not exceed 0,15 kPa/(l/s) for the defined test profiles listed in Table C.1 with flows up to 14 l/s. NOTE A breathing system filter is considered an ACCESSORY. Check compliance by the tests described in Annex B. 8 Constructional requirements 8.1 Effects of dropping components of a hand-held spirometer or accessory The HAND-HELD components and ACCESSORIES of a SPIROMETER shall be tested by the method given in 15.3.4.1 of IEC 60601:2005. Following the test, the SPIROMETER, including its ACCESSORIES and detachable parts, shall meet the requirements of Clause 7. NOTE Any components that become disassembled should be fitted together again following each drop. Check compliance by application of the tests of IEC 60601:2005, 15.3.4.1. Subsequently, ensure that the SPIROMETER, including its ACCESSORIES and detachable parts, complies with Clause 7. 8.2 Calibration The SPIROMETER, including its ACCESSORIES, shall be provided with a means of checking the calibration of the SPIROMETER using a 3 l calibration syringe with an accuracy of 0,5 % or better. Check compliance by inspection. 8.3 Dismantling and re-assembly
If intended for dismantling by the OPERATOR, the SPIROMETER shall: a) be designed or marked to ensure correct assembly when all the parts are mated; b) when re-assembled, meet the requirements of Clause 7. Check compliance by disassembling and re-assembling the spirometer as indicated in the ACCOMPANYING DOCUMENT. Ensure that following re-assembly, the SPIROMETER, including its ACCESSORIES and detachable parts, complies with Clause 7. 9 Cleaning, sterilization and disinfection 9.1 Re-usable spirometer and parts All components specified for re-use in the ACCOMPANYING DOCUMENTS, and which come into contact with the PATIENT, shall be capable of being cleaned and disinfected or cleaned and sterilized. Check compliance by a review of the ACCOMPANYING DOCUMENTS for methods of cleaning and disinfection or cleaning and sterilization (see 5.5.2) and by inspection of the relevant validation reports. SIST EN ISO 26782:2009

ISO 26782:2009(E) © ISO 2009 – All rights reserved 11 9.2 Spirometer and parts requiring processing before use All components specified in the ACCOMPANYING DOCUMENTS to be cleaned and disinfected or cleaned and sterilized before use and which come into contact with the PATIENT shall be capable of being cleaned and disinfected or cleaned and sterilized. Check compliance by a review of the ACCOMPANYING DOCUMENTS for methods of cleaning and disinfection or cleaning and sterilization (see 5.5.2) and by inspection of the relevant validation reports. 9.3 Spirometer and parts delivered sterile SPIROMETERS or ACCESSORIES labelled sterile shall have been sterilized using an appropriate, validated method as described in ISO 14937. Check compliance by inspection of the relevant validation reports. 10 Biocompatibility SPIROMETERS and parts thereof intended to come into contact with biological tissues, cells, body fluids or breathing gases shall be assessed and documented according to the guidance and principles given in ISO 10993-1. Check compliance by inspection of the relevant validation reports. SIST EN ISO 26782:2009

ISO 26782:2009(E) 12 © ISO 2009 – All rights reserved Annex A (informative)
Rationale This annex provides a rationale for certain requirements of this International Standard and is intended for those who are familiar with the subject of this International Standard but who have not participated in its development. An understanding of the reasons for these requirements is considered to be essential for their proper application and is provided to aid in the application of this International Standard. Furthermore, as clinical practice and technology change, it is believed that a rationale will facilitate any revision of this International Standard necessitated by those developments. The numbering of the following rationale corresponds to the numbering of the clauses in this International Standard. The numbering is, therefore, not consecutive. 1 *Scope SPIROMETERS are used for a variety of tasks within the context of measuring lung function. This International Standard is limited to only those SPIROMETERS that are used for making timed measurements of forced expiratory volumes. Such SPIROMETERS can use one of a wide variety of transduction systems to obtain these timed volumes and this International Standard applies to all such systems. Future standards might include other types of SPIROMETER such as those measuring inspiratory volumes or un-timed (continuous) expiratory volumes. This International Standard is designed to ensure these SPIROMETERS can record those lung function indices that are recognised to have value in PATIENT care. These include forced expiratory volume in 1 s (FEV1), forced vital capacity (FVC) and forced expiratory volume in 6 s (FEV6). FEF25−75 % can be calculated from a volume/time trace of a maximum forced exhalation. It is the slope of the line joining the volume when 25 % and 75 % of the FVC had been exhaled. It has the units of flow (litres per second) but it is not necessary for the SPIROMETERS to record flow as the primary signal in order to calculate this spirometric index. FEF25−75 % is not included in this International Standard as an index to be tested. It is not recommended for use in clinical practice, as it is not as repeatable within individuals because its magnitude changes substantially with relatively small changes in FVC and its normal values vary widely within the population. A SPIROMETER meeting this International Standard for accuracy of volumes across its range should be accurate to derive FEF25−75 % should it be required. No flow measurements are included in this International Standard. ISO 23747 [4] covers devices for measuring peak expiratory flow (PEF) and a device meeting these requirements should be adequate to record other instantaneous flows during a forced exhalation if they are needed. 3.12 *Model or type reference The MODEL OR TY
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