SIST EN ISO 26782:2009
(Main)Anaesthetic and respiratory equipment - Spirometers intended for the measurement of time forced expired volumes in humans (ISO 26782:2009)
Anaesthetic and respiratory equipment - Spirometers intended for the measurement of time forced expired volumes in humans (ISO 26782:2009)
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.
Anästhesie- und Beatmungsgeräte - Spirometer zur Messung des zeitbezogenen forcierten Exspirationsvolumens beim Menschen (ISO 26782:2009)
Diese Internationale Norm legt Anforderungen für Spirometer zur Beurteilung der Lungenfunktion beim Menschen mit einem Körpergewicht über 10 kg fest.
Die vorliegende Internationale Norm gilt für Spirometer, die exspirierte Volumina je Zeiteinheit entweder als Bestandteil eines integrierten Lungenfunktionsgerätes oder als eigenständiges Gerät, ungeachtet des angewendeten Umwandlungsverfahren messen.
Geräte, die zur kontinuierlichen Überwachung von Patienten vorgesehen sind, liegen außerhalb des Anwendungsbereich dieser Norm.
Matériel d'anesthésie et de réanimation respiratoire - Spiromètres destinés au mesurage des volumes expiratoires forcés chronométrés chez les humains (ISO 26782:2009)
L'ISO 26782:2009 spécifie les exigences relatives à des spiromètres destinés à l'évaluation de la fonction pulmonaire chez des humains pesant plus de 10 kg.
L'ISO 26782:2009 s'applique à des spiromètres qui mesurent des volumes expiratoires forcés chronométrés, intégrés à un dispositif d'essai de la fonction pulmonaire ou sous forme de dispositif autonome, indépendamment de la méthode de détection utilisée.
Anestezijska in dihalna oprema - Merilniki pretoka zraka (spirometri) za merjenje pospešenega volumna izdiha pri ljudeh (ISO 26782:2009)
Ta mednarodni standard določa zahteve za SPIROMETRE, ki se uporabljajo za ocenjevanje pljučne funkcije pri ljudeh, ki tehtajo več kot 10 kg. Ta mednarodni standard velja za SPIROMETRE, ki merijo pospešeni volumen izdiha in so del vgrajene naprave za pljučno funkcijo ali pa samostojni pripomoček, ne glede na uporabljeno metodo merjenja. Pripomočki, ki se uporabljajo za neprekinjeno spremljanje BOLNIKOV, so izven območja uporabe tega mednarodnega standarda.
General Information
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Standards Content (Sample)
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
SIST EN ISO 26782:2009
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
EN ISO 26782:2009 (E) 2 Contents Page Foreword .3Annex ZA (informative)
Relationship between this standard and the Essential Requirements of EU Directive 93/42/EEC .4 SIST EN ISO 26782:2009
EN ISO 26782:2009 (E) 3 Foreword This document (EN ISO 26782:2009) 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 2010, and conflicting national standards shall be withdrawn at the latest by March 2010. 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 has been prepared under a mandate given to CEN by the European Commission and the European Free Trade Association, and supports essential requirements of EC Directive. For relationship with EC Directive, 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 the United Kingdom. Endorsement notice The text of ISO 26782:2009 has been approved by CEN as a EN ISO 26782:2009 without any modification. SIST EN ISO 26782:2009
EN ISO 26782:2009 (E) 4 Annex ZA (informative)
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
EN ISO 26782:2009 (E) 5 Table ZA.1 (continued) Clause(s)/sub-clause(s) of this International Standard Essential requirements (ERs) of EU Directive 93/42/EEC Qualifying remarks/Notes5.5.1 a) 13.6 a)
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.
SIST EN ISO 26782:2009
SIST EN ISO 26782:2009
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
SIST EN ISO 26782:2009
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SIST EN ISO 26782:2009
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
SIST EN ISO 26782:2009
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.
SIST EN ISO 26782:2009
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 (*).
SIST EN ISO 26782:2009
SIST EN ISO 26782:2009
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 o
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