EN ISO 9360-1-2009 en Anaesthetic and respiratory equipment - Heat and moisture exchangers (HMEs) for humidifying respired gases in humans - Part 1 HMEs for use with minimum tidal .pdf

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1、BS EN ISO9360-1:2009ICS 11.040.10,NO COPYING WITHOUT BSI PERMISSION EXCEPT AS PERMITTED BY COPYRIGHT LAWBRITISH STANDARDAnaesthetic andrespiratory equipment Heat and moistureexchangers (HMEs) forhumidifying respiredgases in humansPart 1: HMEs for use with minimumtidal volumes of 250 ml (ISO9360-1:20

2、00)This British Standardwas published under theauthority of the StandardsPolicy and StrategyCommittee on 31 May 2009 BSI 2009ISBN 978 0 580 65660 6Amendments/corrigenda issued since publicationDate CommentsBS EN ISO 9360-1:2009National forewordThis British Standard is the UK implementation of EN ISO

3、 9360-1:2009.It is identical to ISO 9360-1:2000. It supersedes BS EN ISO 9360-1:2000which is withdrawn.The UK participation in its preparation was entrusted to TechnicalCommittee CH/121/1, Breathing attachments and anaesthetic machines.A list of organizations represented on this committee can be obt

4、ained onrequest to its secretary.This publication does not purport to include all the necessary provisionsof a contract. Users are responsible for its correct application.Compliance with a British Standard cannot confer immunityfrom legal obligations.EUROPEAN STANDARDNORME EUROPENNEEUROPISCHE NORMEN

5、 ISO 9360-1April 2009ICS 11.040.10 Supersedes EN ISO 9360-1:2000 English VersionAnaesthetic and respiratory equipment - Heat and moistureexchangers (HMEs) for humidifying respired gases in humans -Part 1: HMEs for use with minimum tidal volumes of 250 ml (ISO9360-1:2000)Matriel danesthsie et de rani

6、mation respiratoire -changeurs de chaleur et dhumidit (ECH) utiliss pourhumidifier les gaz respirs par les tres humains - Partie 1:ECH pour utilisation avec des volumes courants dau moins250 ml (ISO 9360-1:2000)Ansthesie- und Beatmungsgerte - Wrme- undFeuchtigkeitsaustauscher zur Anfeuchtung von Ate

7、mgasenbeim Menschen - Teil 1: Wrme- undFeuchtigkeitsaustauscher zur Verwendung beiMindesthubvolumina von 250 ml (ISO 9360-1:2000)This European Standard was approved by CEN on 28 March 2009.CEN members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for gi

8、ving 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 vers

9、ions (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, B

10、ulgaria, 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 STANDARD

11、IZATIONCOMIT EUROPEN DE NORMALISATIONEUROPISCHES KOMITEE FR NORMUNGManagement Centre: Avenue Marnix 17, B-1000 Brussels 2009 CEN All rights of exploitation in any form and by any means reservedworldwide for CEN national Members.Ref. No. EN ISO 9360-1:2009: EBS EN ISO 9360-1:2009EN ISO 9360-1:2009 (E

12、) 3 Foreword The text of ISO 9360-1:2000 has been prepared by Technical Committee ISO/TC 121 “Anaesthetic and respiratory equipment” of the International Organization for Standardization (ISO) and has been taken over as EN ISO 9360-1:2009 by Technical Committee CEN/TC 215 “Respiratory and anaestheti

13、c 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 October 2009, and conflicting national standards shall be withdrawn at the latest by March 201

14、0. 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 9360-1:2000. This document has been prepared under

15、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,

16、 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,

17、 Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland and the United Kingdom. Endorsement notice The text of ISO 9360-1:2000 has been approved by CEN as a EN ISO 9360-1:2009 without any modification. BS EN ISO 9360-1:2009EN ISO 9360-1:2009 (E) 4 Annex ZA (Informative) Re

18、lationship 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 th

19、e 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.1 c

20、onfers, 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 European Standard and EU Directives Clause(s)/sub-clause(s) of this EN Essentia

21、l Requirements (ERs) of Directive 93/42/EEC Qualifying remarks/Notes 4 13.25 7.5 (1st paragraph) This relevant Essential Requirement is not fully addressed in this European Standard - 7.5 (2nd paragraph) This relevant Essential Requirement is not addressed in this European Standard - 7.5 (3rd paragr

22、aph) This relevant Essential Requirement is not addressed in this European Standard 5.1 9.1, 13.6 c)5.2 13 c) 5.3 8.3 5, 6, 7 1 (1st paragraph) This relevant Essential Requirement is not fully addressed in this European Standard 5, 6, 7 1 (2nd paragraph, 1st dash) This relevant Essential Requirement

23、 is not fully addressed in this European Standard 5, 6, 7 1 (2nd paragraph, 2nd dash) This relevant Essential Requirement is not fully addressed in this European Standard BS EN ISO 9360-1:2009EN ISO 9360-1:2009 (E) 5 Clause(s)/sub-clause(s) of this EN Essential Requirements (ERs) of Directive 93/42/

24、EEC Qualifying remarks/Notes - 6a)This relevant Essential Requirement is not addressed in this European Standard 7.1 a) 9.1, 13.2, 13.3 k), 13.6 c) 7.1 b) 9.1, 13.2, 13.3 j) 7.2 13.17.2 13.3 (a): This relevant Essential Requirement is not fully addressed in this European Standard - 13.3 (f) This rel

25、evant Essential Requirement is not addressed in this European Standard - 13.6 (h)(2nd paragraph) This relevant Essential Requirement is not addressed in this European Standard 7.2 a) 13.3 a) 7.2 b) 13.3 b) 7.2 c) 8.7, 13.3 c) 7.2 d) 13.3 i) 7.2 e) 13.3 l) 7.2 f) 13.3 e) 7.3 13.3 f)7.4 13.17.4 13.6 (

26、q) This relevant Essential Requirement is not addressed in this European Standard 7.4 a) 13.1, 13.6 a), 13.6 b) 7.4 b) 9.1, 13.3 j) 7.4 d) 13.6 b) 7.4 f) 13.6 b) 7.4 g) 13.6 b) 7.4 h) 13.3 j), 13.3 k) 7.4 i) 13.3 m), 13.6 h) 7.4 j) 13.3 j), 13.3 k) 7.4 k) 13.6 n) WARNING: Other requirements and othe

27、r EU Directives may be applicable to the product(s) falling within the scope of this standard. BS EN ISO 9360-1:2009ISO 9360-1:2000(E) ISO 2000 All rights reserved iiiContents PageForeword.ivIntroduction.v1 Scope12 Normative references13 Terms and definitions .14 Symbols and abbreviated terms 25 Gen

28、eral requirements and recommendations25.1 HME patient port connector25.2 Additional ports .25.3 Packaging of sterile HME36 Test methods36.1 General36.2 Measurement of moisture loss.36.3 Measurement of pressure drop136.4 Test for gas leakage136.5 Test for compliance.137 Marking.15Annex A (informative

29、) Lists of parts and specifications in Figures 1 and 2.17Annex B (informative) Rationale18BS EN ISO 9360-1:2009ISO 9360-1:2000(E)iv ISO 2000 All rights reservedForewordISO (the International Organization for Standardization) is a worldwide federation of national standards bodies (ISOmember bodies).

30、The work of preparing International Standards is normally carried out through ISO technicalcommittees. Each member body interested in a subject for which a technical committee has been established hasthe right to be represented on that committee. International organizations, governmental and non-gov

31、ernmental, inliaison with ISO, also take part in the work. ISO collaborates closely with the International ElectrotechnicalCommission (IEC) on all matters of electrotechnical standardization.International Standards are drafted in accordance with the rules given in the ISO/IEC Directives, Part 3.Draf

32、t 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 part of

33、 ISO 9360 may be the subject of patentrights. ISO shall not be held responsible for identifying any or all such patent rights.International Standard ISO 9360-1 was prepared by Technical Committee ISO/TC 121, Anaesthetic and respiratoryequipment, Subcommittee SC 3, Lung ventilators and related equipm

34、ent.This first edition of ISO 9360-1 cancels and replaces, in part, the first edition of ISO 9360 (ISO 9360:1992), whichhas been technically revised.ISO 9360 consists of the following parts, under the general title Anaesthetic and respiratory equipment Heat andmoisture exchangers (HMEs) for humidify

35、ing respired gases in humans: Part 1: HMEs for use with minimum tidal volumes of 250 ml Part 2: HMEs for use with tracheostomized patients having minimum tidal volumes of 250 mlAnnexes A and B of this part of ISO 9360 are for information only.BS EN ISO 9360-1:2009ISO 9360-1:2000(E) ISO 2000 All righ

36、ts reserved vIntroductionThe gases generally available for medical use lack sufficient moisture to be physiologically acceptable to therespiratory tract of patients. Heat and moisture exchangers are used to raise the water content and the temperatureof the gas delivered to the respiratory tract. The

37、y are primarily intended for use independently or as part of abreathing system.BS EN ISO 9360-1:2009BS EN ISO 9360-1:2009INTERNATIONAL STANDARD ISO 9360-1:2000(E) ISO 2000 All rights reserved 1Anaesthetic and respiratory equipment Heat and moistureexchangers (HMEs) for humidifying respired gases in

38、humans Part 1:HMEs for use with minimum tidal volumes of 250 ml1 ScopeThis part of ISO 9360 specifies certain requirements for heat and moisture exchangers (HMEs), including thoseincorporating breathing system filters, intended for the humidification of respired gases for use primarily withpatients

39、with a tidal volume equal to or greater than 250 ml, and incorporating at least one machine port, anddescribes test methods for their evaluation.2 Normative referencesThe following normative documents contain provisions which, through reference in this text, constitute provisions ofthis part of ISO

40、9360. For dated references, subsequent amendments to, or revisions of, any of these publicationsdo not apply. However, parties to agreements based on this part of ISO 9360 are encouraged to investigate thepossibility of applying the most recent editions of the normative documents indicated below. Fo

41、r undatedreferences, the latest edition of the normative document referred to applies. Members of ISO and IEC maintainregisters of currently valid International Standards.ISO 4135: 1995, Anaesthesiology Vocabulary.ISO 5356-1:1996, Anaesthetic and respiratory equipment Conical connectors Part 1: Cone

42、s and sockets.ISO 5356-2:1987, Anaesthetic and respiratory equipment Conical connectors Part 2: Screw-threaded weight-bearing connectors.ISO 7000:1989, Graphical symbols for use on equipment Index and synopsis.ISO 11607, Packaging for terminally sterilized medical devices.IEC 60601-1:1988, Medical e

43、lectrical equipment Part 1: General requirements for safety.3 Terms and definitionsFor the purposes of this part of ISO 9360, the terms and definitions given in ISO 4135 and the following apply.3.1heat and moisture exchangerHMEdevice intended to retain a portion of the patients expired moisture and

44、heat, and return it to the respiratory tractduring inspirationBS EN ISO 9360-1:2009ISO 9360-1:2000(E)2 ISO 2000 All rights reserved3.2HME machine portthat port of the HME which is connected to the patient connection port of a breathing system3.3HME patient portthat port of the HME which is connected

45、 to the patients respiratory tract3.4HME accessory portthat port of the HME which can be connected to an accessory deviceEXAMPLE An accessory device may be e.g. a gas sampling line.3.5HME internal volumevolume contained within the HME, when unpressurized, minus the volume of all solid elements withi

46、n the HME,minus the volume inside all female connectors3.6HME moisture losstotal amount of water lost from the test apparatus when tested as specified in 6.2NOTE It is expressed in milligrams water per litre of air.3.7pressure dropdifference between the pressure measured in a gas stream flowing into

47、 a device and the pressure measured in thegas stream flowing out of the device, with a given continuous gas flowrate through the device4 Symbols and abbreviated termsThe principal symbols and abbreviations used in this part of ISO 9360 are given in Table 1. Other symbols andabbreviations are explain

48、ed in the relevant context.Table 1 Symbols and abbreviationsSymbol Term UnitVTTidal volume mlf Frequency minG2d1I:E ratio Inspiratory:expiratory ratio RH Relative humidity %5 General requirements and recommendations5.1 HME patient port connectorThe connector at the patient port shall be either a 15

49、mm female conical connector or a 15 mm female/22 mm malecoaxial connector complying with ISO 5356-1.5.2 Additional portsThe connectors at other ports intended to accept breathing attachments, for example a Y-piece, if present, shall be15 mm male and/or 22 mm conical connectors as specified in ISO 5356-1.BS EN ISO 9360-1:2009ISO 9360-1:2000(E) ISO 2000 All rights reserved 3If the HME incorporates an accessory port, that port shall not accept the 15 mm or 22 mm connectors specified inISO 5356-1 or ISO 5356-2.5.3 Packagi