EN ISO 9360-2-2009 en Anaesthetic and respiratory equipment - Heat and moisture exchangers (HMEs) for humidifying respired gases in humans - Part 2 HMEs for use with tracheostomize.pdf

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1、BS EN ISO9360-2:2009ICS 11.040.10NO COPYING WITHOUT BSI PERMISSION EXCEPT AS PERMITTED BY COPYRIGHT LAWBRITISH STANDARDAnaesthetic andrespiratory equipment Heat and moistureexchangers (HMEs) forhumidifying respiredgases in humansPart 2: HMEs for use withtracheostomized patients havingminimum tidal v

2、olumes of 250 ml (ISO9360-2:2001)This British Standardwas published under theauthority of the StandardsPolicy and StrategyCommittee on 31 May 2009 BSI 2009ISBN 978 0 580 65026 0Amendments/corrigenda issued since publicationDate CommentsBS EN ISO 9360-2:2009National forewordThis British Standard is t

3、he UK implementation of EN ISO 9360-2:2009.It supersedes BS EN ISO 9360-2:2002which is withdrawn.The UK participation in its preparation was entrusted to TechnicalCommittee CH/121/1, Breathing attachments and anaesthetic machines.A list of organizations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 obtained

4、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 ISO 9

5、360-2April 2009ICS 11.040.10 Supersedes EN ISO 9360-2:2002 English VersionAnaesthetic and respiratory equipment - Heat and moistureexchangers (HMEs) for humidifying respired gases in humans -Part 2: HMEs for use with tracheostomized patients havingminimum tidal volumes of 250 ml (ISO 9360-2:2001)Mat

6、riel danesthsie et de ranimation respiratoire -changeurs de chaleur et dhumidit (ECH) utiliss pourhumidifier les gaz respirs par les tres humains - Partie 2:ECH pour utilisation avec des patients trachotomissayant des volumes courants dau moins 250 ml (ISO 9360-2:2001)Ansthesie- und Beatmungsgerte -

7、 Wrme- undFeuchtigkeitsaustauscher zur Anfeuchtung von Atemgasenbeim Menschen - Teil 2: Wrme- undFeuchtigkeitsaustauscher zur Verwendung beitracheostomierten Patienten mit Mindesthubvolumina von250 ml (ISO 9360-2:2001)This European Standard was approved by CEN on 28 March 2009.CEN members are bound

8、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 Ma

9、nagement 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

10、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

11、, Slovenia, Spain, Sweden, Switzerland and United Kingdom.EUROPEAN COMMITTEE FOR STANDARDIZATIONCOMIT 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

12、national Members.Ref. No. EN ISO 9360-2:2009: EBS EN ISO 9360-2:2009EN ISO 9360-2:2009 (E) 3 Foreword The text of ISO 9360-2:2001 has been prepared by Technical Committee ISO/TC 121 “Anaesthetic and respiratory equipment” of the International Organization for Standardization (ISO) and has been taken

13、 over as EN ISO 9360-2:2009 by 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 Octob

14、er 2009, 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 ri

15、ghts. This document supersedes EN ISO 9360-2:2002. 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

16、 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, Gre

17、ece, 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 9360-2:2001 has been approved by CEN as a EN ISO 9360-2:2009 without

18、any modification. BS EN ISO 9360-2:2009EN ISO 9360-2:2009 (E) 4 Annex ZA (Informative) Relationship between this European Standard and the Essential Requirements of EU Directive 93/42/EEC This European Standard has been prepared under a mandate given to CEN by the European Commission and the Europea

19、n Free Trade Association to provide a means of conforming to Essential Requirements of the New Approach Directive 93/42/EEC on medical devices. Once this standard is cited in the Official Journal of the European Communities under that Directive and has been implemented as a national standard in at l

20、east 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 bet

21、ween this European Standard and EU Directives Clause(s)/sub-clause(s) of this EN Essential 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 5.1 9.1, 13.6 c)5.2 13 c) 5.3

22、 8.3 5, 7 1 (2nd paragraph, 1st dash) This relevant Essential Requirement is not fully addressed in this European Standard 5,7 1 (2nd paragraph, 2nd dash) This relevant Essential Requirement is not fully addressed in this European Standard - 6a This relevant Essential Requirement is not addressed in

23、 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 7.5 (2nd paragraph) This relevant Essential Requirement is not addressed in this European Standard BS EN ISO 9360-2:2009EN ISO 9360-2:2009 (E) 5 Clause(s)/sub-clause(s) of this EN Essential Requirements

24、(ERs) of Directive 93/42/EEC Qualifying remarks/Notes 7.2 13.3 (a): This relevant Essential Requirement is not fully 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)7.3 13.3 (f) This relevant Essential Requ

25、irement is not fully addressed in this European Standard 7.4 13.17.4 7.5 (3rd paragraph) This relevant Essential Requirement is not addressed in this European Standard 7.4 13.6 (h)(2nd paragraph) This relevant Essential Requirement is not fully addressed in this European Standard 7.4 13.6 (q) This r

26、elevant 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) 13.3 m), 13.6 h) 7.4 g) 13.3 j), 13.3 k) 7.4 k) 13.6 n) WARNING: Other requirements and other EU Directives may be applicable to the product(s) falling wit

27、hin the scope of this standard. BS EN ISO 9360-2:2009ISO 9360-2:2001(E) ISO 2001 All rights reserved iiiContents PageForeword.iv1 Scope 12 Normative references 13 Terms and definitions .14 Symbols and abbreviated terms.25 General requirements and recommendations 26 Test methods27 Marking, labelling

28、and packaging 6Annex A (informative) Rationale 7BS EN ISO 9360-2:2009ISO 9360-2:2001(E)iv ISO 2001 All rights reservedForewordISO (the International Organization for Standardization) is a worldwide federation of national standards bodies (ISOmember bodies). The work of preparing International Standa

29、rds 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-governmental, inliaison with ISO, also take p

30、art 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.Draft International Standards adopted by the t

31、echnical 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 ISO 9360 may be the subject of patentrigh

32、ts. ISO shall not be held responsible for identifying any or all such patent rights.International Standard ISO 9360-2 was prepared by Technical Committee ISO/TC 121, Anaesthetic and respiratoryequipment, Subcommittee SC 3, Lung ventilators and related equipment.This first edition of ISO 9360-2 cance

33、ls 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 humidifying respired gases in humans:Gbe Part 1: H

34、MEs for use with minimum tidal volumes of 250 mlGbe Part 2: HMEs for use with tracheostomized patients having minimum tidal volumes of 250 mlAnnex A of this part of ISO 9360 is for information only.Clauses and subclauses to which there is a rationale are marked with (R). These rationales are found i

35、n annex A.BS EN ISO 9360-2:2009INTERNATIONAL STANDARD ISO 9360-2:2001(E) ISO 2001 All rights reserved 1Anaesthetic and respiratory equipment Heat and moistureexchangers (HMEs) for humidifying respired gases in humansPart 2:HMEs for use with tracheostomized patients having minimum tidalvolumes of 250

36、 ml1 ScopeThis part of ISO 9360 is based on ISO 9360-1:2000 and specifies certain requirements and test methods for heatand moisture exchangers (HMEs) without machine connector ports, including those incorporating breathing systemfilters. These devices are intended for the humidification of respired

37、 gases for tracheostomized patients having atidal volume of 250 ml or greater.2 Normative referencesThe following normative documents contain provisions which, through reference in this text, constitute provisions ofthis part of ISO 9360. For dated references, subsequent amendments to, or revisions

38、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. For undatedreferences, the latest edition of the normative document r

39、eferred to applies. Members of ISO and IEC maintainregisters of currently valid International Standards.ISO 4135, Anaesthetic and respiratory equipment Vocabulary.ISO 5356-1:1996, Anaesthetic and respiratory equipment Conical connectors Part 1: Cones and sockets.ISO 7000, Graphical symbols for use o

40、n equipment Index and synopsis.ISO 9360-1:2000, Anaesthetic and respiratory equipment Heat and moisture exchangers (HMEs) for humidifyingrespired gases in humans Part 1: HMEs for use with minimum tidal volumes of 250 ml.ISO 11607, Packaging for terminally sterilized medical devices.3 Terms and defin

41、itionsFor the purposes of this part of ISO 9360, the terms and definitions given in ISO 4135 and ISO 9360-1 apply, exceptas follows.3.1 (R)HME internal volumevolume contained within the HME, when not pressurized, consisting of the internal surface of the impermeablematerial of the HME and a hypothet

42、ical boundary surface which consists of the minimum surface area whichencloses the active element of the HME, minus the volume of all solid elements within the HME, minus the volumeinside all the female connectorsBS EN ISO 9360-2:2009ISO 9360-2:2001(E)2 ISO 2001 All rights reserved4 Symbols and abbr

43、eviated termsThe symbols and abbreviated terms given in ISO 9360-1 apply.5 General requirements and recommendations5.1 (R) HME patient port connectorThe patient port connector shall mate with a 15 mm male connector complying with ISO 5356-1.5.2 Additional portsThe connectors at other ports intended

44、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.If 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 Packaging of

45、sterile HMEHME supplied sterile shall comply with the requirements specified in ISO 11607.6 Test methods6.1 GeneralThe apparatus and test methods specified in 6.2 to 6.5 are not intended to exclude the use of other measuringdevices or methods yielding results of an accuracy equal to or greater than

46、those specified. In the case of a dispute,the methods given in this part of ISO 9360 shall be the reference methods.The tests shall be performed at a temperature of 23 Gb0C Gb1 2 Gb0C, a relative humidity of 50 % Gb1 20 %, and anatmospheric pressure of 86 kPa to 106 kPa.6.2 (R) Measurement of moistu

47、re loss6.2.1 PrincipleThe performance of an HME shall be measured by recording the mass of water lost from the test apparatusspecified in 6.2.2.6.2.2 Test apparatusThe test apparatus (see Figure 1 in ISO 9360-1:2000) shall comprise the following components.6.2.2.1 Bidirectional flow generatorThis is

48、 a mechanically-driven piston used to produce a flow having sinusoidal waveform.6.2.2.2 Humidity generator (HG), consisting ofa) a heated water bath (see Figure 2 in ISO 9360-1:2000) through which air is bubbled in both directions;b) a rigid cylindrical reservoir (see Figure 3 in ISO 9360-1:2000) wi

49、th a maximum volume of 7 l and a diameter ofapproximately 150 mm, containinga2lreservoirbag;BS EN ISO 9360-2:2009ISO 9360-2:2001(E) ISO 2001 All rights reserved 3c) a thermally insulated chamber (see Figure 4 in ISO 9360-1:2000), which contains the water bath, the reservoirand a heat source.6.2.2.3 Air delivery system, to supply dry air that is directed into the chamber (see Figure 1 of this part ofISO 9360).6.2.2.4 Test chamber (see Figure 1 of this part of ISO 9360) which allows the delivery of dry air to the HME.6.2.2.5 Weigh