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

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1、September 2009DEUTSCHE NORM English price group 10No part of this standard may be reproduced without prior permission ofDIN Deutsches Institut fr Normung e. V., Berlin. Beuth Verlag GmbH, 10772 Berlin, Germany,has the exclusive right of sale for German Standards (DIN-Normen).ICS 11.040.10!$YaC“15462

2、32www.din.deDDIN EN ISO 9360-2Anaesthetic and respiratory equipment Heat and moisture exchangers (HMEs) for humidifying respired gases inhumans Part 2: HMEs for use with tracheostomized patients having minimumtidal volumes of 250 ml (ISO 9360-2:2001)English version of DIN EN ISO 9360-2:2009-09Ansthe

3、sie- und Beatmungsgerte Wrme- und Feuchtigkeitsaustauscher zur Anfeuchtung von Atemgasen beimMenschen Teil 2: Wrme- und Feuchtigkeitsaustauscher zur Verwendung bei tracheostomiertenPatienten mit Mindesthubvolumina von 250 ml (ISO 9360-2:2001)Englische Fassung DIN EN ISO 9360-2:2009-09SupersedesDIN E

4、N ISO 9360-2:2003-01See start of validitywww.beuth.deDocument comprises 14 pagesDIN EN ISO 9360-2:2009-09 2 Start of validity This standard takes effect on 1 September 2009. DIN EN ISO 9360-2:2003-01 may be used in parallel until 21 March 2010. National foreword This standard has been prepared by Te

5、chnical Committee ISO/TC 121 “Anaesthetic and respiratory equipment” (Secretariat: BSI, United Kingdom) in collaboration with Technical Committee CEN/TC 215 “Respiratory and anaesthetic equipment” (Secretariat: BSI, United Kingdom). The responsible German body involved in its preparation was the Nor

6、menausschuss Rettungsdienst und Krankenhaus (Rescue Services and Hospital Standards Committee), Technical Committee NA 053-03-01 AA Ansthesie und Beatmung. This standard contains specifications meeting the essential requirements set out in EU Directive 93/42/EEC on medical devices. Amendments This s

7、tandard differs from DIN EN ISO 9360-2:2003-01 as follows: a) Annex ZA concerning normative references to international publications with their relevant European publications has been deleted. b) Annex ZB (informative) (now Annex ZA) concerning the relationship between this European Standard and the

8、 essential requirements of EU Directive 93/42/EEC on medical devices has been updated on the basis of EU Directive 2007/47/EC of the European Parliament and of the Council of 5 September 2007 amending Council Directives 90/385/EEC on the approximation of the laws of the Member States relating to act

9、ive implantable medical devices and 93/42/EEC on medical devices and EU Directive 98/8/EC on the placing on the market of biocidal products. Previous editions DIN EN ISO 9360-2: 2003-01 EUROPEAN STANDARD NORME EUROPENNE EUROPISCHE NORM EN ISO 9360-2 April 2009 ICS 11.040.10 Supersedes EN ISO 9360-2:

10、2002 English Version Anaesthetic and respiratory equipment - Heat and moisture exchangers (HMEs) for humidifying respired gases in humans - Part 2: HMEs for use with tracheostomized patients having minimum tidal volumes of 250 ml (ISO 9360-2:2001) Matriel danesthsie et de ranimation respiratoire - c

11、hangeurs de chaleur et dhumidit (ECH) utiliss pour humidifier les gaz respirs par les tres humains - Partie 2: ECH pour utilisation avec des patients trachotomiss ayant des volumes courants dau moins 250 ml (ISO 9360-2:2001) Ansthesie- und Beatmungsgerte - Wrme- und Feuchtigkeitsaustauscher zur Anfe

12、uchtung von Atemgasen beim Menschen - Teil 2: Wrme- und Feuchtigkeitsaustauscher zur Verwendung bei tracheostomierten Patienten mit Mindesthubvolumina von 250 ml (ISO 9360-2:2001) This European Standard was approved by CEN on 28 March 2009. CEN members are bound to comply with the CEN/CENELEC Intern

13、al Regulations which stipulate the conditions for giving this European Standard the status of a national standard without any alteration. Up-to-date lists and bibliographical references concerning such national standards may be obtained on application to the CEN Management Centre or to any CEN membe

14、r. This European Standard exists in three official versions (English, French, German). A version in any other language made by translation under the responsibility of a CEN member into its own language and notified to the CEN Management Centre has the same status as the official versions. CEN member

15、s 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, Swi

16、tzerland and United Kingdom. EUROPEAN COMMITTEE FOR STANDARDIZATION COMIT EUROPEN DE NORMALISATION EUROPISCHES KOMITEE FR NORMUNG Management Centre: Avenue Marnix 17, B-1000 Brussels 2009 CEN All rights of exploitation in any form and by any means reserved worldwide for CEN national Members. Ref. No

17、. EN ISO 9360-2:2009: EContents2 EN ISO 9360-2:2009 (E) DIN EN ISO 9360-2:2009-09 Page Foreword3 1 Scope .4 2 Normative references .4 3 Terms and definitions 4 4 Symbols and abbreviated terms 5 5 General requirements and recommendations .5 6 Test methods5 7 Marking, labelling and packaging .9 Annex

18、A (informative) Rationale 10 Annex ZA (informative) Relationship between this European Standard and the Essential Requirements of EU Directive 93/42/EEC. 11 3 EN ISO 9360-2:2009 (E) DIN EN ISO 9360-2:2009-09 Foreword The text of ISO 9360-2:2001 has been prepared by Technical Committee ISO/TC 121 “An

19、aesthetic and respiratory equipment” of the International Organization for Standardization (ISO) and has been taken 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

20、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 2010. Attention is drawn to the possibility that some of the elements of this document may be the s

21、ubject 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 9360-2:2002. This document has been prepared under a mandate given to CEN by the European Commission and the European Free Trade Association, and s

22、upports 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 Eur

23、opean 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 Unite

24、d Kingdom. Endorsement notice The text of ISO 9360-2:2001 has been approved by CEN as a EN ISO 9360-2:2009 without any modification. 1 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 con

25、nector ports, including those incorporating breathing systemfilters. These devices are intended for the humidification of respired gases for tracheostomized patients having atidal volume of 250 ml or greater.2 Normative referencesThe following normative documents contain provisions which, through re

26、ference in this text, constitute provisions ofthis part of ISO 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

27、 recent editions of the normative documents indicated below. For undatedreferences, the latest edition of the normative document referred to applies. Members of ISO and IEC maintainregisters of currently valid International Standards.ISO 4135, Anaesthetic and respiratory equipment Vocabulary.ISO 535

28、6-1:1996, Anaesthetic and respiratory equipment Conical connectors Part 1: Cones and sockets.ISO 7000, Graphical symbols for use on equipment Index and synopsis.ISO 9360-1:2000, Anaesthetic and respiratory equipment Heat and moisture exchangers (HMEs) for humidifyingrespired gases in humans Part 1:

29、HMEs for use with minimum tidal volumes of 250 ml.ISO 11607, Packaging for terminally sterilized medical devices.3 Terms and definitionsFor 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 conta

30、ined within the HME, when not pressurized, consisting of the internal surface of the impermeablematerial of the HME and a hypothetical 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

31、 the volumeinside all the female connectors4 EN ISO 9360-2:2009 (E) DIN EN ISO 9360-2:2009-09 4 Symbols and abbreviated 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 w

32、ith a 15 mm male 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.If the HME incorporates an accessory port,

33、 that port shall not accept the 15 mm or 22 mm connectors specified inISO 5356-1 or ISO 5356-2.5.3 Packaging of 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 t

34、o exclude the use of other measuringdevices or methods yielding results of an accuracy equal to or greater than 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 r

35、elative humidity of 50 % Gb1 20 %, and anatmospheric pressure of 86 kPa to 106 kPa.6.2 (R) Measurement of moisture 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

36、Figure 1 in ISO 9360-1:2000) shall comprise the following components.6.2.2.1 Bidirectional flow generatorThis is 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) throu

37、gh which air is bubbled in both directions;b) a rigid cylindrical reservoir (see Figure 3 in ISO 9360-1:2000) with a maximum volume of 7 l and a diameter ofapproximately 150 mm, containinga2lreservoirbag;5 EN ISO 9360-2:2009 (E) DIN EN ISO 9360-2:2009-09 c) a thermally insulated chamber (see Figure

38、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 a

39、ir to the HME.6.2.2.5 Weighing equipment, with an accuracy of Gb1 0,1 g or better in the range of the mass to be measured.6.2.2.6 Flowrate measuring equipment, with an accuracy of at least 5 % of the reading.6.2.2.7 Calibration HME (see Figure 6 in ISO 9360-1:2000) consisting of a housing containing

40、 81 polyvinylchloride (PVC) tubes arranged in a 9 Gb4 9 array, each with an internal diameter of 2 mm, an external diameter of4 mm, and a length of 50 mm.When the apparatus has been constructed and operated as specified in 6.2.2, the moisture loss from the humiditygenerator with the calibration HME

41、will be as shown in Table 3 of ISO 9360-1:2000.6.2.3 Test conditions6.2.3.1 The air delivered to the test chamber by the air delivery system shall be at a temperature of23 Gb0C Gb1 1 Gb0C and shall have humidity not exceeding 1 g/m3.6.2.3.2 The HME shall be tested at those conditions specified in Ta

42、ble 2 of ISO 9360-1:2000 which are withinthe range specified for the HME by the manufacturer, at the maximum tidal volume recommended by themanufacturer if this value is greater than 1 l, at a frequency of 10 breaths min1, and at an I:E ratio of 1:1.6.2.3.3 For HME that can be used to provide supple

43、mental oxygen, the test specified in 6.2.3.2 shall berepeated with the maximum oxygen flowrate recommended by the manufacturer, or 10 l/min if a maximum flowrateis not recommended.6.2.4 Procedure6.2.4.1 Connect the HG to the bidirectional flow generator.6.2.4.2 Adjust the bidirectional flow generato

44、r to give one of the test conditions in Table 2 of ISO 9360-1:2000,measured at the HME connector of the test apparatus, within the operating range of the HME as specified by themanufacturer. Adjust the flowrate of air delivered by the air delivery system to be between 1 and 1,5 times the peakflowrat

45、e of air drawn into HME connector of the test apparatus. The peak flowrate is stated in Table 2 ofISO 9360-1:2000.6.2.4.3 Operate the test apparatus with an HME of the same type that is to be tested, placed within the testchamber, for a minimum of 1 h, with the water bath at a temperature of 37 Gb0C

46、 Gb1 0,5 Gb0C, and the air within theinsulated chamber at temperature of 37 Gb0C Gb1 1 Gb0C. Maintain this temperature for the duration of the test procedure.6.2.4.4 With the HME and test chamber connected to the test apparatus, confirm that the volume of air leavingthe HME connector is that require

47、d for the test condition chosen from Table 2 of ISO 9360-1:2000.6 EN ISO 9360-2:2009 (E) DIN EN ISO 9360-2:2009-09 Dimensions in millimetresKey1 HME connector, 15 mm male conical (ISO 5356)2 Test apparatus connector, 15 mm female conical (ISO 5356)3 Air delivery system connector, 22 mm male conical

48、(ISO 5356)4 O-ringaVent holes equally spaced around the periphery of the container.bIn accordance with ISO 5356.Figure 1 Test chamber6.2.4.5 Record the mass of the humidity generator (HG) only (i.e. not including the HME and test chamber)(m0).6.2.4.6 Replace the HME with the one to be tested and ope

49、rate the test apparatus for (60 Gb1 5) min.6.2.4.7 Record the mass of the HG only (i.e. not including the HME and test chamber) (m1).6.2.4.8 Continue to operate the test apparatus up to the maximum time of use recommended by themanufacturer.6.2.4.9 Record the mass of the HG only (i.e. not including the HME and test chamber) (m2).6.2.4.10 With the HME and test chamber connected to the test apparatus, confirm that the volume of air leavingthe HME connector is that required for the test condition chosen from Table 2 of ISO 9360-1:2000.6.2.4.11