DIN EN ISO 9360-1-2009 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、September 2009DEUTSCHE NORM English price group 14No 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!$YaB“15462

2、31www.din.deDDIN EN ISO 9360-1Anaesthetic and respiratory equipment Heat and moisture exchangers (HMEs) for humidifying respired gases inhumans Part 1: HMEs for use with minimum tidal volumes of 250 ml(ISO 9360-1:2000)English version of DIN EN ISO 9360-1:2009-09Ansthesie- und Beatmungsgerte Wrme- un

3、d Feuchtigkeitsaustauscher zur Anfeuchtung von Atemgasen beimMenschen Teil 1: Wrme- und Feuchtigkeitsaustauscher zur Verwendung bei Mindesthubvoluminavon 250 ml (ISO 9360-1:2000)Englische Fassung DIN EN ISO 9360-1:2009-09SupersedesDIN EN ISO 9360-1:2000-04See start of validitywww.beuth.deDocument co

4、mprises 27 pagesDIN EN ISO 9360-1:2009-09 2 Start of validity This standard takes effect on 1 September 2009. DIN EN ISO 9360-1:2000-04 may be used in parallel until 21 March 2010. National foreword This standard has been prepared by Technical Committee ISO/TC 121 “Anaesthetic and respiratory equipm

5、ent” (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 Normenausschuss Rettungsdienst und Krankenhaus (Rescue Services and

6、 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 standard differs from DIN EN ISO 9360-1:2000-04 as follows: a) An

7、nex 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 essential requirements of EU Directive 93/42/EEC on medical dev

8、ices 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 active implantable medical devices and 93/42/EEC on medical devices

9、 and EU Directive 98/8/EC on the placing on the market of biocidal products. Previous editions DIN EN ISO 9360-1: 2000-04 EUROPEAN STANDARD NORME EUROPENNE EUROPISCHE NORM EN ISO 9360-1 April 2009 ICS 11.040.10 Supersedes EN ISO 9360-1:2000 English Version Anaesthetic and respiratory equipment - Hea

10、t and moisture exchangers (HMEs) for humidifying respired gases in humans - Part 1: HMEs for use with minimum tidal volumes of 250 ml (ISO 9360-1:2000) Matriel danesthsie et de ranimation respiratoire - changeurs de chaleur et dhumidit (ECH) utiliss pour humidifier les gaz respirs par les tres humai

11、ns - Partie 1: ECH pour utilisation avec des volumes courants dau moins 250 ml (ISO 9360-1:2000) Ansthesie- und Beatmungsgerte - Wrme- und Feuchtigkeitsaustauscher zur Anfeuchtung von Atemgasen beim Menschen - Teil 1: Wrme- und Feuchtigkeitsaustauscher zur Verwendung bei Mindesthubvolumina von 250 m

12、l (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 giving this European Standard the status of a national standard without any alteration. Up-to-date lists and b

13、ibliographical references concerning such national standards 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 translation under the responsibil

14、ity of a CEN member into its own language and notified to the CEN Management Centre has the same status as the official versions. CEN members are the national standards bodies of Austria, Belgium, Bulgaria, Cyprus, Czech Republic, Denmark, Estonia, Finland, France,Germany, Greece, Hungary, Iceland,

15、Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland and United Kingdom. EUROPEAN COMMITTEE FOR STANDARDIZATION COMIT EUROPEN DE NORMALISATION EUROPISCHES KOMITEE FR NORMUNG Management Centre: Avenue Marn

16、ix 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. EN ISO 9360-1:2009: EContents2 DIN EN ISO 9360-1:2009-09 EN ISO 9360-1:2009 (E) Page Foreword3 Introduction 4 1 Scope .5 2 Normative references .5 3 Terms and

17、 definitions 5 4 Symbols and abbreviated terms .6 5 General requirements and recommendations 6 5.1 HME patient port connector6 5.2 Additional ports 6 5.3 Packaging of sterile HME7 6 Test methods7 6.1 General7 6.2 Measurement of moisture loss.7 6.3 Measurement of pressure drop. 17 6.4 Test for gas le

18、akage 17 6.5 Test for compliance 17 7 Marking . 19 Annex A (informative) Lists of parts and specifications in Figures 1 and 2 . 21 Annex B (informative) Rationale. 22 Annex ZA (informative) Relationship between this European Standard and the Essential Requirements of EU Directive 93/42/EEC. 24 Forew

19、ord3 DIN EN ISO 9360-1:2009-09 EN ISO 9360-1:2009 (E) 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 Committ

20、ee 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 October 2009, and conflicting national standards shal

21、l 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 supersedes EN ISO 9360-1:200

22、0. 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

23、 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, L

24、ithuania, Luxembourg, Malta, Netherlands, 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. IntroductionThe gases generall

25、y 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. They are primarily intended for use independen

26、tly or as part of abreathing system.4 DIN EN ISO 9360-1:2009-09 EN ISO 9360-1:2009 (E) 1 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

27、 primarily withpatients 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 provis

28、ions 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 recent editions of the normative docum

29、ents 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: 1995, Anaesthesiology Vocabulary.ISO 5356-1:1996, Anaesthetic and respiratory equipment Conical

30、 connectors Part 1: Cones 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

31、 60601-1:1988, Medical electrical 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 patien

32、ts expired moisture and heat, and return it to the respiratory tractduring inspiration5 DIN EN ISO 9360-1:2009-09 EN ISO 9360-1:2009 (E) 3.2HME 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 con

33、nected 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

34、 within 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 flowin

35、g into 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 e

36、xplained 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

37、 a 15 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

38、ISO 5356-1.6 DIN EN ISO 9360-1:2009-09 EN ISO 9360-1:2009 (E) 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 sterile HMEHME supplied sterile shall comply with the requirements specified in ISO

39、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 those specified. In the case of adispute, the methods given in this part of ISO 9360

40、 shall be the reference methods.The tests shall be performed at a temperature of 23 Gb0C Gb1 2 Gb0C, a RH of 50 % Gb1 20 %, and an atmospheric pressureof 86 kPa to 106 kPa.6.2 Measurement of moisture loss6.2.1 PrincipleThe performance of an HME shall be measured by recording the mass of water lost f

41、rom the test apparatusspecified in 6.2.2.6.2.2 Test apparatusThe test apparatus (Figure 1) shall comprise the following components.6.2.2.1 Bidirectional flow generator.This is a mechanically-driven piston used to produce a flow having sinusoidal waveform.6.2.2.2 Humidity generator (HG), consisting o

42、fa) a heated water bath (Figure 2) through which air is bubbled in both directions;b) a rigid cylindrical reservoir (Figure 3) with a maximum volume of 7 l and a diameter of approximately 150 mm,containing a 2 l reservoir bag;c) a thermally insulated chamber (Figure 4), which contains the water bath

43、, the reservoir and a heat source.6.2.2.3 Air delivery system (Figure 5), consisting of a T-piece with an internal diameter greater than 15 mm,and an exhaust tube at least 200 mm in length.6.2.2.4 Weighing equipment,withanaccuracyofGb1 0,1 g or better in the range of the mass to be measured.6.2.2.5

44、Flowrate measuring equipment, with an accuracy of at least 5 % of the reading.6.2.2.6 Calibration HME (Figure 6) consisting of a housing containing 81 polyvinyl chloride (PVC) tubesarranged in a 9 Gb4 9 array, each with an internal diameter of 2 mm, an external diameter of 4 mm, and a length of50 mm

45、.When the apparatus has been constructed and operated as specified in 6.2.2, the moisture loss from the humiditygenerator with the calibration HME will be as shown in Table 3.7 DIN EN ISO 9360-1:2009-09 EN ISO 9360-1:2009 (E) Key1 to 19 see annex A20 Sinewave generator inlet21 Air outlet22 Dry air s

46、upply (23 Gb1 1) C, G3c 1mgH2O per litre air23 Weighing equipmentFigure 1 Test apparatus side view8 DIN EN ISO 9360-1:2009-09 EN ISO 9360-1:2009 (E) Dimensions in millimetres2 a) Heated water bath Front view 2 b) Heated water bath Side view2 c) Cover of heated water bath9 DIN EN ISO 9360-1:2009-09 E

47、N ISO 9360-1:2009 (E) Dimensions in millimetres2 d) Heated water bath dividing plateKey1 to 19 see annex A 22 Highest water level 25 Tracheal tube20 Tracheal tube inlet 23 Lowest water level 26 Bag hole21 Rubber bag inlet 24 Heater hole 27 Temperature sensor holeFigure 2 Water bath (at 37 C)10 DIN E

48、N ISO 9360-1:2009-09 EN ISO 9360-1:2009 (E) Dimensions in millimetresKey1 Thin O-ringFigure 3 Reservoir11 DIN EN ISO 9360-1:2009-09 EN ISO 9360-1:2009 (E) Dimensions in millimetres4a)Sideview12 DIN EN ISO 9360-1:2009-09 EN ISO 9360-1:2009 (E) Dimensions in millimetres4 b) Top view showing temperatur

49、e sensor and heater arrangementFigure 4 Thermally insulated chamber13 DIN EN ISO 9360-1:2009-09 EN ISO 9360-1:2009 (E) Dimensions in millimetresKey1 Air outlet2 Dry air supply (23 Gb1 1) C, G3c 1mgH2O per litre air3HMEaInside diameterFigure 5 Air delivery system14 DIN EN ISO 9360-1:2009-09 EN ISO 9360-1:2009 (E) Dimensions in millimetresKey1 81tubings;ID=2mm,OD=4mm2 Male22cone3 Male15cone4 Female 15 coneAll parts made of acrylic except tubings, which are made of PVCaOutside dimension, sides angled to fitFigure 6 Calibra