DIN EN ISO 10651-4-2009 Lung ventilators - Part 4 Particular requirements for operator-powered resuscitators (ISO 10651-4 2002) English version of DIN EN ISO 10651-4 2009-08《肺部呼吸器 .pdf

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1、August 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!$X other defi

2、nitions, which are given in EN ISO 4135, for apparatus in general, have been modified slightly for thepurposes of this European Standard as they apply specifically to resuscitators.3.1reverse leakagevolume of expired gas which does not pass through the expiratory port but returns to the resuscitator

3、3.2bag inlet valvevalve activated by the subatmospheric pressure in the compressible unit of the resuscitator to refill thecompressible unit with gas at ambient pressure3.3bag refill valvevalve, with no manual trigger, activated by the sub-atmospheric pressure in the compressible unit of theresuscit

4、ator to refill the compressible unit from a pressurized gas source4 DIN EN ISO 10651-4:2009-08 EN ISO 10651-4:2009 (E) 3.4compressible unitthat part of an operator-powered resuscitator e.g. a bag or bellows that, when compressed by the operator, deliversa volume of gas3.5delivered oxygen concentrati

5、onaverage concentration of oxygen in the gas delivered from the resuscitator3.6delivered volume, Vdelvolume of gas, expressed in millilitres, leaving the resuscitator through the patient connection port during theinspiratory phase3.7forward leakagevolume of gas produced by the resuscitator during th

6、e inspiratory phase which does not pass through the patientport to the patient but passes to the atmosphere3.8minute volume, Vvolume of gas per minute entering or leaving the patients lungs3.9operator-powered resuscitatorresuscitation device in which ventilation of the lungs is produced by the opera

7、tor compressing the compressibleunit of the deviceNOTE Hereinafter called “resuscitator“.3.10patient connection portthat opening through which gas flows to and from the patient3.11patient connection port connectorconnector at the patient connection port which connects directly to a face mask or an a

8、ppropriate mating airwaydevice3.12patient valvevalve in the breathing system that directs gas into the lungs for the inspiratory phase and into the atmosphereduring the expiratory phase3.13pressure limiting systemmeans for limiting the maximum delivery pressure3.14resuscitator deadspace, VD,appthat

9、volume of previously exhaled gas which is delivered from the resuscitator in the succeeding inspiratory phase3.15tidal volume, VTvolume of gas, expressed in millilitres, entering or leaving the patient or the lung model during the inspiratory orexpiratory phase3.16ventilatory cycleventilation cycle

10、comprising the inspiratory phase plus the expiratory phase of breathing5 EN ISO 10651-4:2009 (E) DIN EN ISO 10651-4:2009-08 4 Connectors4.1 Patient connection port connectorThe patient connection port connector of the resuscitator shall be a 15 mm female and 22 mm male coaxialconnector complying wit

11、h EN 1281-1.4.2 R) Expiratory port connector for breathing gasesIf an expiratory port connector is provided, it shall be one of the following :a) a 30 mm male conical connector complying with EN 1281-1 or ;b) a permanent connection or propriatory connector incompatible with EN 1281-1 and EN 737-1 ;a

12、nd with a means to prevent connection with internal lumen to any breathing attachment.4.3 Face mask connectorsIf provided with the resuscitator, face masks shall have either a 22 mm female connector or a 15 mm maleconnector which shall mate with the corresponding connectors specified in EN 1281-1.4.

13、4 R) Bag refill valve connectorsIf a conical connector is provided for attachment of a bag refill valve, it shall be a unique 32 mm female design. Thedimensions of this connector, when submitted to the test gauge given in Figure A.1, shall fit within the tolerancesteps.4.5 Bag inlet valve connectors

14、Bag inlet valve connectors shall not be compatible with connectors dimensioned in accordance with EN 1281-1.The bag inlet valve should be designed to minimize the risk of unintentional connection of breathing attachmentswhich might block the valve4.6 Threaded gas filter connectorsIf the resuscitator

15、 is fitted with a threaded gas filter connection, it shall comply with EN 148-1.4.7 Oxygen tube connector and pressure gauge connectorThe oxygen tube connector, if provided, shall comply with prEN 13544-2:2000. The pressure gauge connector (ifprovided) shall not be compatible with tubing fitting the

16、 oxygen tube connector.5 Operational requirements5.1 GeneralAll test performance requirements in this European Standard shall be satisfied when the resuscitator is operated byone person.5.2 R) Dismantling and reassemblyA resuscitator intended to be dismantled by the user, e.g. for cleaning, etc. sho

17、uld be designed so as to minimizethe risk of incorrect reassembly when all parts are mated.The manufacturer shall recommend a functional test of operation to be carried out after reassembly (see 10.2d).6 DIN EN ISO 10651-4:2009-08 EN ISO 10651-4:2009 (E) 5.3 R) Patient valve function after contamina

18、tion with vomitusAfter the resuscitator has been tested in accordance with the test described in A.4.3, it shall meet the requirementsspecified in 6.2, 6.4, 6.7.1 and 6.7.2.NOTE It is preferable that the valve housing be constructed so that operation of the mechanism can be observed by theoperator,

19、e.g. through a transparent housing. Observation of the functioning mechanism of the patient valve can assist theoperator in detecting abnormal operation.5.4 Mechanical shock5.4.1 R) Drop testThe resuscitator shall meet, at room temperature, the requirements specified in 6.2, 6.4 and 6.7.1, following

20、 thedrop test described in A.4.4.5.5 Immersion in waterAfter immersion in water by the method described in A.4.5, the resuscitator shall comply with the requirementsspecified in 6.2, 6.4, 6.7.1 and 6.7.2.5.6 R) Bag refill valvesBag refill valves for use with resuscitators shall not have provision fo

21、r manual operation.5.7 Materials of constructionAll gas conducting parts shall be from materials selected to take into account the chemical and physical propertiesof any substances that the manufacturer declares can be administered by the resuscitator6 Ventilatory requirements6.1 R) Supplementary ox

22、ygen and delivered oxygen concentrationWhen tested by the method described in A.4.6 in accordance with the requirements of its classification (see 6.7.1)a resuscitator shall provide a minimum delivered oxygen concentration of at least 35 % (V/V) when connected to anoxygen source supplying not more t

23、han 15 l/min and, in addition, shall be capable of providing an oxygenconcentration of at least 85 % (V/V) (see note). The manufacturer shall state the range of delivered oxygenconcentrations at representative flows, i.e. 2 l/min, 4 l/min, 6 l/min, 8 l/min, etc.NOTE The 85 % (V/V) requirement can be

24、 accomplished with the use of an attachment.6.2 R) Expiratory resistanceIn the absence of positive end-expiratory pressure devices, and when tested by the method described in A.4.7, thepressure generated at the patient connection port shall not exceed 0,5 kPa ( 5 cmH20). (See also 10.2 c) 8).6.3 R)

25、Inspiratory resistanceWhen tested by the method described in A.4.8, the pressure at the patient connection port shall not exceed 0,5 kPa( 5 cmH20) below atmospheric pressure. (See also 10.2 c) 8).6.4 R) Patient valve malfunctionWhen tested by the method described in A.4.9, an inadvertent positive ex

26、piratory pressure greater than 0,6 kPa( 6 cmH2O) shall not be created at an added input flow of up to 30 l/min when this flow is added in accordancewith the manufacturers instructions.7 EN ISO 10651-4:2009 (E) DIN EN ISO 10651-4:2009-08 6.5 R) Patient valve leakage - Forward leakageIf forward leakag

27、e is a design feature, it shall be so stated in the instruction manual.6.6 R) Resuscitator deadspace and rebreathingWhen tested by the method described in A.4.10, the resuscitator deadspace shall not exceed 5 ml + 10 % of theminimal delivered volume specified for the classification of the resuscitat

28、or (see 6.7.1).Excessive rebreathing should not occur during spontaneous breathing.6.7 R) Ventilation performance6.7.1 R) Minimum delivered volume (Vdel)When tested as described in A.4.11 using the compliance, resistance, frequency and I:E ratio given in Table 1, theminimum delivered volume shall be

29、 as given in Table 1.6.7.2 R) Pressure limitation6.7.2.1 For resuscitators designated for use with a body mass less than 10 kg, a pressure-limiting system shallbe provided so that the airway pressure does not exceed 4,5 kPa ( 45 cmH20) under the test conditions describedin A.4.12. However, it shall

30、be possible to generate an airway pressure of at least 3 kPa ( 30 cm H2O).NOTE An override mechanism can be provided.6.7.2.2 If a pressure-limiting system is provided for a resuscitator designated for use with patients of over10 kg body mass, the pressure at which it operates shall be stated in the

31、instruction manual see 10.2 c)9). Anypressure-limiting device provided that limits pressure to below 6 kPa ( 60 cmH20) shall be equipped with anoverride mechanism. If provided with a locking mechanism, pressure override mechanisms shall be so designedthat the operating mode, i.e. on or off, is readi

32、ly apparent to the user by obvious control position, flag, etc.Compliance is tested by visual inspection.8 DIN EN ISO 10651-4:2009-08 EN ISO 10651-4:2009 (E) Table 1 Test conditions for ventilatory performancePatient Bodymass BaCompliance Resistance Inspiration:ExpirationratioFrequency fBreaths/minM

33、inimumdeliveredvolume VDelKg l/kPa kPa/(l/s) 20 % 10 % mlB 5 0,01 40 1:1 60 205 40 0,2 2 1:2 20 600aB = Body mass, in kilograms, designated by the manufacturer in the manual.7 Storage and operating conditions7.1 StorageThe resuscitator and the resuscitator kit (if provided) shall, after storage at t

34、emperatures of - 40 C and + 60 C andat any relative humidity between 40 % r.h. and 95 % r.h., comply with clause 6 except 6.6 (deadspace).7.2 R) Operating conditionsWhen tested by the method described in A.4.13, the resuscitator shall comply with clause 6 throughout the range ofrelative humidity fro

35、m 15 % r.h. to 95 % r.h either :throughout the temperature range from - 18 C to + 50 C ; orif a specific operating range is given (see 9.2 and 10) throughout the temperature range declared by themanufacturer.8 Requirements for resuscitator, or parts, supplied sterile8.1 Sterility assuranceResuscitat

36、ors or parts supplied and marked as “STERILE” shall satisfy requirement 4.1 of EN 556:1994+A1:1998for the assurance of sterility needed to make the claim of being sterile.8.2 Packaging for resuscitators or parts supplied sterileThe packaging shall serve as an effective barrier to the penetration of

37、micro-organisms and particulate material inaccordance with EN 868-1.The packaging shall not be capable of reclosure without clearly revealing that it has been opened.9 Marking9.1 GeneralMarking of resuscitators, or parts if applicable, packages, inserts and information to be supplied by themanufactu

38、rer shall comply with EN 1041.NOTE Some requirements of 9 can be met by the use of appropriate symbols as given in EN 980.9 EN ISO 10651-4:2009 (E) DIN EN ISO 10651-4:2009-08 9.2 Indication of operating conditionsIf the resuscitator cannot function as specified in 7.2 between - 18 C and + 50 C, a wa

39、rning shall be marked onthe device.NOTE Examples of warnings are :“only for use between C and C ; or a symbol as shown in Figure 1.Figure 1 Example of symbol for showing operation condition between - 10 C and + 50 C9.3 Indication of pressure-limiting system settingIf the resuscitator is supplied wit

40、h a pressure-limiting system set at one fixed pressure, the nominal pressure settingat which the system is activated shall be marked on the resuscitator.10 Information to be provided by the manufacturer in operating and maintenanceinstructions10.1 GeneralThe manufacturer shall provide instructions f

41、or use and maintenance. The size and shape of these instructions foruse should be such that they can be enclosed with or attached to the resuscitator container.10.2 ContentsIn addition of EN 1041 the instructions for use and maintenance shall include the following information, whereapplicable :a) a

42、warning to the effect that incorrect operation of the resuscitator can be hazardous ;b) instructions on how to make the resuscitator operational in all intended modes of operation ;c) a specification detailing the following information for the resuscitator and its recommended accessories ifapplicabl

43、e :10 DIN EN ISO 10651-4:2009-08 EN ISO 10651-4:2009 (E) 1) the body mass range for which the resuscitator is suitable for use ;2) operating environmental limits ;3) storage environmental limits ;4) any substances, other than air, which can be administered by the resuscitator (e.g. oxygen, volatilea

44、naesthetic agents) ;5) delivered oxygen concentrations under various test conditions ;6) delivered volume range ;7) resuscitator deadspace, backward leakage and forward leakage ;8) expiratory resistance and inspiratory resistance, and the resistance imposed by any recommendedaccessory ;9) the end-ex

45、piratory pressure generated by the resuscitator in normal use, if greater than 0,2 kPa( 2 cmH20) ;10) details of the pressure-limiting system and override mechanism operation, if any ;11) accuracy of controls or indicating devices, if any, supplied with the resuscitator ;12) external dimensions of t

46、he resuscitator and, if provided, the resuscitator case ;13) mass of the resuscitator and, if provided, the resuscitator case ;d) instructions for the dismantling and reassembly of components for cleaning (including cleaning of any vomitus)and sterilization (if applicable), and details of a function

47、al test of operation to be carried out after reassembly.NOTE These instructions can be given, if possible, with a schematic also ;e) recommended methods of cleaning and disinfection or sterilization of the resuscitator, its components and itsaccessories if applicable ;f) functional test for operatio

48、n to be carried out prior to use ;g) list of operator-replaceable parts ;h) maintenance requirements ;i) guidance regarding use in hazardous or explosive atmospheres, including a warning that if the resuscitator willentrain or permit the patient to inhale gas from the atmosphere, its use in contamin

49、ated environments can behazardous unless entrainment is prevented. If applicable, a description of how to prevent such entrainment orinhalation, e.g. by the use of a filter ;j) warnings that in the presence of high oxygen concentrations there is danger from smoking or naked flamesand that oil or grease should not be used with the resuscitator ;k) for sterile resuscitators or parts, the method of sterilization used.11 EN ISO 10651-4:2009 (E) DIN EN ISO 10651-4:2009-08 Annex A (normative)Test methodsA.1 General test conditionsThe ambient temperature for the duration