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1、BRITISH STANDARD BS 7711-2: 1994 Respiratory therapy equipment Part 2: Specification for air entrainment devices UDC 615.816.2 Licensed Copy: London South Bank University, London South Bank University, Fri Dec 08 10:29:50 GMT+00:00 2006, Uncontrolled Copy, (c) BSI BS 7711-2:1994 This British Standar
2、d, having been prepared under the direction of the Health Care Standards Policy Committee, was published under the authority of the Standards Board and comes into effect on 15 January 1994 BSI 07-1999 The following BSI references relate to the work on this standard: Committee reference HCC/44 Draft
3、for comment 92/58529 DC ISBN 0 580 22351 5 Committees responsible for this British Standard The preparation of this British Standard was entrusted by the Health Care Standards Policy Committee (HCC/-) to Technical Committee HCC/44, upon which the following bodies were represented: Association of Ana
4、esthetists of Great Britain and Ireland Association of British Health Care Industries Association of Veterinary Anaesthetists of Great Britain and Ireland British Anaesthetic and Respiratory Equipment Manufacturers Association Department of Health Medical Sterile Products Association Amendments issu
5、ed since publication Amd. No.DateComments Licensed Copy: London South Bank University, London South Bank University, Fri Dec 08 10:29:50 GMT+00:00 2006, Uncontrolled Copy, (c) BSI BS 7711-2:1994 BSI 07-1999i Contents Page Committees responsibleInside front cover Forewordii 1Scope1 2References1 3Defi
6、nition1 4Oxygen supply1 5Connections1 6Delivered oxygen concentration1 7Marking and identification1 8Information supplied by the manufacturer2 Annex A (normative) Method of test for delivered oxygen concentration3 Figure A.1 T-piece for oxygen output determination4 Figure A.2 Test rig for oxygen out
7、put determination4 Table 1 Delivered oxygen concentrations1 Table 2 Colour coding2 List of referencesInside back cover Licensed Copy: London South Bank University, London South Bank University, Fri Dec 08 10:29:50 GMT+00:00 2006, Uncontrolled Copy, (c) BSI BS 7711-2:1994 ii BSI 07-1999 Foreword This
8、 Part of BS 7711 has been prepared under the direction of the Health Care Standards Policy Committee. This Part of BS 7711 relates to air entrainment devices designed for providing respiratory therapy in which an air entrainment system is used to provide a pre-set mixture of oxygen and room air, thu
9、s supplying the patient with a controlled oxygen concentration above atmospheric level. This type of therapy requires close control of the inhaled oxygen concentration, and the clinician may require to be able to make small but significant changes in this factor and then to ensure continuity over qu
10、ite long periods. Devices are therefore manufactured to produce a number of different concentrations each to relatively close limits. A British Standard does not purport to include all the necessary provisions of a contract. Users of British Standards are responsible for their correct application. C
11、ompliance with a British Standard does not of itself confer immunity from legal obligations. Summary of pages This document comprises a front cover, an inside front cover, pages i and ii, pages 1 to 4, an inside back cover and a back cover. This standard has been updated (see copyright date) and may
12、 have had amendments incorporated. This will be indicated in the amendment table on the inside front cover. Licensed Copy: London South Bank University, London South Bank University, Fri Dec 08 10:29:50 GMT+00:00 2006, Uncontrolled Copy, (c) BSI BS 7711-2:1994 BSI 07-19991 1 Scope This Part of BS 77
13、11 specifies minimum performance and safety requirements for air entrainment devices and gives a test method to check the oxygen concentration in the air/oxygen mixture generated by the air entrainment device. It also specifies marking requirements and a system of colour coding to assist the user to
14、 identify the designated oxygen concentration. NOTEThe laboratory tests given in Annex A are intended to enable manufacturers and purchasers to apply suitable quality assurance measures to the air entrainment devices and thus ensure performance consistency during clinical use. Compliance with these
15、tests does not ensure that the patient will necessarily receive the designated oxygen concentration, because physiological factors such as the patients ventilatory pattern, lung compliance and airway resistance, together with apparatus factors such as the volume of reservoirs, fit of the mask to the
16、 patient, etc. will influence the actual inspired oxygen concentration 1. 2 References 2.1 Normative references This Part of BS 7711 incorporates, by reference, provisions from specific editions of other publications. These normative references are cited at the appropriate points in the text and the
17、 publications are listed on the inside back cover. Subsequent amendments to, or revisions of, any of these publications apply to this Part of BS 7711 only when incorporated in it by updating or revision. 2.2 Informative references This Part of BS 7711 refers to other publications that provide inform
18、ation or guidance. Editions of these publications current at the time of issue of this standard are listed on the inside back cover, but reference should be made to the latest editions. 3 Definition For the purposes of this Part of BS 7711, the following definition applies. air entrainment device a
19、device consisting of a jet orifice (to which the oxygen supply is connected) adjacent to a series of air entrainment ports, the distal end of the device being designed for connection to an oxygen delivery system supplying a patient NOTEThese devices are sometimes described as venturi devices. This t
20、erm has been avoided as very few actually use the venturi principle 2. 4 Oxygen supply The device shall be designed to operate with an oxygen supply controlled by a flowmeter control valve capable of delivering at least 15 l/min of oxygen. 5 Connections 5.1 Oxygen supply inlet The inlet for oxygen t
21、o the air entrainment device shall be a nipple conforming to BS 7711-1:1994 which accepts heavy duty tubing. 5.2 Air inlet attachments If an air inlet attachment such as a humidity adaptor or cowling is attached in order to enable humidified air to be administered in conjunction with oxygen therapy,
22、 the attachment shall: a) not cover or obstruct observation of the designated oxygen concentration marking on the air entrainment device when attached to it for use; b) when tested as described in A.2.8 be capable of withstanding, without becoming detached, a force of (5 0.5) N applied for 1 min at
23、a temperature of (22 2) C; c) not obstruct the air entrainment ports. 6 Delivered oxygen concentration When tested as described in Annex A, the delivered oxygen concentration shall be as given in Table 1. Table 1 Delivered oxygen concentrations 7 Marking and identification 7.1 Marking 7.1.1 Each fix
24、ed concentration air entrainment device shall be marked with: a) the designated oxygen concentration in characters at least 2.5 mm high; b) the recommended flow. 7.1.2 The immediate packaging of the device shall also carry the above information, together with the following: a) the name or trade mark
25、 of the manufacturer; b) a lot number or date of manufacture; c) the number and date of this standard (i.e. BS 7711-2:1994)1); Designated O2 concentration Delivered O2 concentration (%)min. (%)max. (%) 24 28 31 35 40 50 60 23 27 30 33 38 47 56 25 29 32 37 42 53 64 Licensed Copy: London South Bank Un
26、iversity, London South Bank University, Fri Dec 08 10:29:50 GMT+00:00 2006, Uncontrolled Copy, (c) BSI BS 7711-2:1994 2 BSI 07-1999 d) if designed for single use only, the words “SINGLE USE”. NOTESymbol number 1051 of ISO 7000 may be used in addition. 7.1.3 Air entrainment devices with a control to
27、adjust the oxygen concentration shall conform to item b) of 7.1.1 and items a) to d) of 7.1.2 and in addition with either of the following. a) The minimum and maximum settings shall be marked with their respective oxygen concentrations in characters at least 2.5 mm high, and the direction of movemen
28、t of the control to increase the delivered oxygen concentration shall be indicated. b) A scale of delivered oxygen concentration shall be provided, marking each of the designated concentrations listed in Table 1 which is attainable by the adjustment of the control. 7.2 Colour coding 7.2.1 If colour
29、coding is used as an additional means of identification of the designated oxygen concentration on air entrainment devices, the colour code given in Table 2 shall be used. The colour codes shall be applied directly to the air entrainment device and shall have an area of at least 1 cm2. The colour cod
30、ing shall either be visible through the immediate external packaging or shall be repeated on the outside of the immediate external packaging. Table 2 Colour coding 7.2.2 The colours of the code shall not be used for any purpose other than identifying the delivered oxygen concentration. NOTEAir entra
31、inment devices provided with a control to adjust the delivered oxygen concentration may use the colour code given in Table 2 to identify the selected values. 8 Information supplied by the manufacturer The manufacturer shall provide with each package of devices operating instructions and information
32、including: a) a table or graph showing the relationship between the oxygen flow and the total flow of the delivered air/oxygen mixture; b) the minimum, recommended and maximum flows of oxygen which enable the device to achieve the designed performance; c) technical guidelines concerning suitable met
33、hods of providing humidification to patients during controlled oxygen therapy; d) if the device is intended for sterilization and re-use, details of suitable methods of cleaning and sterilization; e) a warning note on the hazards of re-use of air entrainment devices following certain methods of chem
34、ical or gas sterilization. 1) Marking BS 7711-2:1994 on or in relation to a product represents a manufacturers declaration of conformity, i.e. a claim by or on behalf of the manufacturer that the product meets the requirements of the standard. The accuracy of the claim is solely the claimants respon
35、sibility. Such a declaration is not to be confused with third party certification of conformity, which may also be desirable. Designated O2 concentration (%) Colour as specified in BS 381C:1988 24 28 31 35 40 50 60 Blue: 156 White Orange: 557 Yellow: 309 Red: 537 Pink: 447 Green: 218 Licensed Copy:
36、London South Bank University, London South Bank University, Fri Dec 08 10:29:50 GMT+00:00 2006, Uncontrolled Copy, (c) BSI BS 7711-2:1994 BSI 07-19993 Annex A (normative) Method of test for delivered oxygen concentration A.1 Apparatus A.1.1 Oxygen supply and flowmeter with control valve, the flowmet
37、er to be capable of delivering and measuring flows between 3 l/min and 30 l/min with an accuracy of 2.5 % (VDE class 2.5). A.1.2 Sampling T-piece, shown in Figure A.1. NOTE 1It is essential that the manufacturer designs the T-piece inlet to connect to the particular design of air entrainment device,
38、 and makes details of this T-piece available to test houses. The side branch may be varied to suit the design of oxygen analyser, and it is essential that it provides a close fit to the oxygen sensor or analyser sampling tube in order to prevent leakage to or from the exterior. NOTE 2The inclusion o
39、f corrugated breathing tubing between the outlet of an air entrainment device and the face mask has been found to modify the inspired oxygen concentration. If an air entrainment device is intended to be used only with a particular delivery system, the manufacturer may perform these tests with the sy
40、stem attached, and record this fact in the test report(s). A.1.3 Oxygen analyser, capable of measuring the concentration of oxygen with an accuracy of 0.1. To oxygen within the zone shown in Figure A.1. A.1.4 Equipment capable of measuring barometric pressure and ambient temperature with an accuracy
41、 of 2 %. NOTEOxygen analysers are sensitive to absolute temperature and pressure and it is necessary to correct the readings of the oxygen analyser to 20 C and 101.3 kPa. A.2 Procedure NOTEGood ventilation or scavenging of the mixture from the devices under test is necessary to prevent entrainment o
42、f air which has already been enriched by oxygen from previous experiments. A.2.1 If the device is intended to be re-used, condition it prior to these tests by subjecting it to twenty cycles of cleaning and sterilization in accordance with the manufacturers instructions. A.2.2 Carry out the tests at
43、a temperature of (22 2) C. A.2.3 Assemble the device to be tested to the T-piece (A.1.2) ensuring that there are no visible gaps which might permit leakage of air or gas. Connect the oxygen supply flowmeter (A.1.1) to the oxygen nipple with the tubing recommended by the manufacturer (see Figure A.2)
44、. A.2.4 Calibrate the oxygen analyser (A.1.3) according to the manufacturers instructions and connect or position it so as to take samples from the zone shown in Figure A.1. A.2.5 Adjust the oxygen supply flowmeter control to the minimum flow stated by the manufacturer of the air entrainment device,
45、 and record the oxygen analyser reading after approximately 3 min. Correct the reading to 20 C and 101.3 kPa (A.1.4). A.2.6 Repeat the test at the recommended flow and at the maximum flow stated by the manufacturer of the air entrainment device. A.2.7 If the device is intended for use with an air in
46、let attachment, repeat the tests with the attachment fitted. A.2.8 Test the security of the air inlet attachment by securing the attachment so that it is not distorted and applying an axial tensile force of (5 0.5) N to the oxygen nipple of the air entrainment device for (60 2) s. Record whether the
47、 device separates from the air inlet attachment. Repeat the test applying the axial force in the opposite direction, i.e. compressing the device into the attachment. A.3 Test report The test report shall contain at least the following information: a) the name of the manufacturer of the air entrainme
48、nt device; b) identification of the device by, e.g. model number or name; c) the designed delivered oxygen concentration; d) batch number(s) of the device(s) tested; e) results of the tests described in A.2.5, A.2.6 and, if appropriate, A.2.7 and A.2.8; f) whether the air entrainment device was test
49、ed with a particular delivery system attached (see note 2 to A.1.2); g) identification of the test house and name of the tester; h) date of testing. Licensed Copy: London South Bank University, London South Bank University, Fri Dec 08 10:29:50 GMT+00:00 2006, Uncontrolled Copy, (c) BSI BS 7711-2:1994 4 BSI 07-1999 Figure A.1 T-piece for oxygen output determination (see A.1.2) Figure A.2 Test rig for oxygen output determination (see A.2.3) Licensed Copy: London South Bank University, London South Bank University, Fri Dec 08 10:29:50