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1、BRITISH STANDARD BS 7711-3:1994 Respiratory therapy equipment Part 3: Specification for gas-powered nebulizers for the delivery of drugs Licensed Copy: London South Bank University, London South Bank University, Fri Dec 08 10:29:39 GMT+00:00 2006, Uncontrolled Copy, (c) BSI BS 7711-3:1994 This Briti
2、sh Standard, having been prepared under the direction of the Health Care and Environment Sector Board, was published under the authority of the Standards Board and comes into effect on 15 October 1994 BSI 03-1999 The following BSI references relate to the work on this standard: Committee reference H
3、CC/44 Draft for comment 92/59245 DC ISBN 0 580 22958 0 Committees responsible for this British Standard The preparation of this British Standard was entrusted by the Health Care and Environment Sector Board to Technical Committee HCC/44, upon which the following bodies were represented: Association
4、of Anaesthetists 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 The follo
5、wing bodies were also represented in the drafting of the standard, through subcommittees and panels. Guild of Hospital Pharmacists Coopted members Amendments issued since publication Amd. No.DateComments Licensed Copy: London South Bank University, London South Bank University, Fri Dec 08 10:29:39 G
6、MT+00:00 2006, Uncontrolled Copy, (c) BSI BS 7711-3:1994 BSI 03-1999i Contents Page Committees responsibleInside front cover Foreword ii 1Scope1 2References1 3Definitions1 4General1 5Connections2 6Marking2 7Information to be supplied by the manufacturer2 Annex A (normative) Methods of test3 Figure A
7、.1 Typical test apparatus for determination of aerosol output4 Figure A.2 Typical test apparatus for use with laser diffraction particle sizer6 List of referencesInside back cover Licensed Copy: London South Bank University, London South Bank University, Fri Dec 08 10:29:39 GMT+00:00 2006, Uncontrol
8、led Copy, (c) BSI BS 7711-3:1994 ii BSI 03-1999 Foreword This Part of BS 7711 has been prepared under the direction of the Health Care and Environment Sector Board. It relates to gas-powered nebulizers that are directly in contact with respirable gases and used for the delivery of drugs as part of r
9、espiratory therapy. The efficiency of these devices depends largely on the proportion of their output which is of suitable size to penetrate the respiratory system of the patient to the required extent 1, 2, 3. A British Standard does not purport to include all the necessary provisions of a contract
10、. Users of British Standards are responsible for their correct application. Compliance 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 8, an inside back cover
11、and a back cover. This standard has been updated (see copyright date) and may 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 10:29:39 GMT+00:00 2006, Unco
12、ntrolled Copy, (c) BSI BS 7711-3:1994 BSI 03-19991 1 Scope This Part of BS 7711 specifies minimum performance and safety requirements for gas-powered nebulizers used for the delivery of drugs to patients through the respiratory system. Test methods for measuring performance are given in Annex A. The
13、 standard does not include humidifiers operating on the nebulizing principle, nebulizers using ultrasonic power or devices for the delivery of drugs by dry powder inhalation. 2 References 2.1 Normative references This Part of BS 7711 incorporates, by dated or undated reference, provisions from other
14、 publications. These normative references are made at the appropriate places in the text and the cited publications are listed on the inside back cover. For dated references, only the edition cited applies; any subsequent amendments to or revisions of the cited publication apply to this Part of BS 7
15、711 only when incorporated in the reference by amendment or revision. For undated references, the latest edition of the cited publication applies, together with any amendments. 2.2 Informative references This Part of BS 7711 refers to other publications that provide information or guidance. Editions
16、 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 Definitions For the purposes of this Part of BS 7711, the following definitions apply. 3.1 gas-powered nebulizer device which converts a li
17、quid into an aerosol by means of compressed gas NOTEHereinafter referred to as a nebulizer. 3.2 liquid container that part of the nebulizer which contains the liquid for nebulization 3.3 maximum fill volume maximum volume of liquid in the liquid container during normal operation when the nebulizer i
18、s filled to the maximum filling level 3.4 residual volume volume of liquid remaining in the liquid container after continuous nebulization has ceased 3.5 aerosol suspension of liquid particles in a gas 3.6 aerosol output rate of production of particles in aerosol form by the nebulizer, expressed in
19、mg/min 3.7 respirable particles aerosol particles 5 m or less in diameter NOTECurrent opinion is that deposition of particles of aerosol from nebulizers is as follows: a) tracheobronchial deposition: particles of 2 m to 5 m diameter; b) alveolar deposition: particles of less than 2 m diameter. 3.8 r
20、espirable fraction proportion of respirable particles in the aerosol output, expressed as a percentage by mass 3.9 respirable output rate of production of respirable particles by the nebulizer, expressed in mg/min NOTERespirable output = aerosol output respirable fraction. 4 General NOTE 1The nebuli
21、zer should be sufficiently robust to withstand reasonable mechanical stresses and to resist degradation by vapours or medicaments which are not specifically prohibited by the manufacturer. NOTE 2In clinical use drugs will be dispensed into the nebulizer by volume. For the purpose of laboratory tests
22、, however, gravimetric methods are preferred and the requirements specified in this Part of BS 7711 have been expressed in gravimetric units. The solutions used have densities close to 1 g/ml. 4.1 Testing The test methods given in Annex A or other test methods which have been demonstrated to be of c
23、omparable accuracy shall be used. In case of dispute the test methods given in Annex A shall be used. In either case the test report shall give the information listed in A.6. Licensed Copy: London South Bank University, London South Bank University, Fri Dec 08 10:29:39 GMT+00:00 2006, Uncontrolled C
24、opy, (c) BSI BS 7711-3:1994 2 BSI 03-1999 4.2 Output 4.2.1 Respirable output When measured as described in A.2 and A.3, or using an alternative method of comparable accuracy, the respirable output at each of the driving gas flows stated by the manufacturer see clause 7 c) shall be within 20 % of the
25、 value stated by the manufacturer see clause 7 e). 4.2.2 Respirable fraction When measured as described in A.3, or using an alternative method of comparable accuracy, the respirable fraction shall be at least 50 % at each of the driving gas flows stated by the manufacturer see clause 7 c). 4.3 Leaka
26、ge When measured as described in A.5, or using an alternative method of comparable accuracy, the loss of mass shall not exceed 5 % of the total fill mass. 5 Connections 5.1 Connections to breathing system If the nebulizer is intended to be connected to an anaesthetic breathing system or a lung venti
27、lator breathing system, it shall have conical connectors of 15 mm or 22 mm diameter conforming to BS 3849-1:1988 or BS 3849-2:1988. 5.2 Connections for gas supply The oxygen or compressed air connector shall conform to BS 7711-1:1994. 6 Marking 6.1 The nebulizer or, if the nebulizer is intended for
28、single use, its immediate packaging shall be marked with at least the following information: a) name or trademark of manufacturer or supplier; b) lot number or other identification; c) manufacturers recommended driving gas flow; d) if intended for single use only, the words “SINGLE USE”; NOTESymbol
29、no. 1051 given in BS 7324 may also be given. 6.2 The liquid container of the nebulizer shall be marked at the maximum filling level. 7 Information to be supplied by the manufacturer At least the following information shall be provided by the manufacturer with each nebulizer or package of nebulizers.
30、 a) a description of the intended use; b) the suitability of the nebulizer for use in anaesthetic breathing systems and/or lung ventilator breathing systems; c) the minimum, maximum and recommended driving gas flows; d) the driving gas pressures, in kPa, corresponding to the manufacturers stated min
31、imum, maximum and recommended driving gas flows; e) the respirable output, determined as described in A.2 and A.3, or using an alternative method of comparable accuracy, at the manufacturers stated minimum, maximum and recommended driving gas flows; f) the distribution of aerosol particle size, meas
32、ured as described in A.3, or using an alternative method of comparable accuracy, at the manufacturers recommended driving gas flow; g) the residual volume at each driving gas flow, determined as described in A.4, or using an alternative method of comparable accuracy, and the maximum fill volume of t
33、he liquid container; h) any contra-indications to the use of the nebulizer; i) if intended for single use only, the words “SINGLE USE”; NOTESymbol no. 1051 given in BS 7324 may also be given. j) for re-usable nebulizers, procedures for cleaning, disinfection and/or sterilization of the nebulizer; k)
34、 details of recommended accessories for use with the nebulizer; l) the name or trade mark of the manufacturer or supplier. Licensed Copy: London South Bank University, London South Bank University, Fri Dec 08 10:29:39 GMT+00:00 2006, Uncontrolled Copy, (c) BSI BS 7711-3:1994 BSI 03-19993 Annex A (no
35、rmative) Methods of test A.1 General conditions Perform the tests under the following general conditions. a) Maintain an ambient temperature for the duration of the test of (22 2) C. b) Use medical air as the driving gas, supplied at a pressure sufficient to produce the driving gas flows stated by t
36、he manufacturer see clause 7 c). NOTEAs a guide, a pressure of at least 100 kPa will be needed. c) Use a test solution comprising 9.0 g/l sodium chloride in distilled water, except for the determination of aerosol output (see A.2). d) Determine mass to an accuracy of 0.01 g. e) Measure air flow to a
37、n accuracy of 2.5 % of the reading, corrected to 101.3 kPa and 22 C. f) Pre-condition nebulizers designed to be reuseable by subjecting them to twenty cycles of the cleaning and disinfection/sterilization procedures recommended by the manufacturer see clause 7 j). A.2 Measurement of aerosol output a
38、nd determination of respirable output A.2.1 Principle A known concentration of a chemical tracer is added to the test solution. The nebulizer is operated for a specified period of time during which all released aerosol is entrained in air drawn over the nebulizer and is impacted onto a filter. The f
39、ilter is placed in a known volume of eluant solution, and the chemical tracer is eluted from the filter. The quantity of chemical tracer eluted from the filter is determined by quantitative analysis, enabling the mass of aerosol released per unit time to be calculated. NOTEIt has been demonstrated 4
40、 that estimating aerosol output by loss of mass is grossly inaccurate, because loss of mass includes loss in vapour form. The test method adopted is to determine the total aerosol output by electrochemical analysis of the amount of a tracer carried over onto a filter in a known time. The respirable
41、output is then determined by multiplying this total aerosol output by the respirable fraction determined by a laser diffraction particle sizer (see A.3). The performance of the timer-operated valve is critical to the accuracy of the results. It is essential that this valve provides: a) rapid respons
42、e during opening and closing; b) constant flow during the “on” period. The latter is best achieved by using a diverting valve so that flow is essentially continuous. The time scale of the test is limited by the capacity of the filter because it is essential that the filter does not become saturated
43、by the aerosol. It is recommended that a preliminary series of tests be performed on a single nebulizer to determine aerosol output at various time intervals. The results should theoretically be independent of time but it may be found that low results are obtained at short times, due to timer-operat
44、ed valve response, and also at long times due to filter saturation. The time to be used for test should be set within a range where time-independence has been demonstrated. A.2.2 Materials A.2.2.1 Test solution, comprising 10 g/l sodium fluoride in distilled water. NOTECare should be taken to limit
45、the dispersion of this solution into the atmosphere, e.g. by conducting the tests in a fume cupboard. A.2.2.2 Eluant solution, comprising total ionic strength adjustment buffer (TISAB) solution, having the following composition: A.2.3 Apparatus A.2.3.1 T-piece, to fit the nebulizer under test and a
46、47 mm filter holder. NOTEAn adaptor may be needed. A.2.3.2 47 mm diameter glass fibre filters. A.2.3.3 Suction pump, capable of drawing 20 l/min of ambient air through the collection filter. A.2.3.4 Timer-operated valve, capable of activating the nebulizer by switching the driving gas supply on and
47、off for periods of time within the range 0.5 s to 10 s with an accuracy of 2 % of the setting. (See A.2.1.) A.2.3.5 Water bath, maintained at (25 0.5) C. A.2.3.6 Electrochemical analysis apparatus, comprising a fluoride-specific ion electrode, calomel reference electrode and specific ion meter. A.2.
48、4 Procedure A.2.4.1 Fill the nebulizer with the maximum volume of test solution (A.2.2.1) stated by the manufacturer see clause 7 g). Attach the nebulizer to the T-piece (A.2.3.1) so that the axis of the nebulizer is at 20 to the vertical. NOTENebulizers may be used attached directly to face masks o
49、r mouth pieces and are rarely operated in an upright position. Sodium chloride58 g CDTA (trans- 1,2-diaminocyclohexane- N, N, N9, N9 tetra-acetic acid)3.6 g Distilled or deionized waterto 1 l Licensed Copy: London South Bank University, London South Bank University, Fri Dec 08 10:29:39 GMT+00:00 2006, Uncontrolled Copy, (c) BSI BS 7711-3:1994 4 BSI 03-1999 Before connection to the remainder of the test apparatus, operate the nebulizer at the recommended driving gas flow see clause 7 c) for approximately 3 s to wet all surface