1、BRITISH STANDARDBS EN ISO 23328-1:2008Breathing system filters for anaesthetic and respiratory use Part 1: Salt test method to assess filtration performanceICS 11.040.10g49g50g3g38g50g51g60g44g49g42g3g58g44g55g43g50g56g55g3g37g54g44g3g51g40g53g48g44g54g54g44g50g49g3g40g59g38g40g51g55g3g36g54g3g51g40
2、g53g48g44g55g55g40g39g3g37g60g3g38g50g51g60g53g44g42g43g55g3g47g36g58BS EN ISO 23328-1:2008This British Standard was published under the authority of the Standards Policy and Strategy Committee on 30 May 2008 BSI 2008ISBN 978 0 580 59141 9National forewordThis British Standard is the UK implementati
3、on of EN ISO 23328-1:2008. It is identical with ISO 23328-1:2003. It supersedes BS EN 13328-1:2001 which is withdrawn.The UK participation in its preparation was entrusted by Technical Committee CH/121, Anaesthetic and respiratory equipment, to Subcommittee CH/121/5, Lung ventilators, tracheal tubes
4、 and related equipment.A list of organizations represented on this committee can be obtained on request to its secretary.This publication does not purport to include all the necessary provisions of a contract. Users are responsible for its correct application.Compliance with a British Standard canno
5、t confer immunity from legal obligations.Amendments/corrigenda issued since publicationDate CommentsEUROPEAN STANDARDNORME EUROPENNEEUROPISCHE NORMEN ISO 23328-1March 2008ICS 11.040.10 Supersedes EN 13328-1:2001 English VersionBreathing system filters for anaesthetic and respiratory use -Part 1: Sal
6、t test method to assess filtration performance (ISO23328-1:2003)Filtres pour matriel danesthsie et de ranimationrespiratoire - Partie 1: Mthode dessai laide dunesolution saline pour lvaluation de lefficacit de filtration(ISO 23328-1:2003)Filter fr Atemsysteme zur Anwendung bei Ansthesie undBeatmung
7、- Teil 1: Prfverfahren mit Salzpartikeln zurBewertung der Filterleistung (ISO 23328-1:2003)This European Standard was approved by CEN on 24 February 2008.CEN members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for giving this EuropeanStandard the stat
8、us of a national standard without any alteration. Up-to-date lists and bibliographical references concerning such nationalstandards 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 v
9、ersion in any other language made by translationunder the responsibility of a CEN member into its own language and notified to the CEN Management Centre has the same status as theofficial versions.CEN members are the national standards bodies of Austria, Belgium, Bulgaria, Cyprus, Czech Republic, De
10、nmark, Estonia, Finland,France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal,Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland and United Kingdom.EUROPEAN COMMITTEE FOR STANDARDIZATIONCOMIT EUROPEN DE NORMALISATI
11、ONEUROPISCHES KOMITEE FR NORMUNGManagement Centre: rue de Stassart, 36 B-1050 Brussels 2008 CEN All rights of exploitation in any form and by any means reservedworldwide for CEN national Members.Ref. No. EN ISO 23328-1:2008: EForeword The text of ISO 23328-1:2003 has been prepared by Technical Commi
12、ttee ISO/TC 121 “Anaesthetic and respiratory equipment” of the International Organization for Standardization (ISO) and has been taken over as EN ISO 23328-1:2008 by Technical Committee CEN/TC 215 “Respiratory and anaesthetic equipment”, the secretariat of which is held by BSI. This European Standar
13、d shall be given the status of a national standard, either by publication of an identical text or by endorsement, at the latest by September 2008, and conflicting national standards shall be withdrawn at the latest by September 2008. Attention is drawn to the possibility that some of the elements of
14、 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 13328-1:2001. This document has been prepared under a mandate given to CEN by the European Commission and the European Free
15、Trade Association, and supports essential requirements of EC Directive(s). For relationship with EC Directive(s), 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 a
16、re bound to implement this European 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, Swe
17、den, Switzerland and the United Kingdom. Endorsement notice The text of ISO 23328-1:2003 has been approved by CEN as a EN ISO 23328-1:2008 without any modification. BS EN ISO 23328-1:2008iiiContents Page Foreword iv Introduction v 1 Scope 1 2 Terms and definitions. 1 3 Method 2 3.1 Principle . 2 3.2
18、 Test conditions 2 3.3 Apparatus. 2 3.4 Conditioning of BSF . 2 3.5 Sample size 3 3.6 Procedure. 3 4 Calculation and expression of test results. 4 5 Test report 4 Annex A (normative) Conditioning of BSF 5 Annex B (informative) Aerosol particle size distribution . 8 Annex C (informative) Rationale fo
19、r chosen test method 9 Annex D (informative) Clauses of this part of ISO 23328 addressing the essential principles of ISO/TR 16142 . 11 Bibliography . 12 BS EN ISO 23328-1:2008Annex ZA (informative) Relationship between this European Standard and the EssentialRequirements of EU Directive 93/42/EEC M
20、edical devices13iv Foreword ISO (the International Organization for Standardization) is a worldwide federation of national standards bodies (ISO member bodies). The work of preparing International Standards is normally carried out through ISO technical committees. Each member body interested in a su
21、bject for which a technical committee has been established has the right to be represented on that committee. International organizations, governmental and non-governmental, in liaison with ISO, also take part in the work. ISO collaborates closely with the International Electrotechnical Commission (
22、IEC) on all matters of electrotechnical standardization. International Standards are drafted in accordance with the rules given in the ISO/IEC Directives, Part 2. The main task of technical committees is to prepare International Standards. Draft International Standards adopted by the technical commi
23、ttees are circulated to the member bodies for voting. Publication as an International Standard requires approval by at least 75 % of the member bodies casting a vote. Attention is drawn to the possibility that some of the elements of this document may be the subject of patent rights. ISO shall not b
24、e held responsible for identifying any or all such patent rights. ISO 23328-1 was prepared by Technical Committee ISO/TC 121, Anaesthetic and respiratory equipment, Subcommittee SC 3, Lung ventilators and related equipment. ISO 23328 consists of the following parts, under the general title Breathing
25、 system filters for anaesthetic and respiratory use: Part 1: Salt test method to assess filtration performance Part 2: Non-filtration aspects BS EN ISO 23328-1:2008vIntroduction This part of ISO 23328 gives a method of test for assessing the filtration performance of breathing system filters (BSF).
26、BSF are used to reduce the number of particulates, including microorganisms, in gases delivered to, and exhaled from, patients. BSF are exposed to various levels of humidity during clinical use. Exposure of the BSF to humidified air to simulate clinical use forms part of this method (see Annex A), a
27、s it is possible that such exposure can influence the filtration performance of the BSF. In the test, the BSF is challenged with sodium chloride particles of the most penetrating size range, i.e. 0,1 m to 0,3 m (see Annex C). It is recognized that transmission of microorganisms across a filter can o
28、ccur due to “channeling” and “grow-through”. There are at present no accepted methods to quantify these occurrences. This test method is for comparison purposes only, and has no proven clinical relevance. The results are specific to the test method and no risk factor should be derived from it. BS EN
29、 ISO 23328-1:2008blank1Breathing system filters for anaesthetic and respiratory use Part 1: Salt test method to assess filtration performance 1 Scope This part of ISO 23328 gives a short-term airborne sodium chloride particle challenge test method for assessing the filtration performance of breathin
30、g system filters (BSF) intended for the filtration of respired gases. This part of ISO 23328 is applicable to BSF used with a clinical breathing system. It is not applicable to other types of filter, e.g. those designed to protect vacuum sources or gas sample lines, to filter compressed gases, or to
31、 protect test equipment for physiological respiratory measurements. NOTE Non-filtration aspects of BSF are addressed in ISO 23328-2. 2 Terms and definitions For the purposes of this document, the following terms and definitions apply. 2.1 breathing system filter BSF device intended to reduce transmi
32、ssion of particulates, including microorganisms, in breathing systems 2.2 challenge concentration concentration of sodium chloride particles in the airstream as it reaches the BSF NOTE Challenge concentration is expressed in milligrams per cubic metre. 2.3 penetration concentration concentration of
33、sodium chloride particles in the airstream flowing out of the BSF NOTE Penetration concentration is expressed in milligrams per cubic metre. 2.4 penetration value concentration of sodium chloride particles passing through the BSF as a percentage of the concentration in the challenge 2.5 percent filt
34、ration efficiency 100 minus the penetration value BS EN ISO 23328-1:20082 3 Method 3.1 Principle 3.1.1 The ability of a BSF to remove particles is measured by nebulizing a sodium chloride solution into an airstream and passing the sodium chloride particles produced by the nebulizer through the BSF.
35、Annexes B and C give further explanation. 3.1.2 The generation of aerosols from a nebulizer produces particles that are charged electrostatically. The magnitude of the charge is reduced by mixing the airstream containing the particles with a flow of ionized air so that, when the two flows are mixed,
36、 the particles are neutralized to the Boltzmann equilibrium state. 3.1.3 The flows chosen for testing represent the typical flows likely to be encountered during the intended use of the BSF. 3.1.4 The performance of the BSF is assessed by measuring the penetration concentration of sodium chloride pa
37、rticles in the airstream leaving the BSF and comparing this with the challenge concentration in the airstream entering the BSF. BSF are tested in the unused state as removed from the packaging and after conditioning to simulate clinical use. 3.2 Test conditions The ambient conditions during the test
38、s shall be: temperature: (23 2) C; relative humidity: (60 15) % RH; and pressure: (96 10) kPa. 3.3 Apparatus 3.3.1 Flowmeter, with an accuracy of 5 % of the actual value to be measured. 3.3.2 Sodium chloride aerosol generator1), capable of generating an aerosol at (25 5) C and relative humidity of (
39、30 10) % with a concentration between 10 mgm3and 20 mgm3which has been neutralized to the Boltzmann equilibrium state. 3.3.3 Scanning mobility particle sizer2), or equivalent instrument. 3.3.4 Suitable forward-light-scattering photometer3), or equivalent instrument. 3.4 Conditioning of BSF Condition
40、 the BSF in accordance with Annex A. 1) Model 8118A sodium chloride aerosol generator is an example of a suitable product available commercially from TSI Inc., PO Box 64394, St. Paul, MN 55164, USA. This information is given for the convenience of users of this part of ISO 23328 and does not constit
41、ute an endorsement by ISO of this product. 2) Model 3936 scanning mobility particle sizer is an example of a suitable product available commercially from TSI Inc., PO Box 64394, St. Paul, MN 55164, USA. This information is given for the convenience of users of this part of ISO 23328 and does not con
42、stitute an endorsement by ISO of this product. 3) Model AFT 8130 forward-light-scattering photometer is an example of a suitable product available commercially from TSI Inc., PO Box 64394, St. Paul, MN 55164, USA. This information is given for the convenience of users of this part of ISO 23328 and d
43、oes not constitute an endorsement by ISO of this product. BS EN ISO 23328-1:200833.5 Sample size It is the responsibility of the BSF manufacturer to document the rationale for the test BSF sample size chosen in order to demonstrate the filtration efficiency of the BSF. 3.6 Procedure NOTE Rationales
44、for various aspects of this method are given in Annex C. 3.6.1 Set the flowrate through the test apparatus (see Figure 1) to the appropriate value for the intended use of the BSF given in Table 1, using the flowmeter (3.3.1). 3.6.2 Using the aerosol generator (3.3.2), generate a sodium chloride aero
45、sol at (25 5) C and relative humidity of (30 10) %, with a concentration between 10 mgm3and 20 mgm3, that has been neutralized to the Boltzmann equilibrium state. 3.6.3 Using the scanning mobility particle sizer (3.3.3), confirm that the sodium chloride test aerosol has a particle size distribution
46、with a count median diameter of (0,075 0,020) m and a geometric standard deviation not exceeding 1,86 at the specified test conditions. NOTE 1 A particle size distribution with a count median diameter of 0,075 m and a geometric standard deviation of 1,86 has a mass median aerodynamic diameter (MMAD)
47、 of 0,26 m. See Annex B. NOTE 2 This is a calibration step of the aerosol generator and only needs to be performed as recommended by the manufacturer. 3.6.4 Without a BSF attached, interconnect the two photometers (3.3.4) and measure the challenge concentration at the upstream photometer. Check that
48、 the challenge concentration at the downstream photometer is 2,5 % of this value each time the apparatus is switched on, when the airflow is changed and after the BSF sample size (3.5) has been tested. 3.6.5 Fit a BSF in the unconditioned state to the test apparatus. Test the BSF using the flow dire
49、ction stated by the manufacturer. If the flow direction is not stated, perform the test with the airstream entering the BSF at the machine port. 3.6.6 Repeat the generation of aerosol as described in 3.6.2. 3.6.7 Measure the challenge concentration (cC) and penetration concentration (cP) whilst continuing the test until an aerosol mass of (0,2 0,1) mg for adult BSF and (0,1 0,05) mg for paediatric BSF has contacted the BSF. 3.6.8 Repeat 3.6.5 to 3.6.7 using a BSF in the conditioned state (see 3.4). BS EN ISO 23
