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1、BRITISH STANDARD BS EN 13328-1:2001 Breathing system filters for anaesthetic and respiratory use Part 1: Salt test method to assess filtration performance The European Standard EN 13328-1:2001 has the status of a British Standard ICS 11.040.10 NO COPYING WITHOUT BSI PERMISSION EXCEPT AS PERMITTED BY
2、 COPYRIGHT LAW Licensed Copy: sheffieldun sheffieldun, na, Sun Oct 29 08:53:57 GMT+00:00 2006, Uncontrolled Copy, (c) BSI BS EN 13328-1:2001 This British Standard, having been prepared under the direction of the Health and Environment Sector Policy and Strategy Committee, was published under the aut
3、hority of the Standards Policy and Strategy Committee on 27 March 2002 BSI 27 March 2002 ISBN 0 580 38205 2 National foreword This British Standard is the official English language version of EN 13328-1:2001. The UK participation in its preparation was entrusted to Technical Committee CH/45, Trachea
4、l tubes and related equipment, which has the responsibility to: A list of organizations represented on this committee can be obtained on request to its secretary. Cross-references The British Standards which implement international or European publications referred to in this document may be found i
5、n the BSI Standards Catalogue under the section entitled “International Standards Correspondence Index”, or by using the “Find” facility of the BSI Standards Electronic Catalogue. A British Standard does not purport to include all the necessary provisions of a contract. Users of British Standards ar
6、e responsible for their correct application. Compliance with a British Standard does not of itself confer immunity from legal obligations. aid enquirers to understand the text; present to the responsible European committee any enquiries on the interpretation, or proposals for change, and keep the UK
7、 interests informed; monitor related international and European developments and promulgate them in the UK. Summary of pages This document comprises a front cover, an inside front cover, the EN title page, pages 2 to 16, an inside back cover and a back cover. The BSI copyright date displayed in this
8、 document indicates when the document was last issued. Amendments issued since publication Amd. No. DateComments Licensed Copy: sheffieldun sheffieldun, na, Sun Oct 29 08:53:57 GMT+00:00 2006, Uncontrolled Copy, (c) BSI EUROPEAN STANDARD NORME EUROPENNE EUROPISCHE NORM EN 13328-1 December 2001 ICS 1
9、1.040.10 English version Breathing system filters for anaesthetic and respiratory use - Part 1: Salt test method to assess filtration performance This European Standard was approved by CEN on 29 June 2001. CEN members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the
10、conditions for giving this European Standard the status of a national standard without any alteration. Up-to-date lists and bibliographical references concerning such national standards may be obtained on application to the Management Centre or to any CEN member. This European Standard exists in thr
11、ee official versions (English, French, German). A version in any other language made by translation under the responsibility of a CEN member into its own language and notified to the Management Centre has the same status as the official versions. CEN members are the national standards bodies of Aust
12、ria, Belgium, Czech Republic, Denmark, Finland, France, Germany, Greece, Iceland, Ireland, Italy, Luxembourg, Netherlands, Norway, Portugal, Spain, Sweden, Switzerland and United Kingdom. EUROPEAN COMMITTEE FOR STANDARDIZATION COMIT EUROPEN DE NORMALISATION EUROPISCHES KOMITEE FR NORMUNG Management
13、Centre: rue de Stassart, 36 B-1050 Brussels 2001 CENAll rights of exploitation in any form and by any means reserved worldwide for CEN national Members. Ref. No. EN 13328-1:2001 E Licensed Copy: sheffieldun sheffieldun, na, Sun Oct 29 08:53:57 GMT+00:00 2006, Uncontrolled Copy, (c) BSI EN 13328-1:20
14、01 (E) 2 Foreword This European Standard has been prepared by Technical Committee 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 end
15、orsement, at the latest by June 2002, and conflicting national standards shall be withdrawn at the latest by June 2002. This European Standard has been prepared under a mandate given to CEN by the European Commission and the European Free Trade Association, and supports essential requirements of EU
16、Directive(s). For relationship with EU Directive(s), see informative annex ZA, which is an integral part of this standard. EN 13328 consists of the following parts under the general title Breathing system filters for anaesthetic and respiratory use : Part 1 : Salt test method to assess filtration pe
17、rformance Part 2 : Non-filtration aspects EN 13328-1 gives a test method for the assessment of the filtration performance of breathing system filters (BSFs) for anaesthetic and respiratory use. The method is based on the USA National Institute for Occupational Safety and Health (NIOSH) method for Re
18、spiratory Protective Devices (42 CFR Part 84) 1 and uses sodium chloride particles. Annex A is normative and forms part of this European Standard. Annexes B, C and ZA are for information only. According to the CEN/CENELEC Internal Regulations, the national standards organizations of the following co
19、untries are bound to implement this European Standard: Austria, Belgium, Czech Republic, Denmark, Finland, France, Germany, Greece, Iceland, Ireland, Italy, Luxembourg, Netherlands, Norway, Portugal, Spain, Sweden, Switzerland and the United Kingdom. Licensed Copy: sheffieldun sheffieldun, na, Sun O
20、ct 29 08:53:57 GMT+00:00 2006, Uncontrolled Copy, (c) BSI EN 13328-1:2001 (E) 3 Introduction This European Standard gives a method of test for assessing the filtration performance of breathing system filters (BSFs). BSFs are used to reduce the number of particulates, including micro-organisms, in ga
21、ses delivered to, and exhaled from, patients. BSFs 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), as it is possible that such exposure can influence the filtration performance of t
22、he BSF. In the test, the BSF is challenged with sodium chloride particles of the particle size range that is considered to be the most penetrating i.e. 0,1 m to 0,3 m (see Annex B). Experience gained in testing filters for respiratory protective devices has shown that by using a test aerosol of the
23、most penetrating size range, the greatest penetration through the filter will be shown compared to any size aerosol. Therefore it is not necessary to subject the filter to a bio-aerosol as a condition of test. It is recognized that transmission of micro-organisms across a filter can occur due to “ch
24、annelling” and “grow through”. There are at present no accepted methods to quantify this occurrence. 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. Licensed Copy: sheffie
25、ldun sheffieldun, na, Sun Oct 29 08:53:57 GMT+00:00 2006, Uncontrolled Copy, (c) BSI EN 13328-1:2001 (E) 4 1 Scope This part of this European Standard establishes a short-term airborne sodium chloride particle challenge test method for assessing the filtration performance of breathing system filters
26、 (BSFs) intended for the filtration of respired gases in humans. The test method is intended for BSFs used with a clinical breathing system. It is not intended for other types of filter e.g. those designed to protect vacuum sources or gas sample lines, to filter compressed gases, to protect test equ
27、ipment or for physiological respiratory measurements. NOTE Non-filtration aspects of BSFs are addressed in prEN 13328-2. 2 Terms and definitions For the purposes of this European Standard, the following terms and definitions apply: 2.1 breathing system filter device intended to reduce transmission o
28、f particulates including micro-organisms in breathing systems NOTE Referred to in this European Standard as BSF; (plural BSFs). 2.2 challenge concentration C concentration of sodium chloride particles in the airstream as it enters the BSF 2.3 penetration concentration P concentration of sodium chlor
29、ide particles in the airstream leaving the BSF 2.4 penetration value PV concentration of sodium chloride particles passing through the BSF as a percentage of the concentration in the challenge 2.5 filtration efficiency percent 100 minus the penetration value Licensed Copy: sheffieldun sheffieldun, n
30、a, Sun Oct 29 08:53:57 GMT+00:00 2006, Uncontrolled Copy, (c) BSI EN 13328-1:2001 (E) 5 3 Test 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 aerosol produced by the nebulizer through the BSF
31、. Annex B gives a further explanation of the particle size terminology. 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 an ionized flow of air so that
32、, when the two flows are mixed, 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 conc
33、entration of sodium chloride particles in the airstream leaving the BSF and comparing this with the challenge concentration in the airstream entering the BSF. BSFs are tested in the unused state as removed from their packaging and after conditioning to simulate clinical use. 3.2 Test conditions The
34、ambient conditions during the tests shall be: - temperature: (23 2) C; - relative humidity: (60 15) %; - pressure: (96 10) kPa. 3.3 Apparatus 3.3.1 Flowmeter, with an error limit of 5 % of the actual value to be measured. 3.3.2 Sodium chloride aerosol generator, capable of generating an aerosol at (
35、25 5) C and relative humidity of (30 10) % with a concentration from 10 mg?-3 to 20 mg?-3 which has been neutralized to the Boltzmann equilibrium state. NOTE Suitable equipment is Model 8118A sodium chloride aerosol generator, TSI Inc., PO Box 64394, St. Paul, MN 55164, USA.1) 3.3.3 Scanning mobilit
36、y particle sizer, or equivalent instrument. NOTE Suitable equipment is Model 3936 scanning mobility particle sizer, TSI Inc., PO Box 64394, St. Paul, MN 55164, USA.1) 3.3.4 Suitable forward-light-scattering photometer, or equivalent instrument. NOTE Suitable equipment is Model AFT 8130, TSI Inc., PO
37、 Box 64394, St. Paul, MN 55164, USA.1) 1) This information is given for the convenience of users of this standard and does not constitute an endorsement by CEN of the product named. Licensed Copy: sheffieldun sheffieldun, na, Sun Oct 29 08:53:57 GMT+00:00 2006, Uncontrolled Copy, (c) BSI EN 13328-1:
38、2001 (E) 6 3.4 Conditioning of BSFs Condition the BSF in accordance with annex A. 3.5 Sample size The BSF manufacturer shall 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 for various aspects of t
39、his method are given in annex C. 3.6.1 Set the flow 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 aerosol at (25 5) C and relative
40、 humidity of (30 10) % with a concentration from 10 mg?-3 to 20 mg?-3 which 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 with a count median diameter o
41、f (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) of 0,26 m. See annex B. NOTE
42、2 This is a calibration step and only needs to be performed as recommended by the manufacturer of the test equipment. 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 the challenge concentration at t
43、he 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 direction stated by the manufacturer.
44、 If the flow direction is not stated, perform the test with the airstream entering the BSF at the machine port. 3.6.6 Repeat 3.6.2. 3.6.7 Measure the challenge concentration (C) and penetration concentration (P) whilst continuing the test until an aerosol mass of (0,2 0,1) mg for adult BSFs or (0,1
45、0,05) mg for paediatric BSFs 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). Licensed Copy: sheffieldun sheffieldun, na, Sun Oct 29 08:53:57 GMT+00:00 2006, Uncontrolled Copy, (c) BSI EN 13328-1:2001 (E) 7 1 2 3 5 4 13 6 11 12 9 7 10 8 8 8 Key 1 Com
46、pressed air8 To vacuum 2 Aerosol generator9 BSF under test 3 Neutralizer10 Downstream photometer 4 Mixing chamber11 Flowmeter 5 Exhaust12 Flow control valve 6 Switching valve 7 Upstream photometer 13 Position for scanning mobility particle sizer, when used Figure 1 - Apparatus for testing BSF 4 Calc
47、ulation and expression of test results For the BSFs tested, calculate the penetration value (PV) from the following expression: PV = P/C x 100 where P is the penetration concentration, determined in accordance with 3.6; C is the challenge concentration, determined in accordance with 3.6. Table 1 Flo
48、w rates for testing BSFs BSF intended useFlow rate l?-1 paediatric15 adult30 Licensed Copy: sheffieldun sheffieldun, na, Sun Oct 29 08:53:57 GMT+00:00 2006, Uncontrolled Copy, (c) BSI EN 13328-1:2001 (E) 8 5 Test report The test report shall include the identification of the BSFs and the filtration
49、efficiencies of the BSFs in the unconditioned and conditioned states. Licensed Copy: sheffieldun sheffieldun, na, Sun Oct 29 08:53:57 GMT+00:00 2006, Uncontrolled Copy, (c) BSI EN 13328-1:2001 (E) 9 Annex A (normative) Conditioning of BSFs A.1 Principle BSFs are exposed to humidified air in a conditioning apparatus to simulate a period of clinical use before they are tested for filtration efficiency. The conditioning apparatus consists of a humidity-generating patient model connected to a breathing system w