1、July 2009DEUTSCHE NORM English price group 10No 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!$XU“1538850www.
2、din.deDDIN EN ISO 23328-2Breathing system filters for anaesthetic and respiratory use Part 2: Non-filtration aspects (ISO 23328-2:2002)English version of DIN EN ISO 23328-2:2009-07Filter fr Atemsysteme zur Anwendung bei Ansthesie und Beatmung Teil 2: Aspekte, die nicht die Filtration betreffen (ISO
3、23328-2:2002)Englische Fassung DIN EN ISO 23328-2:2009-07SupersedesDIN EN ISO 23328-2:2008-06See start of validitywww.beuth.deDocument comprises pages15DIN EN ISO 23328-2:2009-07 Start of validity This standard takes effect on 1 July 2009. DIN EN ISO 23328-2:2008-06 may be used in parallel until 21
4、March 2010. National foreword This standard has been prepared by Technical Committee ISO/TC 121 “Anaesthetic and respiratory equipment” in collaboration with Technical Committee CEN/TC 215 “Respiratory and anaesthetic equipment” (Secretariat: BSI, United Kingdom). The responsible German body involve
5、d in its preparation was the Normenausschuss Rettungsdienst und Krankenhaus (Rescue Services and Hospital Standards Committee), Technical Committee NA 053-03-01 AA Ansthesie und Beatmung. This standard contains specifications meeting the essential requirements set out in EU Directive 93/42/EEC on me
6、dical devices. DIN EN ISO 23328 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 performance Part 2: Non-filtration aspects The DIN Standards corresponding to the International Standar
7、ds referred to in this document are as follows: ISO 5356-1 DIN EN ISO 5356-1 ISO 5356-2 DIN EN ISO 5356-2 ISO 9360-1 DIN EN ISO 9360-1 ISO 11607 DIN EN ISO 11607 IEC 60601-1 DIN EN 60601-1 (VDE 0750-1-1) Amendments This standard differs from DIN EN ISO 23328-2:2008-06 as follows: a) Annex ZA (inform
8、ative) concerning the relationship between this European Standard and the essential requirements of EU Directive 93/42/EEC on medical devices has been updated on the basis of EU Directive 2007/47/EC of the European Parliament and of the Council of 5 September 2007 amending Council Directives 90/385/
9、EEC on the approximation of the laws of the Member States relating to active implantable medical devices and 93/42/EEC on medical devices and EU Directive 98/8/EC on the placing on the market of biocidal products. Previous editions DIN EN 13328-2: 2003-02, 2004-03 DIN EN ISO 23328-2: 2008-06 2 DIN E
10、N ISO 23328-2:2009-07 National Annex NA (informative) Bibliography DIN EN 60601-1 (VDE 0750-1), Medical electrical equipment Part 1: General requirements for basic safety and essential performance DIN EN ISO 5356-1, Anaesthetic and respiratory equipment Conical connectors Part 1: Cones and sockets D
11、IN EN ISO 5356-2, Anaesthetic and respiratory equipment Conical connectors Part 2: Screw-threaded weight-bearing connectors DIN EN ISO 9360-1, Heat and moisture exchangers (HMEs) for humidifying respired gases in humans Part 1: HMEs for use with minimum tidal volumes of 250 ml DIN EN ISO 11607 (all
12、parts), Packaging for terminally sterilized medical devices 3 DIN EN ISO 23328-2:2009-07 4 This page is intentionally blank EUROPEAN STANDARD NORME EUROPENNE EUROPISCHE NORM EN ISO 23328-2 March 2009 ICS 11.040.10 Supersedes EN ISO 23328-2:2008 English Version Breathing system filters for anaestheti
13、c and respiratory use Part 2: Non-filtration aspects (ISO 23328-2:2002) Filtres pour matriel danesthsie et de ranimation respiratoire Partie 2: Aspects autres que la filtration (ISO 23328-2:2002) Filter fr Atemsysteme zur Anwendung bei Ansthesie und Beatmung Teil 2: Aspekte, die nicht die Filtration
14、 betreffen (ISO 23328-2:2002) This European Standard was approved by CEN on 24 February 2009. CEN members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for giving this EuropeanStandard the status of a national standard without any alteration. Up-to-date
15、 lists and bibliographical references concerning such national standards 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 version in any other language made by translationunder the
16、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, Denmark, Estonia, Finland, France,Germany, Greece, Hungary,
17、 Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland and United Kingdom. EUROPEAN COMMITTEE FOR STANDARDIZATION COMIT EUROPEN DE NORMALISATION EUROPISCHES KOMITEE FR NORMUNG Management Centre: A
18、venue Marnix 17, B-1000 Brussels 2009 CEN All rights of exploitation in any form and by any means reserved worldwide for CEN national Members. Ref. No. EN ISO 23328-2:2009: EContents Page Foreword . 3 Introduction. 4 1 Scope 5 2 Normative references 5 3 Terms and definitions. 5 4 BSF port connectors
19、. 6 4.1 BSF breathing system and patient connection ports 6 4.2 Accessory ports 6 5 Test methods . 6 5.1 Ambient conditions of test. 6 5.2 Measurement of pressure drop . 6 5.3 Test for gas leakage 7 6 Packaging of sterile BSF 7 7 Marking. 7 7.1 Use of symbols 7 7.2 Marking of BSF 7 7.3 Marking of pa
20、ckage. 7 7.4 BSF intended for single use. 7 8 Information to be provided by the manufacturer. 8 Bibliography 9 2DIN EN ISO 23328-2:2009-07 EN ISO 23328-2:2009 (E) Annex ZA (informative) Relationship between this European Standard and the Essential Requirements of EU Directive 93/42/EEC 10 Foreword T
21、he text of ISO 23328-2:2002 has been prepared by Technical Committee ISO/TC 121 “Anaesthetic and respiratory equipment” of the International Organization for Standardization (ISO) and has been taken over as EN ISO 23328-2:2009 by Technical Committee CEN/TC 215 “Respiratory and anaesthetic equipment”
22、 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 endorsement, at the latest by September 2009, and conflicting national standards shall be withdrawn at the latest by March 2010. Attenti
23、on is drawn to the possibility that some of the elements of 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 ISO 23328-2:2008. This document has been prepared under a mandate
24、 given to CEN by the European Commission and the European Free Trade Association, and supports essential requirements of EC Directive. For relationship with EC Directive, see informative Annex ZA, which is an integral part of this document. According to the CEN/CENELEC Internal Regulations, the nati
25、onal standards organizations of the following countries are 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,
26、Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland and the United Kingdom. Endorsement notice The text of ISO 23328-2:2002 has been approved by CEN as a EN ISO 23328-2:2009 without any modification. 3DIN EN ISO 23328-2:2009-07 EN ISO 23328-2:2009 (E) Introduction This part of
27、ISO 23328 gives requirements for non-filtration aspects of breathing system filters (BSF). BSF are used to reduce 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 humidif
28、ied air to simulate clinical use forms part of the test method, as it is possible that such exposure can influence the filtration performance of the BSF. A test method to assess filtration performance is found in ISO 23328-1. 4DIN EN ISO 23328-2:2009-07 EN ISO 23328-2:2009 (E) 1 Scope This part of I
29、SO 23328 specifies requirements for non-filtration aspects of breathing system filters (BSF) intended for anaesthetic and respiratory use, and addresses connection ports, leakage, resistance to flow, packaging, marking and information supplied. The test method is intended for BSF used with a clinica
30、l 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 protect test equipment for physiological respiratory measurements. NOTE A method for assessing filtration performance of BSF is give
31、n in ISO 23328-1. 2 Normative references The following normative documents contain provisions which, through reference in this text, constitute provisions of this part of ISO 23328. For dated references, subsequent amendments to, or revisions of, any of these publications do not apply. However, part
32、ies to agreements based on this part of ISO 23328 are encouraged to investigate the possibility of applying the most recent editions of the normative documents indicated below. For undated references, the latest edition of the normative document referred to applies. Members of ISO and IEC maintain r
33、egisters of currently valid International Standards. ISO 5356-1, Anaesthetic and respiratory equipment Conical connectors Part 1: Cones and sockets ISO 5356-2, Anaesthetic and respiratory equipment Conical connectors Part 2: Screw-threaded weight-bearing connectors ISO 9360-1:2000, Anaesthetic and r
34、espiratory equipment Heat and moisture exchangers (HMEs) for humidifying respired gases in humans Part 1: HMEs for use with minimum tidal volumes of 250 ml ISO 11607, Packaging for terminally sterilized medical devices IEC 60601-1:1988, Medical electrical equipment Part 1: General requirements for s
35、afety; Amendment 1:1991 and Amendment 2:1995 3 Terms and definitions For the purposes of this part of ISO 23328, the following terms and definitions apply: 3.1 breathing system filter BSF device intended to reduce transmission of particulates, including microorganisms, in breathing systems 5DIN EN I
36、SO 23328-2:2009-07 EN ISO 23328-2:2009 (E) 3.2 BSF breathing system port port of the BSF that connects to the breathing system 3.3 BSF patient connection port port of the BSF intended for connection to a device such as a tracheal or tracheostomy tube connector or a face mask 3.4 BSF accessory port p
37、ort of the BSF that can be connected to an accessory device for purposes such as gas sampling, monitoring and pressure measurement 3.5 BSF internal volume volume contained in the BSF, when unpressurized, minus the volume of all solid elements within the BSF and the volume inside all female connector
38、s 3.8 pressure drop difference between the pressure measured in a gas stream flowing into a BSF and the pressure measured in the gas stream flowing out of the BSF at a constant gas flowrate through the BSF 4 BSF port connectors 4.1 BSF breathing system and patient connection ports The connectors at
39、the breathing system port and the patient connection port shall comply with ISO 5356-1. 4.2 Accessory ports If the BSF incorporates an accessory port, that port shall not accept 15 mm or 22 mm conical connectors that comply with ISO 5356-1 and ISO 5356-2 and shall be provided with means of closure o
40、f the port. 5 Test methods 5.1 Ambient conditions of test The ambient conditions during the tests shall be: temperature: (23 2) C; relative humidity: (60 15) % RH; pressure: (96 10) kPa. 5.2 Measurement of pressure drop The measurement of pressure drop shall be determined in accordance with 6.3 of I
41、SO 9360-1:2000, using the flowrates given in Table 1. 6DIN EN ISO 23328-2:2009-07 EN ISO 23328-2:2009 (E) Table 1 Gas flowrates for measurement of pressure drop BSF intended use Flowrate lmin1Pediatric 15 Adult 30 5.3 Test for gas leakage The BSF shall comply with 6.4 of ISO 9360-1:2000. 6 Packaging
42、 of sterile BSF The packaging of BSF supplied sterile shall comply with the requirements of ISO 11607. 7 Marking 7.1 Use of symbols Some of the requirements of 7.3 and 7.4 may be met by use of appropriate symbols as given in ISO 15223 or ISO 7000. 7.2 Marking of BSF BSF shall be marked with the foll
43、owing: a) direction of orientation towards the patient in the case of orientation-sensitive BSF; b) the letters “APG” (see IEC 60601-1:1988) if the manufacturer states that the BSF is safe for use with flammable anesthetics. 7.3 Marking of package The package shall be marked with the following: a) t
44、he name or trademark and address of the manufacturer or supplier, or their authorized representative; b) the intended use of the BSF; c) the word “STERILE” (or the equivalent), if applicable; d) storage instructions, if appropriate; e) date of manufacture or lot number or batch number; f) use-by dat
45、e, if the BSF is sensitive to storage or has a limited shelf-life. 7.4 BSF intended for single use For BSF intended for single use, either the BSF or the package shall be marked with the words “single use” or the equivalent. 7DIN EN ISO 23328-2:2009-07 EN ISO 23328-2:2009 (E) 8 Information to be pro
46、vided by the manufacturer The following information shall be provided by the manufacturer: a) instructions for use; b) the recommended range of tidal volumes and/or flowrates; c) the pressure drop at the gas flowrate specified in Table 1, measured as specified in 5.2; d) the internal volume of the B
47、SF, expressed in millilitres; e) the gas leakage, expressed in millilitres per minute, measured as specified in 5.3; f) if applicable, a warning of the hazards associated with the use of the BSF with any type of inhalant during inhalation therapy, anaesthetic gases and vapours, and humidifiers and n
48、ebulizers; g) if the BSF or parts thereof are reusable, instructions for maintenance and details of cleaning, disinfection and sterilization; h) recommended maximum time of use before either disposal or cleaning; i) instructions for safe disposal after use; j) penetration value, pre- and post-condit
49、ioning, for example as indicated in ISO 23328-1. k) if the BSF is fitted with one or more small-bore connectors such as a Luer, a warning highlighting the potential for inappropriate connection to other devices that can result in a patient hazard. 8DIN EN ISO 23328-2:2009-07 EN ISO 23328-2:2009 (E) Bibliography 1 ISO 15223, Medical devices Symbols to be used with medical device labels, labelling and information to be supplied 2 ISO 7000, Graphical symbols for use on equipment Index and synopsis 3
