EN ISO 23328-2-2009 en Breathing system filters for anaesthetic and respiratory use - Part 2 Non-filtration aspects《麻醉和呼吸用呼吸系统过滤器 第2部分 非过滤特性》.pdf

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1、BS EN ISO23328-2:2009ICS 11.040.10NO COPYING WITHOUT BSI PERMISSION EXCEPT AS PERMITTED BY COPYRIGHT LAWBRITISH STANDARDBreathing systemfilters for anaestheticand respiratory usePart 2: Non-filtration aspects (ISO23328-2:2002)This British Standardwas published under theauthority of the StandardsPoli

2、cy and StrategyCommittee on 30 April2009 BSI 2009ISBN 978 0 580 65025 3Amendments/corrigenda issued since publicationDate CommentsBS EN ISO 23328-2:2009National forewordThis British Standard is the UK implementation of EN ISO23328-2:2009. It is identical to ISO 23328-2:2002. It supersedes BS ENISO 2

3、3328-2:2008 which is withdrawn.The UK participation in its preparation was entrusted to TechnicalCommittee CH/121/5, Lung ventilators, tracheal tubes and relatedequipment.A list of organizations represented on this committee can be obtained onrequest to its secretary.This publication does not purpor

4、t to include all the necessary provisionsof a contract. Users are responsible for its correct application.Compliance with a British Standard cannot confer immunityfrom legal obligations.EUROPEAN STANDARDNORME EUROPENNEEUROPISCHE NORMEN ISO 23328-2March 2009ICS 11.040.10 Supersedes EN ISO 23328-2:200

5、8 English VersionBreathing system filters for anaesthetic and respiratory use -Part 2: Non-filtration aspects (ISO 23328-2:2002)Filtres pour matriel danesthsie et de ranimationrespiratoire - Partie 2: Aspects autres que la filtration (ISO23328-2:2002)Filter fr Atemsysteme zur Anwendung bei Ansthesie

6、 undBeatmung - Teil 2: Aspekte, die nicht die Filtration 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

7、 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 version

8、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, Denmark,

9、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 NORMALISATIONEUROP

10、ISCHES KOMITEE FR NORMUNGManagement Centre: Avenue Marnix 17, B-1000 Brussels 2009 CEN All rights of exploitation in any form and by any means reservedworldwide for CEN national Members.Ref. No. EN ISO 23328-2:2009: EBS EN ISO 23328-2:2009EN ISO 23328-2:2009 (E) 3 Foreword The text of ISO 23328-2:20

11、02 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” the secretariat of which

12、 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. Attention is drawn to the possib

13、ility 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 given to CEN by the Euro

14、pean 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 national standards organizati

15、ons 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, Poland, Portugal, Romania

16、, 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. BS EN ISO 23328-2:2009EN ISO 23328-2:2009 (E) 4 Annex ZA (informative) Relationship between this Europe

17、an Standard and the Essential Requirements of EU Directive 93/42/EEC This European Standard has been prepared under a mandate given to CEN by the European Commission and the European Free Trade Association to provide a means of conforming to Essential Requirements of the New Approach Directive 93/42

18、/EEC on medical devices. Once this standard is cited in the Official Journal of the European Communities under that Directive and has been implemented as a national standard in at least one Member State, compliance with the clauses of this standard given in Table ZA. confers, within the limits of th

19、e scope of this standard, a presumption of conformity with the corresponding Essential Requirements of that Directive and associated EFTA regulations. Table ZA. - Relationship between this European Standard and the Essential Requirements of EU Directive 93/42/EEC Clause(s)/sub-clause(s) of this EN E

20、ssential Requirements (ERs) of Directive 93/42/EEC Qualifying remarks/Notes 4 1, 2, 3, 4, 7.5, 9.1 5 3, 4, 7.5, 7.6 - 6a This relevant Essential Requirement is not addressed in this European Standard 5.3 7.5 (1st paragraph) This relevant Essential Requirement is not fully addressed in this European

21、Standard - 7.5 (2nd paragraph) This relevant Essential Requirement is not addressed in this European Standard - 7.5 (3rd paragraph) This relevant Essential Requirement is not addressed in this European Standard 6 2, 5, 7.2, 8.1, 8.3, 8.4, 8.5 7 13.1 7.1 13.2 7.2 13.1, 13.2, 13.3j), 13.6c) 7.3 13.3a)

22、, b), c), d), e), i), 13.4, 13.5 7.3 13.3 (a): This relevant Essential Requirement is not fully addressed in this European Standard 7.3c) 8.7, 13.3c) 7.4 13.3b), f)BS EN ISO 23328-2:2009EN ISO 23328-2:2009 (E) 5 7.4 13.3 (f) This relevant Essential Requirement is not fully addressed in this European

23、 Standard 8 13.1, 13.6a), b) 8 13.6 (h)(2nd paragraph) This relevant Essential Requirement is not fully addressed in this European Standard - 13.6 (q) This relevant Essential Requirement is not addressed in this European Standard 8a) 13.6d) 8f) 13.6f), m)8g) 8.7, 13.3m), 13.6d), g), h), i) 8i) 13.6n

24、)8k) 13.6c) Warning Other requirements and other EU Directives may be applicable to the products falling within the scope of this International standard. BS EN ISO 23328-2:2009ISO 23328-2:2002(E) ISO 2002 All rights reserved iiiContents Page Foreword iv Introduction. v 1 Scope 1 2 Normative referenc

25、es 1 3 Terms and definitions. 1 4 BSF port connectors. 2 4.1 BSF breathing system and patient connection ports 2 4.2 Accessory ports 2 5 Test methods . 2 5.1 Ambient conditions of test. 2 5.2 Measurement of pressure drop . 2 5.3 Test for gas leakage 3 6 Packaging of sterile BSF 3 7 Marking. 3 7.1 Us

26、e of symbols 3 7.2 Marking of BSF 3 7.3 Marking of package. 3 7.4 BSF intended for single use. 3 8 Information to be provided by the manufacturer. 4 Bibliography 5 BS EN ISO 23328-2:2009ISO 23328-2:2002(E) iv ISO 2002 All rights reservedForeword ISO (the International Organization for Standardizatio

27、n) 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 subject for which a technical committee has been established has the right to be rep

28、resented 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 (IEC) on all matters of electrotechnical standardization. International Standards a

29、re drafted in accordance with the rules given in the ISO/IEC Directives, Part 3. The main task of technical committees is to prepare International Standards. Draft International Standards adopted by the technical committees are circulated to the member bodies for voting. Publication as an Internatio

30、nal 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 part of ISO 23328 may be the subject of patent rights. ISO shall not be held responsible for identifying any or all such patent rights. ISO 233

31、28-2 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 system filters for anaesthetic and respiratory use: Part 1: Salt test me

32、thod to assess filtration performance Part 2: Non-filtration aspects BS EN ISO 23328-2:2009ISO 23328-2:2002(E) ISO 2002 All rights reserved vIntroduction This part of ISO 23328 gives requirements for non-filtration aspects of breathing system filters (BSF). BSF are used to reduce particulates, inclu

33、ding 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 the test method, as it is possible that such exposure can influence the filtration per

34、formance of the BSF. A test method to assess filtration performance is found in ISO 23328-1. BS EN ISO 23328-2:2009BS EN ISO 23328-2:2009INTERNATIONAL STANDARD ISO 23328-2:2002(E) ISO 2002 All rights reserved 1Breathing system filters for anaesthetic and respiratory use Part 2: Non-filtration aspect

35、s 1 Scope This part of ISO 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

36、 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 protect test equipment for physiological respiratory measurements. NOTE A method for assessing filtration pe

37、rformance of BSF is given 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

38、not apply. However, parties 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 o

39、f ISO and IEC maintain registers 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

40、:2000, Anaesthetic and respiratory 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: Ge

41、neral requirements for safety; 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 bre

42、athing systems BS EN ISO 23328-2:2009ISO 23328-2:2002(E) 2 ISO 2002 All rights reserved3.2 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 conne

43、ctor or a face mask 3.4 BSF accessory port port 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 BS

44、F and the volume inside all female connectors 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

45、 patient connection ports The connectors at 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 a

46、nd shall be provided with means of closure of 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 sha

47、ll be determined in accordance with 6.3 of ISO 9360-1:2000, using the flowrates given in Table 1. BS EN ISO 23328-2:2009ISO 23328-2:2002(E) ISO 2002 All rights reserved 3Table 1 Gas flowrates for measurement of pressure drop BSF intended use Flowrate lmin1Pediatric 15 Adult 30 5.3 Test for gas leaka

48、ge The BSF shall comply with 6.4 of ISO 9360-1:2000. 6 Packaging 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 o

49、r ISO 7000. 7.2 Marking of BSF BSF shall be marked with the following: 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) the 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”