EN 13544-2-2002 en Respiratory therapy equipment - Part 2 Tubing and connectors (Incorporates Amendment A1 2009)《呼吸治疗设备 第2部分 管道和连接器 包含修改件A1-2009》.pdf

《EN 13544-2-2002 en Respiratory therapy equipment - Part 2 Tubing and connectors (Incorporates Amendment A1 2009)《呼吸治疗设备 第2部分 管道和连接器 包含修改件A1-2009》.pdf》由会员分享，可在线阅读，更多相关《EN 13544-2-2002 en Respiratory therapy equipment - Part 2 Tubing and connectors (Incorporates Amendment A1 2009)《呼吸治疗设备 第2部分 管道和连接器 包含修改件A1-2009》.pdf（22页珍藏版）》请在麦多课文档分享上搜索。

1、BRITISH STANDARD BS EN 13544-2:2002 +A1:2009 Respiratory therapy equipment Part 2: Tubing and connectors ICS 11.040.10 National foreword This British Standard is the UK implementation of EN 13544-2:2002+A1:2009. It supersedes BS EN 13544-2:2002 which is withdrawn. The start and finish of text introd

2、uced or altered by amendment is indicated in the text by tags. Tags indicating changes to CEN text carry the number of the CEN amendment. For example, text altered by CEN amendment A1 is indicated by !“. The UK participation in its preparation was entrusted by Technical Committee CH/121, Anaesthetic

3、 and respiratory equipment, to Subcommittee CH/121/5, Lung ventilators, tracheal tubes and related equipment. A list of organizations represented on this subcommittee can be obtained on request to its secretary. This publication does not purport to include all the necessary provisions of a contract.

4、 Users are responsible for its correct application. Compliance with a British Standard cannot confer immunity from legal obligations. BS EN 13544-2:2002+A1:2009 This British Standard, having been prepared under the direction of the Health and Environment Sector Policy and Strategy Committee, was pub

5、lished under the authority of the Standards Policy and Strategy Committee on 31 October 2002 BSI 2010 Amendments/corrigenda issued since publication Date Comments 31 March 2010 Implementation of CEN amendment A1:2009 ISBN 978 0 580 65093 2 EUROPEAN STANDARD NORME EUROPENNE EUROPISCHE NORM EN 13544-2

6、:2002+A1 September 2009 ICS 11.040.10 Supersedes EN 13544-2:2002 English Version Respiratory therapy equipment - Part 2: Tubing and connectors Equipement de thrapie respiratoire - Partie 2: Tubes et raccords Atemtherapiegerte - Teil 2: Schlauchsysteme und Verbindungsstcke This European Standard was

7、approved by CEN on 1 August 2002 and includes Amendment 1 approved by CEN on 30 July 2009. CEN members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for giving this European Standard the status of a national standard without any alteration. Up-to-date l

8、ists 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 translation under the r

9、esponsibility of a CEN member into its own language and notified to the CEN Management Centre has the same status as the official versions. CEN members are the national standards bodies of Austria, Belgium, Bulgaria, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary

10、, 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:

11、Avenue 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 13544-2:2002+A1:2009: EEN 13544-2:2002+A1:2009 (E) 2 CONTENTS Page Foreword 3 1 Scope 4 2 Normative references 4 3 Nipples 4 3.1 Dimensions . 4

12、3.2 Performance . 4 4 Weight-bearing screw-threaded connectors 4 5 Tubing . 4 5.1 General 4 6 Marking of tubing, labels and packaging 7 7 Packaging . 7 8 Usability 8 9 Clinical evaluation . 8 Annex A (normative) Test methods . 9 A.1 Apparatus . 9 A.2 Method of test for strength of nipple . 9 A.3 Met

13、hod of test for resistance to gas flow of tubing . 12 A.4 Method of test for security of connection between end connector and tubing 13 A.5 Method of test for security of connection of end connectors and nipple . 13 A.6 Method of test for resistance to kinking . 14 Annex B (normative) Weight-bearing

14、 screw-threaded connectors for oxygen and air . 16 Annex C (informative) Information on method of testing security of connections 17 Annex ZA (informative) ! ! ! !Relationship between this European Standard and the Essential Requirements of EU Directive 93/42/EEC“ “ “ “ 18 BS EN 13544-2:2002+A1:2009

15、EN 13544-2 :2002+A1:2009 (E) 3 Foreword This document (EN13544-2:2002+A1:2009) 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 pu

16、blication of an identical text or by endorsement, at the latest by March 2010, and conflicting national standards shall be withdrawn at the latest by March 2010. Attention is drawn to the possibility that some of the elements of this document may be the subject of patent rights. CEN and/or CENELEC s

17、hall not be held responsible for identifying any or all such patent rights. This document includes Amendment 1, approved by CEN on 2009-07-30. This document supersedes EN 13544-2:2002. The start and finish of text introduced or altered by amendment is indicated in the text by tags !“. This European

18、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 Directive(s). Annexes A and B are normative. Annex C is informative. For relationship with EU Directive(s), see informative Annex ZA,

19、which is an integral part of this document. EN 13544 consists of the following parts, under the general title Respiratory therapy equipment. Part 1: Nebulizing systems and their components Part 2: Tubing and connectors Part 3: Air entrainment devices According to the CEN/CENELEC Internal Regulations

20、, the national 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

21、, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland and United Kingdom. BS EN 13544-2:2002+A1:2009EN 13544-2:2002+A1:2009 (E) 4 1 Scope This part of EN 13544 specifies requirements for tubing to be used with equipment for the therapeutic administration of respirable g

22、ases in domiciliary, ambulance and hospital practice including the interface to the equipment i.e. nipples and screw threaded connectors. This tubing is mainly used with oxygen, air or mixtures of these gases. The interface specifications are given to ensure interchangeability of respiratory therapy

23、 equipment thereby enabling patients to receive continuous treatment in all these clinical situations. Weight-bearing screw-threaded connectors are specified for use at the outlet of e.g. flowmeters to which devices such as humidifiers or nebulizers can be attached. NOTE This standard does not speci

24、fy the devices where these connectors have to be used. It is expected that specific device standards will specify the devices where these connectors are going to the used e.g. EN ISO 10651-4, EN 738-1 and EN 13220. 2 Normative references This European Standard incorporates by dated or undated refere

25、nce, provisions from other publications. These normative references are cited at the appropriate places in the text and the publications are listed hereafter. For dated references, subsequent amendments to or revisions of any of these publications apply to this European Standard only when incorporat

26、ed in it by amendment or revision. For undated references the latest edition of the publication referred to applies (including amendments). EN 980, Graphical symbols for use in the labelling of medical devices. 3 Nipples 3.1 Dimensions The dimensions of nipples for the attachment of tubing to respir

27、atory therapy equipment shall conform to the dimensions given in Figure 1 a), and also, if corrugated, shall conform to 1 b). 3.2 Performance When tested as described in A.2, nipples shall neither fracture nor distort by more than 2 mm. 4 Weight-bearing screw-threaded connectors 4.1 Weight-bearing s

28、crew-threaded connectors for oxygen shall comply with Figure B.1. 4.2 Weight-bearing screw-threaded connectors for air shall comply with Figure B.2. 5 Tubing 5.1 General Material used for tubing shall be : a) compatible with oxygen or air or any other gas mixture specified by the manufacturer ; b) n

29、on-toxic ; BS EN 13544-2:2002+A1:2009EN 13544-2 :2002+A1:2009 (E) 5 c) designed and manufactured to minimize health risks by leaching of substances from tubing during normal use to levels below those assumed to be non-toxic; ! d) if phthalates are incorporated in parts of the medical devices coming

30、directly or indirectly into contact with the patient the medical device shall be labelled accordingly. If such devices are used for the treatment of children or treatment of pregnant or nursing women, the residual risk has to be identified and stated in the instructions for use. NOTE Attention is dr

31、awn to substances which are carcinogenic, mutagenic or toxic to reproduction.“ Evidence shall be provided by the manufacturer on request. 5.1.1 Resistance to gas flow of tubing When tested as described in A.3, the resistance to flow shall not exceed 0,9 kPa/m. 5.1.2 End connectors Tubing for respira

32、tory therapy equipment shall terminate at each end with a connector able to produce a secure connection conforming to 5.1.4 to the nipple specified in clause 3. NOTE Connectors can either be formed in the material of the tubing or can be joined to the tubing by e.g. welding or adhesives. BS EN 13544

33、-2:2002+A1:2009EN 13544-2:2002+A1:2009 (E) 6 Dimensions in millimetres 6.35 6.0 3.52 inc. l 1 l 2Key l 1 10 mm datum l 212 mm minimum to shoulder or projection NOTE The axis of the nipple can be curved. a) Basic profile and nominal dimensions of nipple 6.35 3.52 inc. l 1 l 2Key l 110 mm datum with a

34、 minimum of two corrugations within this length l 212 mm minimum to shoulder or projection NOTE The external diameter of all corrugations falls on the profile of the nipple as shown in 1a. The shape of the corrugations is given as an example. b) Dimensions for corrugated nipple Figure 1 Nipple for r

35、espiratory therapy equipment 5.1.3 Security of joint between end connector and tubing When tested as described in A.4, if the end connector is joined to the tubing, the end connector shall not become detached from the tubing. BS EN 13544-2:2002+A1:2009EN 13544-2 :2002+A1:2009 (E) 7 5.1.4 Security of

36、 connection of end connectors to nipple When tested as described in A.5, heavy duty tubing shall not become detached from the test nipple. NOTE See annex C for information on the method of testing the security of connection between an end connector and a nipple. 5.1.5 Resistance to kinking When test

37、ed as described in A.6, the flow through the kinked tubing shall be not less than 75 % of the initial flow. 6 Marking of tubing, labels and packaging Tubing, labels, and/or packaging shall contain the following as applicable : !name and address of the manufacturer and the name and address of authori

38、zed representative where the manufacturer does not have a registered place of business in the European Community;“ !if the intended purpose of the device is not obvious to the operator, the device shall be provided with instructions for use. The instructions for use shall contain the date of issue o

39、r the latest revision;“ device identification and content information ; symbol STERILE in accordance with EN 980 together with the method of sterilization ; batch code, preceded by the symbol LOT in accordance with EN 980, or serial number ; declaration of the maximum pressure the tubing shall withs

40、tand at ambient conditions specified in Table A.1 ; !date by which the device can be used, expressed as the year and month. For single use devices the manufacturer shall disclose the risks associated with reusing in the instructions for use or upon request; NOTE Manufacturers attention is drawn to t

41、he regulatory provision for a consistent use of indication for single use devices. “ indication that the device is for single use ; any special storage and/or handling conditions ; any warning and/or precaution to take ; recommended method(s) of cleaning, disinfection and sterilization ; device pack

42、aging and/or labelling shall differentiate between the same or similar products, both sterile and non-sterile, placed on the market by the same manufacturer ; packages containing parts made of antistatic or conductive material shall be clearly marked with the word “ANTISTATIC” or “CONDUCTIVE”. 7 Pac

43、kaging The method of packaging should be designed to minimize the risk of kinking of the tubing occurring while in storage. BS EN 13544-2:2002+A1:2009EN 13544-2:2002+A1:2009 (E) 8 8 ! ! ! !Usability The manufacturer shall address in a usability engineering process the risk resulting from poor usabil

44、ity (see IEC 60601-1-6 and EN 62366). Check compliance by inspection of the usability engineering file. 9 Clinical evaluation A clinical evaluation shall be performed and documented in the risk management file. Check compliance by inspection of the risk management file.“ BS EN 13544-2:2002+A1:2009EN

45、 13544-2 :2002+A1:2009 (E) 9 Annex A (normative) Test methods A.1 Apparatus A.1.1 Tensile testing machine capable of applying a force of at least 30 N with an accuracy of 5 %. A.1.2 Test gas supply, comprising either dry compressed air or oxygen. A.1.3 Equipment to control flow and pressure of the t

46、est gas supply to values of at least 10 l/min and 200 kPa respectively. A.1.4 T-piece connector for gas pathway. A.1.5 Equipment to measure ambient temperature and atmospheric pressure with an accuracy of 2 %. A.1.6 Pressure gauge(s) capable of measuring pressure with an accuracy of 5 %. A.1.7 Test

47、nipple with construction and dimensions as shown in Figure A.1. A.1.8 Equipment for testing security of connection of termination to nipple as exemplified in figure A.2. NOTE Other methods of force application are acceptable. A.1.9 Equipment for testing resistance to kinking as shown in Figure A.3.

48、A.1.10 Flowmeter to measure flows of air between 4 l/min and 10 l/min with an accuracy of 5 %. A.1.11 Two tubular spacers, outside diameter 12 mm minimum and inside diameter (6,5 0,05) mm, and of lengths as follows : spacer a : (10,0 0,1) mm ; spacer b : (8,0 0,1) mm. A.2 Method of test for strength

49、 of nipple A.2.1 Test conditions If the nipple is to be attached to, or forms part of, a device which is intended to operate at elevated temperature, perform the test at the maximum operating temperature of the device if stated by the manufacturer, or otherwise at (45 2) C. A.2.2 Procedure Securely fix the equipment end of the nipple