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1、BRITISH STANDARD BS EN 13014:2000 Incorporating Corrigendum No. 1 Connections for gas sampling tubes to anaesthetic and respiratory equipment The European Standard EN 13014:2000 has the status of a British Standard ICS 11.040.10 ? Licensed Copy: sheffieldun sheffieldun, na, Sun Oct 29 08:56:50 GMT+0
2、0:00 2006, Uncontrolled Copy, (c) BSI BS EN 13014:2000 This British Standard, having been prepared under the direction of the Health and Environment Sector Policy and Strategy Committee, was published under the authority of the Standards Policy and Strategy Committee on 15 April 2000 BSI 16 December
3、 2002 ISBN 0 580 32752 3 National foreword This British Standard is the official English language version of EN 13014:2000, including Corrigendum July 2002. The UK participation in its preparation was entrusted by Technical Committee CH/44, Anaesthetic machines, breathing attachments, medical gas pi
4、peline systems and hose assemblies, to Subcommittee CH/44/1, Anaesthetic machines, breathing systems and anaesthetic gas scavenging systems, which has the responsibility to: A list of organizations represented on this subcommittee can be obtained on request to its secretary. Further information User
5、s of this standard are informed that the UK submitted a negative vote on the final voting stage of the draft EN because it believes the use of Luer fittings as connectors in circuits carrying gases to be inherently unsound due to the risk of cross-connection with vascular lines. Cross-references The
6、 British Standards which implement international or European publications referred to in this document may be found in the BSI Catalogue under the section entitled “International Standards Correspondence Index”, or by using the “Search” facility of the BSI Electronic Catalogue or of British Standard
7、s Online. 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 does not of itself confer immunity from legal obligations. aid enquirers to understand the text; present to the res
8、ponsible international/European committee any enquiries on the interpretation, or proposals for change, and keep the UK 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 c
9、over, the EN title page, pages 2 to 15 and a back cover. The BSI copyright date displayed in this document indicates when the document was last issued. Amendments issued since publication Amd. No. DateComments 14062 Corrigendum No. 1 16 December 2002Changes to Figure 2 and Figure 3 Licensed Copy: sh
10、effieldun sheffieldun, na, Sun Oct 29 08:56:50 GMT+00:00 2006, Uncontrolled Copy, (c) BSI EUROPEAN STANDARD NORME EUROPENNE EUROPISCHE NORM EN 13014 January 2000 ICS 11.040.10 Incorporating corrigendum July 2002 English version Connections for gas sampling tubes to anaesthetic and respiratory equipm
11、ent Raccordements pour tubes prlvement de gaz du matriel respiratoire et anesthsique Verbindungen fr Gasprobenentnahmeschluche an Ansthesie- und Beatmungsgerten This European Standard was approved by CEN on 6 June 1999. CEN members are bound to comply with the CEN/CENELEC Internal Regulations which
12、stipulate the 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 Central Secretariat or to any CEN member. This European Standa
13、rd exists in three 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 Central Secretariat has the same status as the official versions. CEN members are the national standa
14、rds bodies of Austria, 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 N
15、ORMUNG Central Secretariat: rue de Stassart, 36 B-1050 Brussels 2000 CENAll rights of exploitation in any form and by any means reserved worldwide for CEN national Members. Ref. No. EN 13014:2000 E Licensed Copy: sheffieldun sheffieldun, na, Sun Oct 29 08:56:50 GMT+00:00 2006, Uncontrolled Copy, (c)
16、 BSI Page 2 EN 13014:2000 ? BSI 16 December 2002 Contents Page Foreword3 1Scope4 2Normative references5 3Definitions5 4Materials and construction6 5Dimensions and tolerances8 6Requirements8 7Marking9 8Information to be supplied by the manufacturer10 Annex ZA (informative) Clauses of this European St
17、andard addressing essential requirements or other provisions of EU Directives14 Licensed Copy: sheffieldun sheffieldun, na, Sun Oct 29 08:56:50 GMT+00:00 2006, Uncontrolled Copy, (c) BSI Page 3 EN 13014:2000 ? BSI 16 December 2002 Foreword This European Standard has been prepared by Technical Commit
18、tee 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 endorsement, at the latest by July 2000, and conflicting national standards shall
19、be withdrawn at the latest by July 2000. 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 Directive(s). For relationship with EU Directive(s), see informative Annex ZA,
20、which is an integral part of this standard. According to the CEN/CENELEC Internal Regulations, the national standards organizations of the following countries are bound to implement this European Standard: Austria, Belgium, Czech Republic, Denmark, Finland, France, Germany, Greece, Iceland, Ireland,
21、 Italy, Luxembourg, Netherlands, Norway, Portugal, Spain, Sweden, Switzerland and the United Kingdom. Licensed Copy: sheffieldun sheffieldun, na, Sun Oct 29 08:56:50 GMT+00:00 2006, Uncontrolled Copy, (c) BSI Page 4 EN 13014:2000 ? BSI 16 December 2002 1 Scope This European Standard specifies requir
22、ements for construction, dimensions and marking for the connectors in gas sampling tubes which transfer gas from the breathing system of anaesthetic and respiratory equipment to diverting gas monitors and back to the breathing system and/or to the anaesthetic gas scavenging system (AGSS). This Europ
23、ean Standard gives requirements for the following gas sampling tube ports and connectors: Gas sampling port on breathing system; Gas return port on breathing system and AGSS; Gas sampling and return ports on monitors; Gas sampling tube inlet and outlet connectors; Gas return tube inlet and outlet co
24、nnectors. This European Standard does not apply to connection ports intended for connection of sensors in the breathing system. NOTE 1: It is expected that requirements for the application of this standard will be included in particular standards for specific medical devices and accessories. NOTE 2:
25、 One important consideration is that gas sampling tube connectors are secure but nevertheless can be disconnected by the operator. EN 1707 includes requirements and test methods for separation force, unscrewing torque and air leakage. According to EN 1707, Luer lock fittings are intended to be used
26、for syringes, needles and certain other medical equipment. In order to minimize the risk of mis-connections, this standard specifies the arrangements of male and female fittings and the marking requirements to identify the different connectors, ports and tubes. Tables 1 to 4 specify the type of Luer
27、 lock fitting that is used in actual applications. NOTE 3: Another important consideration is that the ports in the breathing system can be sealed when gas sampling tubes are not connected. Licensed Copy: sheffieldun sheffieldun, na, Sun Oct 29 08:56:50 GMT+00:00 2006, Uncontrolled Copy, (c) BSI Pag
28、e 5 EN 13014:2000 ? BSI 16 December 2002 2 Normative references This European Standard incorporates by dated or undated reference, provisions from other publications. These normative references are cited at the appropriate places in the text and the publications are listed hereafter. For dated refer
29、ences, subsequent amendments to or revision of any of these publications apply to this European Standard only when incorporated in it by amendment or revision. For undated references the latest edition of the publication referred to applies. EN 1041:1998Information supplied by the manufacturer with
30、medical devices EN 1089-3:1997Transportable gas cylinders - Cylinder identification - Part 3: Colour coding EN 1707:1996Conical fittings with a 6 % (Luer) taper for syringes, needles and certain other medical equipment - Lock fittings EN 60601-1:1990Medical electrical equipment - Part 1: General req
31、uirements for safety (IEC 60601-1:1988) ISO 7000:1989Graphical symbols for use on equipment - Index and synopsis 3 Definitions For the purposes of this standard, the following definitions apply: 3.1 gas sampling port that port on a breathing system and/or monitor to which a gas sampling tube can be
32、connected and gas can be collected and routed to a diverting monitor 3.2 gas return port that port on a breathing system or AGSS to which a gas return tube can be connected and gas is returned 3.3 diverting monitor monitor which transports the gas mixture from the sampling site to the sensing area 3
33、.4 gas sampling tube inlet connector that connector on a gas sampling tube which is connected to a breathing system gas sampling port Licensed Copy: sheffieldun sheffieldun, na, Sun Oct 29 08:56:50 GMT+00:00 2006, Uncontrolled Copy, (c) BSI Page 6 EN 13014:2000 ? BSI 16 December 2002 3.5 gas samplin
34、g tube outlet connector that connector on a gas sampling tube which is connected to a diverting monitor gas sampling port 3.6 monitor gas sampling port connector that connector on a monitor to which a gas sampling tube can be connected 3.7 monitor gas return port connector that connector on a monito
35、r to which a gas return tube can be connected 3.8 gas return tube inlet connector that connector on a gas return tube which can be connected to a monitor gas sampling port 3.9 gas return tube outlet connector that connector on a gas return tube which can be connected to a breathing system or AGSS 4
36、Materials and construction NOTE 1: Attention is drawn to the fact that some connectors are used, disinfected, or sterilized at elevated temperatures, and extra care is required when selecting suitable materials. 4.1 Cleaning, disinfection and sterilization If connectors are intended for re-use, 44.7
37、 of EN 60601-1:1990 shall apply. 4.2 Constructional requirements Materials used shall be selected with regard to: a) Compatibility with substances and gases with which they come into contact during normal use; b) Toxicity; c) Minimization of health risks due to substances leached from materials. Com
38、pliance shall be checked via manufacturer certification. NOTE 1: Evidence of compliance with the specification(s), either by test or by other methods should be provided by the manufacturer to a Notified Body during CE conformity assessment or to appropriate authorities on request. Licensed Copy: she
39、ffieldun sheffieldun, na, Sun Oct 29 08:56:50 GMT+00:00 2006, Uncontrolled Copy, (c) BSI Page 7 EN 13014:2000 ? BSI 16 December 2002 4.3 Alternative constructions Gas sampling tube connectors using materials, or having forms of construction different from those detailed in this standard shall be acc
40、epted if it can be demonstrated that an equivalent degree of safety is obtained. Evidence shall be provided by the manufacturer. Licensed Copy: sheffieldun sheffieldun, na, Sun Oct 29 08:56:50 GMT+00:00 2006, Uncontrolled Copy, (c) BSI Page 8 EN 13014:2000 ? BSI 16 December 2002 5 Dimensions and tol
41、erances 5.1 Gas sampling ports on breathing systems The dimensions of the connector shall be according to EN 1707:1996 and the connector type shall be as given in Table 1. 5.2 Gas return ports on breathing systems or AGSS Gas return ports on a breathing system or AGSS shall comply with EN 1707:1996
42、and the connector type shall be as given in Table 1. 5.3 Gas sampling ports on monitors The dimensions of the connector shall be according to EN 1707:1996 and the connector type shall be as given in Table 2. 5.4 Gas return ports on monitors The dimensions of the connector shall be according to EN 17
43、07:1996 and the connector type shall be as given in Table 2. 5.5 Gas sampling tube connectors The dimensions of the connector shall be according to EN 1707:1996 and the connector type shall be as given in Table 3. 5.6 Gas return tube connectors The dimensions of the connector shall be according to E
44、N 1707:1996 and the connector type shall be as given in Table 4. 6 Requirements 6.1 General When connected, the probe shall engage with the socket connector and shall meet the requirements of 6.2 to 6.8. 6.2 Gauging When tested, Luer lock type fittings shall comply with 4.1 of EN 1707:1996. 6.3 Leak
45、age When tested, Luer lock type fittings shall comply with 4.2 of EN 1707:1996. Licensed Copy: sheffieldun sheffieldun, na, Sun Oct 29 08:56:50 GMT+00:00 2006, Uncontrolled Copy, (c) BSI Page 9 EN 13014:2000 ? BSI 16 December 2002 6.4 Separation force When tested, Luer lock type fittings shall compl
46、y with 4.3 of EN 1707:1996. 6.5 Unscrewing torque When tested, Luer lock type fittings shall comply with 4.4 of EN 1707:1996. 6.6 Ease of assembly When tested, Luer lock type fittings shall comply with 4.5 of EN 1707:1996. 6.7 Resistance to overriding When tested, Luer lock type fittings shall compl
47、y with 4.6 of EN 1707:1996. 6.8 Stress cracking When tested, Luer lock type fittings shall comply with 4.7 of EN 1707:1996. 7 Marking 7.1 Marking of ports and connectors on the outside of the equipment or equipment parts 7.1.1 General If colour coding is used, it shall be different from that specifi
48、ed in EN 1089-3:1997. Marking shall be in accordance with 4.1.6 of EN 1041:1998. Ports or connectors for gas sampling tubes on the breathing system or their surroundings shall be clearly and legibly marked with the names or symbols given in 7.1.2 to 7.1.5 (see also Tables 1 to 4 and Figures 2 and 3)
49、. NOTE 1: A port can have both markings if it can be alternatively used for gas sampling or return. 7.1.2 Gas ports on breathing systems and AGSS Gas sampling ports on breathing systems shall be marked with the words “Gas sample” and/or symbol No 0795 of ISO 7000:1989 (see Figure 3). Gas return ports on breathing systems or AGSS shall be marked with the words “Gas return” and/or symbol No 0794 of ISO 7000:1989 (see Figure 2). Licensed Copy: sheffieldun sheffieldun, na, Sun Oct 2
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