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1、| | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | BRITISH STANDARD BS EN 737-4:1998 The Euro
2、pean Standard EN 737-4:1998 has the status of a British Standard ICS 11.040.10 NO COPYING WITHOUT BSI PERMISSION EXCEPT AS PERMITTED BY COPYRIGHT LAW Medical gas pipeline systems Part 4: Terminal units for anaesthetic gas scavenging systems This British Standard, having been prepared under the direc
3、tion of the Health and Environment Sector Board, was published under the authority of the Standards Board and comes into effect on 15 May 1998 BSI 1998 ISBN 0 580 29764 0 BS EN 737-4:1998 Amendments issued since publication Amd. No.DateText affected National foreword This British Standard is the Eng
4、lish language version of EN 737-4:1998. Together with BS EN 737-2:1998 and clause 111 of BS EN 740:1998, it supersedes BS 6834:1987, which will be withdrawn in due course. The UK participation in its preparation was entrusted by Technical Committee CH/44, Anaesthetic machines, breathing attachments,
5、 medical gas pipeline systems and hose assemblies, to Subcommittee CH/44/2, Medical gas supply systems, which has the responsibility to: aid enquirers to understand the text; present to the responsible international/European committee any enquiries on the interpretation, or proposals for change, and
6、 keep the UK interests informed; monitor related international and European developments and promulgate them in the UK. A list of organizations represented on this subcommittee can be obtained on request to its secretary. Cross-references The British Standards which implement international or Europe
7、an publications referred to in this document may be found in 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
8、provisions of a contract. Users of British Standards are responsible for their correct application. Compliance with a British Standard does not of itself confer immunity from legal obligations. Summary of pages This document comprises a front cover, an inside front cover, the EN title page, pages 2
9、to 14, an inside back cover and a back cover. CEN European Committee for Standardization Comite Europe en de Normalisation Europa isches Komitee fu r Normung Central Secretariat: rue de Stassart 36, B-1050 Brussels 1998 CEN All rights of exploitation in any form and by any means reserved worldwide f
10、or CEN national Members. Ref. No. EN 737-4:1998 E EUROPEAN STANDARDEN 737-4 NORME EUROPE ENNE EUROPA ISCHE NORM January 1998 ICS 11.040.10; 23.040.60; 23.060.01 Descriptors: Gas distribution, disposal, medical gases, anaesthesia, junctions, walls, definitions, materials, design, tests, marking, colo
11、ur codes, packing English version Medical gas pipeline systems Part 4: Terminal units for anaesthetic gas scavenging systems Syste mes de distribution de gaz me dicaux Partie 4: Prises murales pour syste mes de vacuation des gaz danesthe sie Rohrleitungssysteme fu r medizinische Gase Teil 4: Entnahm
12、estellen fu r Ana sthesiegas-Fortleitungssysteme This European Standard was approved by CEN on 5 July 1997. 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 alterat
13、ion. 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 Standard exists in three official versions (English, French, German). A version in any other language made by translat
14、ion 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 standards bodies of Austria, Belgium, Czech Republic, Denmark, Finland, France, Germany, Greece, Iceland, Ireland, Ita
15、ly, Luxembourg, Netherlands, Norway, Portugal, Spain, Sweden, Switzerland and United Kingdom. Page 2 EN 737-4:1998 BSI 1998 Foreword This European Standard has been prepared by Technical Committee CEN/TC 215, Respiratory and anaesthetic equipment, of which the Secretariat is held by BSI. This Europe
16、an 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 1998, and conflicting national standards shall be withdrawn at the latest by July 1998. This European Standard has been prepared under a mandate given to
17、CEN by the European Commission and the European Free Trade Association, and supports essential requirements of EU Directive(s). EN 737 consists of the following parts under the general title Medical gas pipeline systems. Part 1: Terminal units for compressed medical gases and vacuum Part 2: Anaesthe
18、tic gas scavenging disposal systems Part 3: Pipelines for compressed medical gases and vacuum Part 5: Oxygen concentrators Part 6: Dimensions of probes for terminal units for compressed medical gases and vacuum. Annexes A and B are informative. For relationship with EU Directive(s), see informative
19、annex ZA, 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
20、, Ireland, Italy, Luxembourg, Netherlands, Norway, Portugal, Spain, Sweden, Switzerland and the United Kingdom. Contents Page Foreword2 Introduction3 1Scope3 2Normative references3 3Definitions3 4Terminology5 5General requirements5 6Test methods10 7Marking, colour coding and packaging11 8Information
21、 to be supplied by the manufacturer12 Annex A (informative) Bibliography13 Annex B (informative) Rationale13 Annex ZA (informative) Clauses of this European Standard addressing essential requirements or other provisions of EU Directives13 ? Page 3 EN 737-4:1998 BSI 1998 Introduction Anaesthetic gas
22、scavenging system (AGSS) terminal units are the points in an AGSS where the operator makes connections and disconnections for the disposal of medical gases and anaesthetic vapours from anaesthetic machines or other items of medical equipment, and where a wrong connection may create a hazard to the l
23、ife of a patient. It is important that terminal units and their components are designed, manufactured, installed and maintained in such a way as to meet the basic requirements specified in this part of this European Standard. This part of this European Standard pays particular attention to: suitabil
24、ity of materials; type-specificity; dimensions of probes and type-specific connection points; cleanliness; testing; identification; information supplied. In any healthcare facility, it is strongly recommended that terminal units of only one type are used for any particular service. This part of this
25、 European Standard specifies the provision of information for the installation and testing of terminal units. Testing after installation is critical to patient safety and it is essential that terminal units are not used until full testing in accordance with prEN 737-2 has been completed. Rationales
26、for some of the requirements of this part of this European Standard are given in annex B. These requirements are indicated by the letter R after the clause number. 1 Scope This part of this European Standard specifies requirements and dimensions for terminal units intended for use in anaesthetic gas
27、 scavenging systems specified in prEN 737-2 for the scavenging of medical gases and anaesthetic vapours. It is intended especially to ensure the type-specific assembly of terminal units and to prevent their interchange between different services. This part of this European Standard also specifies re
28、quirements and dimensions for the mating counterpart (probe) of the type-specific connection point which is part of the terminal unit. This part of this European Standard does not specify the ranges of nominal operating pressures for terminal units (see prEN 737-2). This part of this European Standa
29、rd specifies two types of terminal units which are non-interchangeable, for use where the power device is upstream or downstream of the terminal unit. Figure 1 shows the use of the two types of terminal unit. 2 Normative references This European Standard incorporates by dated or undated reference, p
30、rovisions 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 incorporated in
31、it by amendment or revision. For undated references, the latest edition of the publication referred to applies. prEN 737-2, Medical gas pipeline systems Part 2: Anaesthetic gas scavenging disposal systems EN 1441, Medical devices Risk analysis ISO 554, Standard atmospheres for conditioning and/or te
32、sting Specifications 3 Definitions For the purposes of this part of this European Standard, the following definitions apply. 3.1 AGSS Type 1 terminal unit connection point between the receiving system and disposal system at which an operator makes connections and disconnections 3.2 AGSS Type 2 termi
33、nal unit connection point between the power device or the disposal hose and the remainder of the disposal system at which an operator makes connections and disconnections 3.3 anaesthetic gas scavenging system; AGSS system which is connected to the exhaust port(s) of an anaesthetic workstation, or wh
34、ich is integrated into an anaesthetic workstation, for the purpose of conveying expired and/or excess anaesthetic gases to an appropriate place of discharge NOTEFunctionally, an AGSS comprises three different parts, a transfer system, a receiving system and a disposal system. These three functionall
35、y discrete parts may be either separate or sequentially combined in part or in total. In addition, one or more parts of an AGSS may be sequentially combined with a breathing system to include the transfer system or transfer and receiving system. 3.4 disposal hose that part of an AGSS which transfers
36、 expired and/or excess gases from the power device to the probe of an AGSS Type 2 terminal unit 3.5 disposal system means by which the expired and/or excess anaesthetic gases are conveyed from the receiving system to an appropriate place of discharge NOTEA place of discharge may be, e.g. the exterio
37、r of a building or a non-recirculating exhaust ventilation system. ? Page 4 EN 737-4:1998 BSI 1998 1 2 3 4 5 6 7 8 9 10 Apparatus including breathing system and integral transfer/receiving system and power device Apparatus including breathing system Transfer/receiving system and power device Apparat
38、us including breathing system and integral transfer/receiving system Permanent or proprietary connector Receiving hose Breathing system or anaesthetic ventilator Transfer tube Receiving system Power device 11 12 13 14 15 16 17 18 19 20 21 22 Permanent connection Discharge Flexible hose or pendant Di
39、sposal hose Limit of breathing system Limit of transfer system Limit of receiving system Limit of disposal system Proprietary connection (functionally specific) 30 mm conical connection Type 1 terminal unit probe/socket Type 2 terminal unit probe/socket NOTE 1Type 1 terminal unit is for negative pre
40、ssure. Type 2 terminal unit is for positive pressure. NOTE 2The limit between the receiving system and the disposal system as shown may not coincide with an actual physical limit such as a wall. In the arrangement shown, a terminal unit on a wall would be located on the outlet of the power device. F
41、igure 1 Schematic diagram of typical anaesthetic gas scavenging systems ? Page 5 EN 737-4:1998 BSI 1998 3.6 maximum operating pressure maximum pressure at which a terminal unit is designed to operate NOTEOperating pressure for Type 1 is negative, and for Type 2 is positive. 3.7 maximum test pressure
42、 maximum pressure to which a terminal unit is designed to be subject during pipeline pressure testing 3.8 power device that part of the disposal system of an AGSS which provides the gas flow for scavenging 3.9 probe non-interchangeable male component designed for acceptance by, and retention in, the
43、 socket 3.10 quick connector pair of non-threaded type-specific components which can be easily and rapidly joined together by a single action of one or both hands without the use of tools 3.11 receiving hose that part of an AGSS which transfers expired and/or excess gases from the receiving system t
44、o the disposal system 3.12 receiving system that part of an AGSS which provides an interface between the transfer system and the disposal system, and may contain means of sub-atmospheric and/or positive pressure relief 3.13 single fault condition condition in which a single means for protection agai
45、nst a safety hazard in equipment is defective, or a single external abnormal condition is present 3.14 socket that part of a terminal unit which is either integral or attached to the base block by a type-specific interface, and which contains the type-specific connection point 3.15 terminal unit bas
46、e block that part of a terminal unit which is attached to the disposal system 3.16 terminal unit check valve valve which remains closed until opened by insertion of an appropriate probe, and which then permits flow in either direction 3.17 transfer system that part of an AGSS, which may or may not i
47、ncorporate tubing, which transfers expired and/or excess anaesthetic gases from the exhaust port of the anaesthetic breathing system and/or anaesthetic ventilator to the receiving system, and which can contain a means of pressure relief 3.18 transfer tube that part of an AGSS which transfers expired
48、 and/or excess gases from the anaesthetic breathing system and/or anaesthetic ventilator to the receiving system 3.19 type-specific having characteristics which prevent interchangeability and thereby allow assignment to one type only 3.20 type-specific connection point that part of a socket which is
49、 the receptor for a typespecific probe 4 Terminology A diagram of a typical terminal unit, with examples of terminology, is given in Figure 2. 5 General requirements 5.1 Safety Terminal units shall, when transported, stored, installed, operated in normal use and maintained according to the instructions of the manufacturer, cause no safety hazard which could be foreseen using risk analysis procedures in accordance with EN 1441 and which is connected with their intended application, in normal con