【BS英国标准】BS EN 737-4-1998 Medical gas pipeline systems Part 4 Terminal units for anaesthetic gas scavenging systems.doc

british standardmedical gas pipeline systemspart 4: terminal units for anaesthetic gas scavenging systemsthe european standard en 737-4:1998 has the status of abritish standardics 11.040.10| bs en737-4:1998|no copying without bsi permission except as permitted by copyright lawbs en 737-4:1998national forewordthis british standard is the english language version of en 737-4:1998. together with bs en 737-2:1998 and clause 111 of bs en 740:1998, it supersedesbs 6834:1987, which will be withdrawn in due course.the uk participation in its preparation was entrusted by technical committee ch/44, anaesthetic machines, breathing attachments, medical gas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 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-referencesthe british standards which implement international or european 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 thefind facility of the bsi standards electronic catalogue.a british standard does not purport to include all the necessary 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 pagesthis document comprises a front cover, an inside front cover, the en title page, pages 2 to 14, an inside back cover and a back cover.amd. no.datetext affectedthis british standard, having been prepared under the direction of the health and environment sector board, was published under the authority of the standards board and comes into effect on 15 may 1998bsi 1998isbn 0 580 29764 0amendments issued since publicationeuropean standarden 737-4norme europe enneeuropa ische normjanuary 1998ics 11.040.10; 23.040.60; 23.060.01descriptors: gas distribution, disposal, medical gases, anaesthesia, junctions, walls, definitions, materials, design, tests, marking, colour codes, packingenglish versionmedical gas pipeline systems part 4: terminal units for anaesthetic gas scavenging systemssyste mes de distribution de gaz me dicaux partie4: prises murales pour syste mes de vacuation des gaz danesthe sierohrleitungssysteme fu r medizinische gase teil 4: entnahmestellen fu rana sthesiegas-fortleitungssystemethis 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 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 standard 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 standards bodies of austria, belgium, czech republic, denmark, finland, france, germany, greece, iceland, ireland, italy, luxembourg, netherlands, norway, portugal, spain, sweden, switzerland and united kingdom.ceneuropean committee for standardization comite europe en de normalisation europa isches komitee fu r normungcentral secretariat: rue de stassart 36, b-1050 brussels1998 cen all rights of exploitation in any form and by any means reserved worldwide for cen nationalmembers.ref. no. en 737-4:1998 epage 9en 737-4:1998bsi 1998forewordthis european standard has been prepared bytechnical committee cen/tc 215, respiratory andcontentspageanaesthetic equipment, of which the secretariat 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 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 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 vacuumpart 2: anaesthetic gas scavenging disposal systems part 3: pipelines for compressed medical gases and vacuumpart 5: oxygen concentratorspart 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 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, ireland, italy, luxembourg, netherlands, norway, portugal, spain, sweden, switzerland and the united kingdom.foreword 2introduction 31scope 32normative references 33definitions 34terminology 55general requirements 56test methods 107marking, colour coding and packaging 118information to be supplied by themanufacturer 12annex a (informative) bibliography 13annex b (informative) rationale 13annex za (informative) clauses of this european standard addressing essential requirements or other provisions of eudirectives 13introductionanaesthetic gas 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 createa hazard to the life 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: suitability 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 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 withpren 737-2 has been completed.rationales 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 scopethis part of this european standard specifies requirements and dimensions for terminal units intended for use in anaesthetic gas 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 requirements 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 standard 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 referencesthis 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 references, subsequent amendments to or revisions of any of these publications apply to this european standard onlywhen incorporated in 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 systemsen 1441, medical devices risk analysisiso 554, standard atmospheres for conditioning and/or testing specifications3 definitionsfor the purposes of this part of this europeanstandard, the following definitions apply.3.1agss type 1 terminal unitconnection point between the receiving system and disposal system at which an operator makes connections and disconnections3.2agss type 2 terminal unitconnection point between the power device or the disposal hose and the remainder of the disposal system at which an operator makes connections and disconnections3.3anaesthetic gas scavenging system; agsssystem which is connected to the exhaust port(s) of an anaesthetic workstation, or which is integrated into an anaesthetic workstation, for the purpose of conveying expired and/or excess anaesthetic gases to an appropriate place of dischargenote functionally, an agss comprises three different parts, a transfer system, a receiving system and a disposal system. these three functionally 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.3.4disposal hosethat part of an agss which transfers expired and/or excess gases from the power device to the probe of an agss type 2 terminal unit3.5disposal systemmeans by which the expired and/or excess anaesthetic gases are conveyed from the receiving system to an appropriate place of dischargenote a place of discharge may be, e.g. the exterior of a building or a non-recirculating exhaust ventilation system.1apparatus including breathing system and integral transfer/receiving system and power device2apparatus including breathing system3transfer/receiving system and power device4apparatus including breathing system and integral transfer/receiving system5permanent or proprietary connector6receiving hose7breathing system or anaesthetic ventilator8transfer tube9receiving system10power device11permanent connection12discharge13flexible hose or pendant14disposal hose15limit of breathing system16limit of transfer system17limit of receiving system18limit of disposal system19proprietary connection (functionally specific)2030 mm conical connection21type 1 terminal unit probe/socket22type 2 terminal unit probe/socketnote 1 type 1 terminal unit is for negative pressure. type 2 terminal unit is for positive pressure. note 2 the limit between the receiving system and the disposal system as shown may notcoincide with an actual physical limit such as a wall. in the arrangement shown, a terminal unit ona wall would be located on the outlet of the power device.figure 1 schematic diagram of typical anaesthetic gas scavenging systems3.6maximum operating pressuremaximum pressure at which a terminal unit is designed to operatenote operating pressure for type 1 is negative, and for type 2 is positive.3.7maximum test pressuremaximum pressure to which a terminal unit is designed to be subject during pipeline pressure testing3.8power devicethat part of the disposal system of an agss which provides the gas flow for scavenging3.9 probenon-interchangeable male component designed for acceptance by, and retention in, the socket3.10quick connectorpair 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 tools3.11receiving hosethat part of an agss which transfers expired and/or excess gases from the receiving system to the disposal system3.12receiving systemthat 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 relief3.13single fault conditioncondition in which a single means for protection against a safety hazard in equipment is defective, or a single external abnormal condition is present3.14 socketthat 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 point3.15terminal unit base blockthat part of a terminal unit which is attached to the disposal system3.16terminal unit check valvevalve which remains closed until opened by insertion of an appropriate probe, and which then permits flow in either direction3.17transfer systemthat part of an agss, which may or may not incorporate 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 relief3.18transfer tubethat part of an agss which transfers expired and/or excess gases from the anaesthetic breathing system and/or anaesthetic ventilator to the receiving system3.19type-specifichaving characteristics which prevent interchangeability and thereby allow assignment to one type only3.20type-specific connection pointthat part of a socket which is the receptor for a typespecific probe4 terminologya diagram of a typical terminal unit, with examples of terminology, is given in figure 2.5 general requirements5.1 safetyterminal 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 condition and in single fault condition.5.2r alternative constructionterminal units and components or parts thereof, using materials or having forms of construction (except for dimensions and allocation of probes and thetype-specific connection points) different from those detailed in this part of this european standard, shall be accepted if it can be demonstrated that an equivalent degree of safety is obtained.such evidence shall be provided by the manufacturer.1 type-specific connection2 hose insert (permanent)3 point for brazed connection (permanent)4 terminal unit base block5 type-specific interface6 terminal unit check valve (type 1 only)7 type-specific connection point8 socket9 probefigure 2 diagram of a typical agss terminal unit5.3 materials5.3.1 the materials in contact with the gas shall be compatible with the medical gases and anaesthetic vapours in the temperature range specified in 5.3.2.note corrosion resistance includes resistance against moisture and surrounding materials.5.3.2 the materials shall permit the terminal units and their components to meet the requirements of 5.4 inthe temperature range of 220 8c to +60 8c.5.3.3 terminal units shall be capable, while packed for transport and storage, of being exposed to environmental conditions as stated by the manufacturer.5.3.4r evidence of conformity with the requirements of 5.3.1, 5.3.2 and 5.3.3 shall be provided by the manufacturer.5.4 design requirements5.4.1 incomplete assemblyif any type-specific component is removed from the terminal unit, either the terminal unit shall be rendered inoperable or the type-specificity of the terminal unit shall be maintained.if the terminal unit can be dismantled, the components shall not be capable of being reassembled in such a way