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BRITISH STANDARD Medical gas pipeline systems Ð Part 1: Terminal units for compressed medical gases and vacuum The European Standard EN 737-1:1998 has the status of a British Standard ICS 11.040.10; 23.040.60 NO COPYING WITHOUT BSI PERMISSION EXCEPT AS PERMITTED BY COPYRIGHT LAW | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | BS EN 737-1:1998 BS EN 737-1:1998 National foreword This British Standard is the English language version of EN 737-1:1998 and covers terminal units for compressed medical gases and vacuum Together with BS EN 739:1998, which covers hose assemblies and non-interchangeable screw-threaded (NIST) connectors, it partially supersedes BS 5682:1984 (as amended by AMD 5419:1987) which covered hose assemblies, terminal units and their connectors The remainder of the content of BS 5682:1984, i.e ªquick connectº probes, is the subject of EN 737-6, currently in preparation When published, EN 737-6 is expected to have a lengthy transitional period, the date of withdrawal of conflicting national standards (DOW) being set several years in the future BS 5682:1984 will be withdrawn on 13 June 1998 and replaced by a new edition (BS 5682:1998) which will retain only the requirements for quick connect probes given in the amended 1984 edition This new edition is expected to co-exist with the forthcoming BS EN 737-6 until the expiry of the DOW of EN 737-6, at which time BS 5682:1998 will be withdrawn The UK participation in its preparation was entrusted to Technical Committee CH/44, Anaesthetic machines, breathing attachments, medical gas pipeline systems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: Ð aid enquirers to understand the text; Ð present to the responsible European committee any enquiries on the interpretation, or proposals for change, and keep the UK interests informed; Ð monitor related international and European developments and promulgate them in the UK A list of organizations represented on this committee can be obtained on request to its secretary Cross-references The 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 ªInternational Standards Correspondence Indexº, or by using the ªFindº 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 pages This document comprises a front cover, an inside front cover, the EN title page, pages to 15 and a back cover This 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 June 1998 BSI 1998 ISBN 580 29706 Amendments issued since publication Amd No Date Text affected EN 737-1 EUROPEAN STANDARD NORME EUROPÊENNE EUROPẰISCHE NORM January 1998 ICS 11.040.10; 23.040.60; 23.060.01 Descriptors: Gas distribution, medical gases, compressed gas, junctions, definitions, design, equipment specifications, mechanical properties, tests, marking, colour codes, packing English version Medical gas pipeline systems Ð Part 1: Terminal units for compressed medical gases and vacuum SysteÁmes de distribution de gaz meÂdicaux Ð Partie 1: Prises murales pour gaz meÂdicaux comprimeÂs et pour le vide (aspiration) Rohrleitungssysteme fuÈr medizinische Gase Ð Teil 1: Entnahmestellen fuÈr medizinische Druckgase und Vakum This European Standard was approved by CEN on 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 CEN European Committee for Standardization Comite EuropeÂen de Normalisation EuropaÈisches Komitee fuÈr 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 for CEN national Members Ref No EN 737-1:1998 E Page EN 737-1:1998 Foreword This European Standard 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 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) For special national conditions and transition periods for clause 7.2.1, see annex C 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: Anaesthetic gas scavenging disposal systems; Part 3: Pipelines for compressed medical gases and vacuum; Part 4: Terminal units for anaesthetic gas scavenging systems; Part 5: Oxygen concentrators; Part 6: Dimensions of probes for terminal units for compressed medical gases and vacuum Dimensions of probes are specified in prEN 737-6, which has a Date of Withdrawal (DoW) of (DOP + 15 years) Until this time, products complying with national standards may continue to be used for the maintenance and repair of probes Annex C forms a normative part of this part of this European Standard 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 Contents Page 3 3 Foreword Introduction Scope Normative references Definitions Terminology General requirements Test methods Marking, colour coding and packaging Information to be supplied by the manufacturer Annex A (informative) Bibliography Annex B (informative) Rationale Annex C (normative) Special national conditions Annex ZA (informative) Clauses of this European Standard addressing essential requirements or other provisions of EU Directives 13 13 13 14 BSI 1998 Page EN 737-1:1998 Introduction It is intended especially to ensure the gas-specific assembly of terminal units and to prevent their interchange between different gases Terminal units are the points on a medical gas pipeline system where the operator makes connections and disconnections for the supply of specified medical gases to anaesthetic machines, lung ventilators or other items of medical equipment, and where a wrong connection may create a 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: Ð suitability of materials; Ð gas-specificity; Ð cleanliness; Ð testing; Ð identification; Ð information supplied In any health care facility, it is strongly recommended that terminal units of only one type (i.e with the same set of dimensions for probe and socket) are used for any particular gas During hospital renovation it may be desirable to upgrade existing medical gas installations rather than renew them completely It is recognized that with modified terminal units it may not be possible to achieve the flow and pressure drop requirements of this part of this European Standard, due to limitations imposed by the pipeline system itself or by those components of the original terminal units that remain in the pipeline system 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 with prEN 737-3 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 ªRº after the clause number This part of 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 references, subsequent amendments to or revisions 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 prEN 737-3, Medical gas pipeline systems Ð Part 3: Pipelines for compressed medical gases and vacuum Ð Basic requirements EN 739, Low-pressure hose assemblies for use with medical gases prEN 1441, Medical devices Ð Risk analysis ISO 32, Gas cylinders for medical use Ð Marking for identification of content ISO 554, Standard atmospheres for conditioning and/or testing Ð Specifications Scope Definitions 1.1 This part of this European Standard specifies requirements for terminal units intended for use in medical gas pipeline systems specified in prEN 737-3 for use with the following medical gases: Ð oxygen; Ð nitrous oxide; Ð air for breathing; Ð carbon dioxide; Ð oxygen/nitrous oxide mixture [50 %/50 % (V/V)]; Ð air for driving surgical tools; Ð nitrogen for driving surgical tools; Ð vacuum For the purposes of this part of this European Standard, the following definitions apply BSI 1998 1.2 This part of this European Standard also specifies requirements for: Ð terminal units for the supply and disposal of air for driving surgical tools; Ð probes intended to be connected to the gas-specific connection point which is part of a terminal unit; 1.3 This part of this European Standard does not specify: Ð the dimensions of probes and of the gas-specific connection points of the terminal unit (see prEN 737-6); Ð the dimensions of NIST connectors (see EN 739); Ð requirements for terminal units for anaesthetic gas scavenging systems (see EN 737-4) Normative references 3.1 gas-specific having characteristics which prevent interchangeability and thereby allow assignment to one gas or vacuum service only 3.2 gas-specific connection point that part of the socket which is the receptor for a gas-specific probe Page EN 737-1:1998 3.3 gas-specific connector NIST (non-interchangeable screw-threaded) connector (see EN 739) or a probe (see prEN 737-6) 3.4 low-pressure hose assembly assembly which consists of a flexible hose with permanently-attached gas-specific inlet and outlet connectors which is designed to conduct a medical gas at pressures between 300 kPa and 400 kPa and for use with a vacuum service at pressures above 10 kPa absolute (see EN 739) 3.5 medical gas any gas or mixture of gases intended to be administered to patients for therapeutic, diagnostic or prophylactic purposes or for surgical tool application 3.6 medical gas pipeline system central supply system with control equipment, a pipeline distribution system and terminal units at the points where medical gases or vacuum are required 3.7 medical gas supply system either: a) a medical gas pipeline system; or b) any other installation having no permanent pipeline system but employing a medical gas supply source complete with pressure regulators 3.8 NIST connectors; non-interchangeable screw-threaded connectors range of male and female components intended to maintain gas-specificity by the allocation of a set of different diameters and a left or right hand screw thread to the mating components for each particular gas 3.9 nominal distribution pressure pressure which the pipeline distribution system is intended to deliver at the terminal units 3.10 probe non-interchangeable male component designed for acceptance by and retention in the socket 3.11 quick connector pair of non-threaded gas-specific components which can be easily and rapidly joined together by a single action of one or both hands without the use of tools 3.12 single fault condition condition in which a single means for protection against a safety hazard in equipment is defective or a single external abnormal condition is present 3.13 socket that part of a terminal unit which is either integral or attached to the base block by a gas-specific interface and which contains the gas-specific connection point 3.14 terminal unit outlet assembly (inlet for vacuum) in a medical gas supply system at which the operator makes connections and disconnections 3.15 terminal unit base block that part of a terminal unit which is attached to the pipeline distribution 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 terminal unit for supply and disposal of air for driving tools combination of an outlet assembly (for the supply) and an inlet assembly (for disposal) which are connected to a supply system and to a disposal system respectively and at which the operator makes connections and disconnections by means of a combined probe 3.18 terminal unit maintenance valve valve which permits maintenance of the terminal unit without shutting down the pipeline system to other terminal units Terminology A diagram of a typical terminal unit with examples of terminology is given in Figure BSI 1998 Page EN 737-1:1998 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 prEN 1441 and which is connected with their intended application, in normal condition and in single fault condition 5.2 R Alternative construction Terminal units and components or parts thereof, using materials or having forms of construction different from those detailed in clause of this part of this 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 See annex C for special national conditions and transition periods 5.3 Materials 5.3.1 The materials in contact with the gas shall be compatible with oxygen, the other medical gases and their mixtures in the temperature range specified in 5.3.2 NOTE Corrosion resistance includes resistance against moisture and surrounding materials NOTE Compatibility with oxygen involves both combustibility and ease of ignition Materials which burn in air will burn violently in pure oxygen Many materials which not burn in air will so in pure oxygen, particularly under pressure Similarly, materials which can be ignited in air require lower ignition energies for ignition in oxygen Many such materials may be ignited by adiabatic compression produced when oxygen at high pressure is rapidly introduced into a system initially at low pressure NOTE A standard, Compatibility of medical equipment with oxygen, is in preparation by ISO/TC 121/SC6 5.3.2 The materials shall permit the terminal units and their components to meet the requirements of 5.4 in the temperature range of 220 ÊC to +60 ÊC 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 5.3.4 R 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 requirements 5.4.1 Medical gas supply pressure 5.4.1.1 R Terminal units for oxygen, nitrous oxide, air for breathing, carbon dioxide and oxygen/nitrous oxide mixture 50 %/50 % (V/V) shall operate and meet the requirements of this part of this European Standard for a medical gas supply having a pressure range from 320 kPa to 600 kPa BSI 1998 5.4.1.2 R Terminal units for oxygen, nitrous oxide, air for breathing, carbon dioxide and oxygen/nitrous oxide mixture 50 %/50 % (V/V) shall not create a hazard to the patient or operator at an inlet pressure of 000 kPa Evidence shall be provided by the manufacturer 5.4.1.3 R Terminal units for oxygen, nitrous oxide, air for breathing, carbon dioxide and oxygen/nitrous oxide mixture 50 %/50 % (V/V) shall meet the requirements of 5.4.1.1 following exposure to an inlet pressure of 000 kPa for 10 5.4.1.4 R Terminal units for air for driving surgical tools and nitrogen for driving surgical tools shall operate and meet the requirements of this part of this European Standard for a medical gas supply having a pressure range from 640 kPa to 200 kPa 5.4.1.5 R Terminal units for air for driving surgical tools and nitrogen for driving surgical tools shall not create a hazard to the patient or operator at an inlet pressure of 000 kPa Evidence shall be provided by the manufacturer 5.4.1.6 R Terminal units for air for driving surgical tools and nitrogen for driving surgical tools shall meet the requirements of 5.4.1.4 following exposure to an inlet pressure of 000 kPa for 10 5.4.1.7 R Terminal units for vacuum shall operate and meet the requirements of this part of this European Standard for a vacuum supply having a minimum absolute pressure of 10 kPa 5.4.2 Terminal units for different pressures Terminal units for the same gas at different nominal operating pressures shall have gas-specific connection points for each pressure (e.g the supply of air for driving surgical tools and air for breathing) 5.4.3 Incomplete assembly If any gas-specific component is removed from the terminal unit, either the terminal unit shall be rendered inoperable or the gas-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 that the fully-assembled terminal unit is no longer gas-specific 5.4.4 Gas-specific connection point Each terminal unit shall include a gas-specific connection point which shall accept the appropriate gas-specific probe only This connection point shall be included in a socket 5.4.5 Terminal unit check valve Each terminal unit shall include a check valve which shall open the gas supply when the probe is connected and which shall shut off automatically when the probe is disconnected The check valve shall be a separate component or assembly from the maintenance valve specified in 5.4.6 Page EN 737-1:1998 5.4.6 Terminal unit maintenance valve Except for vacuum services, each terminal unit shall be equipped with a maintenance valve, which can be manual or automatic The maintenance valve shall be a separate component or assembly from the check valve specified in 5.4.5 5.4.7 Connection of terminal units to the pipeline NOTE See also 8.2 5.4.7.1 The base block of a terminal unit shall be designed and manufactured for either permanent or gas-specific connection to a pipeline 5.4.7.2 Except for connection to a disposal system, connection to a pipeline distribution system shall be by brazing, welding or by means of a NIST body and shall comply with prEN 737-3 5.4.7.3 Connection to a low-pressure flexible connecting assembly shall be either by direct ferruling or by means of a NIST body and shall comply with EN 739 5.4.8 Socket The arrangement for attaching a socket to its base block for a particular service shall be of a design which prevents interchangeability with the base block of any other service 5.4.9 Testing Compliance with clauses 5.4.2 to 5.4.8 shall be tested by visual inspection 5.4.10 Endurance (connection/release) 5.4.10.1 Socket The socket shall meet the requirements given in 5.4.11, 5.4.12, 5.4.13, 5.4.14, 5.4.15, 5.4.16 and 5.4.17 after testing in accordance with clause 6.2.1 5.4.10.2 Probe The probe shall meet the requirements given in 5.4.11, 5.4.12, 5.4.13, 5.4.14, 5.4.15, 5.4.16 and 5.4.17 after testing in accordance with 6.2.2 5.4.11 R Pressure drop The pressure drop across the terminal unit and its probe shall not exceed the values given in Table For terminal units for supply and disposal of air for driving surgical tools, the pressure drop across the outlet assembly shall not exceed the value given in Table 1; the pressure drop across the inlet assembly shall not exceed 25 kPa with a back pressure not exceeding 15 kPa The test for pressure drop is given in 6.3 5.4.12 Connection force and torque The force and the torque required to insert the probe into the terminal unit shall be: a) an axial force not exceeding 100 N and/or b) a torque not exceeding N´m The test for connection force and torque is given in 6.4 5.4.13 Disconnection force and torque The force and the torque required to release the locking mechanism shall be: a) a push or pull of not more than 110 N and not less than 20 N and/or b) a torque of not more than N´m and not less than 0,1 N´m When all locking provisions have been released, according to the manufacturer's instructions, disconnection of the probe from the terminal unit shall require a force of not more than 100 N The test for disconnection force and torque is given in 6.5 NOTE Danger to personnel can occur as a result of the rapid expulsion of probes from terminal units The design should prevent this from occurring 5.4.14 Mechanical strength The terminal unit shall withstand the application of a steady axial tensile force of not less than 500 N The test for mechanical strength is given in 6.6 Table Ð Requirements for flow and pressure drop across terminal units with probe inserted Terminal unit nominal distribution pressure (see prEN 737-3) Test pressure Test flow Maximum pressure drop across a terminal unit kPa kPa l/min kPa 400 to 500 400 to 500 800 to 000 Vacuum 1) 320 320 640 401) 60 200 300 40 15 70 70 15 Absolute pressure BSI 1998 Page EN 737-1:1998 5.4.15 Leakage The leakage from a terminal unit with and without the probe inserted shall not exceed 0,296 ml/min (0,03 kPa l/min) The test for leakage is given in 6.7.1 and 6.7.2 The leakage from a terminal unit with the probe inserted and with side force applied shall not exceed 0,296 ml/min (0,03 kPa l/min) The test for leakage with side force applied is given in 6.7.3 5.4.16 Gas-specificity The terminal unit shall only accept the probe for the medical gas for which it is intended The test for gas specificity is given in 6.8 5.4.17 Effective connection of probes A tactile or audible indication of locking shall be perceived on retention of the gas-specific probe The test for effective connection of probes is given in 6.9 5.5 Constructional requirements 5.5.1 R Cleaning The components of terminal units for all services shall be supplied clean and free from oil, grease and particulate matter Evidence shall be provided by the manufacturer NOTE Any method of cleaning and degreasing can be used which effectively removes all surface dirt and hydrocarbons, and which leaves no residue itself Chemical cleaning methods will normally require a subsequent washing and drying process to remove residues NOTE Examples of cleaning procedures will be described in a standard, Compatibility of medical equipment with oxygen, which is in preparation by ISO/TC 121/SC6 5.5.2 R Lubricants If lubricants are used, they shall be compatible with oxygen, the other medical gases and their mixtures in the temperature range specified in 5.3.2 Evidence shall be provided by the manufacturer Test methods 6.1 General 6.1.1 Ambient conditions Except if otherwise stated, carry out tests at (23 ± 2) ÊC 6.1.2 Test gas Carry out tests in accordance with ISO 554 with clean, oil-free dry air or nitrogen In all cases, carry out tests with dry gas with a maximum moisture content of 50 ppm (parts per million = 1026) corresponding to a dew point of 248 ÊC at atmospheric pressure BSI 1998 6.1.3 Reference conditions Correct flows to 23 ÊC and 101,3 kPa 6.2 Test method for endurance 6.2.1 Socket Fix the terminal unit to a horizontal or vertical surface, as appropriate, using the procedure recommended by the manufacturer Apply a test pressure at the inlet to the base block of the terminal unit Use a test pressure of 200 kPa for terminal units for air for driving surgical tools and for nitrogen for driving surgical tools, or a test pressure of 600 kPa for all other terminal units Using a test probe made of corrosion-resistant steel of minimum chromium content 17 % and a surface Brinell hardness of 210 HB 1/30, connect and release the probe 10 000 times, at a frequency of not more than 10 operations per minute, changing the seals every 000 operations or according to the manufacturer's instructions, whichever is the greater interval Test the socket for compliance with 5.4.11, 5.4.12, 5.4.13, 5.4.14, 5.4.15, 5.4.16 and 5.4.17 6.2.2 Probe Fix a terminal unit complying with this part of this European Standard to a horizontal or vertical surface, as appropriate, using the procedure recommended by the manufacturer Apply a test pressure at the inlet to the base block of the terminal unit Use a test pressure of 200 kPa for terminal units for air for driving surgical tools and for nitrogen for driving surgical tools, or a test pressure of 600 kPa for all other terminal units Connect and release the probe 10 000 times, at a frequency of not more than 10 operations per minute, changing the seals every 000 operations or according to the manufacturer's instructions, whichever is the greater interval Test the probe for compliance with 5.4.11, 5.4.12, 5.4.13, 5.4.14, 5.4.15, 5.4.16 and 5.4.17 6.3 Test method for pressure drop Using an apparatus of typical configuration shown in Figure for terminal units for compressed medical gases, Figure for terminal units for vacuum or Figure for terminal units for supply and disposal of air for driving surgical tools, set the test pressure and flow at the inlet of the terminal unit to the appropriate values given in Table and in 5.4.11 Measure the pressure drop across the terminal unit with the probe inserted For terminal units for the supply and disposal of air for driving surgical tools, measure the pressure drops across the outlet and inlet assemblies simultaneously Page EN 737-1:1998 6.4 Test method for connection force and torque Adapt a probe to accommodate a suitable measuring device Fix the terminal unit to a horizontal or vertical surface, as appropriate, using the procedure recommended by the manufacturer Apply a test pressure at the inlet to the base block of the terminal unit Use a test pressure of 200 kPa for terminal units for air for driving surgical tools and for nitrogen for driving surgical tools, or a test pressure of 600 kPa for all other terminal units In accordance with the manufacturer's instructions, insert the adapted probe into the terminal unit and record the force and/or torque required to insert and engage the probe fully 6.5 Test method for disconnection force and torque Adapt a probe to accommodate a suitable measuring device Fix the terminal unit to a horizontal or vertical surface, as appropriate, using the procedure recommended by the manufacturer Apply a test pressure at the inlet to the base block of the terminal unit Use a test pressure of 640 kPa for terminal units for driving surgical tools and for nitrogen for driving surgical tools, or a test pressure of 320 kPa for all other terminal units Insert the adapted probe into the terminal unit in accordance with the manufacturer's instructions and ensure that it is fully engaged Disconnect the probe in accordance with the manufacturer's instructions and record the force and/or torque required to release the locking mechanism If the recommended disconnection method involves applying, for example, compressive force to the probe to reduce the effort required to disengage the locking mechanism, measure each separate force/torque involved 6.6 Test method for mechanical strength Adapt a blanked probe in order to apply tensile force Fix the terminal unit to a suitable surface using the procedure recommended by the manufacturer Apply a test pressure at the inlet to the base block of the terminal unit Use a test pressure of 200 kPa for terminal units for air for driving surgical tools and for nitrogen for driving surgical tools, or a test pressure of 600 kPa for all other terminal units Insert the adapted probe Apply a tensile force of 500 N and hold it for Remove the tensile force, check that the terminal unit is completely functional and the leakage is according to 5.4.15 Dismantle the terminal unit and check that no damage or distortion has occurred to either the terminal unit components or the probe 6.7 Test methods for leakage 6.7.1 Fix the terminal unit to a horizontal or vertical surface, as appropriate, using the procedure recommended by the manufacturer Apply a test pressure at the inlet of the base block of the terminal unit Use the following test pressures a) 320 kPa and 600 kPa for terminal units for compressed medical gases; b) 640 kPa and 200 kPa for terminal units for air for driving surgical tools and nitrogen for driving surgical tools; c) 40 kPa absolute pressure for terminal units for vacuum Measure the leakage under the conditions of maximum and minimum test pressure 6.7.2 Keep the terminal unit pressurized as described in 6.7.1 and insert a gas-specific blanked probe Measure the leakage under the conditions of maximum and minimum test pressure 6.7.3 Apply a force of 20 N perpendicular to the long axis of the probe, 50 mm from the outermost surface of the terminal unit Measure the leakage whilst the force is applied to the probe under the conditions of maximum and minimum test pressure 6.8 Test method for gas-specificity Carry out the test by attempting to connect all gas-specific test probes in turn to the gas-specific connection point of each socket 6.9 Test method for effective connection of probes Carry out the test by inserting the gas-specific probe and checking that a tactile or audible indication of locking is given 6.10 Test method for durability of markings and colour coding Rub markings and colour coding by hand, without undue pressure, first for 15 s with a cloth rag soaked with distilled water, then for 15 s with a cloth rag soaked with methylated spirit and then for 15 s with a cloth rag soaked with isopropyl alcohol Carry out this test at ambient temperature Marking, colour coding and packaging 7.1 Marking 7.1.1 Terminal units, probes and their gas-specific components shall be durably and legibly marked with the symbol of the relevant gas in accordance with Table NOTE In addition to the symbol, the name of the gas can be used The test for the durability of markings is given in 6.10 7.1.2 The height of the lettering shall be at least 2,5 mm BSI 1998 Page EN 737-1:1998 Table Ð Symbols and colour coding for medical gases Medical gas or mixture Oxygen Nitrous oxide Air for breathing Air for driving surgical tools Air for driving surgical tools (with disposal) Nitrogen for driving surgical tools Carbon dioxide Mixture of oxygen/nitrous oxide [50 %/50 % (V/V)] Vacuum 1) In accordance with ISO 32 2) An example of yellow is NCS 0060Y in SS 01 91 02 3) National languages may be used for air and vacuum 7.1.3 Terminal units and probes shall be marked with the manufacturer's name or identification mark and, if applicable, with additional means to ensure traceability such as type, batch or serial number or year of manufacture 7.2 Colour coding 7.2.1 If colour coding is used, it shall be in accordance with Table See annex C for special national conditions and transition periods 7.2.2 Colour coding shall be durable The test for the durability of colour coding is given in clause 6.10 7.3 Packaging 7.3.1 Terminal units, gas-specific probes and spare parts shall be sealed to protect against particulate contamination and packaged to prevent damage during storage and transportation 7.3.2 Packages shall provide a means of identification of the contents BSI 1998 Symbol O2 N2O Air3) Air: 800 Air: motor N2: 800 CO2 O2/N2O Vac3) Colour coding White1) Blue1) Black±white1) Black±white1) Black±white1) Black1) Grey1) White±blue1) Yellow2) Information to be supplied by the manufacturer 8.1 Terminal units shall be accompanied by documents containing at least a technical description, instructions for use and an address to which the operator can refer The accompanying documents shall be regarded as a component part of terminal units 8.2 The manufacturer shall provide instructions for installation and a reference to the testing procedures for terminal units given in prEN 737-3 8.3 Instructions for use shall include all information necessary for the operation of the terminal unit in accordance with its specification and shall include a description of the procedure for connection and disconnection of probes Instructions for use shall give detailed instructions for the safe performance of cleaning, inspection and preventive maintenance to be performed by the operator or by authorized persons and shall indicate the frequency of such activities Particular attention shall be given to the following safety-related items: ± the danger of fire or explosion due to the use of lubricants not recommended by the manufacturer; ± the range of operating pressures; ± the hazard due to the use of improper probes A list of recommended spare parts shall be provided Page 10 EN 737-1:1998 1) NIST body 6) Check valve 2) Hose insert 7) Gas-specific interface 3) Point for brazed connection 8) Socket 4) Base block 9) Gas-specific connection point 5) Maintenance valve 10) Probe Figure Ð Diagram showing the typical components of a terminal unit BSI 1998 Page 11 EN 737-1:1998 1) Pressure differential measuring device 5) Terminal unit with probe inserted 2) Pressure gauge 6) Flow control valve 3) Pressure regulator 7) Pressure supply 4) Flowmeter Figure Ð Typical apparatus for measuring pressure drop across terminal units for compressed medical gases 1) Pressure differential measuring device 5) Terminal unit with probe inserted 2) Pressure gauge 6) Flow control valve 3) Vacuum regulator 7) Vacuum supply 4) Flowmeter Figure Ð Typical apparatus for measuring pressure drop across terminal units for vacuum BSI 1998 Page 12 EN 737-1:1998 1) Pressure differential measuring device 6) Flow control valve 2) Pressure gauge 7) Pressure supply 3) Pressure regulator 8) Disposal assembly of the terminal unit with the probe inserted 4) Flowmeter 9) Connection between the supply and the probe disposal sides of the probe 5) Supply assembly of the terminal unit with the probe inserted Figure Ð Typical apparatus for measuring pressure drop across terminal units for supply and disposal of air for driving surgical tools BSI 1998 Page 13 EN 737-1:1998 Annex A (informative) Bibliography EN 737-4, Medical gas pipeline systems Ð Part 4: Terminal units for anaesthetic gas scavenging systems prEN 737-6, Medical gas pipeline systems Ð Part 6: Dimensions of probes for terminal units for compressed medical gases and vacuum EN 1089, Transportable gas cylinders Ð Gas cylinder identification (excluding LPG) SS 01 91 02, Colour atlas Annex B (informative) Rationale B.5.2 Evidence will be provided to e.g a Notified Body during CE conformity assessment and upon request to the Competent Authority Attention is drawn to prEN 1441 on risk analysis and to the standards under development by ISO/TC 210 on risk evaluation and risk control B.5.3.4 Evidence of such compatibility will be provided e.g to a Notified Body during CE conformity assessment and Competent Authority upon request B.5.4.1.1 The values of 320 kPa and 600 kPa are derived from the range of nominal operating pressure +100 of 400 kPa and from the maximum allowable deviation of ± 20 % of the nominal distribution pressure (see prEN 737-3) B.5.4.1.2 The value of 000 kPa is equal to times the +100 maximum nominal operating pressure of 400 kPa (see prEN 737-3) This pressure can be applied to the terminal units by the supply system in single fault condition Evidence will be provided e.g to a Notified Body during CE conformity assessment and Competent Authority upon request B.5.4.1.3 See B.5.4.1.2 B.5.4.1.4 The values of 640 kPa and 200 kPa are derived from the range of nominal operating pressure +200 of 800 kPa and from the maximum allowable deviation of ± 20 % of the nominal distribution pressure (see prEN 737-3) ( ) ( ( BSI 1998 ) ) B.5.4.1.5 The value of 000 kPa is equal to times the maximum nominal distribution pressure of 800 +200 kPa (see prEN 737-3) This pressure can be applied to the terminal units by the supply system in single fault condition Evidence will be provided e.g to a Notified Body during CE conformity assessment and Competent Authority upon request B.5.4.1.6 See B.5.4.1.5 B.5.4.1.7 The value of 10 kPa is the lower limit of the possible absolute pressure supplied by vacuum pumps B.5.4.11 Lung ventilators can require peak flows of 200 l/min for up to s Experience shows that such ventilators can be supplied by terminal units which meet the requirements of 5.4.11 B.5.5.1 Evidence of such compatibility will be provided e.g to a Notified Body during CE conformity assessment and Competent Authority upon request B.5.5.2 Evidence of such compatibility will be provided e.g to a Notified Body during CE conformity assessment and Competent Authority upon request ( ) Annex C (normative) Special national conditions Special national condition: National characteristic or practice that cannot be changed even over a long period, e.g climatic conditions, electrical earthing conditions If it affects harmonization, it forms part of the European Standard In the countries in which the relevant national condition applies these provisions are normative; for other countries they are informative Clause 7.2.1 and Table 2: special national condition for Austria, Germany, Switzerland The requirement to comply with Table does not apply until the latest date of withdrawal of the special national conditions (2006-07-01) subject to review taking into account e.g the results of a forthcoming European study and the ongoing European standardization activities of the EN 1089 series Page 14 EN 737-1:1998 Annex ZA (informative) Clauses of this European Standard addressing essential requirements or other provisions of EU Directives 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 93/42/EEC WARNING: Other requirements and other EU Directives may be applicable to the product(s) falling within the scope of this standard The following clauses of this standard (see Table ZA.1) are likely to support requirements of Directive 93/42/EEC Compliance with these clauses of this standard provides one means of conforming with the specific essential requirements of the Directive concerned and associated EFTA regulations Table ZA.1 Ð Correspondence between this European Standard and EU Directives Clause/subclause/annex of this European Standard Section Section 5.1 5.2 5.3 5.3.1 5.3.2 5.3.3 5.3.4 5.4 5.4.1 5.4.1.2 5.4.1.5 5.4.2 5.4.3 5.4.4 5.4.5 5.4.6 5.4.7 5.4.8 5.4.9 5.4.10 5.4.11 5.4.12 5.4.13 5.4.14 5.4.15 5.4.16 5.4.17 5.5.1 5.5.2 Corresponding essential requirement of Directive 93/42/EEC Comments 1 2 7.1, 7.2, 7.3, 9.3 4, 7.1, 9.2 3, 2, 3, 4, 5, 7.1, 7.3, 9.2, 9.3 2, 3, 9.1, 9.2 12.7.1 12.7.1 9.1, 12.7.4 12.7.4 9.1, 12.7.4 12.8.2 12.8.2 9.1, 12.7.4 12.7.4 12.7.4 12.7.4 12.7.4 9.2, 12.7.4 9.2, 12.7.4 12.7.1, 12.7.4 7.5, 12.7.4 12.7.4 12.7.4 9.3 9.3 BSI 1998 Page 15 EN 737-1:1998 Table ZA.1 Ð Correspondence between this European Standard and EU Directives (continued) Clause/subclause/annex of this European Standard 6.2 6.3 6.4 6.5 6.6 6.7 6.8 6.9 6.10 7.1 7.1.3 7.2 7.3 7.3.1 7.3.2 8.1 8.2 8.3 8.3 1st dash 8.3 2nd dash 8.3 3rd dash BSI 1998 Corresponding essential requirement of Directive 93/42/EEC 12.7.4 2, 3, 2, 3, 2, 3, 4, 9.2 2, 3, 4, 9.2 2, 3, 4, 12.7.1 2, 3, 4, 7.5 2, 3, 2, 3, 13.2 13.2 13.1, 13.3a), 13.3d), 13.5 13.2 5, 7.2, 7.6 13.1, 13.3b) 13.1, 13.3a), 13.4, 13.6a) 7.6, 9.1, 12.7.4, 13.6c), d) 2, 13.1 9.3 9.2 9.1, 12.7.4, 13.6c) Comments BSI 389 Chiswick High Road London W4 4AL | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | BSI Ð British Standards Institution BSI is the independent national body responsible for preparing British Standards It presents the 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