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BRITISH STANDARD Medical gas pipeline systems Part 4: Terminal units for anaesthetic gas scavenging systems The European 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 | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | BS EN 737-4:1998 BS EN 737-4:1998 National foreword This 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737-4:1998 Together with BS EN 737-2:1998 and clause 111 of BS EN 740:1998, it supersedes BS 6834:1987, which will be withdrawn in due course The UK participation in its preparation was entrusted by Technical Committee CH/44, Anaesthetic machines, breathing attachments, medical gas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-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 14, an inside back cover 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 May 1998 BSI 1998 ISBN 580 29764 Amendments issued since publication Amd No Date Text affected EN 737-4 EUROPEAN STANDARD NORME EUROPÊENNE EUROPẰISCHE 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, colour codes, packing English version Medical gas pipeline systems Ð Part 4: Terminal units for anaesthetic gas scavenging systems SysteÁmes de distribution de gaz meÂdicaux Ð Partie 4: Prises murales pour systeÁmes d'eÂvacuation des gaz d'anestheÂsie Rohrleitungssysteme fuÈr medizinische Gase Ð Teil 4: Entnahmestellen fuÈr AnaÈsthesiegas-Fortleitungssysteme 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 737-4:1998 E Page EN 737-4:1998 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 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 vacuum Part 2: Anaesthetic 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 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 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 ZA (informative) Clauses of this European Standard addressing essential requirements or other provisions of EU Directives Page 3 3 5 10 11 12 13 13 13 BSI 1998 Page EN 737-4:1998 Introduction Normative references Anaesthetic 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 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: ± 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 with prEN 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 ªRº after the clause number 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 737-2, Medical gas pipeline systems Ð Part 2: Anaesthetic gas scavenging disposal systems EN 1441, Medical devices Ð Risk analysis ISO 554, Standard atmospheres for conditioning and/or testing Ð Specifications Definitions For the purposes of this part of this European Standard, the following definitions apply 3.1 AGSS Type terminal unit connection point between the receiving system and disposal system at which an operator makes connections and disconnections ｗｗｗ．ｂｚｆｘｗ．ｃｏｍ Scope This 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 shows the use of the two types of terminal unit BSI 1998 3.2 AGSS Type terminal 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 which is integrated into an anaesthetic workstation, for the purpose of conveying expired and/or excess anaesthetic gases to an appropriate place of discharge NOTE 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 3.4 disposal hose that part of an AGSS which transfers expired and/or excess gases from the power device to the probe of an AGSS Type 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 NOTE A place of discharge may be, e.g the exterior of a building or a non-recirculating exhaust ventilation system Page EN 737-4:1998 ｗｗｗ．ｂｚｆｘｗ．ｃｏｍ 10 Apparatus including breathing system and integral transfer/receiving system and power device Apparatus including breathing system Transfer/receiving system and power device Apparatus 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 Disposal 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 terminal unit probe/socket Type terminal unit probe/socket NOTE Type terminal unit is for negative pressure Type terminal unit is for positive pressure NOTE The 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 Figure Ð Schematic diagram of typical anaesthetic gas scavenging systems BSI 1998 Page EN 737-4:1998 3.6 maximum operating pressure maximum pressure at which a terminal unit is designed to operate NOTE Operating pressure for Type is negative, and for Type is positive 3.7 maximum test pressure 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 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 3.16 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 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 relief 3.18 transfer tube that part of an AGSS which transfers expired 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 ｗｗｗ．ｂｚｆｘｗ．ｃｏｍ 3.11 receiving hose that part of an AGSS which transfers expired and/or excess gases from the receiving system to 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 against 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 base block that part of a terminal unit which is attached to the disposal system BSI 1998 3.20 type-specific connection point that part of a socket which is the receptor for a typespecific probe Terminology A diagram of a typical terminal unit, with examples of terminology, is given in Figure 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 condition and in single fault condition 5.2R Alternative construction Terminal units and components or parts thereof, using materials or having forms of construction (except for dimensions and allocation of probes and the type-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 Page EN 737-4:1998 ｗｗｗ．ｂｚｆｘｗ．ｃｏｍ Type-specific connection Hose insert (permanent) Point for brazed connection (permanent) Terminal unit base block Type-specific interface Terminal unit check valve (Type only) Type-specific connection point Socket Probe Figure Ð Diagram of a typical AGSS terminal unit BSI 1998 Page EN 737-4:1998 5.3 Materials 5.3.1 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 in the 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 requirements 5.4.1 Incomplete assembly If 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 that the fully assembled terminal unit is no longer type-specific 5.4.2 Type-specific connection point Each terminal unit shall include a type-specific connection point which shall accept the appropriate type-specific probe only This connection point shall be included in a socket 5.4.3 Terminal unit check valve Each Type terminal unit socket shall include a check valve which shall open when the probe is connected and which shall shut off automatically when the probe is disconnected 5.4.4 Connection of terminal units to the disposal system 5.4.4.1 The base block of the terminal unit shall be designed and manufactured for either permanent or type-specific connection to a pipeline (See also 8.2) 5.4.4.2 Such type-specific connections shall be incompatible with those used for compressed medical gases and vacuum pipeline systems, hose assemblies, breathing systems and other AGSS components 5.4.5 Connection of receiving or disposal hoses to hose inserts 5.4.5.1 Hoses shall be attached to the hose inserts of connectors by means of compression swaging, a crimped ferrule or other method which permits compliance with 5.4.5.2 and 5.4.5.3 5.4.5.2 It shall be impossible to remove the fitted sleeve or ferrule without it becoming unfit for re-use 5.4.5.3 The connection shall withstand the application of a steady axial tensile force of 600 N for 60 s The test is given in 6.10 5.4.6 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 5.4.7 Test methods for compliance Compliance with 5.4.1 to 5.4.6 (except for 5.4.5.3) shall be tested by visual inspection and functional testing where applicable 5.4.8 Pressure drop The pressure drop across the terminal unit and its probe shall not exceed the values given in Table The test for pressure drop is given in 6.3 Table Ð Requirements for flow and pressure drop across terminal units with probe inserted Terminal unit type Test pressure Test flow Maximum pressure drop across a terminal unit l/min kPa Atmospheric pressure 90 Atmospheric pressure 50 15 ｗｗｗ．ｂｚｆｘｗ．ｃｏｍ BSI 1998 5.4.9 Connection force The force required to insert the probe into the terminal unit shall be an axial force not exceeding 100 N The test for connection force is given in 6.4 5.4.10 Disconnection force The force required to release the locking mechanism shall be a push or pull of not more than 110 N and not less than 20 N 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 is given in 6.5 5.4.11 Mechanical strength The terminal unit shall comply with the requirements of clause following the application of a steady axial tensile force of 500 N The test for mechanical strength is given in 6.6 5.4.12 Leakage The leakage from a terminal unit, with and without probe inserted, shall not exceed 2,96 ml/min (0,3 kPa´l/min) The test for leakage is given in 6.7 5.4.13 Type-specificity The terminal unit shall only accept the type-specific probe for which it is intended The test for type-specificity is given in 6.8 5.4.14 Effective connection of probes A tactile or audible indication of locking shall be perceived on retention of the type-specific probe The test for effective connection of probes is given in 6.9 Page EN 737-4:1998 5.4.15 Endurance (connection/release) 5.5 Constructional requirements 5.4.15.1 Socket The terminal unit shall meet the requirements given in 5.4.8, 5.4.9, 5.4.10, 5.4.11, 5.4.12, 5.4.13 and 5.4.14 after testing in accordance with 6.2.1 5.5.1R Cleaning The components of terminal units shall be supplied clean and free from oil, grease and particulate matter Evidence shall be provided by the manufacturer 5.4.15.2 Probe The probe shall meet the requirements given in 5.4.8, 5.4.9, 5.4.10, 5.4.11, 5.4.12, 5.4.13 and 5.4.14 after testing in accordance with 6.2.2 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 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/SC 5.4.16 Dimensions The dimensions of the Type probe and the corresponding type-specific connection point shall comply with Figure The dimensions of the Type probe and the corresponding type-specific connection point shall comply with Figure Compliance shall be verified by measurement 5.5.2R Lubricants If lubricants are used, they shall be compatible with medical gases and anaesthetic vapours in the temperature range specified in 5.3.2 Evidence shall be provided by the manufacturer ｗｗｗ．ｂｚｆｘｗ．ｃｏｍ Dimensions in millimetres Probe sealing area NOTE All length tolerances to be ± 0,1 mm NOTE All diameters to be ± 0,05 mm unless otherwise stated NOTE All diameters to be concentric to within 0,05 mm NOTE Surface finish to be 1,6 unless otherwise specified NOTE All sharp edges and burrs to be removed (maximum radius 0,2 mm) unless otherwise specified Figure Ð Dimensions of Type probe and type-specific connection point BSI 1998 Page EN 737-4:1998 Dimensions in millimetres Probe sealing area NOTE All length tolerances to be ± 0,1 mm NOTE All diameters to be ± 0,05 mm unless otherwise stated NOTE All diameters to be concentric to within 0,05 mm NOTE Surface finish to be 1,6 unless otherwise specified NOTE All sharp edges and burrs to be removed (maximum radius 0,2 mm) unless otherwise specified Figure Ð Dimensions of Type probe and type-specific connection point BSI 1998 Page 10 EN 737-4:1998 Test methods 6.1 General 6.1.1 Ambient conditions: Unless otherwise stated, carry out tests at (23 ± 2) 8C and atmospheric pressure 6.1.2 Test gas Carry out tests according to 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 8C at atmospheric pressure 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 Using a test probe made of corrosion-resistant steel of minimum chromium content of 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 5.4.8, 5.4.9, 5.4.10, 5.4.11, 5.4.12, 5.4.13 and 5.4.14 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 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 5.4.8, 5.4.9, 5.4.10, 5.4.11, 5.4.12, 5.4.13 and 5.4.14 6.3 Test method for pressure drop Using an apparatus of typical configuration shown in Figure 5, set the test pressure and flow to the appropriate values given in Table Measure the pressure drop across the terminal unit 6.4 Test method for connection force 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 In accordance with the manufacturer's instructions, insert the adapted probe into the terminal unit and record the force required to insert and engage the probe fully Pressure differential measuring device Flowmeter Terminal unit with probe inserted Flow control valve Vacuum supply Figure Ð Typical apparatus for measuring pressure drop across AGSS terminal units BSI 1998 Page 11 EN 737-4:1998 6.5 Test method for disconnection force 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 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 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 6.6 Test method for mechanical strength Adapt a blanked probe to apply a tensile force Fix the terminal unit complete to a suitable surface, using the procedure recommended by the manufacturer Insert the adapted probe Apply a tensile force of 500 N and hold it for Remove the tensile force; check that the terminal unit complies with the requirements of clause 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 the maximum and then the minimum operating pressure specified by the manufacturer at the inlet to the base block of the terminal unit Measure the leakage under the conditions of maximum and minimum operating pressure 6.9 Test method for effective connection of probes Carry out the test by inserting the type-specific probe and checking that a tactile or audible indication of locking is given 6.10 Test method for connection of receiving or disposal hoses to hose inserts Subject the hose and connectors of the test specimen to an axial force of 600 N for 60 s Destroy the hose of the test specimen after testing 6.11 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 type-specific components shall be durably and legibly marked with the letters ªAGSSº and the type The test for durability of markings is given in 6.11 7.1.2 The height of the lettering shall be at least 2,5 mm 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 red magenta NOTE An example of red magenta is 3050-R40 B in accordance with SS 01 91 02 6.7.2 Keep the terminal unit pressurized as described in 6.7.1 and insert a type-specific blanked probe Measure the leakage under the conditions of maximum and minimum operating pressures specified by the manufacturer 7.2.2 Colour coding shall be durable The test for the durability of colour coding is given in 6.11 6.8 Test method for type-specificity Carry out the test by attempting to connect all type-specific test probes in turn to the type-specific connection point of each socket 7.3.1 Terminal units, probes and spare parts shall be sealed to protect against particulate contamination, and packaged to prevent damage during storage and transportation 7.3 Packaging 7.3.2 Packages shall provide a means of identification of the contents BSI 1998 Page 12 EN 737-4:1998 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 737-2 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, preventive inspection and 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 BSI 1998 Page 13 EN 737-4:1998 Annex A (informative) Bibliography SS 01 91 02 Annex ZA (informative) Clauses of this European Standard addressing essential requirements or other provisions of EU Directives 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 EN 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.5.5.1 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 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 complying 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 of this European Standard Corresponding essential requirement of Directive 93/42/EEC Clause Clause 5.1 5.2 5.3 5.3.1 7.1, 7.3, 9.3 5.3.2 4, 7.1, 9.2 5.3.3 3, 5.3.4 2, 3, 4, 5, 7.1, 7.3, 9.2, 9.3 5.4 2, 3, 5.4.2 9.1, 12.7.4 5.4.3 9.1 5.4.4 9.1, 12.7.4 5.4.5 9.1, 12.7.4 5.4.9 9.2 5.4.10 9.2 5.4.11 12.7.1 5.4.12 7.5 5.4.13 9.1 5.4.16 9.1, 12.7.4 BSI 1998 Comments Page 14 EN 737-4:1998 Table ZA.1 Ð Correspondence between this European Standard and EU Directives (continued) Clause/subclause of this European Standard Corresponding essential requirement of Directive 93/42/EEC 5.5.1 9.3 5.5.2 9.3 6.2 2, 3, 6.3 2, 3, 6.4 2, 3, 4, 9.2 6.5 2, 3, 4, 9.2 6.6 2, 3, 4, 12.7.1 6.7 2, 3, 4, 7.5 6.8 2, 3, 4, 9.1 6.9 2, 3, 6.10 2, 3, 4, 9.1, 12.7.4 6.11 13.2 7.1.3 13.1, 13.3 a), 13.3 d), 13.5 7.2 13.2 7.3 7.3, 13.2 7.3.1 5, 7.6 7.3.2 13.1, 13.3 b) 8.1 13.1, 13.3 a), 13.4, 13.6 a) 8.2 7.6, 9.1, 12.7.4, 13.6 c), 13.6 d) 8.3 2, 13.1 8.3 first dash 9.3 8.3 second dash 9.2 8.3 third dash 9.1, 12.7.4, 13.6 c) Comments BSI 1998 blank BSI 389 Chiswick High Road London W4 4AL | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | BSI Ð British Standards Institution BSI is the 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