BS-EN-ISO-15002-2008.pdf

BRITISH STANDARD BS EN ISO 15002:2008 Flow-metering devices for connection to terminal units of medical gas pipeline systems ICS 11.040.10 ? Licensed CopyChinese University of Hong Kong, 21/10/2008 03:07, Uncontrolled Copy, (c) BSI BS EN ISO 15002:2008 This British Standard was published under the authority of the Standards Policy and Strategy Committee on 29 August 2008 © BSI 2008 ISBN 978 0 580 55059 1 National foreword This British Standard is the UK implementation of EN ISO 15002:2008. It supersedes BS EN 13220:1999 which is withdrawn. The UK participation in its preparation was entrusted by Technical Committee CH/121, Anaesthetic and respiratory equipment, to Subcommittee CH/121/6, Medical gas supply systems. A list of organizations represented on this committee can be obtained on request to its secretary. This publication does not purport to include all the necessary provisions of a contract. Users are responsible for its correct application. Compliance with a British Standard cannot confer immunity from legal obligations. Amendments/corrigenda issued since publication DateComments Licensed CopyChinese University of Hong Kong, 21/10/2008 03:07, Uncontrolled Copy, (c) BSI EUROPEAN STANDARD NORME EUROPÉENNE EUROPÄISCHE NORM EN ISO 15002 July 2008 ICS 11.040.10Supersedes EN 13220:1998 English Version Flow-metering devices for connection to terminal units of medical gas pipeline systems (ISO 15002:2008) Dispositifs de mesure de débit pour raccordement aux prises murales des systèmes de distribution de gaz médicaux (ISO 15002:2008) Durchflussmesseinrichtungen zum Anschluss an Entnahmestellen von Rohrleitungssystemen für medizinische Gase (ISO 15002:2008) This European Standard was approved by CEN on 21 June 2008. 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 CEN Management Centre 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 CEN Management Centre has the same status as the official versions. CEN members are the national standards bodies of Austria, Belgium, Bulgaria, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland and United Kingdom. EUROPEAN COMMITTEE FOR STANDARDIZATION COMITÉ EUROPÉEN DE NORMALISATION EUROPÄISCHES KOMITEE FÜR NORMUNG Management Centre: rue de Stassart, 36 B-1050 Brussels © 2008 CENAll rights of exploitation in any form and by any means reserved worldwide for CEN national Members. Ref. No. EN ISO 15002:2008: E Licensed CopyChinese University of Hong Kong, 21/10/2008 03:07, Uncontrolled Copy, (c) BSI Foreword This document (EN ISO 15002:2008) has been prepared by Technical Committee ISO/TC 121 “Anaesthetic and respiratory equipment“ in collaboration with 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 January 2009, and conflicting national standards shall be withdrawn at the latest by July 2010. Attention is drawn to the possibility that some of the elements of this document may be the subject of patent rights. CEN and/or CENELEC shall not be held responsible for identifying any or all such patent rights. This document supersedes EN 13220:1998. This document has been prepared under a mandate given to CEN by the European Commission and the European Free Trade Association, and supports essential requirements of EC Directive. For relationship with EC Directive, see informative Annex ZA, which is an integral part of this document. According to the CEN/CENELEC Internal Regulations, the national standards organizations of the following countries are bound to implement this European Standard: Austria, Belgium, Bulgaria, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland and the United Kingdom. Endorsement notice The text of ISO 15002:2008 has been approved by CEN as a EN ISO 15002:2008 without any modification. BS EN ISO 15002:2008 Licensed CopyChinese University of Hong Kong, 21/10/2008 03:07, Uncontrolled Copy, (c) BSI iii Contents Page Introduction v 1 Scope . 1 2 *Normative references 2 3 Terms and definitions. 2 4 Arrangement of flow-metering systems and devices. 4 5 General requirements. 4 5.1 Safety . 4 5.2 Alternative construction 4 5.3 Materials 4 5.4 Design requirements 5 5.5 Constructional requirements. 10 6 Test methods. 10 6.1 General. 10 6.2 Test method for mechanical strength. 11 6.3 Test method for leakage 11 6.4 Test method for durability of markings and colour coding 12 7 Marking, colour coding and packaging 12 7.1 Marking 12 7.2 Colour coding 13 7.3 Packaging 13 8 Information to be supplied by the manufacturer. 13 Annex A (informative) Rationale. 15 Annex B (informative) Arrangements of flow-metering systems and devices 17 Annex C (informative) Environmental aspects 20 Bibliography. 21 BS EN ISO 15002:2008 Annex ZA (informative) Correspondence between this International Standard and Directive 93/42/EEC 22 Licensed CopyChinese University of Hong Kong, 21/10/2008 03:07, Uncontrolled Copy, (c) BSI blank Licensed CopyChinese University of Hong Kong, 21/10/2008 03:07, Uncontrolled Copy, (c) BSI v Introduction Flow-metering devices are widely used for delivery of medical gases supplied by a medical gas supply system directly to a patient. These devices need to deliver accurate flows under varying conditions of temperature and inlet pressure. Therefore it is important that the operating characteristics be specified and tested in a defined manner. This International Standard pays particular attention to: safety (mechanical strength, safe relief of excess pressure, resistance to ignition); gas specificity; cleanliness; suitability of materials; accuracy; testing; identification; information supplied. Annex A contains rationale statements for some of the requirements of this International Standard. The clauses and subclauses marked with an asterix (*) after their number have corresponding rationale contained in informative Annex A, included to provide additional insight into the reasoning that led to the requirements and recommendations that have been incorporated in this International Standard. It is considered that knowledge of the reasons for the requirements will not only facilitate the proper application of this International Standard, but will expedite any subsequent revisions. BS EN ISO 15002:2008 Licensed CopyChinese University of Hong Kong, 21/10/2008 03:07, Uncontrolled Copy, (c) BSI blank Licensed CopyChinese University of Hong Kong, 21/10/2008 03:07, Uncontrolled Copy, (c) BSI 1 Flow-metering devices for connection to terminal units of medical gas pipeline systems 1 Scope 1.1 This International Standard is applicable to: flow-metering devices that are connected, either directly or by means of flexible connecting assemblies, and disconnected by the operator at terminal units of a medical gas pipeline system for flow adjustment, measurement and delivery of medical gases; flow-metering devices that are connected and disconnected by the operator at gas-specific connection points of devices such as pressure regulators. 1.2 This International Standard applies to: a) flow-metering devices intended to be used with the following medical gases: oxygen; nitrous oxide; medical air; carbon dioxide; oxygen/nitrous oxide mixture 50 %/50 % (by volume); specified mixtures of the gases listed above; b) flow-metering devices intended to be used with the following gases: oxygen-enriched air; helium; xenon. NOTE Regional or national regulations might permit use of oxygen-specific connection points for oxygen-enriched air. 1.3 This International Standard does not apply to electrical or electronic flow-metering devices. 1.4 This International Standard does not apply to gases used for driving surgical tools. BS EN ISO 15002:2008 Licensed CopyChinese University of Hong Kong, 21/10/2008 03:07, Uncontrolled Copy, (c) BSI 2 2 *Normative references The following referenced documents are indispensable for the application of this document. For dated references, only the edition cited applies. For undated references, the latest edition of the referenced document (including any amendments) applies. ISO 32, Gas cylinders for medical use Marking for identification of content ISO 5359:2008, Low-pressure hose assemblies for use with medical gases ISO 7396-1, Medical gas pipeline systems Part 1: Pipeline systems for compressed medical gases and vacuum ISO 9170-1, Terminal units for medical gas pipeline systems Part 1: Terminal units for use with compressed medical gases and vacuum ISO 11114-3:1997, Transportable gas cylinders Compatibility of cylinder and valve materials with gas contents Part 3: Autogenous ignition test in oxygen atmosphere ISO 14971:2007, Medical devices Application of risk management to medical devices ISO 15001:2003, Anaesthetic and respiratory equipment Compatibility with oxygen ISO 19054, Rail systems for supporting medical equipment EN 837-1:1996, Pressure gauges Part 1: Bourdon tube pressure gauges Dimensions, metrology, requirements and testing EN 1089-3:2004, Transportable gas cylinders Gas cylinder identification (excluding LPG) Part 3: Colour coding EN 13544-2, Respiratory therapy equipment Part 2: Tubing and connectors 3 Terms and definitions For the purposes of this document, the following terms and definitions apply. 3.1 diameter index safety system connectors DISS connectors any of a range of male and female components intended to maintain gas-specificity by allocation of a set of different diameters to the mating connectors for each particular gas 3.2 flowgauge device that measures pressure and is calibrated in units of flow NOTE The flowgauge does not measure flow. It indicates flow by measuring the pressure upstream of a fixed orifice. 3.3 flowmeter device that measures and indicates the flow of a specific gas 3.4 flow-metering device device fitted with an inlet connector and an outlet connector and which incorporates one of the following: a) a flowmeter with a flow control valve; b) a flowgauge and a fixed orifice with a flow control valve; BS EN ISO 15002:2008 Licensed CopyChinese University of Hong Kong, 21/10/2008 03:07, Uncontrolled Copy, (c) BSI 3 c) one or more fixed orifices with a means of flow selection. NOTE Typical examples of flow-metering systems and devices are given in Figures B.1 and B.2. 3.5 gas-specific having characteristics which prevent connections between different gas services 3.6 gas-specific connection point that part of the socket which is the receptor for a gas-specific probe 3.7 hose insert that portion of a connector which is pushed into and secured within the bore (lumen) of the hose 3.8 manufacturer natural or legal person with responsibility for the design, manufacture, packaging and labelling of a device before it is placed on the market under his or her own name, regardless of whether these operations are carried out by that person or on his or her behalf by a third party 3.9 medical gas pipeline system complete system which comprises a supply system, a monitoring and alarm system and a pipeline distribution system with terminal units at the points where medical gases or vacuum may be required 3.10 medical gas supply system either a) a medical gas pipeline system or b) an installation having no permanent pipeline system but employing a medical gas supply source complete with pressure regulator(s) 3.11 non-interchangeable screw-threaded connector NIST connector 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 3.12 probe gas-specific male component designed for acceptance by and retention in the socket 3.13 rated inlet pressure p1 maximum upstream pressure for which the flow-metering device is designed to operate 3.14 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 3.15 socket female part of a terminal unit which is either integral or attached to the terminal unit base block by a gas-specific interface and which contains the gas-specific connection point BS EN ISO 15002:2008 Licensed CopyChinese University of Hong Kong, 21/10/2008 03:07, Uncontrolled Copy, (c) BSI 4 3.16 terminal unit outlet assembly (inlet for vacuum) in a medical gas supply system at which the operator makes connections and disconnections 4 Arrangement of flow-metering systems and devices Typical examples of flow-metering systems are shown in Annex B. 5 General requirements NOTE Unless otherwise specified, pressures in this International Standard are expressed as gauge pressures (i.e. atmospheric pressure is defined as 0). 5.1 Safety Flow-metering devices shall, when transported, stored, installed, operated in normal use and maintained according to the instructions of the manufacturer, present no risks that are not reduced to an acceptable level using procedures in accordance with ISO 14971 and which are connected with their intended application, in normal conditions and in single fault conditions. 5.2 Alternative construction Flow-metering devices, and components or parts thereof, using materials or having forms of construction different from those detailed in this clause (except for dimensions and allocation of DISS and NIST connectors and probes used as inlet connectors), shall be presumed to be in compliance with the safety objectives of this International Standard if it can be demonstrated that an equivalent degree of safety is obtained (i.e. compliance with requirements presumes that risks have been mitigated to acceptable levels) unless objective evidence to the contrary becomes available. NOTE 1 Objective evidence might be obtained by postmarket surveillance. Evidence of an equivalent degree of safety shall be provided by the manufacturer upon request. NOTE 2 Regional or national regulations may require