1、April 2010 Translation by DIN-Sprachendienst.English price group 12No part of this translation may be reproduced without prior permission ofDIN Deutsches Institut fr Normung e. V., Berlin. Beuth Verlag GmbH, 10772 Berlin, Germany,has the exclusive right of sale for German Standards (DIN-Normen).ICS
2、11.040.10!$aZb“1625563www.din.deDDIN EN ISO 21969High-pressure flexible connections for use with medical gas systems(ISO 21969:2009)English translation of DIN EN ISO 21969:2010-04Flexible Hochdruck-Verbindungen zur Verwendung in Systemen fr medizinische Gase(ISO 21969:2009)Englische bersetzung von D
3、IN EN ISO 21969:2010-04Raccords flexibles haute pression pour utilisation avec les systmes de gaz mdicaux(ISO 21969:2009)Traduction anglaise de DIN EN ISO 21969:2010-04SupersedesDIN EN ISO 21969:2006-10See start of validitywww.beuth.deIn case of doubt, the German-language original shall be considere
4、d authoritative.Document comprises 21 pages04.10 DIN EN ISO 21969:2010-04 2 A comma is used as the decimal marker. Start of validity This standard takes effect on 1 April 2010. National foreword This standard has been prepared by Technical Committee ISO/TC 121 “Anaesthetic and respiratory equipment”
5、 (Secretariat: BSI, United Kingdom) in collaboration with Technical Committee CEN/TC 215 “Respiratory and anaesthetic equipment” (Secretariat: BSI, United Kingdom). The responsible German body involved in its preparation was the Normenausschuss Rettungsdienst und Krankenhaus (Rescue Services and Hos
6、pital Standards Committee), Working Committee NA 053-03-06 AA Zentrale Gasversorgungsanlagen. Annex A “Rationale” contains information relating to some requirements specified in this standard. The corresponding clauses and subclauses are marked with an asterisk (*). The DIN Standards corresponding t
7、o the International Standards referred to in clause 2 and in the bibliography of this document are as follows: ISO 407:2004 DIN EN ISO 407:2005-02 ISO 4135:2001 DIN EN ISO 4135:2002-03 ISO 7291:1999 DIN EN ISO 7291:2001-11 ISO 10524-1:2006 DIN EN ISO 10524-1:2006-05 ISO 10524-2:2005 DIN EN ISO 10524
8、-2:2006-07 ISO 14971:2007 DIN EN ISO 14971:2007-07 ISO 15001:2003 DIN EN ISO 15001:2004-08 IEC 60601-1:2005 DIN EN 60601-1 (VDE 0750-1):2007-07 This standard includes safety requirements in clauses 5, 6 and 8. Amendments This standard differs from DIN EN ISO 21969:2006-10 as follows: a) The introduc
9、tion has been deleted. b) Clause 3 (subclauses 3.1 and 3.4) have been revised. c) The list of medical gases in the scope now also includes oxygen-enriched air. d) Subclauses 5.1 “Safety” and 5.2 “Alternative construction” have been revised. e) The standard has been editorially revised. DIN EN ISO 21
10、969:2010-04 3 Previous editions DIN EN 13221: 2004:04 DIN EN ISO 21969: 2006-10 National Annex NA (informative) Bibliography DIN EN 60601-1 (VDE 0750-1), Medical electrical equipment Part 1: General requirements for basic safety and essential performance DIN EN ISO 407, Small medical gas cylinders P
11、in-index yoke-type valve connections DIN EN ISO 4135, Anaesthetic and respiratory equipment Vocabulary DIN EN ISO 7291, Gas welding equipment Pressure regulators for manifold systems used in welding, cutting and allied processes up to 300 bar DIN EN ISO 10524-1, Pressure regulators for use with medi
12、cal gases Part 1: Pressure regulators and pressure regulators with flow-metering devices DIN EN ISO 10524-2, Pressure regulators for use with medical gases Part 2: Manifold and line pressure regulators DIN EN ISO 14971, Medical devices Application of risk management to medical devices DIN EN ISO 150
13、01, Anaesthetic and respiratory equipment Compatibility with oxygen DIN EN ISO 21969:2010-04 4 This page is intentionally blank EUROPEAN STANDARD NORME EUROPENNE EUROPISCHE NORM EN ISO 21969 November 2009 ICS 11.040.10 Supersedes EN ISO 21969:2006English Version High-pressure flexible connections fo
14、r use with medical gas systems (ISO 21969:2009) Raccords flexibles haute pression pour utilisation avec les systmes de gaz mdicaux (ISO 21969:2009) Flexible Hochdruck-Verbindungen zur Verwendung in Systemen fr medizinische Gase (ISO 21969:2009) This European Standard was approved by CEN on 8 Septemb
15、er 2009. 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 obta
16、ined 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 Manage
17、ment 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, Norw
18、ay, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland and United Kingdom. EUROPEAN COMMITTEE FOR STANDARDIZATION COMIT EUROPEN DE NORMALISATION EUROPISCHES KOMITEE FR NORMUNG Management Centre: Avenue Marnix 17, B-1000 Brussels 2009 CEN All rights of exploitation in any form
19、and by any means reserved worldwide for CEN national Members. Ref. No. EN ISO 21969:2009: EContents DIN EN ISO 21969:2010-04 EN ISO 21969:2009 (E) 2 Page Foreword .3 1 Scope4 2 * Normative references .5 3 Terms and definitions .5 4 Terminology .6 5 General requirements .7 5.1 Safety7 5.2 Alternative
20、 construction .7 5.3 Materials .7 5.4 Design requirements.7 5.5 Constructional requirements .9 6 Test methods .9 6.1 General .9 6.2 Type tests.10 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
21、A (informative) Rationale15 Bibliography16 Annex ZA (informative) Relationship between this International Standard and the Essential Requirements of EU Directive 93/42/EEC .17Foreword anaesthetic equipment” the secretariat of which is held by BSI. This European Standard shall be given the status of
22、a national standard, either by publication of an identical text or by endorsement, at the latest by May 2010, and conflicting national standards shall be withdrawn at the latest by May 2010. Attention is drawn to the possibility that some of the elements of this document may be the subject of patent
23、 rights. CEN and/or CENELEC shall not be held responsible for identifying any or all such patent rights. This document supersedes EN ISO 21969:2006. This document has been prepared under a mandate given to CEN by the European Commission and the European Free Trade Association, and supports essential
24、 requirements of EU Directive. For relationship with EU 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: A
25、ustria, 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. Endors
26、ement notice The text of ISO 21969:2009 has been approved by CEN as a EN ISO 21969:2009 without any modification. DIN EN ISO 21969:2010-04 EN ISO 21969:2009 (E) 3 and respiratory equipment” in collaboration with Technical Committee CEN/TC 215 “Respiratory and This document (EN ISO 21969:2009) has be
27、en prepared by Technical Committee ISO/TC 121 “Anaesthetic 1 Scope 1.1 This International Standard applies to high-pressure flexible connections intended to be connected to cylinders or cylinder bundles with nominal filling pressures up to 25 000 kPa at 15 C for use with the following medical gases:
28、 oxygen; nitrous oxide; air for breathing; helium; carbon dioxide; xenon; mixtures of the gases listed above; air for driving surgical tools; nitrogen for driving surgical tools; oxygen-enriched air. 1.2 This International Standard applies to high-pressure flexible connections intended to connect cy
29、linders or cylinder bundles to manifolds within sources of supply of medical gas pipeline systems complying with ISO 7396-1. 1.3 This International Standard applies to high-pressure flexible connections intended to connect a cylinder to an inlet port of medical equipment (e.g. anaesthetic workstatio
30、n or lung ventilator) fitted with an integral pressure regulator complying with ISO 10524-1. 1.4 This International Standard does not apply to high-pressure flexible connections intended to be used to fill cylinders nor does it apply to low-pressure flexible hose assemblies that are covered by ISO 5
31、359. DIN EN ISO 21969:2010-04 EN ISO 21969:2009 (E) 4 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 (inclu
32、ding any amendments) applies. ISO 32:1977, Gas cylinders for medical use Marking for identification of content ISO 407:2004, Small medical gas cylinders Pin-index yoke-type valve connections ISO 5145:2004, Cylinder valve outlets for gases and gas mixtures Selection and dimensioning ISO 7396-1:2007,
33、Medical gas pipeline systems Part 1: Pipeline systems for compressed medical gases and vacuum ISO 14971:2007, Medical devices Application of risk management to medical devices ISO 15001:2003, Anaesthetic and respiratory equipment Compatibility with oxygen 3 Terms and definitions For the purposes of
34、this document the following terms and definitions apply. 3.1 cylinder bundle pack or pallet of cylinders linked together with one or more connectors for filling and emptying 3.2 gas-specific having characteristics which prevent connection between different gas services 3.3 manifold device for connec
35、ting the outlet(s) of one or more cylinders or cylinder bundles of the same gas to the pipeline system 3.4 medical gas any gas or mixture of gases intended for administration to patients for anaesthetic, therapeutic, diagnostic or prophylactic purposes 3.5 nominal inlet pressure P1pressure for which
36、 the high-pressure flexible connection is intended to be used NOTE P1is specified by the manufacturer. 3.6 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 NOTE This definition
37、 was taken from IEC 60601-1. DIN EN ISO 21969:2010-04 EN ISO 21969:2009 (E) 5 4 Terminology Typical examples of high-pressure flexible connections are given in Figure 1. a) Coiled metal pipe (e.g. copper) b) Metal (e.g. copper or stainless steel) pipe connected by a swivel c) Corrugated metal (e.g.
38、stainless steel) hose fitted with retaining straps Key 1 inlet connector 2 outlet connector 3 swivel 4 restraining cable 5 handle to prevent torsion Figure 1 Typical examples of high-pressure flexible connections DIN EN ISO 21969:2010-04 EN ISO 21969:2009 (E) 6 5 General requirements 5.1 Safety High
39、-pressure flexible connections 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 risk management procedures in accordance with ISO 14971 and which are
40、 connected with their intended application, in normal condition and in single fault condition. 5.2 Alternative construction High-pressure flexible connections and components or parts thereof, using materials or having forms of construction different from those detailed in Clause 5 shall be presumed
41、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 a
42、vailable. Evidence that an equivalent degree of safety is obtained shall be provided by the manufacturer upon request. 5.3 Materials 5.3.1 * The materials in contact with the medical gases listed in 1.1, during normal use shall be resistant to corrosion and compatible with oxygen, with the other med
43、ical gases and with their mixtures in the temperature range specified in 5.3.3. NOTE 1 Corrosion resistance includes resistance against moisture and surrounding materials. NOTE 2 Compatibility with oxygen involves both combustibility and ease of ignition. Materials that burn in air will burn violent
44、ly in pure oxygen. Many materials that do not burn in air will do so in pure oxygen, particularly under pressure. Similarly, materials that can be ignited in air require lower ignition energies for ignition in oxygen. Many such materials can be ignited by friction at a valve seat or by adiabatic com
45、pression produced when oxygen at high pressure is rapidly introduced into a system initially at low pressure. NOTE 3 Criteria for the selection of metallic and non-metallic materials are given in ISO 15001. 5.3.2 * Non-metallic (e.g. polymer-lined or rubber-reinforced) flexible hoses shall not be us
46、ed. 5.3.3 The materials shall permit the high-pressure flexible connections and their components to meet the requirements of 5.4 in the temperature range of 20 C to + 60 C. NOTE Regional or national environmental conditions may require deviation from this range of temperatures. 5.3.4 High-pressure f
47、lexible connections shall meet the requirements of this International Standard after being packed for transport and storage and after being exposed to environmental conditions as stated by the manufacturer. 5.3.5 Evidence of conformity with the requirements of 5.3.1, 5.3.3 and 5.3.4 shall be provide
48、d by the manufacturer upon request. 5.4 Design requirements 5.4.1 Inlet connector The inlet connector, for connection to the cylinder valve, shall be gas-specific and conform to ISO 407, ISO 5145 or the relevant regional or national standard (see ISO/TR 7470 for information). DIN EN ISO 21969:2010-0
49、4 EN ISO 21969:2009 (E) 7 5.4.2 Outlet connector 5.4.2.1 The outlet connector shall be one of the following: a) a connector for connection to the manifold; b) a connector for connection to the inlet port of medical equipment; this connector shall be the cylinder valve outlet for the specific medical gas, in accordance with ISO 407, ISO 5145 or the relevant national standard (see ISO/TR 7470 for information). 5.4.2.2 Means shall be provided to prevent the installation of an incorrect high-pressure flexib
