1、February 2015 Translation by DIN-Sprachendienst.English price group 18No 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).I
2、CS 11.040.10!%R“2296147www.din.deDDIN EN ISO 5367Anaesthetic and respiratory equipment Breathing sets and connectors (ISO 5367:2014);English version EN ISO 5367:2014,English translation of DIN EN ISO 5367:2015-02Ansthesie- und Beatmungsgerte Atemsets und Verbindungsstcke (ISO 5367:2014);Englische Fa
3、ssung EN ISO 5367:2014,Englische bersetzung von DIN EN ISO 5367:2015-02Matriel danesthsie et de ranimation respiratoire Systmes respiratoires et raccords (ISO 5367:2014);Version anglaise EN ISO 5367:2014,Traduction anglaise de DIN EN ISO 5367:2015-02SupersedesDIN EN 12342:2010-01See start of applica
4、tionwww.beuth.deDocument comprises 46 pagesIn case of doubt, the German-language original shall be considered authoritative.02.15DIN EN ISO 5367:2015-02 2 A comma is used as the decimal marker. Start of application The start of application of this standard is 2015-02-01. DIN EN 12342:2010-01 may be
5、used in parallel until 2017-10-31. National foreword This document (EN ISO 5367:2014) 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” (Secretariat: BSI, United Kin
6、gdom). The responsible German body involved in its preparation was the DIN-Normenausschuss Rettungsdienst und Krankenhaus (DIN Standards Committee Rescue Services and Hospital), Working Committee NA 053-03-02 AA Medizinprodukte fr das Atemwegssystem. The DIN Standards corresponding to the Internatio
7、nal Standards referred to in this document are as follows: ISO 4135 DIN EN ISO 4135 ISO 5356-1 DIN EN ISO 5356-1 ISO 7000 DIN ISO 7000 ISO 8185 DIN EN ISO 8185 ISO 10993-1 DIN EN ISO 10993-1 ISO 11607-1 DIN EN ISO 11607-1 ISO 14971 DIN EN ISO 14971 ISO 15223-1 DIN EN ISO 15223-1 ISO 23328-2 DIN EN I
8、SO 23328-2 ISO 80601-2-12 DIN EN ISO 80601-2-12 ISO 80601-2-13 DIN EN ISO 80601-2-13 IEC 60601-1 DIN EN 60601-1 IEC 60601-1-6 DIN EN 60601-1-6 IEC 62366 DIN EN 62366 Amendments This standard differs from DIN EN 12342:2010-01 as follows: a) the scope has been extended to include breathing sets as fin
9、ished assemblies and coaxial breathing tubes; b) requirements for flow resistance, leakage and compliance have been revised and aligned with DIN EN ISO 80601-2-12 and DIN EN ISO 80601-2-13; c) limit values to prevent electrostatic charges have been revised; d) requirements for labelling, marking and
10、 instructions for use have been revised; e) test methods have been revised to be in line with the extended scope; f) an informative Annex A providing a rationale for specifications and explanations concerning the flow resistance and leakage test methodology has been added; g) an informative Annex B
11、dealing with hazard identification for risk assessment has been added; h) the standard has been editorially revised. Previous editions DIN EN 12342: 1998-09, 2010-01 DIN EN ISO 5367:2015-02 3 National Annex NA (informative) Bibliography DIN EN 60601-1, Medical electrical equipment Part 1: General re
12、quirements for basic safety and essential performance DIN EN 60601-1-6, Medical electrical equipment Part 1-6: General requirements for basic safety and essential performance Collateral standard: Usability DIN EN 62366, Medical devices Application of usability engineering to medical devices DIN EN I
13、SO 4135, Anaesthetic and respiratory equipment Vocabulary DIN EN ISO 53561, Anaesthetic and respiratory equipment Conical connectors Part 1: Cones and sockets DIN EN ISO 8185, Respiratory tract humidifiers for medical use Particular requirements for respiratory humidification systems DIN EN ISO 1099
14、3-1, Biological evaluation of medical devices Part 1: Evaluation and testing within a risk management system DIN EN ISO 11607-1, Packaging for terminally sterilized medical devices Part 1: Requirements for materials, sterile barrier systems and packaging systems DIN EN ISO 14971, Medical devices App
15、lication of risk management to medical devices DIN EN ISO 15223-1, Medical devices Symbols to be used with medical device labels, labelling and information to be supplied Part 1: General requirements DIN EN ISO 23328-2, Breathing system filters for anaesthetic and respiratory use Part 2: Non-filtrat
16、ion aspects DIN EN 80601-2-12, Medical electrical equipment Part 2-12: Particular requirements for basic safety and essential performance of critical care ventilators DIN EN 80601-2-13, Medical electrical equipment Part 2-13: Particular requirements for basic safety and essential performance of an a
17、naesthetic workstation DIN ISO 7000, Graphical symbols for use on equipment Index and synopsis DIN EN ISO 5367:2015-02 4 This page is intentionally blank EUROPEAN STANDARD NORME EUROPENNE EUROPISCHE NORM EN ISO 5367 October 2014 ICS 11.040.10 Supersedes EN 12342:1998+A1:2009English Version Anaesthet
18、ic and respiratory equipment - Breathing sets and connectors (ISO 5367:2014) Matriel danesthsie et de ranimation respiratoire - Systmes respiratoires et raccords (ISO 5367:2014) Ansthesie- und Beatmungsgerte - Atemsets und Verbindungsstcke (ISO 5367:2014) This European Standard was approved by CEN o
19、n 18 July 2014. 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
20、be obtained on application to the CEN-CENELEC 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
21、 the CEN-CENELEC Management Centre has the same status as the official versions. CEN members are the national standards bodies of Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, Former Yugoslav Republic of Macedonia, France, Germany, Greece, Hungary, Iceland,
22、Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and United Kingdom. EUROPEAN COMMITTEE FOR STANDARDIZATION COMIT EUROPEN DE NORMALISATION EUROPISCHES KOMITEE FR NORMUNG CEN-CENELEC Management
23、 Centre: Avenue Marnix 17, B-1000 Brussels 2014 CEN All rights of exploitation in any form and by any means reserved worldwide for CEN national Members. Ref. No. EN ISO 5367:2014 EContents PageForeword .3Introduction 41 Scope . 52 Normative references 53 Terms and definitions . 64 General requiremen
24、ts . 84.1 Risk management . 84.2 Usability 84.3 Clinical evaluation 94.4 Biophysical or modelling research 94.5 Test methods . 94.6 Recommended service life 95 Specific requirements . 95.1 Materials . 95.2 Length . 95.3 Means of connection . 105.4 Leakage . 115.5 Resistance to flow 115.6 Compliance
25、126 Prevention of electrostatic charges . 137 Requirements for breathing sets and breathing tubes supplied sterile . 137.1 Sterility assurance . 137.2 Packaging of breathing sets and breathing tubes supplied sterile 138 Marking .148.1 General 148.2 Marking of breathing sets and breathing tubes .148.
26、3 Marking of packages 148.4 Information to be supplied by the manufacturer .16Annex A (informative) Rationale 17Annex B (informative) Hazard identification for risk assessment 27Annex C (normative) Test for security of attachment of plain end to conical connector .28Annex D (normative) Test for secu
27、rity of attachment of adaptor to breathing tube .29Annex E (normative) Test for leakage 30Annex F (normative) Measurement of resistance to flow .32Annex G (normative) Test for increase in flow resistance with bending 35Annex H (normative) Test for compliance 37Bibliography 42Annex ZA (informative) R
28、elationship between this European Standard and the Essential Requirements of EU Directive 93/42/EEC. .39 2EN ISO 5367:2014 (E) DIN EN ISO 5367:2015-02 Foreword This document (EN ISO 5367:2014) has been prepared by Technical Committee ISO/TC 121 “Anaesthetic and respiratory equipment” in collaboratio
29、n 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 April 2015, and conflicting n
30、ational standards shall be withdrawn at the latest by October 2017. 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 supe
31、rsedes EN 12342:1998+A1:2009. 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 EU Directive(s). For relationship with EU Directive(s), see informative Annex ZA, which is an integral
32、 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, Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, Former Yugoslav Republic o
33、f Macedonia, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and the United Kingdom. Endorsement notice The text of ISO 5367:2014 has been approved
34、by CEN as EN ISO 5367:2014 without any modification. 3EN ISO 5367:2014 (E) DIN EN ISO 5367:2015-02 IntroductionThis International Standard contains requirements for breathing sets, breathing tubes, and connectors that are intended to function as accessories to anaesthetic and respiratory equipment.
35、Breathing sets and breathing tubes are characterized by certain design requirements such as a means of connection and leakage limits. Disclosure requirements for compliance and flow resistance values allow the user to make an informed choice when connecting these accessories to a breathing system. T
36、hese design requirements are intended to allow operation within the limits of performance of the anaesthetic breathing systems and ventilator breathing systems with which the accessories are intended to operate.This International Standard includes requirements for both single-use and reusable breath
37、ing sets and breathing tubes. Re-usable breathing sets and breathing tubes are intended to comply with the requirements of this International Standard for the recommended service life.Certain tests are performed under constant pressure to simplify the test methodology. It is recognized that this doe
38、s not reflect clinical use, where pressure is intermittent and peak pressures occur for short periods. The limits in the test methods take this into account. While such test methods do not address product variability, the limits required also take this into account.Terms defined in this Internationa
39、l Standard are set in bold type.Throughout this International Standard, text for which a rationale is provided in Annex A is indicated by an asterisk (*).Throughout this International Standard, all pressures are denoted in SI units of hPa with corresponding cmH2O equivalent values rounded to the nea
40、rest whole cmH2O.NOTE The unit cmH2O is not an SI notation and is not used in ISO documents; rounded cmH2O values are given for information only to allow comparison to medical literature and related breathing system standards.4EN ISO 5367:2014 (E) DIN EN ISO 5367:2015-02 1 Scope*This International S
41、tandard specifies basic requirements for breathing sets and breathing tubes intended to be used with anaesthetic breathing systems, ventilator breathing systems, humidifiers or nebulizers. It applies to breathing sets and breathing tubes and patient end adaptors supplied already assembled and to tho
42、se supplied as components and assembled in accordance with the manufacturers instructions.This International Standard is applicable to breathing sets which include special components (e.g. water traps) between the patient end and machine end which are supplied already assembled.This International St
43、andard is not applicable to breathing sets and breathing tubes for special purposes.EXAMPLE 1 Ventilators having special compliance, pressure or breathing frequency requirements.EXAMPLE 2 High Frequency Oscillatory Ventilation, (HFOV) or High Frequency Jet Ventilation (HFJV).EXAMPLE 3 Breathing sets
44、 and breathing tubes with special connectors for neonatal ventilation.Provision is made for coaxial and related bifurcated, double-lumen, or multiple-lumen breathing sets and breathing tubes suitable for use with patient end adaptors.NOTE 1 Examples of various types of breathing sets with patient en
45、d adaptors are depicted in Annex A.Requirements for exhalation valves, exhaust valves, adjustable pressure-limiting (APL) valves, heat and moisture exchangers (HMEs), breathing filters, and reservoir bags, if provided, are not covered by this International Standard.NOTE 2 ISO 80601-2-12, ISO 80601-2
46、-13, ISO 9360-13, ISO 23328-24, and ISO 53621cover these.NOTE 3 Certain aspects of heated-wire breathing tubes are discussed in ISO 81852.2 Normative references*The following documents, in whole or in part, are normatively referenced in this document and are indispensable for its application. For da
47、ted references, only the edition cited applies. For undated references, the latest edition of the referenced document (including any amendments) applies.NOTE See Annex A for information on the use of dated and undated normative references.ISO 5356-1, Anaesthetic and respiratory equipment Conical con
48、nectors Part 1: Cones and socketsISO 7000, Graphical symbols for use on equipment Registered symbolsISO 10993-1, Biological evaluation of medical devices Part 1: Evaluation and testing within a risk management processISO 11607-1, Packaging for terminally sterilized medical devices Part 1: Requiremen
49、ts for materials, sterile barrier systems and packaging systemsISO 14971, Medical devices Application of risk management to medical devices5EN ISO 5367:2014 (E) DIN EN ISO 5367:2015-02 ISO 15223-1:2012, Medical devices Symbols to be used with medical device labels, labelling and information to be supplied Part 1: General requirementsIEC 60417, Graphical symbols for use on equipmentIEC 60601-1:2005, Medical electrical equipment Part 1: General requirements for basic safety and esse
