1、February 2015 Translation by DIN-Sprachendienst.English price group 17No 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 11.040.25!%BEnglish version EN ISO 8836:2014,English translation of DIN EN ISO 8836:2015-02Absaugkatheter zur Verwendung im Atemtrakt (ISO 8836:2014);Englische Fassung EN ISO 8836:2014,Englische bersetzung von DIN EN ISO 8836:2015-02Sondes daspiration pour les voies respiratoires (ISO 8836:2014);
3、Version anglaise EN ISO 8836:2014,Traduction anglaise de DIN EN ISO 8836:2015-02SupersedesDIN EN ISO 8836:2009-08www.beuth.deDocument comprises 38 pagesIn case of doubt, the German-language original shall be considered authoritative.01.15 DIN EN ISO 8836:2015-02 2 A comma is used as the decimal mark
4、er. National foreword This document (EN ISO 8836:2014) has been prepared by Technical Committee ISO/TC 121 “Anaesthetic and respiratory equipment”, Subcommittee SC 2 “Airways and related equipment” (Secretariat: ANSI, USA) in collaboration with Technical Committee CEN/TC 215 “Respiratory and anaesth
5、etic equipment” (Secretariat: BSI, United Kingdom). 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. In a
6、ddition to the internationally recognized SI unit for pressure, the pascal (here, Pa or kPa), this standard expresses pressure in terms of the manometric unit (cmH2O) as an alternative. Users of this standard should note that in Germany use of the latter unit in official or commercial correspondence
7、 is not permitted according to the German Act on Units in Metrology (MeEinhG) of 22 February 1985, and the Implementing Ordinance on the Act on Units in Metrology (EinhV) of 13 December 1985, as amended on 29 October 2001 and 25 November 2003. For clauses and subclauses marked with an asterisk (*) a
8、fter their number, Annex A (informative) provides a concise rationale. The DIN Standards corresponding to the International Standards referred to in this document are as follows: ISO 594-1 DIN EN 20594-1 ISO 594-2 DIN EN 1707 ISO 4135 DIN EN ISO 4135 ISO 5356-1 DIN EN ISO 5356-1 ISO 5367 DIN EN ISO
9、5367 ISO 7000 DIN ISO 7000 ISO 10079-1 DIN EN ISO 10079-1 ISO 10079-2 DIN EN ISO 10079-2 ISO 10079-3 DIN EN ISO 10079-3 ISO 10993-1 DIN EN ISO 10993-1 ISO 11135-1 DIN EN ISO 11135-1 ISO 11137-1 DIN EN ISO 11137-1 ISO 11607-1 DIN EN ISO 11607-1 ISO 11607-2 DIN EN ISO 11607-2 ISO 14155 DIN EN ISO 1415
10、5 ISO 14971 DIN EN ISO 14971 ISO 15223-1 DIN EN ISO 15223-1 IEC 62366 DIN EN 62366 DIN EN ISO 8836:2015-02 3 Amendments This standard differs from DIN EN ISO 8836:2009-08 as follows: a) the scope has been extended to include closed suction catheters; b) term, definition and requirements for “suction
11、 catheter connector” have been included; c) general requirements relating to risk evaluation and safety have been supplemented; d) the requirement has been added that suction catheters shall not contain natural rubber latex; e) the test procedure for checking the durability and legibility of the mar
12、king of suction catheters has been specified; f) the requirement for the shaft design as regards the visualization of secretions removed has been revised; g) the requirement for the marking of suction catheters or parts incorporating phthalates has been supplemented; h) further requirements includin
13、g test methods for closed suction catheters have been added; i) the force required to detach components not securely attached including the test method has been specified; j) the requirement for radiopacity including the test method has been supplemented; k) the requirements for the marking of sucti
14、on catheters, labelling of individual packs and shelf/multi-unit packs have been revised; l) an informative Annex A providing a rationale for the important requirements has been added; m) an informative Annex E dealing with hazard identification for risk assessment has been added: n) Annex ZA “Relat
15、ionship between this European Standard and the Essential Requirements of EU Directive 93/42/EEC” on Medical devices has been revised; o) the standard has been editorially revised. Previous editions DIN EN 1733: 1998-05, 2003-02 DIN EN ISO 8836: 2008-09, 2009-08 DIN EN ISO 8836:2015-02 4 National Ann
16、ex NA (informative) Bibliography DIN EN 1707, Conical fittings with a 6 % (Luer) taper for syringes, needles and certain other medical equipment Lock fittings DIN EN 20594-1, Conical fittings with a 6 % (Luer) taper for syringes, needles and certain other medical equipment Part 1: General requiremen
17、ts DIN EN 62366 (VDE 0750-241), Medical devices Application of usability engineering to medical devices DIN EN ISO 4135, Anaesthetic and respiratory equipment Vocabulary DIN EN ISO 5356-1, Anaesthetic and respiratory equipment Conical connectors Part 1: Cones and sockets DIN EN ISO 5367, Anaesthetic
18、 and respiratory equipment Breathing sets and connectors DIN EN ISO 10079-1, Medical suction equipment Part 1: Electrically powered suction equipment Safety requirements DIN EN ISO 10079-2, Medical suction equipment Part 2: Manually powered suction equipment DIN EN ISO 10079-3, Medical suction equip
19、ment Part 3: Suction equipment powered from a vacuum or positive pressure gas source DIN EN ISO 10993-1, Biological evaluation of medical devices Part 1: Evaluation and testing within a risk management system DIN EN ISO 11135-1, Sterilization of health care products Ethylene oxide Part 1: Requiremen
20、ts for development, validation and routine control of a sterilization process for medical devices DIN EN ISO 11137-1, Sterilization of health care products Radiation Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices DIN EN ISO 11607-1
21、, Packaging for terminally sterilized medical devices Part 1: Requirements for materials, sterile barrier systems and packaging systems DIN EN ISO 11607-2, Packaging for terminally sterilized medical devices Part 2: Validation requirements for forming, sealing and assembly processes DIN EN ISO 14155
22、, Clinical investigation of medical devices for human subjects Good clinical practice DIN EN ISO 14971, Medical devices Application 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
23、: General requirements DIN ISO 7000, Graphical symbols for use on equipment Index and synopsis EUROPEAN STANDARD NORME EUROPENNE EUROPISCHE NORM EN ISO 8836 October 2014 ICS 11.040.25; 11.040.10 Supersedes EN ISO 8836:2009English Version Suction catheters for use in the respiratory tract (ISO 8836:2
24、014) Sondes daspiration pour les voies respiratoires(ISO 8836:2014) Absaugkatheter zur Verwendung im Atemtrakt(ISO 8836:2014) This European Standard was approved by CEN on 25 July 2014. CEN members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for givin
25、g 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-CENELEC Management Centre or to any CEN member. This European Standard exists in three offic
26、ial 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-CENELEC Management Centre has the same status as the official versions. CEN members are the national standards bodies of
27、Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, Former Yugoslav Republic of Macedonia, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, S
28、weden, Switzerland, Turkey and United Kingdom. EUROPEAN COMMITTEE FOR STANDARDIZATION COMIT EUROPEN DE NORMALISATION EUROPISCHES KOMITEE FR NORMUNG CEN-CENELEC Management Centre: Avenue Marnix 17, B-1000 Brussels 2014 CEN All rights of exploitation in any form and by any means reserved worldwide for
29、 CEN national Members. Ref. No. EN ISO 8836:2014 EContents PageForeword 3Introduction .41 Scope . 52 Normative references 53 Terms and definitions . 64 *General requirements for open and closed suction catheters . 94.1 Risk management . 94.2 Safety 105 Specific requirements for open and closed sucti
30、on catheters . 105.1 Size and length designations 105.2 *Dimensions . 106 Materials 117 *Design . 127.1 Lumen of the suction catheter 127.2 Suction catheter tip 127.3 *Suction catheter connector . 127.4 Additional requirements for closed suction catheters 148 Performance requirements 168.1 Security
31、of construction . 168.2 Shaft performance . 168.3 *Vacuum control device performance . 178.4 *Leakage 178.5 *Resistance to flow . 178.6 *Radiopacity . 179 Requirements for suction catheters supplied sterile179.1 Sterility assurance . 179.2 Packaging of suction catheters supplied sterile 1810 Marking
32、 .1810.1 Marking on suction catheters 1810.2 Use of symbols 1910.3 Labelling of individual packs . 2010.4 Labelling of shelf/multi-unit packs 20Annex A (informative) Rationale .22Annex B (normative) Test method for security of attachment .25Annex C (normative) Measurement of residual vacuum 26Annex
33、D (normative) Method of testing leakage 28Annex E (informative) Hazard identification for risk assessment .29Bibliography .34Annex ZA (informative) Relationship between this European Standard and the Essential Requirements of EU Directive 93/42/EEC 31 DIN EN ISO 8836:2015-02 EN ISO 8836:2014 (E) 2Fo
34、reword This document (EN ISO 8836:2014) 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” the secretariat of which is held by BSI. This European Standard shall be gi
35、ven the status of a national standard, either by publication of an identical text or by endorsement, at the latest by April 2015, and conflicting national standards shall be withdrawn at the latest by April 2015. Attention is drawn to the possibility that some of the elements of this document may be
36、 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 ISO 8836:2009. This document has been prepared under a mandate given to CEN by the European Commission and the European Free Trade Association, a
37、nd supports essential requirements of EU Directive(s). For relationship with EU Directive(s), 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 implemen
38、t this European Standard: Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, Former Yugoslav Republic of Macedonia, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Sl
39、ovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and the United Kingdom. Endorsement notice The text of ISO 8836:2014 has been approved by CEN as EN ISO 8836:2014 without any modification. DIN EN ISO 8836:2015-02 EN ISO 8836:2014 (E) 3 IntroductionThis International Standard specifies dimensions
40、 and requirements for suction catheters for use in the respiratory tract. It is concerned with the basic requirements and method of size designation of both open and closed suction catheters made of flexible materials.The method of describing tube dimensions and configuration has been devised in ord
41、er to assist clinicians in the selection of the most suitable suction catheter for a particular patient. Size is designated by outside diameter which is important when selecting a catheter because of its relationship to the ease with which the catheter can be passed through a tracheal or tracheostom
42、y tube.234Revisions in this fourth edition are intended to harmonize this International Standard with recent amendments in the European Medical Device Directive.Major technical revisions in this edition include requirements for closed suction catheters, new requirements to harmonize this Internation
43、al Standard with requirements for critical care ventilators, and risk management.Terms defined in Clause 3 of this International Standard or in ISO 41351appear in bold type.Throughout this International Standard, text for which a rationale is provided in Annex A is indicated by an asterisk (*).DIN E
44、N ISO 8836:2015-02 EN ISO 8836:2014 (E) 4 1 ScopeThis International Standard specifies requirements for suction catheters, including closed suction catheters, made of flexible materials and intended for use in suctioning of the respiratory tract.Angled-tip suction catheters (e.g. Coud catheters) and
45、 suction catheters with aspirator collectors are not considered to be specialized and are therefore included in the scope of this International Standard.Suction catheters intended for use with flammable anaesthetic gases or agents, lasers or electrosurgical equipment are not covered by this Internat
46、ional Standard.NOTE See ISO/TR 11991 for guidance on airway management during laser surgery of the upper airway.62 Normative referencesThe following documents, in whole or in part, are normatively referenced in this document and are indispensable to its application. For dated references, only the ed
47、ition cited applies. For undated references, the latest edition of the referenced document (including any amendments) applies.*ISO 594-1, Conical fittings with a 6 % (Luer) taper for syringes, needles and certain other medical equipment Part 1: General requirements*ISO 594-2, Conical fittings with a
48、 6 % (Luer) taper for syringes, needles and certain other medical equipment Part 2: Lock fittingsISO 5356-1, Anaesthetic and respiratory equipment Conical connectors Part 1: Cones and socketsISO 5367:1), Anaesthetic and respiratory equipment Breathing sets and connectorsISO 7000, Graphical symbols for use on equipmen
