DIN EN ISO 10555-3-2013 Intravascular catheters - Sterile and single-use catheters - Part 3 Central venous catheters (ISO 10555-3 2013) German version EN ISO 10555-3 2013《血管内导管 一次性.pdf

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1、November 2013 Translation by DIN-Sprachendienst.English price group 7No 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).IC

2、S 11.040.25!%*,a“2070962www.din.deDDIN EN ISO 10555-3Intravascular catheters Sterile and single-use catheters Part 3: Central venous catheters (ISO 10555-3:2013);English version EN ISO 10555-3:2013,English translation of DIN EN ISO 10555-3:2013-11Intravaskulre Katheter Sterile Katheter zur einmalige

3、n Verwendung Teil 3: Zentrale vense Katheter (ISO 10555-3:2013);Englische Fassung EN ISO 10555-3:2013,Englische bersetzung von DIN EN ISO 10555-3:2013-11Cathters intravasculaires Cathters striles et non rutilisables Partie 3: Cathters centraux veineux (ISO 10555-3:2013);Version anglaise EN ISO 10555

4、-3:2013,Traduction anglaise de DIN EN ISO 10555-3:2013-11SupersedesDIN EN ISO 10555-3:1997-11www.beuth.deDocument comprises 10 pagesIn case of doubt, the German-language original shall be considered authoritative.10.13 DIN EN ISO 10555-3:2013-11 2 A comma is used as the decimal marker. National fore

5、word This document (EN ISO 10555-3:2013) has been prepared by Technical Committee ISO/TC 84 “Devices for administration of medicinal products and intravascular catheters” in collaboration with Technical Committee CEN/TC 205 “Non-active medical devices” (Secretariat: DIN, Germany). The responsible Ge

6、rman body involved in its preparation was the Normenausschuss Medizin (Medical Standards Committee), Working Committee NA 063-01-02 AA Katheter, Drainagen. The DIN Standards corresponding to the International Standards referred to in this document are as follows: ISO 10555-1 DIN EN ISO 10555-1 ISO 1

7、1070 DIN EN ISO 11070 Amendments This standard differs from DIN EN ISO 10555-3:1997-11 as follows: a) Clause 4 “Requirements” has been revised and, to be in line with Part 1 of the standards series, the former Subclauses 4.2 “Radio-detectability”, 4.6 “Flowrate” and 4.3 “Tip configuration” have been

8、 deleted entirely; b) the former Annex A “Determination of flowrate through the catheter” has been deleted (see Part 1 of the standards series); c) the Bibliography has been revised; d) the standard has been editorially revised. Previous editions DIN EN ISO 10555-3: 1997-11 National Annex NA (inform

9、ative) Bibliography DIN EN ISO 10555-1, Intravascular catheters Sterile and single-use catheters Part 1: General requirements DIN EN ISO 11070, Sterile single-use intravascular catheter introducers EUROPEAN STANDARD NORME EUROPENNE EUROPISCHE NORM EN ISO 10555-3 July 2013 ICS 11.040.25 Supersedes EN

10、 ISO 10555-3:1997English Version Intravascular catheters - Sterile and single-use catheters - Part 3: Central venous catheters (ISO 10555-3:2013) Cathters intravasculaires - Cathters striles et non rutilisables - Partie 3: Cathters centraux veineux (ISO 10555-3:2013) Intravaskulre Katheter - Sterile

11、 Katheter zur einmaligen Verwendung - Teil 3: Zentrale vense Katheter (ISO 10555-3:2013) This European Standard was approved by CEN on 29 May 2013. CEN members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for giving this European Standard the status of

12、 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 official versions (English, French, German)

13、. 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 Austria, Belgium, Bulgaria, Croatia, C

14、yprus, 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, Sweden, Switzerland, Turkey and United

15、Kingdom. EUROPEAN COMMITTEE FOR STANDARDIZATION COMIT EUROPEN DE NORMALISATION EUROPISCHES KOMITEE FR NORMUNG Management Centre: Avenue Marnix 17, B-1000 Brussels 2013 CEN All rights of exploitation in any form and by any means reserved worldwide for CEN national Members. Ref. No. EN ISO 10555-3:201

16、3: EContents PageForeword 31 Scope . 42 Normative references 43 Terms and definitions . 44 Requirements 44.1 General . 44.2 Distance markings 44.3 Lumen markings 44.4 Peak tensile force 54.5 Information to be supplied by the manufacturer 5Bibliography 8of EU Directive 93/42/EEC amended by Directive

17、2007/47/EEC.3Annex ZA (informative) Relationship between this European Standard and the Essential RequirementsDIN EN ISO 10555-3:2013-11 EN ISO 10555-3:2013 (E) 26Foreword This document (EN ISO 10555-3:2013) has been prepared by Technical Committee ISO/TC 84 “Devices for administration of medicinal

18、products and intravascular catheters” in collaboration with Technical Committee CEN/TC 205 “Non-active medical devices” the secretariat of which is held by DIN. This European Standard shall be given the status of a national standard, either by publication of an identical text or by endorsement, at t

19、he latest by January 2014, and conflicting national standards shall be withdrawn at the latest by January 2014. 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 o

20、r all such patent rights. This document supersedes EN ISO 10555-3:1997. 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

21、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, Croatia, Cyprus, Czech Republic, Denmark, Es

22、tonia, 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, Sweden, Switzerland, Turkey and the United Kingdom. Endorsement notice Th

23、e text of ISO 10555-3:2013 has been approved by CEN as EN ISO 10555-3:2013 without any modification. This second edition cancels and replaces the first edition (ISO 10555-3:1996), which has been technically revised. It also incorporates the Technical Corrigendum ISO 10555-3:1996/Cor 1:2002. ISO 1055

24、5 consists of the following parts, under the general title Intravascular catheters Sterile and single-use catheters: Part 1: General requirements Part 3: Central venous catheters Part 4: Balloon dilatation catheters Part 5: Over-needle peripheral catheters The following part is under preparation: Pa

25、rt 6: Subcutaneous implanted ports The following part has been withdrawn and the content has been included in ISO 10555-1: Part 2: Angiographic catheters Attention is drawn to ISO 11070, which specifies requirements for accessory devices for use with intravascular catheters. DIN EN ISO 10555-3:2013-

26、11 EN ISO 10555-3:2013 (E) 3 1 ScopeThis part of ISO 10555 specifies requirements for central venous catheters supplied in the sterile condition, and intended for single use.2 Normative referencesThe following documents, in whole or in part, are normatively referenced in this document and are indisp

27、ensable for its application. For dated references, only the edition cited applies. For undated references, the latest edition of the referenced document (including any amendments) applies.ISO 10555-1:2013, Intravascular catheters Sterile and single-use catheters Part 1: General requirements3 Terms a

28、nd definitionsFor the purposes of this document, the terms and definitions given in ISO 10555-1 and the following apply.3.1central venous catheterintravascular catheter, single- or multilumen, designed for introduction into, or withdrawal of liquids from, the central venous system and/or for pressur

29、e or other measurementsNote 1 to entry: The catheter can have a fixation system which is part of the device.4 Requirements4.1 GeneralCatheters shall comply with ISO 10555-1, except for the peak tensile force (see ISO 10555-1:2013, 4.6), for which the requirements of 4.4 of this part of ISO 10555 sha

30、ll apply.4.2 Distance markingsIf the catheter is provided with distance markings, the marking system shall indicate distance from the distal end. From the first mark, the distance between marks shall not exceed 5 cm.It is recommended that the distance marks be 1 cm apart on that portion of the cathe

31、ter likely to be of importance to the user in positioning the catheter and monitoring catheter migration.4.3 Lumen markingsFor multilumen catheters, identification of each lumen shall be apparent to the user.DIN EN ISO 10555-3:2013-11 EN ISO 10555-3:2013 (E) 4 4.4 Peak tensile forceFor catheters hav

32、ing a tip of softer durometer material or of different construction to the shaft and not exceeding 20 mm in length, the minimum peak tensile force of the tip shall be as given in Table 1 when tested in accordance with the method given in ISO 10555-1:2013, Annex B.The minimum peak tensile force of al

33、l other parts of such catheters shall comply with ISO 10555-1:2013, 4.6.Table 1 Minimum peak tensile force of soft tips of length not exceeding 20 mmSmallest outside diameter of catheter bodymmMinimum peak tensile forceN 0,550 and 0,75 3 0,75 and 1,85 4 1,85 54.5 Information to be supplied by the ma

34、nufacturerInformation supplied by the manufacturer shall comply with ISO 10555-1 and shall also contain the following:a) if the catheter is provided with distance markings, a description of the marking system;b) flowrate for each lumen;c) maximum guidewire diameter, where applicable;d) if applicable

35、, a warning against attempting to withdraw the catheter back through the needle;e) at least one recommended cleaning agent.Units of measurement systems other than those specified in this part of ISO 10555 may additionally be used.DIN EN ISO 10555-3:2013-11 EN ISO 10555-3:2013 (E) 5 Annex ZA (informa

36、tive) Relationship between this European Standard and the Essential Requirements of EU Directive 93/42/EEC amended by Directive 2007/47/EEC This European Standard has been prepared under a mandate given to CEN by the European Commission and the European Free Trade Association to provide a means of c

37、onforming to Essential Requirements of Directive 93/42/EEC amended by Directive 2007/47/EEC. Once this standard is cited in the Official Journal of the European Union under that Directive and has been implemented as a national standard in at least one Member State, compliance with the normative clau

38、ses of this standard given in Table ZA.1 confers, within the limits of the scope of this standard, a presumption of conformity with the relevant Essential Requirements of that Directive. NOTE When an Essential Requirement does not appear in Table ZA.1, it means that it is not addressed by this Europ

39、ean Standard. Table ZA.1 Correspondence between this European Standard and Directive 93/42/EEC amended by Directive 2007/47/EEC Essential Requirements (ERs) of Directive 93/42/EEC Clause(s)/sub-clause(s) of this EN ISO 10555-3 7.3 4.1 7.5 4.1 8.1 4.1 8.3 4.1 8.4 4.1 9.1 4.1 9.2 4.1 4.2 4.3 4.4 12.7.

40、1 4.1 4.4 12.7.4 4.1 12.8.1 4.1 12.9 4.2* 4.3* 13.1 4.1 13.2 4.1 13.3 a) 4.1 13.3 b) 4.1 DIN EN ISO 10555-3:2013-11 EN ISO 10555-3:2013 (E) 6 13.3 c) 4.1 13.3 d) 4.1 13.3 e) 4.1 13.3 f) 4.1 13.3 i) 4.1 13.3 j) 4.1 13.3 k) 4.1 4.5 d) 13.3 m) 4.1 13.4 4.1 13.6 a) 4.1 13.6 b) 4.1 4.5 a), b) and c) 13.6

41、 c) 4.1 13.6 e) 4.1 13.6 f) 4.1 13.6 g) 4.1 13.6 h 4.5 c)* 13.6 k) 4.1 13.6 l) 4.1 13.6 n) 4.1 13.6 q) 4.1 (*) Not applicable for the patient. (*) The information is on cleaning even though it is not a reusable devices. WARNING Other requirements and other EU Directives may be applicable to the product(s) falling within the scope of this standard. DIN EN ISO 10555-3:2013-11 EN ISO 10555-3:2013 (E) 7 Bibliography1 ISO 11070, Sterile, single-use intravascular catheter introducersDIN EN ISO 10555-3:2013-11 EN ISO 10555-3:2013 (E) 8