BS EN ISO 10555-3-2013 Intravascular catheters Sterile and single-use catheters Central venous catheters《血管内导管 一次性使用无菌导管 中心静脉导管》.pdf

1、BSI Standards PublicationBS EN ISO 10555-3:2013Intravascular catheters Sterile and single-use cathetersPart 3: Central venous catheters (ISO10555-3:2013)BS EN ISO 10555-3:2013 BRITISH STANDARDNational forewordThis British Standard is the UK implementation of EN ISO10555-3:2013. It supersedes BS EN I

2、SO 10555-3:1997 which iswithdrawn.The UK participation in its preparation was entrusted to TechnicalCommittee CH/84, Catheters and syringes.A list of organizations represented on this committee can beobtained on request to its secretary.This publication does not purport to include all the necessaryp

3、rovisions of a contract. Users are responsible for its correctapplication. The British Standards Institution 2013. Published by BSI StandardsLimited 2013ISBN 978 0 580 73019 1ICS 11.040.25Compliance with a British Standard cannot confer immunity fromlegal obligations.This British Standard was publis

4、hed under the authority of theStandards Policy and Strategy Committee on 31 July 2013.Amendments issued since publicationDate Text affectedEUROPEAN STANDARD NORME EUROPENNE EUROPISCHE NORM EN ISO 10555-3 July 2013 ICS 11.040.25 Supersedes EN ISO 10555-3:1997English Version Intravascular catheters -

5、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 Katheter zur einmaligen Verwendung - Teil 3: Zentrale vens

6、e 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 a national standard without any alteration. Up-to-date lis

7、ts 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). A version in any other language made by translation under

8、 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, Cyprus, Czech Republic, Denmark, Estonia, Finland, Former Yu

9、goslav 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 Kingdom. EUROPEAN COMMITTEE FOR STANDARDIZATION COMIT EUROP

10、EN 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 10555-3:2013: EBS EN ISO 10555-3:2013EN ISO 10555-3:2013 (E) 3 Forewor

11、d 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” the secretariat of which is held by DIN. This Euro

12、pean 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 2014, and conflicting national standards shall be withdrawn at the latest by January 2014. Attention is drawn to the possibility that some of the ele

13、ments 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 ISO 10555-3:1997. This document has been prepared under a mandate given to CEN by the European Commission and the Eu

14、ropean 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 part of this document. According to the CEN-CENELEC Internal Regulations, the national standards organizations of the following

15、 countries are bound to implement 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, Norwa

16、y, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and the United Kingdom. Endorsement notice The text of ISO 10555-3:2013 has been approved by CEN as EN ISO 10555-3:2013 without any modification. BS EN ISO 10555-3:2013EN ISO 10555-3:2013 (E) 4 Annex ZA (informative

17、) 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 confo

18、rming 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 clauses

19、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 European

20、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 12.7.1 4.

21、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 BS EN ISO 10555-3:2013EN ISO 10555-3:2013 (E) 5 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 c) 4.1 1

22、3.6 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) fa

23、lling within the scope of this standard. BS EN ISO 10555-3:2013ISO 10555-3:2013(E) ISO 2013 All rights reserved iiiContents PageForeword iv1 Scope . 12 Normative references 13 Terms and definitions . 14 Requirements 14.1 General . 14.2 Distance markings 14.3 Lumen markings 14.4 Peak tensile force 24

24、.5 Information to be supplied by the manufacturer 2Bibliography 3BS EN ISO 10555-3:2013ISO 10555-3:2013(E)ForewordISO (the International Organization for Standardization) is a worldwide federation of national standards bodies (ISO member bodies). The work of preparing International Standards is norm

25、ally carried out through ISO technical committees. Each member body interested in a subject for which a technical committee has been established has the right to be represented on that committee. International organizations, governmental and non-governmental, in liaison with ISO, also take part in t

26、he work. ISO collaborates closely with the International Electrotechnical Commission (IEC) on all matters of electrotechnical standardization.International Standards are drafted in accordance with the rules given in the ISO/IEC Directives, Part 2.The main task of technical committees is to prepare I

27、nternational Standards. Draft International Standards adopted by the technical committees are circulated to the member bodies for voting. Publication as an International Standard requires approval by at least 75 % of the member bodies casting a vote.Attention is drawn to the possibility that some of

28、 the elements of this document may be the subject of patent rights. ISO shall not be held responsible for identifying any or all such patent rights.ISO 10555-3 was prepared by Technical Committee ISO/TC 84, Devices for administration of medicinal products and intravascular catheters.This second edit

29、ion 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 10555 consists of the following parts, under the general title Intravascular catheters Sterile and single-use catheters: P

30、art 1: General requirements Part 3: Central venous catheters Part 4: Balloon dilatation catheters Part 5: Over-needle peripheral cathetersThe following part is under preparation: Part 6: Subcutaneous implanted portsThe following part has been withdrawn and the content has been included in ISO 10555-

31、1: Part 2: Angiographic cathetersAttention is drawn to ISO 11070, which specifies requirements for accessory devices for use with intravascular catheters.iv ISO 2013 All rights reservedBS EN ISO 10555-3:2013INTERNATIONAL STANDARD ISO 10555-3:2013(E)Intravascular catheters Sterile and single-use cath

32、eters Part 3: Central venous catheters1 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 a

33、re indispensable 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 requirements

34、3 Terms and 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 fo

35、r pressure 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

36、10555 shall 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

37、the catheter 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. ISO 2013 All rights reserved 1BS EN ISO 10555-3:2013ISO 10555-3:2013(E)4.4 Peak te

38、nsile forceFor catheters having 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 mini

39、mum peak tensile force of all 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 Informat

40、ion to be supplied by the manufacturerInformation 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

41、 applicable;d) if applicable, 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.2 ISO 2013 All rights reservedBS EN ISO 10

42、555-3:2013ISO 10555-3:2013(E)Bibliography1 ISO 11070, Sterile, single-use intravascular catheter introducers ISO 2013 All rights reserved 3This page deliberately left blankThis page deliberately left blankBSI is the national body responsible for preparing British Standards and other standards-relate

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