EN ISO 10555-1-2013 en Intravascular catheters - Sterile and single-use catheters - Part 1 General requirements (Incorporates Amendment A1 2017)《血管内导管 一次性使用无菌内导管 第1部分 通用要求》.pdf

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1、BSI Standards PublicationBS EN ISO 10555-1:2013Intravascular catheters Sterile and single-use cathetersPart 1: General requirements Incorporating corrigendum April 2014BS EN ISO 10555-1:2013National forewordThis British Standard is the UK implementation of EN ISO 10555-1:2013. It supersedes BS EN IS

2、O 10555-1:2009 which is withdrawn.The UK participation in its preparation was entrusted to Technical Committee CH/84, Catheters and syringes.A list of organizations represented on this committee can be obtained on request to its secretary.This publication does not purport to include all the necessar

3、y provisions of a contract. Users are responsible for its correct application. The British Standards Institution 2014. Published by BSI Standards Limited 2014ISBN 978 0 580 85610 5ICS 11.040.25Compliance with a British Standard cannot confer immunity fromlegal obligations.This British Standard was p

4、ublished under the authority of the Standards Policy and Strategy Committee on 31 July 2013.Amendments/corrigenda issued since publicationDate Text affected30 April 2014 Implementation of ISO corrected text 15 January 2014: See ISO foreword for detailsBRITISH STANDARDEUROPEAN STANDARD NORME EUROPENN

5、E EUROPISCHE NORM EN ISO 10555-1 July 2013 ICS 11.040.25 Supersedes EN ISO 10555-1:2009English Version Intravascular catheters - Sterile and single-use catheters - Part 1: General requirements (ISO 10555-1:2013, Corrected version 2013-07-01) Cathters intravasculaires - Cathters striles et non rutili

6、sables - Partie 1: Exigences gnrales (ISO 10555-1:2013, Version corrig 2013-07-01) Intravaskulre Katheter - Sterile Katheter zur einmaligen Verwendung - Teil 1: Allgemeine Anforderungen (ISO 10555-1:2013, korrigierte Fassung 2013-07-01) This European Standard was approved by CEN on 29 May 2013. CEN

7、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 obtained on appli

8、cation 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 the CEN-CENELEC Man

9、agement 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, Ireland, Italy, Latv

10、ia, 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 Management Centre: Avenue Marnix 17, B-100

11、0 Brussels 2013 CEN All rights of exploitation in any form and by any means reserved worldwide for CEN national Members. Ref. No. EN ISO 10555-1:2013: EBS EN ISO 10555-1:2013EN ISO 10555-1:2013 (E) 3 Foreword This document (EN ISO 10555-1:2013, Corrected version 2013-07-01) has been prepared by Tech

12、nical 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 European Standard shall be given the status of a national standard,

13、 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 elements of this document may be the subject of patent rights. CEN

14、 and/or CENELEC shall not be held responsible for identifying any or all such patent rights. This document supersedes EN ISO 10555-1:2009. This document has been prepared under a mandate given to CEN by the European Commission and the European Free Trade Association, and supports essential requireme

15、nts 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 implement this European Standard: Austr

16、ia, 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, Sweden

17、, Switzerland, Turkey and the United Kingdom. Endorsement notice The text of ISO 10555-1:2013, Corrected version 2013-07-01 has been approved by CEN as EN ISO 10555-1:2013 without any modification. BS EN ISO 10555-1:2013EN ISO 10555-1:2013 (E)4 Annex ZA (informative) Relationship between this Europe

18、an 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 conforming to Essential Requirements of

19、 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 of this standard given in Table ZA

20、.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 Standard. Table ZA.1 Correspondenc

21、e 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 10555-1 7.3 4.5* 4.9 4.10* 7.5 4.4* 8.1 4.1* 6.2 c) and d)* 8.3 4.1* 6.2 c) and d)* 8.4 4.1* 6.2 d)* 9.1 4.8 4.9 4.10 6

22、.3 b), c) and i) 9.2 4.2 4.4 4.6 4.7 4.8 4.9 4.10 4.11 4.12 5 12.7.1* 4.4 4.6 4.7 4.9 4.10 BS EN ISO 10555-1:2013EN ISO 10555-1:2013 (E) 5 4.11 4.12 12.7.4 4.9 4.10 12.8.1 4.9 4.10 13.1 6.1 6.2 a), b), f), g), h), i), j), k) 6.4 13.2 6.1 13.3 a) 6.2 a) 13.3 b) 6.2 b) 13.3 c) 6.2 c) 13.3 d) 6.2 e) 13

23、.3 e) 6.2 f) 13.3 f) 6.2 g) 13.3 i) 6.2 h) 13.3 j) 6.2 i) and j) 6.3 c) and i) 13.3 k) 6.3 b) and f) 13.3 m) 6.2 d) 13.4 6.2 i) 6.3 a) 13.6 a) 6.3 a) * 13.6 b) 6.3 b) 13.6 c) 6.3 c) and f) 13.6 e) 6.3 f) 13.6 f) 6.3 g) 13.6 g) 6.3 d) 13.6 k) 6.3 b) and f) 13.6 l) 6.3 b) and g) 13.6 n) 6.3 e) 13.6 q)

24、 6.3 h) (*) Not fully covered as the requirements are depended on the specific product. (*) For the user, only 4.7 is applicable. (*) Method of sterilisation not required in the instruction for use as it is required on the device or primary packing. (*) Only concerning sterilisation aspects. WARNING

25、 Other requirements and other EU Directives may be applicable to the product(s) falling within the scope of this standard. ISO 2013Intravascular catheters Sterile and single-use catheters Part 1: General requirementsCathters intravasculaires Cathters striles et non rutilisables Partie 1: Exigences g

26、nralesINTERNATIONAL STANDARDISO10555-1Second edition2013-06-15Reference numberISO 10555-1:2013(E)Corrected version2014-01-15ii ISO 2013 All rights reservedCOPYRIGHT PROTECTED DOCUMENT ISO 2013All rights reserved. Unless otherwise specified, no part of this publication may be reproduced or utilized o

27、therwise in any form or by any means, electronic or mechanical, including photocopying, or posting on the internet or an intranet, without prior written permission. Permission can be requested from either ISO at the address below or ISOs member body in the country of the requester.ISO copyright offi

28、ceCase postale 56 CH-1211 Geneva 20Tel. + 41 22 749 01 11Fax + 41 22 749 09 47E-mail copyrightiso.orgWeb www.iso.orgPublished in SwitzerlandBS EN ISO 10555-1:2013 ISO 10555-1:2013 (E) ISO 2013 All rights reserved iiiContents PageForeword iv1 Scope . 12 Normative references 13 Terms and definitions .

29、 14 Requirements 44.1 General . 44.2 Radio-detectability 44.3 Biocompatibility 44.4 Surface 44.5 Corrosion resistance 44.6 Peak tensile force 44.7 Freedom from leakage 54.8 Hubs . 54.9 Flowrate 54.10 Power injection . 54.11 Side holes . 54.12 Distal tip 55 Designation of nominal size 55.1 Outside di

30、ameter . 55.2 Nominal effective length . 66 Information to be supplied by the manufacturer . 66.1 General . 66.2 Marking on the device and/or primary packaging 66.3 Instructions for use . 76.4 Marking on the secondary packaging 7Annex A (normative) Test method for corrosion resistance . 8Annex B (no

31、rmative) Method for determining peak tensile force 9Annex C (normative) Test method for liquid leakage under pressure 11Annex D (normative) Test method for air leakage into hub assembly during aspiration .13Annex E (normative) Determination of flowrate through catheter 15Annex F (normative) Test for

32、 burst pressure under static conditions.17Annex G (normative) Power injection test for flowrate and device pressure(only for products indicated for power injection) 19Annex H (informative) Units of measurement systems other than those specified in this part of ISO 10555, which may additionally be us

33、ed .22Bibliography .24BS EN ISO 10555-1:2013 ISO 10555-1:2013 (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 normally carried out through ISO technical co

34、mmittees. 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 the work. ISO collaborates closely with th

35、e 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 International Standards. Draft Internation

36、al 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 the elements of this document may be the

37、 subject of patent rights. ISO shall not be held responsible for identifying any or all such patent rights.ISO 10555-1 was prepared by Technical Committee ISO/TC 84, Devices for administration of medicinal products and intravascular catheters.This second edition cancels and replaces the first editio

38、n (ISO 10555-1:1995), which has been technically revised. It also incorporates the amendments ISO 10555-1:1995/Amd 1:1999 and ISO 10555-1:1995/Amd 2:2004.ISO 10555 consists of the following parts, under the general title Intravascular catheters Sterile and single-use catheters: Part 1: General requi

39、rements 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 10555-1: Part 2: Angiograp

40、hic cathetersAttention is drawn to ISO 11070, which specifies requirements for accessory devices for use with intravascular catheters.This corrected version of ISO 10555-1:2013 incorporates an editorial correction in H.3.iv ISO 2013 All rights reservedBS EN ISO 10555-1:2013 ISO 10555-1:2013 (E)INTER

41、NATIONAL STANDARD ISO 10555-1:2013(E)Intravascular catheters Sterile and single-use catheters Part 1: General requirements1 ScopeThis part of ISO 10555 specifies general requirements for intravascular catheters, supplied in the sterile condition and intended for single use, for any application.lt is

42、 not applicable to intravascular catheter accessories, e.g. those covered by ISO 11070.2 Normative referencesThe following documents, in whole or in part, are normatively referenced in this document and are indispensable for its application. For dated references, only the edition cited applies. For

43、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 requirements1)ISO 594-2, Conical fittings with 6 % (Luer) taper for syrin

44、ges, needles and certain other medical equipment Part 2: Lock fittings1)ISO 7886-1, Sterile hypodermic syringes for single use Part 1: Syringes for manual useISO 15223-1, Medical devices Symbols to be used with medical device labels, labelling and information to be supplied Part 1: General requireme

45、nts3 Terms and definitionsFor the purposes of this document, the following terms and definitions apply.3.1intravascular cathetertubular device, single or multilumen, designed to be partially or totally inserted or implanted into the cardiovascular system for diagnostic and/or therapeutic purposes3.2

46、distal endend of the catheter inserted furthest into the patient3.3distal end configurationshape of the catheter which is designed to facilitate its manual manipulation through the cardiovascular system and the placement and anchoring of the distal tip in the chosen location1) Upon its publication,

47、ISO 80369-7 will replace ISO 594-1 and ISO 594-2. ISO 2013 All rights reserved 13.4proximal endaccess endend of the catheter to which connection can be made3.5hubconnector(s) at the proximal end of the catheter which may either be integral with the catheter or be capable of being securely fitted to

48、the proximal end of the catheter3.6effective lengthllength of the catheter, or pre- and post-hydration lengths of hydratable catheters that can be inserted into the body SEE: Figure 1.3.7outside diameterlargest diameter of the catheter or pre- and post-hydration largest diameters of hydratable cathe

49、ters that can be inserted into the vessel3.8junctionthe joining of one tube or more tubes, where the assembly of the tubes provide mechanical support in tension/compression during clinical use3.9hydratable intravascular catheterintravascular catheter consisting of a material that manifests clinically significant hydration when subjected to an aqueous medium3.10post-hydrationstate of a hydratable intravascular catheter after immersion in aqueous medium at (37 2) C for a clinically appropriate period of t