EN ISO 10555-4-2013 en Intravascular catheters - Sterile and single-use catheters - Part 4 Balloon dilatation catheters《血管内导管 一次性使用无菌内导管 第4部分 球形扩张导管》.pdf

1、BSI Standards PublicationBS EN ISO 10555-4:2013Intravascular catheters Sterile and single-use cathetersPart 4: Balloon dilatation catheters (ISO10555-4:2013)BS EN ISO 10555-4:2013 BRITISH STANDARDNational forewordThis British Standard is the UK implementation of EN ISO10555-4:2013. It supersedes BS

2、EN ISO 10555-4:1997 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 necess

3、aryprovisions of a contract. Users are responsible for its correctapplication. The British Standards Institution 2013. Published by BSI StandardsLimited 2013ISBN 978 0 580 73020 7ICS 11.040.25Compliance with a British Standard cannot confer immunity fromlegal obligations.This British Standard was pu

4、blished 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 10555-4 July 2013 ICS 11.040.25 Supersedes EN ISO 10555-4:1997English Version Intravascular catheter

5、s - Sterile and single-use catheters - Part 4: Balloon dilatation catheters (ISO 10555-4:2013) Cathters intravasculaires - Cathters striles et non rutilisables - Partie 4: Cathters de dilatation ballonnets (ISO 10555-4:2013) Intravaskulre Katheter - Sterile Katheter zur einmaligen Verwendung - Teil

6、4: Ballondilatationskatheter (ISO 10555-4:2013) 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 alterati

7、on. 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). A version in any other language made by

8、 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, Cyprus, Czech Republic, Denmark, Estonia,

9、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 Kingdom. EUROPEAN COMMITTEE FOR STANDARDI

10、ZATION 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 10555-4:2013: EBS EN ISO 10555-4:2013EN ISO 10555-4:

11、2013 (E) 3 Foreword This document (EN ISO 10555-4:2013) 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

12、 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 the latest by January 2014, and conflicting national standards shall be withdrawn at the latest by January 2014. Attention is drawn to the possibility th

13、at 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 supersedes EN ISO 10555-4:1997. This document has been prepared under a mandate given to CEN by the European Com

14、mission 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 part of this document. According to the CEN-CENELEC Internal Regulations, the national standards organization

15、s of the following 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,

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

17、ex ZA (informative) 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 provid

18、e a means of conforming 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

19、normative clauses 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

20、 by this European 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 10555-4 7.3 4.1 4.4 7.5 4.1 8.1 4.1 8.3 4.1 8.4 4.1 9.1 4.1 9.2 4.1

21、 4.2 4.3 4.4 12.7.1 4.1 4.4 12.7.4 4.1 12.8.1 4.1 13.1 4.1 4.5 a) 13.2 4.1 13.3 a) 4.1 13.3 b) 4.1 BS EN ISO 10555-4:2013EN ISO 10555-4:2013 (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 4.5 b), c), d) and e) 13.3 k) 4.1 13.3 m) 4.1 13.4 4.1 13.6 a) 4.1 13.6 b) 4.1 4.

22、5 a), b) and c) 13.6 c) 4.1 13.6 e) 4.1 13.6 f) 4.1 13.6 g) 4.1 13.6 k) 4.1 13.6 l) 4.1 13.6 n) 4.1 13.6 q) 4.1 WARNING Other requirements and other EU Directives may be applicable to the product(s) falling within the scope of this standard. BS EN ISO 10555-4:2013ISO 10555-4:2013(E) ISO 2013 All rig

23、hts reserved iiiContents PageForeword iv1 Scope . 12 Normative references 13 Terms and definitions . 14 Requirements 14.1 General . 14.2 Radio-detectability 14.3 Designation of nominal size . 14.4 Physical requirements 24.5 Information to be supplied by the manufacturer 2Annex A (normative) Test for

24、 balloon rated burst pressure (RBP) 3Annex B (normative) Balloon fatigue test for freedom from leakage and damage on inflation 5Annex C (normative) Test for balloon deflation time 7Annex D (normative) Test for balloon diameter to inflation pressure . 9Annex E (informative) Guidance on the selection

25、of balloon materials11Bibliography .12BS EN ISO 10555-4:2013ISO 10555-4:2013(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 IS

26、O 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 the work. ISO collaborates c

27、losely 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 International Standards. Dra

28、ft 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 the elements of this docum

29、ent may be the subject of patent rights. ISO shall not be held responsible for identifying any or all such patent rights.ISO 10555-4 was prepared by Technical Committee ISO/TC 84, Devices for administration of medicinal products and intravascular catheters.This second edition cancels and replaces th

30、e first edition (ISO 10555-4:1996), which has been technically revised. It also incorporates the Technical Corrigendum ISO 10555-4:1996/Cor 1:2002.ISO 10555 consists of the following parts, under the general title Intravascular catheters Sterile and single-use catheters: Part 1: General requirements

31、 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: Angiographic cat

32、hetersAttention is drawn to ISO 11070, which specifies requirements for accessory devices for use with intravascular catheters, to ISO 25539-2 which specifies requirements for delivery systems if they comprise an integral component of the deployment of the vascular stent, and to ISO 14630.iv ISO 201

33、3 All rights reservedBS EN ISO 10555-4:2013INTERNATIONAL STANDARD ISO 10555-4:2013(E)Intravascular catheters Sterile and single-use catheters Part 4: Balloon dilatation catheters1 ScopeThis part of ISO 10555 specifies requirements for balloon dilatation catheters supplied in the sterile condition, a

34、nd intended for single use.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 undated references, the latest edition of the referenced doc

35、ument (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 a 6 % (Luer) taper for syringes, needles and certain other medical equipment Part 2: L

36、ock fittings1)ISO 10555-1, Intravascular catheters Sterile and single-use catheters Part 1: General requirements3 Terms and definitionsFor the purposes of this document, the terms and definitions given in ISO 10555-1 and the following apply.3.1balloon dilatation catheterintravascular catheter fitted

37、 with a balloon near the distal end, which is introduced into an artery or vein to dilate a part or parts of the vascular system4 Requirements4.1 GeneralUnless otherwise specified in this part of ISO 10555, balloon dilatation catheters shall comply with ISO 10555-1.4.2 Radio-detectabilityThe positio

38、n of the balloon shall be radio detectable when the catheter has been inserted into the body.4.3 Designation of nominal sizeThe nominal size of the catheter shall be designated by the following:a) diameter(s) expressed in millimetres of the inflated balloon(s) or, for multidiameter balloon(s), the d

39、iameter of each portion at recommended pressure;1) Upon its publication, ISO 80369-7 will replace ISO 594-1 and ISO 594-2. ISO 2013 All rights reserved 1BS EN ISO 10555-4:2013ISO 10555-4:2013(E)b) effective length of the balloon at recommended pressure;c) diameter of the largest guidewire that can b

40、e used with the catheter, if applicable.NOTE Where a balloon dilation catheter (see Figure B.1) is used as a stent delivery system, refer to the appropriate standard for stents for designation of nominal size.4.4 Physical requirements4.4.1 Balloon rated burst pressure (RBP)Determine the burst pressu

41、re with an appropriate safety margin when tested in accordance with Annex A. Longitudinal failure is the desirable balloon failure mode.4.4.2 Balloon fatigue; freedom from leakage and damage on inflationEvaluate the ability of the balloon to withstand repeated inflation cycles to the RBP. When teste

42、d as described in Annex B, there shall be no leakage or evidence of damage, such as herniation or bursting of the catheter.4.4.3 Balloon deflation timeDetermine the time required to deflate the balloon from the RBP as described in Annex C.4.4.4 Balloon diameter to inflation pressureDetermine the rel

43、ationship between the balloon diameter and the balloon inflation pressure as described in Annex D.4.5 Information to be supplied by the manufacturerInformation supplied by the manufacturer shall comply with ISO 10555-1 and shall also include the following:a) nominal size of the catheter, as designat

44、ed in 4.3;b) position(s) of radio-detectable marker(s);c) RBP of the balloon, expressed in kilopascals;d) balloon inflation pressure, expressed in kilopascals, required to achieve the nominal balloon diameter(s);e) guidewire, guide catheter or sheath or introducer compatibility and size recommendati

45、ons appropriate to the intended clinical use.NOTE Units of measurement systems other than those specified in this part of ISO 10555 can additionally be used.2 ISO 2013 All rights reservedBS EN ISO 10555-4:2013ISO 10555-4:2013(E)Annex A (normative) Test for balloon rated burst pressure (RBP)A.1 Princ

46、ipleThe purpose of this test is to determine the RBP of the balloon.A.2 ApparatusA.2.1 Recommended guidewire or equivalent.A.2.2 Water bath, controlled at (37 2) C.A.2.3 Leak detection mechanism, e.g. dye in test fluid, pressure drop monitor, flow rate monitor.A.2.4 Fluid for inflation, e.g. room te

47、mperature water or other justified clinically relevant media.A.2.5 Timing mechanism, with specified accuracy.A.2.6 Pressure generating device, fitted with a means of measuring pressure with an accuracy of 5 % of the reported value and maintaining the inflation pressure and fitted with a male 6 % (Lu

48、er) taper, complying with ISO 594-1 or ISO 594-2 as applicable, for connection to the catheter.A.3 Test procedureA.3.1 Fill the pressure generating device (A.2.6) with fluid for inflation.A.3.2 If the instructions for use specify that a guidewire should be used during balloon inflation, insert the a

49、ppropriate guidewire (A.2.1) in the device.A.3.3 Connect the pressure generating device to the catheter under test and immerse at least the whole of the balloon portion(s) in the water bath (A.2.2) at (37 2) C.A.3.4 Allow the catheter to equilibrate for a minimum of 2 min.A.3.5 Inflate the balloon using a pre-determined pressure profile versus time until the catheter bursts or fails. Record the burst pressure, failure mode and location of the failure.A.4 Test reportThe test report shall include the following information:a) identit