1、November 2013 Translation by DIN-Sprachendienst.English price group 11No 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!%*,b“2070963www.din.deDDIN EN ISO 10555-4Intravascular catheters Sterile and single-use catheters Part 4: Balloon dilatation catheters (ISO 10555-4:2013);English version EN ISO 10555-4:2013,English translation of DIN EN ISO 10555-4:2013-11Intravaskulre Katheter Sterile Katheter zur einm
3、aligen Verwendung Teil 4: Ballondilatationskatheter (ISO 10555-4:2013);Englische Fassung EN ISO 10555-4:2013,Englische bersetzung von DIN EN ISO 10555-4:2013-11Cathters intravasculaires Cathters striles et non rutilisables Partie 4: Cathters de dilatation ballonnets (ISO 10555-4:2013);Version anglai
4、se EN ISO 10555-4:2013,Traduction anglaise de DIN EN ISO 10555-4:2013-11SupersedesDIN EN ISO 10555-4:1997-11www.beuth.deDocument comprises 21 pagesIn case of doubt, the German-language original shall be considered authoritative.11.13 DIN EN ISO 10555-4:2013-11 2 A comma is used as the decimal marker
5、. National 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” (Secretariat: DIN, Germany). The
6、 responsible German 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 594-1 DIN EN 2059
7、4-1 ISO 594-2 DIN EN 1707 ISO 11070 DIN EN ISO 11070 ISO 14630 DIN EN ISO 14630 ISO 25539-2 DIN EN ISO 25539-2 Amendments This standard differs from DIN EN ISO 10555-4:1997-11 as follows: a) Clause 4 “Requirements” has been revised and the former Subclauses 4.4.1 “Tip configuration”, 4.4.3 “Side hol
8、es” have been deleted entirely. The former Subclause 4.4.2 “Freedom from leakage and damage on inflation” is now given in more detail in Subclauses 4.4.1 to 4.4.4; b) the former Annex A “Test for freedom from leakage and damage on inflation” has been completely revised, extended and divided up into
9、Annexes A, B, C and D (in analogy with the requirements specified in Subclauses 4.4.1 to 4.4.4); c) the former Annex B “Guidance on the selection of balloon materials” is now Annex E; d) the Bibliography has been revised; e) the standard has been editorially revised; Previous editions DIN EN ISO 105
10、55-4: 1997-11 DIN EN ISO 10555-4:2013-11 3 National Annex 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 cer
11、tain other medical equipment Part 1: General requirements DIN EN ISO 11070, Sterile single-use intravascular catheter introducers DIN EN ISO 14630, Non-active surgical implants General requirements DIN EN ISO 25539-2, Cardiovascular implants Endovascular devices Part 2: Vascular stents DIN EN ISO 10
12、555-4:2013-11 4 This page is intentionally blank EUROPEAN STANDARD NORME EUROPENNE EUROPISCHE NORM EN ISO 10555-4 July 2013 ICS 11.040.25 Supersedes EN ISO 10555-4:1997English Version Intravascular catheters - Sterile and single-use catheters - Cathters intravasculaires - Cathters striles et non rut
13、ilisables - Partie 4: Cathters de dilatation ballonnets (ISO 10555-4:2013) Intravaskulre Katheter - Sterile Katheter zur einmaligen Verwendung - Teil 4: BallondilatationskatheterThis European Standard was approved by CEN on 29 May 2013. CEN members are bound to comply with the CEN/CENELEC Internal R
14、egulations 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 application to the CEN-CENELEC Management Centre or to any CEN m
15、ember. 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 Management Centre has the same status as the official versions
16、. 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, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Pola
17、nd, 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-1000 Brussels 2013 CEN All rights of exploitation in any form
18、and by any means reserved worldwide for CEN national Members. Ref. No. EN ISO 10555-4:2013: EPart 4: Balloon dilatation catheters (ISO 10555-4:2013) (ISO 10555-4:2013) EN ISO 10555-4:2013 (E) 2 Contents Page Foreword 3 1 Scope 4 2 Normative references 4 3 Terms and definitions .4 4 Requirements .4 4
19、.1 General 4 4.2 Radio-detectability .4 4.3 Designation of nominal size .4 4.4 Physical requirements 5 4.5 Information to be supplied by the manufacturer 5 Annex A (normative) Test for balloon rated burst pressure (RBP) 6 Annex B (normative) Balloon fatigue test for freedom from leakage and damage o
20、n inflation .8 Annex C (normative) Test for balloon deflation time 10 Annex D (normative) Test for balloon diameter to inflation pressure .12 Annex E (informative) Guidance on the selection of balloon materials 14 Annex ZA (informative) Relationship between this European Standard and the Essential R
21、equirements of EU Directive 93/42/EEC amended by Directive 2007/47/EEC .15 Bibliography 17 DIN EN ISO 10555-4:2013-11 EN ISO 10555-4:2013 (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 intrav
22、ascular 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 the latest by Januar
23、y 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 or all such patent r
24、ights. This document supersedes EN ISO 10555-4:1997. 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 informative Annex Z
25、A, which is an integral part of this document. This second edition cancels and replaces the 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 t
26、itle 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: Part 6: Subcutaneous implanted ports The following part
27、has been withdrawn and the content has been included in ISO 105551: Part 2: Angiographic catheters Attention 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 compri
28、se an integral component of the deployment of the vascular stent, and to ISO 14630. 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 Rep
29、ublic, 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 the United Kingdom. End
30、orsement notice The text of ISO 10555-4:2013 has been approved by CEN as EN ISO 10555-4:2013 without any modification. DIN EN ISO 10555-4:2013-11 1 ScopeThis part of ISO 10555 specifies requirements for balloon dilatation catheters supplied in the sterile condition, and intended for single use.2 Nor
31、mative 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 document (including any amendments)
32、 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: Lock fittings1)ISO 10555-1, Intra
33、vascular 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 with a balloon near the distal
34、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 position of the balloon shall be radio
35、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 diameter of each portion at recom
36、mended pressure;1) Upon its publication, ISO 80369-7 will replace ISO 594-1 and ISO 594-2.EN ISO 10555-4:2013 (E) 4 DIN EN ISO 10555-4:2013-11 b) effective length of the balloon at recommended pressure;c) diameter of the largest guidewire that can be used with the catheter, if applicable.NOTE Where
37、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 pressure with an appropriate safety margin when tested in
38、 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 tested as described in Annex B, there shall be no leakag
39、e 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 relationship between the balloon diameter and the ball
40、oon 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 designated in 4.3;b) position(s) of radio-detectable marker
41、(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 recommendations appropriate to the intended clinical use.NOTE U
42、nits of measurement systems other than those specified in this part of ISO 10555 can additionally be used.EN ISO 10555-4:2013 (E) 5 DIN EN ISO 10555-4:2013-11 Annex A (normative) Test for balloon rated burst pressure (RBP)A.1 PrincipleThe purpose of this test is to determine the RBP of the balloon.A
43、.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 temperature water or other justified clinically relevant media.A.2.5 Ti
44、ming 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 % (Luer) taper, complying with ISO 594-1 or ISO 594-2 as applicable, for c
45、onnection 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 appropriate guidewire (A.2.1) in the device.A.3.3 Connect the pressure
46、 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
47、 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) identity of the catheter;b) mean burst pressure, RBP and maximum, minimum and standard deviation of the burst data, expressed in kilopascals
48、;EN ISO 10555-4:2013 (E) 6 DIN EN ISO 10555-4:2013-11 c) all observed failure modes.NOTE Units of measurement systems other than those specified in this part of ISO 10555 can additionally be used.EN ISO 10555-4:2013 (E) 7 DIN EN ISO 10555-4:2013-11 Annex B (normative) Balloon fatigue test for freedom from leakage and damage on inflationB.1 PrincipleThe catheter is inflated and deflated a number of times to simulate use in vivo. The catheter in an inflated condition is examined for leakage, ruptu
