1、March 2015 Translation by DIN-Sprachendienst.English price group 15No 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).ICS
2、11.040.25!%AR1“2304714www.din.deDDIN EN ISO 11070Sterile single-use intravascular introducers, dilators and guidewires(ISO 11070:2014);English version EN ISO 11070:2014,English translation of DIN EN ISO 11070:2015-03Sterile intravaskulre Einfhrinstrumente, Dilatatoren und Fhrungsdrhte zur einmaligen
3、Verwendung (ISO 11070:2014);Englische Fassung EN ISO 11070:2014,Englische bersetzung von DIN EN ISO 11070:2015-03Introducteurs, dilatateurs et guides intravasculaires striles non rutilisables(ISO 11070:2014);Version anglaise EN ISO 11070:2014,Traduction anglaise de DIN EN ISO 11070:2015-03Supersedes
4、DIN EN ISO 11070:1999-07www.beuth.deDocument comprises 35 pagesIn case of doubt, the German-language original shall be considered authoritative.03.15 DIN EN ISO 11070:2015-03 2 A comma is used as the decimal marker. National foreword This document (EN ISO 11070:2014) has been prepared by Technical C
5、ommittee 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 German body involved in its preparation was the DIN-Normenausschuss Medizin
6、 (DIN Standards Committee Medicine), 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 7864 DIN EN ISO 7864 ISO 7886-1 DIN EN ISO 7886-1 ISO 8601 DIN ISO 8601 ISO 9626 DIN EN ISO 9626
7、 ISO 10555-1 DIN EN ISO 10555-1 ISO 10555-3 DIN EN ISO 10555-3 ISO 10555-4 DIN EN ISO 10555-4 ISO 10555-5 DIN EN ISO 10555-5 ISO 10993-1 DIN EN ISO 10993-1 ISO 11135 DIN EN ISO 11135 ISO 11137 DIN EN ISO 11137 ISO 15223-1 DIN EN ISO 15223-1 Amendments This standard differs from DIN EN ISO 11070:1999
8、-07 as follows: a) the title has been extended to include dilators and guidewires; b) an Introduction has been added; c) normative references and the Bibliography have been revised and updated; d) Subclause 4.5 “Radio-detectability” has been extended to indicate appropriate test methods; e) Subclaus
9、e 4.6 “Information to be supplied by the manufacturer” has been revised; f) requirements for introducer needle tips have been revised; g) Subclauses 7.2 “Size designation” and 7.5 “Hub” have been revised; h) Clause 8 “Additional requirements for guidewires” has been revised; i) Subclause 9.3.2 “Coni
10、cal fitting” has been revised; j) test methods specified in Annexes A to H have been revised; k) the standard has been editorially revised. Previous editions DIN EN ISO 11070: 1999-07 DIN EN ISO 11070:2015-03 3 National Annex NA (informative) Bibliography DIN EN ISO 7864, Sterile hypodermic needles
11、for single use DIN EN ISO 7886-1, Sterile hypodermic syringes for single use Part 1: Syringes for manual use DIN EN ISO 10555-1, Intravascular catheters Sterile and single-use catheters Part 1: General requirements DIN EN ISO 10555-3, Intravascular catheters Sterile and single-use catheters Part 3:
12、Central venous catheters DIN EN ISO 10555-4, Intravascular catheters Sterile and single-use catheters Part 4: Balloon dilatation catheters DIN EN ISO 10555-5, Intravascular catheters Sterile and single-use catheters Part 5: Over-needle peripheral catheters DIN EN ISO 10993-1, Biological evaluation o
13、f medical devices Part 1: Evaluation and testing within a risk management system DIN EN ISO 11135, Sterilization of health care products Ethylene oxide Requirements for the development, validation and routine control of a sterilization process for medical devices DIN EN ISO 11137 (all parts), Steril
14、ization of health care products Radiation DIN EN ISO 15223-1, Medical devices Symbols to be used with medical device labels, labelling and information to be supplied Part 1: General requirements DIN EN ISO 17665 (all parts), Sterilization of health care products Moist heat DIN ISO 8601, Data element
15、s and interchange formats Information interchange Representation of dates and times DIN EN ISO 11070:2015-03 4 This page is intentionally blank EUROPEAN STANDARD NORME EUROPENNE EUROPISCHE NORM EN ISO 11070 November 2014 ICS 11.040.25 Supersedes EN ISO 11070:1999English Version Sterile single-use in
16、travascular introducers, dilators and guidewires (ISO 11070:2014) Introducteurs, dilatateurs et guides intravasculaires striles non rutilisables (ISO 11070:2014) Sterile intravaskulre Einfhrinstrumente, Dilatatoren undFhrungsdrhte zur einmaligen Verwendung(ISO11070:2014) This European Standard was a
17、pproved by CEN on 30 August 2014. 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 lists and bibliographical references concerning such natio
18、nal 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 the responsibility of a CEN member into its own langua
19、ge 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 Yugoslav Republic of Macedonia, France, Germany, Greece,
20、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 EUROPEN DE NORMALISATION EUROPISCHES KOMITEE FR NORMUNG CEN-
21、CENELEC Management Centre: Avenue Marnix 17, B-1000 Brussels 2014 CEN All rights of exploitation in any form and by any means reserved worldwide for CEN national Members. Ref. No. EN ISO 11070:2014 EContents PageForeword 4Introduction 51 Scope 62 Normative references . 63 Terms and definitions 64 Ge
22、neral requirements 104.1 Sterilization . 104.2 Biocompatibility . 104.3 Surface . 104.4 Corrosion resistance . 104.5 Radio-detectability . 104.6 Information to be supplied by the manufacturer . 105 Additional requirements for introducer needles . . 115.1 General . 115.2 Size designation . 115.3 Need
23、le point 115.4 Hub 115.5 Information to be supplied by the manufacturer 116 Additional requirements for introducer catheters 116.1 General . 116.2 Tip . 126.3 Peak tensile force . 126.4 Hub . 126.5 Size designation 126.6 Information to be supplied by the manufacturer . 137 Additional requirements fo
24、r sheath introducers 137.1 General 137.2 Size designation 137.3 Freedom from leakage from sheath introducer 137.4 Freedom from leakage through haemostasis valve 137.5 Hub . 137.6 Peak tensile force . 137.7 Information to be supplied by the manufacturer . 138 Additional requirements for guidewires .
25、138.1 General 138.2 Size designation 148.3 Safety wire . 148.4 Fracture test . 148.5 Flexing test 148.6 Peak tensile force of guidewire 148.7 Information to be supplied by the manufacturer 159 Additional requirements for dilators .159.1 General . 159.2 Size designation . 159.3 Hub 159.4 Information
26、to be supplied by the manufacturer 1510 Additional requirements for kits containing combinations of devices specified in this International Standard .15Annex A (informative) Guidance on materials and design 17DIN EN ISO 11070:2015-03 EN ISO 11070:2014 (E) 2 Annex B (normative) Test method for corros
27、ion resistance 18Annex C (normative) Method for determining peak tensile force of introducer catheters, sheath introducers, and dilators 19Annex D (normative) Test method for liquid leakage from sheath introducers under pressure 21Annex E (normative) Test method for liquid leakage through haemostasi
28、s valves of sheath introducers 22Annex F (normative) Test method for fracture of guidewires 23Annex G (normative) Test method for resistance of guidewires to damage by flexing.26Annex H (normative) Method for determining peak tensile force of guidewires.28Annex I (normative) Determination of strengt
29、h of union of needle hub and needle .30Bibliography .31DIN EN ISO 11070:2015-03 EN ISO 11070:2014 (E) 3 Foreword This document (EN ISO 11070:2014) has been prepared by Technical Committee ISO/TC 84 “Devices for administration of medicinal products and catheters” in collaboration with Technical Commi
30、ttee 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 May 2015, and conflicting national standards shall be withdraw
31、n at the latest by May 2015. 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 rights. This document supersedes EN ISO 11070:1999. According to
32、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, Estonia, Finland, Former Yugoslav Republic of Macedonia, France, Germany, Greece,
33、 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 The text of ISO 11070:2014 has been approved by CEN as EN ISO 11070:2014 without
34、any modification. DIN EN ISO 11070:2015-03 EN ISO 11070:2014 (E) 4 IntroductionThe purpose of this International Standard is to update requirements and test methods to support the function of the guidewire, and update size designation.DIN EN ISO 11070:2015-03 EN ISO 11070:2014 (E) 5 1 ScopeThis Inte
35、rnational Standard specifies requirements for introducer needles, introducer catheters, sheath introducers, guidewires, and dilators supplied in the sterile condition, and intended for single use in conjunction with intravascular catheters specified in ISO 10555-1.NOTE Guidance on materials and desi
36、gn of accessory devices is given in Annex A. 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
37、the referenced document (including any amendments) applies.ISO 594-11), Conical fittings with 6 % (Luer) taper for syringes, needles and certain other medical equipment Part 1: General requirementsISO 594-22), Conical fittings with 6 % (Luer) taper for syringes, needles and certain other medical equ
38、ipment Part 2: Lock fittingsISO 7886-1, Sterile hypodermic syringes for single use Part 1: Syringes for manual useISO 8601, Data elements and interchange formats Information interchange Representation of dates and timesISO 10993-1, Biological evaluation of medical devices Part 1: Evaluation and test
39、ing within a risk management process3 Terms and definitionsFor the purposes of this document, the following terms and definitions apply.NOTE Schematic examples of the devices covered by this International Standard, with examples of terminology, are given for information in Figure 1, Figure 2, Figure
40、 3, and Figure 4.3.1coil (of a guidewire)helically wound wire3.2core wire (of a guidewire)wire used to achieve stiffness of the guidewire (3.6)3.3dilatorflexible, tubular device used for dilating the percutaneous opening into a blood vessel1) Upon its publication, ISO 80369-7 will replace ISO 594-1:
41、1986.2) Upon its publication, ISO 80369-7 will replace ISO 594-2:1998.DIN EN ISO 11070:2015-03 EN ISO 11070:2014 (E) 6 3.4distal endpatient endend of the device, which is inserted into the patient3.5effective lengthlength of the device that can be inserted into the body3.6guidewireflexible device ov
42、er which a catheter or dilator (3.3) is passed to assist in the insertion and location of the catheter or dilator into a blood vesselNote 1 to entry: Examples of guidewire types are shown in Figure 3.3.7hubconnector(s) at the proximal end of the intravascular catheter introducer, which can either be
43、 integral with the introducer or be capable of being securely fitted to the proximal end of the introducer3.8introducer cathetershort, flexible tube which is introduced into a blood vessel, typically over an introducer needle, and through which a catheter or guidewire can be introduced after removal
44、 of the introducer needle3.9intravascular catheter introducerdevice designed to be used in conjunction with an intravascular catheter to facilitate introduction into the vascular system3.10introducer needlepointed, rigid tube through which a guidewire (3.6) or catheter can be introduced into a blood
45、 vessel3.11proximal endfree endend of the device opposite the distal end (3.4)3.12safety wire (of a guidewire)additional wire used to minimize the possibility of detachment of the tip3.13sheath introducerflexible tube which is introduced into a blood vessel, typically over a dilator (3.3), and throu
46、gh which a guidewire or catheter can be introduced after removal of the dilator3.14tipextremity of the distal end (3.4) of the deviceDIN EN ISO 11070:2015-03 EN ISO 11070:2014 (E) 7 a) Introducer catheter b) Introducer needleKey1 effective length2 distal end3 catheter4 catheter hub (optional)5 introducer needle tube6 needle hubFigure 1 Example of an introducer catheter and an introducer needlea) Sheath introducerb) Dilatorc) Assembled deviceKey1 distal end 5 sidearm2 sheath 6 sidearm connection (optional)3 haemostasis valve (optional) 7 hub4 stopcock with Luer fittingFigure 2 Ex
