EN ISO 11070-2014 en Sterile single-use intravascular introducers dilators and guidewires《一次性使用无菌血管内导引器械 扩张器和引导线(ISO 11070 2014)》.pdf

1、BSI Standards PublicationBS EN ISO 11070:2014Sterile single-use intravascularintroducers, dilators andguidewiresBS EN ISO 11070:2014 BRITISH STANDARDNational forewordThis British Standard is the UK implementation of EN ISO11070:2014. It supersedes BS EN ISO 11070:1999 which is withdrawn.The UK parti

2、cipation 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 necessaryprovisions of a contract. Users are responsible

3、 for its correctapplication. The British Standards Institution 2014. Published by BSI StandardsLimited 2014ISBN 978 0 580 81677 2ICS 11.040.25Compliance with a British Standard cannot confer immunity fromlegal obligations.This British Standard was published under the authority of theStandards Policy

4、 and Strategy Committee on 30 November 2014.Amendments issued since publicationDate Text affectedEUROPEAN STANDARD NORME EUROPENNE EUROPISCHE NORM EN ISO 11070 November 2014 ICS 11.040.25 Supersedes EN ISO 11070:1999English Version Sterile single-use intravascular introducers, dilators and guidewire

5、s (ISO 11070:2014) Introducteurs, dilatateurs et guides intravasculaires striles non rutilisables (ISO 11070:2014) Sterile Einfhrungsinstrumente, Dilatatoren und Fhrungsdrhte zur einmaligen Verwendung (ISO 11070:2014) This European Standard was approved by CEN on 30 August 2014. CEN members are boun

6、d 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 application to the CE

7、N-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 Management Centre h

8、as 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, Latvia, Lithuania, L

9、uxembourg, 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-CENELEC Management Centre: Avenue Marnix 17, B-1000 Br

10、ussels 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 EBS EN ISO 11070:2014EN ISO 11070:2014 (E) 3 Foreword This document (EN ISO 11070:2014) has been prepared by Technical Committee ISO/TC 84 “Devices for admi

11、nistration of medicinal products and 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 endorse

12、ment, at the latest by May 2015, and conflicting national standards shall be withdrawn 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

13、 or all such patent rights. This document supersedes EN ISO 11070:1999. 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 Republic, Denma

14、rk, 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. Endorsement not

15、ice The text of ISO 11070:2014 has been approved by CEN as EN ISO 11070:2014 without any modification. BS EN ISO 11070:2014ISO 11070:2014(E)Contents PageForeword vIntroduction vi1 Scope . 12 Normative references 13 Terms and definitions . 14 General requirements . 54.1 Sterilization 54.2 Biocompatib

16、ility 54.3 Surface 54.4 Corrosion resistance 54.5 Radio-detectability 54.6 Information to be supplied by the manufacturer 55 Additional requirements for introducer needles . 65.1 General . 65.2 Size designation . 65.3 Needle point 65.4 Hub 65.5 Information to be supplied by the manufacturer 66 Addit

17、ional requirements for introducer catheters 66.1 General . 66.2 Tip 76.3 Peak tensile force 76.4 Hub 76.5 Size designation . 76.6 Information to be supplied by the manufacturer 87 Additional requirements for sheath introducers . 87.1 General . 87.2 Size designation . 87.3 Freedom from leakage from s

18、heath introducer . 87.4 Freedom from leakage through haemostasis valve . 87.5 Hub 87.6 Peak tensile force 87.7 Information to be supplied by the manufacturer 88 Additional requirements for guidewires 88.1 General . 88.2 Size designation . 98.3 Safety wire 98.4 Fracture test 98.5 Flexing test . 98.6

19、Peak tensile force of guidewire . 98.7 Information to be supplied by the manufacturer .109 Additional requirements for dilators 109.1 General 109.2 Size designation 109.3 Hub . 109.4 Information to be supplied by the manufacturer .1010 Additional requirements for kits containing combinations of devi

20、ces specified in this International Standard 10Annex A (informative) Guidance on materials and design .12 ISO 2014 All rights reserved iiiBS EN ISO 11070:2014ISO 11070:2014(E)Annex B (normative) Test method for corrosion resistance 13Annex C (normative) Method for determining peak tensile force of i

21、ntroducer catheters, sheath introducers, and dilators 14Annex D (normative) Test method for liquid leakage from sheath introducers under pressure 16Annex E (normative) Test method for liquid leakage through haemostasis valves of sheath introducers 18Annex F (normative) Test method for fracture of gu

22、idewires 19Annex G (normative) Test method for resistance of guidewires to damage by flexing.21Annex H (normative) Method for determining peak tensile force of guidewires.23Annex I (normative) Determination of strength of union of needle hub and needle .25Bibliography .26iv ISO 2014 All rights reser

23、vedBS EN ISO 11070:2014ISO 11070:2014(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 committees. Each member bod

24、y 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 the International Electrote

25、chnical Commission (IEC) on all matters of electrotechnical standardization.The procedures used to develop this document and those intended for its further maintenance are described in the ISO/IEC Directives, Part 1. In particular the different approval criteria needed for the different types of ISO

26、 documents should be noted. This document was drafted in accordance with the editorial rules of the ISO/IEC Directives, Part 2 (see www.iso.org/directives).Attention is drawn to the possibility that some of the elements of this document may be the subject of patent rights. ISO shall not be held resp

27、onsible for identifying any or all such patent rights. Details of any patent rights identified during the development of the document will be in the Introduction and/or on the ISO list of patent declarations received (see www.iso.org/patents).Any trade name used in this document is information given

28、 for the convenience of users and does not constitute an endorsement.For an explanation on the meaning of ISO specific terms and expressions related to conformity assessment, as well as information about ISOs adherence to the WTO principles in the Technical Barriers to Trade (TBT) see the following

29、URL: Foreword Supplementary information .The committee responsible for this document is ISO/TC 84, Devices for administration of medicinal products and catheters.This second edition cancels and replaces the first edition (ISO 11070:1998), which has been technically revised. ISO 2014 All rights reser

30、ved vBS EN ISO 11070:2014ISO 11070:2014(E)IntroductionThe purpose of this International Standard is to update requirements and test methods to support the function of the guidewire, and update size designation.vi ISO 2014 All rights reservedBS EN ISO 11070:2014Sterile single-use intravascular introd

31、ucers, dilators and guidewires1 ScopeThis International 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 I

32、SO 10555-1.NOTE Guidance on materials and design 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.

33、For undated references, the latest edition of 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 s

34、yringes, needles and certain other medical equipment 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

35、of medical devices Part 1: Evaluation and testing 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

36、 for information in Figure 1, Figure 2, Figure 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 pu

37、blication, ISO 80369-7 will replace ISO 594-1:1986.2) Upon its publication, ISO 80369-7 will replace ISO 594-2:1998.INTERNATIONAL STANDARD ISO 11070:2014(E) ISO 2014 All rights reserved 1BS EN ISO 11070:2014ISO 11070:2014(E)3.4distal endpatient endend of the device, which is inserted into the patien

38、t3.5effective lengthlength of the device that can be inserted into the body3.6guidewireflexible device over 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 Figu

39、re 3.3.7hubconnector(s) at the proximal end of the intravascular catheter introducer, which can either be 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, typic

40、ally over an introducer needle, and through which a catheter or guidewire can be introduced after removal of the introducer needle3.9intravascular catheter introducerdevice designed to be used in conjunction with an intravascular catheter to facilitate introduction into the vascular system3.10introd

41、ucer needlepointed, rigid tube through which a guidewire (3.6) or catheter can be introduced into a blood 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 i

42、ntroducerflexible tube which is introduced into a blood vessel, typically over a dilator (3.3), and through which a guidewire or catheter can be introduced after removal of the dilator3.14tipextremity of the distal end (3.4) of the device2 ISO 2014 All rights reservedBS EN ISO 11070:2014ISO 11070:20

43、14(E)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 sheat

44、h 6 sidearm connection (optional)3 haemostasis valve (optional) 7 hub4 stopcock with Luer fittingFigure 2 Example of a sheath introducer and a dilator ISO 2014 All rights reserved 3BS EN ISO 11070:2014ISO 11070:2014(E)a) Fixed core guidewire with safety wireb) Movable core guidewire with safety wire

45、c) Movable core J guidewire with safety wired) Guidewire with full length polymer jackete) Mandrel guidewire with distal polymer jacketf) Mandrel guidewire with distal coilsKey1 safety wire2 core wire3 spring coil4 polymer jacketFigure 3 Examples of guidewires4 ISO 2014 All rights reservedBS EN ISO

46、11070:2014ISO 11070:2014(E)4 General requirements4.1 SterilizationThe device shall have been sterilized by a validated method, and shall comply with 4.2 to 4.4 in the sterile condition.NOTE See applicable part(s) of ISO 17665, ISO 11135, and ISO 11137 for appropriate methods of sterilization.4.2 Bio

47、compatibilityThe device shall be free from biological hazard in accordance with appropriate testing under ISO 10993-1.4.3 SurfaceWhen examined by normal or corrected-to-normal vision with minimum 2,5x magnification, the external surface of the effective length of the device shall appear free from ex

48、traneous matter.The external surface of the effective length of the device, including the distal end, shall be free from process and surface defects, which could cause trauma to vessels during use.If the intravascular catheter introducer is lubricated, the lubricant shall not be visible as drops of

49、fluid on the external surface of the effective length of the device when the device is examined under normal or corrected-to-normal vision.4.4 Corrosion resistanceWhen tested in accordance with the method given in Annex B, if metallic components of the device show visible signs of corrosion that can affect functional performance, the level of corrosion shall be evaluated with respect to intended use and risk assessment.4.5 Radio-detectabilityParts of the device shall be radio-detectable if required as determined by the risk