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1、BRITISH STANDARD BS EN ISO 11070:1999 Sterile, single-use intravascular catheter introducers The European Standard EN ISO 11070:1999 has the status of a British Standard ICS 11.040.20 Licensed Copy: sheffieldun sheffieldun, na, Wed Nov 15 13:16:13 GMT+00:00 2006, Uncontrolled Copy, (c) BSI BS EN ISO
2、 11070:1999 This British Standard, having been prepared under the direction of the Health and Environment Sector Committee, was published under the authority of the Standards Committee and comes into effect on 15 July 1999 BSI 03-2000 ISBN 0 580 32463 X National foreword This British Standard is the
3、 English language version of EN ISO 11070:1998. It is identical with ISO 11070:1998. It supersedes BS 7174-4:1990 which is withdrawn. The UK participation in its preparation was entrusted to Technical Committee CH/27, Medical plastics tubing, which has the responsibility to: aid enquirers to underst
4、and the text; present to the responsible international/European committee any enquiries on the interpretation, or proposals for change, and keep the UK interests informed; monitor related international and European developments and promulgate them in the UK. A list of organizations represented on th
5、is committee can be obtained on request to its secretary. Cross-references Attention is drawn to the fact that CEN and CENELEC Standards normally include an annex which lists normative references to international publications with their corresponding European publications. The British Standards whic
6、h implement these international or European publications may be found in the BSI Standards Catalogue under the section entitled “International Standards Correspondence Index”, or by using the “Find” facility of the BSI Standards Electronic Catalogue. A British Standard does not purport to include al
7、l the necessary provisions of a contract. Users of British Standards are responsible for their correct application. Compliance with a British Standard does not of itself confer immunity from legal obligations. Summary of pages This document comprises a front cover, an inside front cover, pages i and
8、 ii, the EN ISO title page, page 2, the ISO title page, pages ii to iv, pages 1 to 16, an inside back cover and a back cover. This standard has been updated (see copyright date) and may have had amendments incorporated. This will be indicated in the amendment table on the inside front cover. Amendme
9、nts issued since publication Amd. No.DateComments Licensed Copy: sheffieldun sheffieldun, na, Wed Nov 15 13:16:13 GMT+00:00 2006, Uncontrolled Copy, (c) BSI BS EN ISO 11070:1999 BSI 03-2000i Contents Page National forewordInside front cover Foreword2 Forewordiii Text of ISO 110701 Licensed Copy: she
10、ffieldun sheffieldun, na, Wed Nov 15 13:16:13 GMT+00:00 2006, Uncontrolled Copy, (c) BSI ii blank Licensed Copy: sheffieldun sheffieldun, na, Wed Nov 15 13:16:13 GMT+00:00 2006, Uncontrolled Copy, (c) BSI EUROPEAN STANDARD NORME EUROPENNE EUROPISCHE NORM EN ISO 11070 April 1999 ICS 11.040.20 English
11、 version Sterile single-use intravascular catheter introducers (ISO 11070:1998) Introducteurs de cathters intravasculaires striles, non rutilisables (ISO 11070:1998) Einfhrinstrumente fr intravaskulre Katheter zur einmaligen Verwendung (ISO 11070:1998) This European Standard was approved by CEN on 2
12、2 March 1999. 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 national standards may be
13、 obtained on application to the Central Secretariat 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 Central
14、 Secretariat has the same status as the official versions. CEN members are the national standards bodies of Austria, Belgium, Czech Republic, Denmark, Finland, France, Germany, Greece, Iceland, Ireland, Italy, Luxembourg, Netherlands, Norway, Portugal, Spain, Sweden, Switzerland and United Kingdom.
15、CEN European Committee for Standardization Comit Europen de Normalisation Europisches Komitee fr Normung Central Secretariat: rue de Stassart 36, B-1050 Brussels 1999 CEN All rights of exploitation in any form and by any means reserved worldwide for CEN national Members. Ref. No. EN ISO 11070:1999 E
16、 Licensed Copy: sheffieldun sheffieldun, na, Wed Nov 15 13:16:13 GMT+00:00 2006, Uncontrolled Copy, (c) BSI EN ISO 11070:1999 BSI 03-2000 2 Foreword The text of the International Standard from Technical Committee ISO/TC 84 “Medical devices for injections” of the International Organization for Standa
17、rdization (ISO) has been taken over as an European Standard by Technical Committee CEN/TC 205 “Non-active medical devices”, the secretariat of which is held by BSI. This European Standard shall be given the status of a national standard, either by publication of an identical text or by endorsement,
18、at the latest by October 1999, and conflicting national standards shall be withdrawn at the latest by October 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, Czec
19、h Republic, Denmark. Finland, France, Germany, Greece, Iceland, Ireland, Italy, Luxembourg, Netherlands, Norway, Portugal, Spain, Sweden, Switzerland and the United Kingdom. Endorsement notice The text of the International Standard ISO 11070:1999 has been approved by CEN as a European Standard witho
20、ut any modification. NOTENormative references to International Standards are listed in Annex ZA (normative). Licensed Copy: sheffieldun sheffieldun, na, Wed Nov 15 13:16:13 GMT+00:00 2006, Uncontrolled Copy, (c) BSI Licensed Copy: sheffieldun sheffieldun, na, Wed Nov 15 13:16:13 GMT+00:00 2006, Unco
21、ntrolled Copy, (c) BSI EN ISO 11070:1999 ii BSI 03-2000 Contents Page Forewordiii 1Scope1 2Normative references1 3Definitions1 4General requirements4 5Additional requirements for introducer needles5 6Additional requirements for introducer catheters5 7Additional requirements for sheath introducers6 8
22、Additional requirements for guide wires7 9Additional requirements for dilators8 10Additional requirements for kits containing combinations of devices specified in this International Standard8 Annex A (informative) Guidance on materials and design9 Annex B (normative) Test for corrosion resistance9 A
23、nnex C (normative) Determination of force at break of introducer catheters, sheath introducers and dilators9 Annex D (normative) Test for liquid leakage from sheath introducers under pressure10 Annex E (normative) Test for liquid leakage through haemostasis valves of sheath introducers11 Annex F (no
24、rmative) Test for fracture of guide wires12 Annex G (normative) Test for resistance of guide wires to damage by flexing13 Annex H (normative) Test for strength of union of core wire and coil of guide wire and union of coil and safety wire14 Annex J (informative) Bibliography16 Annex ZA (normative) N
25、ormative references to international publications with their relevant European publicationsInside back cover Figure 1 Example of an introducer catheter and an introducer needle2 Figure 2 Example of a sheath introducer and a dilator3 Figure 3 Examples of guide wires4 Figure 4 Example of an introducer
26、 needle point and an introducer catheter tip6 Figure D.1 Apparatus for testing liquid leakage from sheath introducers11 Figure F.1 Apparatus for testing guide wires for fracture13 Figure G.1 Test rig for testing flexibility of guide wires14 Figure H.1 Example of a split-tapered clamp15 Table 1 Desig
27、nation of nominal size of introducer needles and introducer catheters5 Table 2 Minimum force at break of introducer catheter, sheath introducer and dilator test pieces6 Table 3 Dimensions to be given for kits8 Table C.1 Examples of conditions for a 20 mm/min/mm strain rate10 Table H.1 Forces for tes
28、ting strength of union16 Descriptors: Medical equipment, sterile equipment, disposable equipment, vascular system, catheters, accessories, specifications, designation, size designation. Licensed Copy: sheffieldun sheffieldun, na, Wed Nov 15 13:16:13 GMT+00:00 2006, Uncontrolled Copy, (c) BSI EN ISO
29、11070:1999 BSI 03-2000iii Foreword ISO (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 body interested
30、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 Electrotechnical Commi
31、ssion (IEC) on all matters of electrotechnical standardization. Draft 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. Internati
32、onal Standard ISO 11070 was prepared by Technical Committee ISO/TC 84, Medical devices for injection, Subcommittee SC 1, Syringes, needles and intravascular catheters for single use. Annex B, Annex C, Annex D, Annex E, Annex F, Annex G, and Annex H form an integral part of this International Standar
33、d. Annex A and Annex J are for information only. Licensed Copy: sheffieldun sheffieldun, na, Wed Nov 15 13:16:13 GMT+00:00 2006, Uncontrolled Copy, (c) BSI iv blank Licensed Copy: sheffieldun sheffieldun, na, Wed Nov 15 13:16:13 GMT+00:00 2006, Uncontrolled Copy, (c) BSI EN ISO 11070:1999 BSI 03-200
34、01 1 Scope This International Standard specifies requirements for introducer needles, introducer catheters, sheath introducers, guide wires and dilators supplied in the sterile condition, and intended for single use in conjunction with intravascular catheters specified in ISO 10555. NOTEGuidance on
35、materials and design of accessory devices is given in Annex A. 2 Normative references The following standards contain provisions which, through reference in this text, constitute provisions of this International Standard. At the time of publication, the editions indicated were valid. All standards a
36、re subject to revision, and parties to agreements based on this International Standard are encouraged to investigate the possibility of applying the most recent editions of the standards indicated below. Members of IEC and ISO maintain registers of currently valid International Standards. ISO 594-1:
37、1986, Conical fittings with a 6 % (Luer) taper for syringes, needles and certain other medical equipment Part 1: General requirements. ISO 594-2:1991, Conical fittings with a 6 % (Luer) taper for syringes, needles and certain other medical equipment Part 2: Lock fittings. ISO 7886-1:1993, Sterile hy
38、podermic syringes for single use Part 1: Syringes for manual use. 3 Definitions For the purposes of this International Standard, the following definitions apply. NOTESchematic examples of the devices covered by this International Standard, with examples of terminology, are given for information in F
39、igure 1, Figure 2 and Figure 3. 3.1 coil (of a guide wire) outer, helically wound wire 3.2 core wire (of a guide wire) inner wire used to achieve stiffness of the guide wire 3.3 dilator flexible, tubular device used for dilating the percutaneous opening into a blood vessel 3.4 distal end patient end
40、 end of the device which is inserted into the patient 3.5 effective length length of the device that can be inserted into the body 3.6 guide wire spring guide flexible device over which a catheter or dilator is passed to assist in the insertion and location of the catheter or dilator into a blood ve
41、ssel NOTEThe guide wire may be pre-formed, such as the J-type guide wire shown in Figure 3, have a fixed or movable core, and may also be coated. 3.7 hub connector(s) at the proximal end of the intravascular catheter introducer which may either be integral with the introducer or be capable of being
42、securely fitted to the proximal end of the introducer Licensed Copy: sheffieldun sheffieldun, na, Wed Nov 15 13:16:13 GMT+00:00 2006, Uncontrolled Copy, (c) BSI EN ISO 11070:1999 2 BSI 03-2000 3.8 introducer catheter short, flexible tube which is introduced into a blood vessel, typically over an int
43、roducer needle, and through which a catheter or guide wire can be introduced after removal of the introducer needle 3.9 intravascular catheter introducer device designed to be used in conjunction with an intravascular catheter to facilitate introduction into the vascular system 3.10 introducer needl
44、e pointed, rigid tube through which a guide wire or catheter can be introduced into a blood vessel 3.11 proximal end free end end of the device opposite the distal end 3.12 safety wire (of a guide wire) additional wire used to minimize the possibility of detachment of the tip 3.13 sheath introducer
45、flexible tube which is introduced into a blood vessel, typically over a dilator, and through which a guide wire or catheter can be introduced after removal of the dilator 3.14 tip extremity of the distal end of the device Key 1 2 3 Effective length Distal end Catheter 4 5 6 Catheter hub (optional) I
46、ntroducer needle tube Needle hub Figure 1 Example of an introducer catheter and an introducer needle Licensed Copy: sheffieldun sheffieldun, na, Wed Nov 15 13:16:13 GMT+00:00 2006, Uncontrolled Copy, (c) BSI EN ISO 11070:1999 BSI 03-20003 Key 1 2 3 Distal end Sheath Haemostasis valve (optional) 4 5
47、6 Stopcock with Luer fitting Sidearm Sidearm connection (optional) 7Hub Figure 2 Example of a sheath introducer and a dilator Licensed Copy: sheffieldun sheffieldun, na, Wed Nov 15 13:16:13 GMT+00:00 2006, Uncontrolled Copy, (c) BSI EN ISO 11070:1999 4 BSI 03-2000 4 General requirements 4.1 Steriliz
48、ation The device shall have been sterilized by a validated method, and shall comply with 4.2 to 4.4 in the sterile condition. NOTESee ISO 11134, ISO 11135 and ISO 11137 for appropriate methods of sterilization. 4.2 Biocompatibility The device shall be free from biological hazard. NOTESee ISO 10993-1
49、 for selection of appropriate test methods. 4.3 Surface When examined by normal or corrected-to-normal vision with 2,5 magnification, the external surface of the effective length of the device shall appear free from extraneous matter. NOTE 1The external surface of the effective length of the device, including the distal end, should be free from process and surface defects and should cause minimum trauma to vessels during use. NOTE 2If the intravascular catheter introducer is lubricated, the lubricant should not be visi