DIN EN ISO 10555-5-2013 Intravascular catheters - Sterile and single-use catheters - Part 5 Over-needle peripheral catheters (ISO 10555-5 2013) German version EN ISO 10555-5 2013《血.pdf

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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!%*,c“2070964www.din.deDDIN EN ISO 10555-5Intravascular catheters Sterile and single-use catheters Part 5: Over-needle peripheral catheters (ISO 10555-5:2013);English version EN ISO 10555-5:2013,English translation of DIN EN ISO 10555-5:2013-11Intravaskulre Katheter Sterile Katheter zur

3、einmaligen Verwendung Teil 5: Periphere Katheter mit innen liegender Kanle (ISO 10555-5:2013);Englische Fassung EN ISO 10555-5:2013,Englische bersetzung von DIN EN ISO 10555-5:2013-11Cathters intravasculaires Cathters striles et non rutilisables Partie 5: Cathters priphriques aiguille interne (ISO 1

4、0555-5:2013);Version anglaise EN ISO 10555-5:2013,Traduction anglaise de DIN EN ISO 10555-5:2013-11SupersedesDIN EN ISO 10555-5:2000-12www.beuth.deDocument comprises 19 pagesIn case of doubt, the German-language original shall be considered authoritative.11.13 DIN EN ISO 10555-5:2013-11 2 A comma is

5、 used as the decimal marker. National foreword This document (EN ISO 10555-5:2013) 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” (Secr

6、etariat: DIN, Germany). The 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 fol

7、lows: ISO 594-1 DIN EN 20594-1 ISO 7864 DIN EN ISO 7864 ISO 9626 DIN EN ISO 9626 ISO 11070 DIN EN ISO 11070 ISO 14630 DIN EN ISO 14630 Amendments This standard differs from DIN EN ISO 10555-5:2000-12 as follows: a) in Clause 3 “Terms and definitions”, the former term “3.5 vent fitting” has been dele

8、ted; b) Clause 4 “Requirements” has been revised and, to be in line with Part 1 of the standards series, the former Subclause 4.4.5 “Flowrate” has been deleted; c) the former Annex B “Determination of flowrate through the catheter” has been deleted in analogy with the deletion of Subclause 4.4.5 “Fl

9、owrate” and subsequent annexes have been renumbered; d) the Bibliography has been revised; e) the standard has been editorially revised. Previous editions DIN EN ISO 10555-5: 1997-11, 2000-12 DIN EN ISO 10555-5:2013-11 3 National Annex NA (informative) Bibliography DIN EN 20594-1, Conical fittings w

10、ith a 6 % (Luer) taper for syringes, needles and certain other medical equipment Part 1: General requirements DIN EN ISO 7864, Sterile hypodermic needles for single use DIN EN ISO 9626, Stainless steel needle tubing for manufacture of medical devices DIN EN ISO 11070, Sterile single-use intravascula

11、r catheter introducers DIN EN ISO 14630, Non-active surgical implants General requirements DIN EN ISO 10555-5:2013-11 4 This page is intentionally blank EUROPEAN STANDARD NORME EUROPENNE EUROPISCHE NORM EN ISO 10555-5 July 2013 ICS 11.040.25 Supersedes EN ISO 10555-5:1997English Version Intravascula

12、r catheters - Sterile and single-use catheters - Cathters intravasculaires - Cathters striles et non rutilisables - Partie 5: Cathters priphriques aiguille interne (ISO 10555-5:2013) Intravaskulre Katheter - Sterile Katheter zur einmaligen Verwendung - Teil 5: Periphere Katheter mit innen liegender

13、Kanle (ISO 10555-5:2013) 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 alteration. Up-to-date lists an

14、d 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 translation under the

15、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, Finland, Former Yugosla

16、v 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 STANDARDIZATION COMIT EUROPEN DE

17、 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 10555-5:2013: EPart 5: Over-needle peripheral catheters (ISO 10555-5:2013)

18、EN ISO 10555-5:2013 (E) 2 Contents Page Foreword 3 1 Scope 4 2 Normative references 4 3 Terms and definitions .4 4 Requirements .5 4.1 General 5 4.2 Multilumen catheters .5 4.3 Physical requirements 6 4.4 Information to be supplied by the manufacturer 7 Annex A (normative) Determination of strength

19、of union of needle hub and needle tube .8 Annex B (informative) Colours for opaque catheter hubs 9 Annex C (informative) Needle point geometries 10 Annex D (normative) Determination of liquid leakage from vent fitting 11 Annex ZA (informative) Relationship between this European Standard and the Esse

20、ntial Requirements of EU Directive 93/42/EEC amended by Directive 2007/47/EEC .13 Bibliography 15 DIN EN ISO 10555-5:2013-11 EN ISO 10555-5:2013 (E) 3 Foreword This document (EN ISO 10555-5:2013) has been prepared by Technical Committee ISO/TC 84 “Devices for administration of medicinal products and

21、 intravascular 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

22、 January 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 p

23、atent rights. This document supersedes EN ISO 10555-5:1997. 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

24、Annex ZA, which is an integral part of this document. This second edition cancels and replaces the first edition (ISO 10555-5:1996), which has been technically revised. It also incorporates the Amendment ISO 10555-5:1996/Amd 1:1999 and the Technical Corrigendum ISO 10555-5:1996/Cor 1:2002. ISO 10555

25、 consists of the following parts, under the general title 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: Par

26、t 6: Subcutaneous implanted ports The following part has been withdrawn and the content has been included in ISO 10555-1: Part 2: Angiographic catheters Attention is drawn to ISO 11070, which specifies requirements for accessory devices for use with intravascular catheters, and to ISO 14972, which s

27、pecifies requirements for sterile obturators for use with over-needle peripheral catheters. 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, C

28、zech Republic, 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 King

29、dom. Endorsement notice The text of ISO 10555-5:2013 has been approved by CEN as EN ISO 10555-5:2013 without any modification. DIN EN ISO 10555-5:2013-11 1 ScopeThis part of ISO 10555 specifies requirements for over-needle peripheral intravascular catheters, intended for accessing the peripheral vas

30、cular system, supplied in the sterile condition and 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 ref

31、erences, the latest edition of the referenced document (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 9626, Stainless steel needle tubing for the manufacture of medical

32、 devicesISO 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.3.1over-needle peripheral intravascular cathetercatheter designed

33、 for the introduction or withdrawal of liquids or devices into or from the peripheral vascular system3.2needleassembly comprising at least a needle tube attached to, and communicating with, a needle hub See Figure 1.3.3needle tuberigid tube with one end sharpened to facilitate entry into body tissue

34、3.4needle hubfitting attached to the needle tube, providing communication with its bore3.5vent fittingfixed or removable fitting permitting venting of air while restricting or preferably preventing the escape of blood1) Upon its publication, ISO 80369-7 will replace ISO 594-1 and ISO 594-2.4 EN ISO

35、10555-5:2013 (E) DIN EN ISO 10555-5:2013-11 3.6catheter unitassembly comprising the catheter tube, catheter hub and any integral fittings See Figure 1.3.7flashbackblood flow into the needle hubKeya 0 a 1 mm (see 4.3.2)l1effective length1 catheter tube2 catheter hub3 needle tube4 needle hub5 vent fit

36、ting6 heel of bevel7 catheter unitNOTE Other design features may include wings, injection ports integral with the catheter hub, other means of connecting to the fluid path, protection against accidental needle stick injury, etc. The catheter tube may have a single lumen or multiple lumens.Figure 1 T

37、ypical over-needle peripheral intravascular catheter4 Requirements4.1 GeneralUnless otherwise specified in this part of ISO 10555, over-needle peripheral catheters shall comply with ISO 10555-1.4.2 Multilumen cathetersFor multilumen catheters, identification of each lumen shall be apparent to the us

38、er.5 EN ISO 10555-5:2013 (E) DIN EN ISO 10555-5:2013-11 4.3 Physical requirements4.3.1 Colour codeThe catheter unit shall be colour coded in accordance with Table 1 to indicate the nominal outside diameter of the catheter tube.4.3.2 Catheter unitThe distal end shall be tapered for ease of insertion

39、and shall fit closely to the needle. When the needle is fully inserted into the catheter unit, the catheter tube shall neither extend beyond the heel of the needle bevel nor be more than 1 mm from it (see dimension a in Figure 1).4.3.3 Needle4.3.3.1 MaterialIf a steel tube is used, it shall comply w

40、ith ISO 9626.Table 1 Colour coding and corresponding sizes of catheterNominal outside diameter of catheter tubemmRange of actual outside diametermmColoura,bGaugec0,6 0,550 to 0,649 Violet 260,7 0,650 to 0,749 Yellow 240,8; 0,9 0,750 to 0,949 Deep blue 221,0; 1,1 0,950 to 1,149 Pink 201,2; 1,3 1,150

41、to 1,349 Deep green 181,4; 1,5 1,350 to 1,549 White 171,6; 1,7; 1,8 1,550 to 1,849 Medium grey 161,9; 2,0; 2,1; 2,2 1,850 to 2,249 Orange 142,3; 2,4; 2,5 2,250 to 2,549 Red 132,6; 2,7; 2,8 2,550 to 2,849 Pale blue 123,3; 3,4 3,250 to 3,549 Light brown 10a The colour may be opaque or translucent. Sug

42、gested colour references for opaque materials are given in Annex B.b The colour coding is usually applied to the catheter hub or to an integral fitting.c The use of gauge number is optional.4.3.3.2 Needle pointWhen examined by normal or corrected-to-normal vision with 2,5 magnification, the needle p

43、oint shall appear sharp and free from feather edges, burrs and hooks.NOTE The point should be designed to be non-coring. Annex C shows examples of typical needle point geometries.4.3.3.3 Needle hubThe needle hub or another feature shall permit detection of flashback and shall be designed to communic

44、ate with the bore of the introducer needle tube. If the introducer needle is provided with a removable vent fitting, the needle hub shall terminate in a female fitting with a 6 % (Luer) taper complying with ISO 594-1.6 EN ISO 10555-5:2013 (E) DIN EN ISO 10555-5:2013-11 4.3.3.4 Strength of union betw

45、een needle hub and needle tubeWhen tested in accordance with Annex A, the needle tube shall not be loosened in the needle hub.4.3.4 Vent fittingA vent fitting shall be provided. When tested in accordance with Annex D, fluid shall not leak out of the vent fitting within 15 s.4.4 Information to be sup

46、plied by the manufacturerInformation supplied by the manufacturer shall comply with ISO 10555-1 and shall also include the following:a) the flowrate for each lumen;b) a warning against attempting to re-insert a partially or completely withdrawn needle;c) on each primary package, the colour code, unl

47、ess the colour on the product is visible through the unit package, and the outside diameter, as defined in Table 1.NOTE Units of measurement systems other than those specified in this part of ISO 10555 can additionally be given.7 EN ISO 10555-5:2013 (E) DIN EN ISO 10555-5:2013-11 Annex A (normative)

48、 Determination of strength of union of needle hub and needle tubeA.1 PrincipleA force is applied (successively tensile and compressive) to the needle tube and needle hub and the tube-hub union is then examined for loosening.A.2 ApparatusTensile testing apparatus, capable of exerting forces of up to 20 N with an accuracy of 1 %.A.3 Test procedureA.3.1 Condition the needle in an atmosphere of 40 % to 60 % relative humidity and a temperature of (22 2) C for 2 h immediately before the test.A.3.2