1、BSI Standards PublicationBS EN ISO 10555-5:2013Intravascular catheters Sterile and single-use cathetersPart 5: Over-needle peripheral catheters(ISO 10555-5:2013)BS EN ISO 10555-5:2013 BRITISH STANDARDNational forewordThis British Standard is the UK implementation of EN ISO10555-5:2013. It supersedes
2、 BS EN ISO 10555-5:1997 which iswithdrawn.The UK participation 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 ne
3、cessaryprovisions of a contract. Users are responsible for its correctapplication. The British Standards Institution 2013. Published by BSI StandardsLimited 2013ISBN 978 0 580 73011 5ICS 11.040.25Compliance with a British Standard cannot confer immunity fromlegal obligations.This British Standard wa
4、s published under the authority of theStandards Policy and Strategy Committee on 31 July 2013.Amendments issued since publicationDate Text affectedEUROPEAN STANDARD NORME EUROPENNE EUROPISCHE NORM EN ISO 10555-5 July 2013 ICS 11.040.25 Supersedes EN ISO 10555-5:1997English Version Intravascular cath
5、eters - Sterile and single-use catheters - Part 5: Over-needle peripheral catheters (ISO 10555-5:2013) Cathters intravasculaires - Cathters striles et non rutilisables - Partie 5: Cathters priphriques aiguille interne (ISO 10555-5:2013) Intravaskulre Katheter - Sterile Katheter zur einmaligen Verwen
6、dung - Teil 5: Periphere Katheter mit innen liegender 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 nationa
7、l 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 member. This European Standard exists in three official versions (English, French, German). A versio
8、n 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. CEN members are the national standards bodies of Austria, Belgium, Bulgaria, Croatia, Cyprus, Cze
9、ch 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 United Kingdom. E
10、UROPEAN 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 and by any means reserved worldwide for CEN national Members. Ref. No. EN ISO 10555-5:2013: EBS EN
11、ISO 10555-5:2013EN 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 intravascular catheters” in collaboration with Technical Committee CEN/TC 205 “Non-active medical devices” t
12、he 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 January 2014, and conflicting national standards shall be withdrawn at the latest by January 2014. Attention
13、 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 10555-5:1997. This document has been prepared under a mandate g
14、iven 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 ZA, which is an integral part of this document. According to the CEN-CENELEC Internal Regulations, the
15、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, Hungary, Iceland, Ireland, Italy, Latvia,
16、 Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and the United Kingdom. Endorsement notice The text of ISO 10555-5:2013 has been approved by CEN as EN ISO 10555-5:2013 without any modification. BS EN ISO 10555-5:20
17、13EN ISO 10555-5:2013 (E) 4 Annex ZA (informative) Relationship between this European Standard and the Essential Requirements of EU Directive 93/42/EEC amended by Directive 2007/47/EEC This European Standard has been prepared under a mandate given to CEN by the European Commission and the European F
18、ree Trade Association to provide a means of conforming to Essential Requirements of Directive 93/42/EEC amended by Directive 2007/47/EEC. Once this standard is cited in the Official Journal of the European Union under that Directive and has been implemented as a national standard in at least one Mem
19、ber State, compliance with the normative clauses of this standard given in Table ZA.1 confers, within the limits of the scope of this standard, a presumption of conformity with the relevant Essential Requirements of that Directive. NOTE When an Essential Requirement does not appear in Table ZA.1, it
20、 means that it is not addressed by this European Standard. Table ZA.1 Correspondence between this European Standard and Directive 93/42/EEC amended by Directive 2007/47/EEC Essential Requirements (ERs) of Directive 93/42/EEC Clause(s)/sub-clause(s) of this EN ISO 10555-5 7.3 4.1 7.5 4.1 8.1 4.1 8.3
21、4.1 8.4 4.1 9.1 4.1 4.3.3.3 9.2 4.1 4.2 4.3.3.2 4.3.3.3 4.3.3.4 4.3.4 12.7.1 4.1 4.3.3.2 12.7.4 4.1 12.8.1 4.1 12.9 4.2 13.1 4.1 13.2 4.1 BS EN ISO 10555-5:2013EN ISO 10555-5:2013 (E) 5 13.3 a) 4.1 13.3 b) 4.1 13.3 c) 4.1 13.3 d) 4.1 13.3 e) 4.1 13.3 f) 4.1 13.3 i) 4.1 13.3 j) 4.1 4.4 a) and c) 13.3
22、 k) 4.1 4.4 b) 13.3 m) 4.1 13.4 4.1 13.6 a) 4.1 13.6 b) 4.1 13.6 c) 4.1 13.6 e) 4.1 13.6 f) 4.1 13.6 g) 4.1 13.6 k) 4.1 13.6 l) 4.1 13.6 n) 4.1 13.6 q) 4.1 WARNING Other requirements and other EU Directives may be applicable to the product(s) falling within the scope of this standard. BS EN ISO 1055
23、5-5:2013ISO 10555-5:2013(E) ISO 2013 All rights reserved iiiContents PageForeword iv1 Scope . 12 Normative references 13 Terms and definitions . 14 Requirements 24.1 General . 24.2 Multilumen catheters 24.3 Physical requirements 34.4 Information to be supplied by the manufacturer 4Annex A (normative
24、) Determination of strength of union of needle hub and needle tube . 5Annex B (informative) Colours for opaque catheter hubs . 6Annex C (informative) Needle point geometries 7Annex D (normative) Determination of liquid leakage from vent fitting 8Bibliography .10BS EN ISO 10555-5:2013ISO 10555-5:2013
25、(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 body interested in a subject for which a
26、 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 Commission (IEC) on all matte
27、rs of electrotechnical standardization.International Standards are drafted in accordance with the rules given in the ISO/IEC Directives, Part 2.The main task of technical committees is to prepare International Standards. Draft International Standards adopted by the technical committees are circulate
28、d to the member bodies for voting. Publication as an International Standard requires approval by at least 75 % of the member bodies casting a vote.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 responsible f
29、or identifying any or all such patent rights.ISO 10555-5 was prepared by Technical Committee ISO/TC 84, Devices for administration of medicinal products and intravascular catheters.This second edition cancels and replaces the first edition (ISO 10555-5:1996), which has been technically revised. It a
30、lso incorporates the Amendment ISO 10555-5:1996/Amd 1:1999 and the Technical Corrigendum ISO 10555-5:1996/Cor 1:2002.ISO 10555 consists of the following parts, under the general title Intravascular catheters Sterile and single-use catheters: Part 1: General requirements Part 3: Central venous cathet
31、ers Part 4: Balloon dilatation catheters Part 5: Over-needle peripheral cathetersThe following part is under preparation: Part 6: Subcutaneous implanted portsThe following part has been withdrawn and the content has been included in ISO 10555-1: Part 2: Angiographic cathetersAttention is drawn to IS
32、O 11070, which specifies requirements for accessory devices for use with intravascular catheters, and to ISO 14972, which specifies requirements for sterile obturators for use with over-needle peripheral catheters.iv ISO 2013 All rights reservedBS EN ISO 10555-5:2013INTERNATIONAL STANDARD ISO 10555-
33、5:2013(E)Intravascular catheters Sterile and single-use catheters Part 5: Over-needle peripheral catheters1 ScopeThis part of ISO 10555 specifies requirements for over-needle peripheral intravascular catheters, intended for accessing the peripheral vascular system, supplied in the sterile condition
34、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 references, the latest edition of the referenced do
35、cument (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 devicesISO 10555-1, Intravascular catheters Ste
36、rile 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 for the introduction or withdrawal of liquids o
37、r 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 tissue3.4needle hubfitting attached to the needle tube
38、, 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. ISO 2013 All rights reserved 1BS EN ISO 10555-5:2013ISO
39、10555-5:2013(E)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 fitting6 heel of bevel7 catheter
40、 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 Typical over-needle peripheral
41、 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 user.2 ISO 2013 All rights rese
42、rvedBS EN ISO 10555-5:2013ISO 10555-5:2013(E)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 and shall f
43、it 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 with ISO 962
44、6.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 to 1,349 De
45、ep 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. Suggested colo
46、ur 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 point shall
47、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 communicate with th
48、e 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. ISO 2013 All rights reserved 3BS EN ISO 10555-5:2013ISO 10555-5:2013(E)4.3.3.4 Strength of un
49、ion between 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 supplied 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
