EN ISO 7885-2010 en Dentistry - Sterile injection needles for single use《牙科 一次性无菌注射针头》.pdf

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1、BS EN ISO7885:2010ICS 11.040.25; 11.060.20NO COPYING WITHOUT BSI PERMISSION EXCEPT AS PERMITTED BY COPYRIGHT LAWBRITISH STANDARDDentistry Sterileinjection needles forsingle useThis British Standardwas published under theauthority of the StandardsPolicy and StrategyCommittee on 31 March2010. BSI 2010

2、ISBN 978 0 580 59580 6Amendments/corrigenda issued since publicationDate CommentsBS EN ISO 7885:2010National forewordThis British Standard is the UK implementation of EN ISO 7885:2010. Itsupersedes BS EN ISO 7885:2001 which is withdrawn.The UK participation in its preparation was entrusted to Techni

3、calCommittee CH/106/4, Dental Instruments and Equipment.A list of organizations represented on this committee can be obtained onrequest to its secretary.This publication does not purport to include all the necessary provisionsof a contract. Users are responsible for its correct application.Complianc

4、e with a British Standard cannot confer immunityfrom legal obligations.EUROPEAN STANDARD NORME EUROPENNE EUROPISCHE NORM EN ISO 7885 February 2010 ICS 11.060.20; 11.040.25 Supersedes EN ISO 7885:2000English Version Dentistry - Sterile injection needles for single use (ISO 7885:2010) Mdecine bucco-de

5、ntaire - Aiguilles striles pour injection, non rutilisables (ISO 7885:2010) Zahnheilkunde -Sterile Injektionskanlen zum Einmalgebrauch (ISO 7885:2010) This European Standard was approved by CEN on 20 January 2010. CEN members are bound to comply with the CEN/CENELEC Internal Regulations which stipul

6、ate 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 CEN Management Centre or to any CEN member. This European Standard e

7、xists 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 Management Centre has the same status as the official versions. CEN members are the national standard

8、s bodies of Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland and Unit

9、ed Kingdom. EUROPEAN COMMITTEE FOR STANDARDIZATION COMIT EUROPEN DE NORMALISATION EUROPISCHES KOMITEE FR NORMUNG Management Centre: Avenue Marnix 17, B-1000 Brussels 2010 CEN All rights of exploitation in any form and by any means reserved worldwide for CEN national Members. Ref. No. EN ISO 7885:201

10、0: EBS EN ISO 7885:2010EN ISO 7885:2010 (E) 3 Foreword This document (EN ISO 7885:2010) has been prepared by Technical Committee ISO/TC 106 “Dentistry“ in collaboration with Technical Committee Technical Committee CEN/TC 55 “Dentistry” the secretariat of which is held by DIN. This European Standard

11、shall be given the status of a national standard, either by publication of an identical text or by endorsement, at the latest by August 2010, and conflicting national standards shall be withdrawn at the latest by August 2010. Attention is drawn to the possibility that some of the elements of this do

12、cument 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 7885:2000. According to the CEN/CENELEC Internal Regulations, the national standards organizations of the following countries ar

13、e bound to implement this European Standard: Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Sp

14、ain, Sweden, Switzerland and the United Kingdom. Endorsement notice The text of ISO 7885:2010 has been approved by CEN as a EN ISO 7885:2010 without any modification. INTERNATIONAL STANDARD ISO 7885:2010(E) ISO 2010 All rights reserved 1Dentistry Sterile injection needles for single use 1 Scope This

15、 International Standard gives dimensional and performance requirements for sterile injection needles for single use which are used in dental cartridge syringes complying with ISO 9997 for injection of dental local anaesthetics. It further specifies requirements with respect to their packaging, label

16、ling and colour coding. It does not cover needles for special applications or techniques. Only the materials used for the construction of the needle tubing are specified. 2 Normative references The following referenced documents are indispensable for the application of this document. For dated refer

17、ences, only the edition cited applies. For undated references, the latest edition of the referenced document (including any amendments) applies. ISO 1942, Dentistry Vocabulary ISO 6009:1992, Hypodermic needles for single use Colour coding for identification ISO 7000, Graphical symbols for use on equ

18、ipment Index and synopsis ISO 7864, Sterile hypodermic needles for single use ISO 8601, Data elements and interchange formats Information interchange Representation of dates and times ISO 9626, Stainless steel needle tubing for the manufacture of medical devices ISO 9997, Dental cartridge syringes I

19、SO 15223-1, Medical devices Symbols to be used with medical device labels, labelling and information to be supplied Part 1: General requirements 3 Terms and definitions For the purposes of this document, the terms and definitions given in ISO 1942 and the following apply. 3.1 needle unit primary con

20、tainer, needle and hub See Figure 1. BS EN ISO 7885:2010ISO 7885:2010(E) 2 ISO 2010 All rights reserved3.2 effective needle length length of the needle from the needle tip to the hub See Figure 1. 3.3 hardpack needle unit, consisting of a rigid butt-end sheath and a rigid effective needle sheath, se

21、aled to form a complete unit See Figure 1. 3.4 softpack needle unit, consisting of a preformed plastic tray with a peel-off cover, in which the needle is protected by a rigid sheath NOTE A butt-end sheath might or might not be present. Key 1 primary container (two parts) 5 effective needle sheath 2

22、butt-end sheath 6 needle 3 butt-end needle length (l2) 7 hub 4 effective needle length (l1) 8 socket depth (l3) aButt-end angle (15 to 55). bPrimary bevel angle (). Figure 1 Schematic diagram of hardpack BS EN ISO 7885:2010ISO 7885:2010(E) ISO 2010 All rights reserved 33.5 primary container protecti

23、ve package, hardpack or softpack, for the needle 3.6 secondary container container in which primary containers are packed 4 Requirements of assembled needle and hub 4.1 Freedom from extraneous matter The surface of the assembled needle and hub shall be clean and free from extraneous matter when view

24、ed by normal visual acuity without magnification. Lubricant on the external surface shall not be visible as droplets of fluid under normal visual acuity without magnification. 4.2 Limits for extractable metals Limits and tests for extractable metals shall be in accordance with ISO 7864. 4.3 Union be

25、tween hub and needle The union between the hub and needle shall not break under a minimum force of 22 N applied at the crosshead speed of 1 mm/sin both directions along the needle axis. 4.4 Biocompatibility See the Introduction for guidance on biocompatibility. 5 Requirements of needle tubing 5.1 Ma

26、terial The tubing used for construction of the needle shall comply with ISO 9626. 5.2 Dimensions 5.2.1 The nominal outside diameter of the needle tubing, in accordance with ISO 9626, shall be between 0,2 mm and 0,5 mm. 5.2.2 The effective needle length (see l1in Figure 1) of the needle tubing shall

27、be within 10 % of that stated by the manufacturer. 5.2.3 The size of the needle shall be designated by the nominal outside diameter and the effective needle length, expressed in millimetres, e.g. 0,4 mm 34 mm. 5.3 Butt end 5.3.1 The angle at the butt end shall be between 15 and 55 when measured thro

28、ugh the long needle axis (see Figure 1). 5.3.2 The butt-end length (see l2in Figure 1) shall be between 9,0 mm and 14,0 mm. BS EN ISO 7885:2010ISO 7885:2010(E) 4 ISO 2010 All rights reserved5.4 Needle tip The needle tip shall be pointed and, when examined under 2,5 magnification, shall appear free f

29、rom feather edges, burrs, hooks and/or other defects. The angle of the primary bevel of the needle tip (see Figure 1) shall be within 2 of that stated by the manufacturer. 6 Requirements of hub 6.1 Compatibility with syringe 6.1.1 General The hub may be threaded or unthreaded. 6.1.2 Threaded hubs Th

30、e internal thread in the hub shall fit on a metric form M6 0,75. 6.1.3 Unthreaded hubs If an internal thread is absent, the needle shall be capable of being securely screwed on to the threaded mounting hub of a cartridge syringe complying with ISO 9997. 6.2 Socket depth The depth of the socket of th

31、e hub (l3 in Figure 1) shall be not less than 5 mm. 6.3 Colour coding The nominal outside diameter of the needle tubing shall be identified by colour coding in accordance with ISO 6009 (see Table 1 below). This colour coding shall be on the primary container or on the needle hub. Attention is drawn

32、to the sets of reference hubs available as reference colour samples (see Annex A of ISO 6009:1992). The colour zones of opaque colours and the nearest colour samples in a number of colour atlases are given for information in Annexes B and C of ISO 6009:1992, respectively. Table 1 Colour code Nominal

33、 outside diameter of needle Colour 0,2 black 0,25 white 0,3 yellow 0,4 medium grey0,5 orange BS EN ISO 7885:2010ISO 7885:2010(E) ISO 2010 All rights reserved 57 Requirements of the primary container 7.1 Each needle shall be supplied in a primary container. 7.2 The material and design of this contain

34、er shall ensure maintenance of sterility, that, once opened, the container shall show clear evidence of having been opened, that the effective needle sheath can be used as an aid for attaching the needle to the syringe, without the operator touching the needle. 8 Sterility The needle unit shall have

35、 been subjected to a validated sterilization process. 9 Labelling The primary or secondary container shall be marked with at least the following information: a) name or trademark and address of manufacturer or distributor; b) size of needle (see 5.2.3); c) type of thread; d) the words “Sterile injec

36、tion needle for single-use”; e) graphical symbol for single use in accordance with ISO 15223-1 or symbol ISO 7000-1051; f) the words “Do not use if seal is broken”, or “Do not use if soft pack is open or damaged”; g) (expiry date) use by date (year and month in accordance with ISO 8601) of the guara

37、nteed sterility; h) method of sterilization; i) lot number; j) the number of single units in the secondary container. BS EN ISO 7885:2010ISO 7885:2010(E) 6 ISO 2010 All rights reservedAnnex A (informative) Imperial thread sizes The Introduction mentions the existence of imperial thread sizes for the

38、 threaded needle hubs. In the interest of patient safety, the imperial thread size used should be: 0,218 in (5,54 mm) 40 TPI (threads per inch) Whitworth form. BS EN ISO 7885:2010ISO 7885:2010(E) ISO 2010 All rights reserved 7Bibliography 1 ISO 7405, Dentistry Evaluation of biocompatibility of medic

39、al devices used in dentistry 2 ISO 10993-1, Biological evaluation of medical devices Part 1: Evaluation and testing within a risk management process 3 ISO 10993-11, Biological evaluation of medical devices Part 11: Tests for systemic toxicity 4 ISO 11499, Dentistry Single-use cartridges for local an

40、aesthetics 5 ISO 21533, Dentistry Reusable cartridge syringes intended for intraligamentary injections 6 ISO 11135 (both parts), Sterilization of health care products Ethylene oxide 7 ISO 11137 (all parts), Sterilization of health care products Radiation 8 ISO 17665 (all parts), Sterilization of hea

41、lth care products Moist heat BS EN ISO 7885:2010BS EN ISO7885:2010BSI GroupHeadquarters 389Chiswick High Road,London, W4 4AL, UKTel +44 (0)20 8996 9001Fax +44 (0)20 8996 - British Standards InstitutionBSI is the independent national body responsible for preparing BritishStandards. It presents the U

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