DIN EN ISO 7885-2010 Dentistry - Sterile injection needles for single use (ISO 7885 2010) German version EN ISO 7885 2010《牙科 一次性无菌注射针头(ISO 7885-2010) 德文版本EN ISO 7885-2010》.pdf

1、June 2010 Translation by DIN-Sprachendienst.English price group 10No 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).ICS 1

2、1.040.25; 11.060.25!$iD“1700433www.din.deDDIN EN ISO 7885Dentistry Sterile injection needles for single use (ISO 7885:2010)English translation of DIN EN ISO 7885:2010-06Zahnheilkunde Sterile Injektionskanlen zum Einmalgebrauch (ISO 7885:2010)Englische bersetzung von DIN EN ISO 7885:2010-06Mdecine bu

3、cco-dentaire Aiguilles striles pour injection, non rutilisables (ISO 7885:2010)Traduction anglaise de DIN EN ISO 7885:2010-06SupersedesDIN EN ISO 7885:2001-07www.beuth.deIn case of doubt, the German-language original shall be considered authoritative.Document comprises 15 pages06.10 DIN EN ISO 7885:

4、2010-06 2 A comma is used as the decimal marker. National foreword This standard has been prepared by Technical Committee ISO/TC 106 “Dentistry” (Secretariat: SCC, Canada) in collaboration with Technical Committee CEN/TC 55 “Dentistry” (Secretariat: DIN, Germany). The responsible German body involve

5、d in its preparation was the Normenausschuss Dental (Dentistry Standards Committee), Working Committee NA 014-00-23 AA Handinstrumente. The DIN Standards corresponding to the International Standards referred to in clause 2 of this document are as follows: ISO 1942 DIN EN ISO 1942 ISO 6009 DIN EN ISO

6、 6009 ISO 7000 DIN ISO 7000 ISO 7864 DIN EN ISO 7864 ISO 8601 DIN ISO 8601 ISO 9626 DIN EN ISO 9626 ISO 9997 DIN EN ISO 9997 ISO 15223-1 E DIN EN ISO 15223-1 Amendments This standard differs from DIN EN ISO 7885:2001-07 as follows: a) The requirement for patency of lumen has been deleted. b) A colou

7、r coding for smaller needle sizes 0,2 and 0,25 has been introduced. c) Marking requirements have been rendered more precise. Previous editions DIN EN ISO 7885: 1999-04, 2001-07 DIN EN ISO 7885:2010-06 3 National Annex NA (informative) Bibliography DIN EN ISO 1942, Dentistry Terminology DIN EN ISO 60

8、09, Hypodermic needles for single use Colour coding for identification 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 9997, Dental cartridge syringes DIN ISO 7000, Graphical symbols for use on eq

9、uipment Index and synopsis DIN ISO 8601, Data elements and interchange formats Information interchange Representation of dates and times E DIN EN ISO 15223-1, Medical devices Symbols to be used with medical device labels, labelling and information to be supplied Part 1: General requirements DIN EN I

10、SO 7885:2010-06 4 This page is intentionally blank 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-dentaire - Aiguilles s

11、triles pour injection, non rutilisables (ISO 7885:2010) 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 stipulate the conditions for giving this European Standard the status

12、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 exists in three official versions (English, French, German). A ve

13、rsion 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 standards bodies of Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech R

14、epublic, 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 United Kingdom. EUROPEAN COMMITTEE FOR STANDARDIZATION COMIT EUROPEN

15、 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 7885:2010: EZahnheilkunde - Sterile Injektionskanlen zum Contents Page F

16、oreword3 Introduction .4 1 Scope 5 2 Normative references 5 3 Terms and definitions .5 4 Requirements of assembled needle and hub .7 4.1 Freedom from extraneous matter 7 4.2 Limits for extractable metals7 4.3 Union between hub and needle7 4.4 Biocompatibility.7 5 Requirements of needle tubing7 5.1 M

17、aterial .7 5.2 Dimensions.7 5.3 Butt end 7 5.4 Needle tip8 6 Requirements of hub.8 6.1 Compatibility with syringe 8 6.1.1 General8 6.1.2 Threaded hubs .8 6.1.3 Unthreaded hubs .8 6.2 Socket depth 8 6.3 Colour coding.8 7 Requirements of the primary container 9 8 Sterility9 9 Labelling .9 Annex A (inf

18、ormative) Imperial thread sizes . 10 Bibliography. 11 2 DIN EN ISO 7885:2010-06 EN ISO 7885:2010 (E) Foreword collaboration with Technical Committee Technical Committee CEN/TC 55 “Dentistry” the secretariat of which is held by DIN. This European Standard shall be given the status of a national stand

19、ard, 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 document may be the subject of patent rights. C

20、EN 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 are bound to implement this European Standard:

21、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 the United Kingd

22、om. Endorsement notice The text of ISO 7885:2010 has been approved by CEN as a EN ISO 7885:2010 without any modification. This document (EN ISO 7885:2010) has been prepared by Technical Committee ISO/TC 106 “Dentistry” in 3 DIN EN ISO 7885:2010-06 EN ISO 7885:2010 (E) Introduction This International

23、 Standard is closely related to ISO 7864. Requirements for validated sterilization processes are described in International Standards prepared by ISO/TC 198, Sterilization of health care products. (See references 6 to 8 in Bibliography.) Specific qualitative and quantitative requirements for freedom

24、 from biological hazards are not included in this International Standard but it is recommended that, in assessing possible biological hazards, reference be made to ISO 10993-1, ISO 10993-11 and ISO 7405. This International Standard specifies requirements for dental injection needles with metric size

25、s only. However, attention is drawn to the existence of dental injection needles with imperial threads (see Annex A). 4 DIN EN ISO 7885:2010-06 EN ISO 7885:2010 (E) 1 Scope This International Standard gives dimensional and performance requirements for sterile injection needles for single use which a

26、re used in dental cartridge syringes complying with ISO 9997 for injection of dental local anaesthetics. It further specifies requirements with respect to their packaging, labelling and colour coding. It does not cover needles for special applications or techniques. Only the materials used for the c

27、onstruction of the needle tubing are specified. 2 Normative references The following referenced documents are indispensable for the application of this document. For dated references, only the edition cited applies. For undated references, the latest edition of the referenced document (including any

28、 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 equipment Index and synopsis ISO 7864, Sterile hypodermic needles for single use ISO 8601, Data elements and interchange forma

29、ts Information interchange Representation of dates and times ISO 9626, Stainless steel needle tubing for the manufacture of medical devices ISO 9997, Dental cartridge syringes ISO 15223-1, Medical devices Symbols to be used with medical device labels, labelling and information to be supplied Part 1:

30、 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 container, needle and hub See Figure 1. 5 DIN EN ISO 7885:2010-06 EN ISO 7885:2010 (E) 3.2 effective needle length length of t

31、he 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, sealed 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 th

32、e 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 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). bP

33、rimary bevel angle (). Figure 1 Schematic diagram of hardpack 6 DIN EN ISO 7885:2010-06 EN ISO 7885:2010 (E) 3.5 primary container protective package, hardpack or softpack, for the needle 3.6 secondary container container in which primary containers are packed 4 Requirements of assembled needle and

34、hub 4.1 Freedom from extraneous matter The surface of the assembled needle and hub shall be clean and free from extraneous matter when viewed by normal visual acuity without magnification. Lubricant on the external surface shall not be visible as droplets of fluid under normal visual acuity without

35、magnification. 4.2 Limits for extractable metals Limits and tests for extractable metals shall be in accordance with ISO 7864. 4.3 Union between 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 direction

36、s along the needle axis. 4.4 Biocompatibility See the Introduction for guidance on biocompatibility. 5 Requirements of needle tubing 5.1 Material 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 acco

37、rdance 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 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 leng

38、th, 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 through 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. 7 DIN EN ISO 7885:2010-06 EN ISO 7885

39、:2010 (E) 5.4 Needle tip The needle tip shall be pointed and, when examined under 2,5 magnification, shall appear free from 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 Requir

40、ements of hub 6.1 Compatibility with syringe 6.1.1 General The hub may be threaded or unthreaded. 6.1.2 Threaded hubs The 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

41、the threaded mounting hub of a cartridge syringe complying with ISO 9997. 6.2 Socket depth The depth of the socket of the 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

42、6009 (see Table 1 below). This colour coding shall be on the primary container or on the needle hub. Attention is drawn 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

43、 colour atlases are given for information in Annexes B and C of ISO 6009:1992, respectively. Table 1 Colour code Nominal outside diameter of needle Colour 0,2 black 0,25 white 0,3 yellow 0,4 medium grey0,5 orange 8 DIN EN ISO 7885:2010-06 EN ISO 7885:2010 (E) 7 Requirements of the primary container

44、7.1 Each needle shall be supplied in a primary container. 7.2 The material and design of this container 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 ne

45、edle to the syringe, without the operator touching the needle. 8 Sterility The needle unit shall have 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 manuf

46、acturer or distributor; b) size of needle (see 5.2.3); c) type of thread; d) the words “Sterile injection 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 ope

47、n or damaged”; g) (expiry date) use by date (year and month in accordance with ISO 8601) of the guaranteed sterility; h) method of sterilization; i) lot number; j) the number of single units in the secondary container. 9 DIN EN ISO 7885:2010-06 EN ISO 7885:2010 (E) Annex A (informative) Imperial thr

48、ead sizes The Introduction mentions the existence of imperial thread sizes for the 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. 10 DIN EN ISO 7885:2010-06 EN ISO 7885:2010 (E) Bibliograp

49、hy 1 ISO 7405, Dentistry Evaluation of biocompatibility of medical 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 anaesthetics 5 ISO 21533, Dentistry Reusable cartridge syringes intended for intraligamentary injections 6 ISO 11135 (both parts), S