DIN EN ISO 9168-2009 Dentistry - Hose connectors for air driven dental handpieces (ISO 9168 2009) English version of DIN EN ISO 9168 2009-10《牙科 空气驱动牙科手持洗液器软管连接器(ISO 9168 2009) DIN .pdf

1、October 2009DEUTSCHE NORM English price group 10No part of this standard 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 11.060.25!$Z-p“1551077

2、www.din.deDDIN EN ISO 9168Dentistry Hose connectors for air driven dental handpieces (ISO 9168:2009)English version of DIN EN ISO 9168:2009-10Zahnheilkunde Schlauchanschlsse fr luftbetriebene zahnrztliche Handstcke (ISO 9168:2009)Englische Fassung DIN EN ISO 9168:2009-10SupersedesDIN EN 29168:1994-0

3、8www.beuth.deDocument comprises pages17 2 National foreword This standard has been prepared by Technical Committee ISO/TC 106 “Dentistry” in collaboration with Technical Committee CEN/TC 55 “Dentistry” (Secretariat: DIN, Germany). The responsible German body involved in its preparation was the Norme

4、nausschuss Dental (Dentistry Standards Committee), Technical Committee NA 014-00-04 AA Rotierende Instrumente. The DIN Standards corresponding to the International Standards referred to in this document are as follows: ISO 261 DIN ISO 261 ISO 1942 DIN EN ISO 1942 ISO 7494-1 DIN EN ISO 7494-1 Amendme

5、nts This standard differs from DIN EN 29168:1994-08 as follows: a) The requirement for resistance to sterilization has been replaced by requirements for resistance to reprocessing. b) The figures have been modified so as to be linguistically neutral. c) The definition for “hose connector” has been i

6、ncluded, and the normative references and bibliography have been updated. d) Annex A “Performance and general design” has been added. Previous editions DIN EN 29168: 1994-08, DIN 13940-2: 1983-11, 1988-12, 1990-08 DIN EN ISO 9168:2009-10 3 National Annex NA (informative) Bibliography DIN ISO 261, IS

7、O general purpose metric screw threads General plan DIN EN ISO 1942, Dentistry Terminology DIN EN ISO 7494-1, Dentistry Dental units Part 1: General requirements and test methods DIN EN ISO 9168:2009-10 4 This page is intentionally blank DIN EN ISO 9168:2009-10 EUROPEAN STANDARDNORME EUROPENNEEUROPI

8、SCHE NORMEN ISO 9168July 2009ICS 11.060.20 Supersedes EN 29168:1994 English VersionDentistry - Hose connectors for air driven dental handpieces(ISO 9168:2009)Art dentaire - Connexions pour pices main dentaires air comprim (ISO 9168:2009)Zahnheilkunde - Schlauchanschlsse fr luftbetriebenezahnrztliche

9、 Handstcke (ISO 9168:2009)This European Standard was approved by CEN on 17 June 2009.CEN members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for giving this EuropeanStandard the status of a national standard without any alteration. Up-to-date lists an

10、d bibliographical references concerning such nationalstandards 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 version in any other language made by translationunder the responsibil

11、ity of a CEN member into its own language and notified to the CEN Management Centre has the same status as theofficial versions.CEN members are the national standards bodies of Austria, Belgium, Bulgaria, Cyprus, Czech Republic, Denmark, Estonia, Finland,France, Germany, Greece, Hungary, Iceland, Ir

12、eland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal,Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland and United Kingdom.EUROPEAN COMMITTEE FOR STANDARDIZATIONCOMIT EUROPEN DE NORMALISATIONEUROPISCHES KOMITEE FR NORMUNGManagement Centre: Avenue Marnix 17,

13、B-1000 Brussels 2009 CEN All rights of exploitation in any form and by any means reservedworldwide for CEN national Members.Ref. No. EN ISO 9168:2009: EEN ISO 9168:2009 (E) 2 Contents Page Foreword .3 1 Scope4 2 Normative references4 3 Terms and definitions 4 4 Classification .4 5 Requirements.5 5.1

14、 General .5 5.2 Dimensions 5 5.3 Resistance to reprocessing .5 6 Sampling 11 7 Test methods11 7.1 Resistance to reprocessing11 7.2 .11 Annex A (informative) Performance and general design12 Bibliography13 DIN EN ISO 9168:2009-10 .Dimensions EN ISO 9168:2009 (E) 3 Foreword This document (EN ISO 9168:

15、2009) has been prepared by Technical Committee ISO/TC 106 collaboration with Technical Committee CEN/TC 55 , 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 b

16、y January 2010, and conflicting national standards shall be withdrawn at the latest by January 2010. 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

17、patent rights. This document supersedes EN 29168:1994. 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, Cyprus, Czech Republic, Denmark, Estonia, Finland, Fran

18、ce, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland and the United Kingdom. Endorsement notice The text of ISO 9168:2009 has been approved by CEN as a EN ISO 9168:2

19、009 without any modification. DIN EN ISO 9168:2009-10 “Dentistry”“Dentistry” in1 Scope This International Standard is applicable for achieving reliable interchangeability between hoses from dental units and dental handpieces. This International Standard specifies four types of hose connector for use

20、 between air driven dental handpieces and the flexible hoses of the dental unit which supply the handpieces with water, air and light, and provide for exhaust. 2 Normative references The following referenced documents are indispensable for the application of this document. For dated references, only

21、 the edition cited applies. For undated references, the latest edition of the referenced document (including any amendments) applies. ISO 261, ISO general purpose metric screw threads General plan ISO 1942, Dentistry Vocabulary ISO 7494-1, Dentistry Dental units Part 1: General requirements and test

22、 methods 3 Terms and definitions For the purposes of this document, the terms and definitions given in ISO 1942 and the following apply. 3.1 hose connector connector at the dental handpiece to enable one to connect the hose with the handpiece 4 Classification For the purpose of this International St

23、andard, hose connectors for air driven dental handpieces are classified into the following four types: Type 1: connector with two or three outlets and connection thread 9/16 40 UNS; Type 2: connector with four or five outlets and connection thread 0,555 36 UNS; Type 3: connector with four outlets an

24、d electrical contacts and connection thread 0,555 36 UNS; Type 4: connector with three outlets and connection thread M12 0,5, in accordance with ISO 261. DIN EN ISO 9168:2009-10 EN ISO 9168:2009 (E) 45 Requirements 5.1 General Hose connectors for air driven dental handpieces are specific parts of de

25、ntal handpieces. Requirements for dental handpieces are specified in the relevant product standards. NOTE Relevant product standards for dental handpieces are e.g. ISO 7785-1, ISO 13294 and ISO 15606. 5.2 Dimensions The dimensions, the outlet configuration and the use of the outlets shall be as spec

26、ified in Figure 1, Figure 2, Figure 3 and Figure 4. The thread characteristics for Type 1, Type 2 and Type 3 shall be as specified in Table 1. The thread characteristics for Type 4 (M12 0,5) shall be in accordance with ISO 261. Testing shall be carried out in accordance with 7.1. 5.3 Resistance to r

27、eprocessing Hose connectors shall be capable of withstanding a minimum of 250 reprocessing cycles as defined in the manufacturers instructions for use without deterioration in appearance or performance. Quick connectors with and without lights supply, which are not permanently fixed to the instrumen

28、t, shall be capable of withstanding the reprocessing procedure as given in the manufacturers instructions. In this case the requirements of ISO 7494-1 are applicable. Testing shall be carried out in accordance with 7.2. DIN EN ISO 9168:2009-10 EN ISO 9168:2009 (E) 5 Dimensions in millimetres a) Hand

29、piece part b) Hose part Key 1 water 2 drive air 3 spray air 4 gasket 5 nut aSee Table 1 for thread characteristics. Figure 1 Type 1 connector DIN EN ISO 9168:2009-10 EN ISO 9168:2009 (E) 6 Dimensions in millimetres a) Handpiece part b) Hose part Key 1 water 4 gasket 7 fibre optic 2 drive air 5 nut 3

30、 spray air 6 exhaust aSee Table 1 for thread characteristics. Figure 2 Type 2 connector DIN EN ISO 9168:2009-10 EN ISO 9168:2009 (E) 7 Dimensions in millimetres a) Handpiece part Figure 3 Type 3 connector DIN EN ISO 9168:2009-10 EN ISO 9168:2009 (E) 8 b) Hose part Key 1 water 2 drive air 3 spray air

31、 4 gasket 5 nut 6 exhaust 7 electrical contacts aSee Table 1 for thread characteristics. Figure 3 Type 3 connector DIN EN ISO 9168:2009-10 EN ISO 9168:2009 (E) 9(continued) Dimensions in millimetres a) handpiece part b) Hose part Key 1 water 2 drive air 3 exhaust 4 gasket 5 nut Figure 4 Type 4 conne

32、ctor DIN EN ISO 9168:2009-10 EN ISO 9168:2009 (E) 106 Sampling One representative sample of the hose connector types shall be selected for the test. Table 1 Thread characteristics Unless otherwise specified, dimensions in millimetres Dimensions of single-start right-hand thread for Thread characteri

33、stics Type 1 Type 2 and Type 3 Thread designationa9/16 40 UNS 0,555 36 UNS Pitch 0,635 0,706 Thread angle 60 60 max. 14,379 14,198 Internal thread min. 14,287 14,097 max. 14,262 14,071 Major diameter External thread min. 14,133 13,932 Basic major diameter 14,287 14,097 max. 13,980 13,777 Internal th

34、read min. 13,876 13,640 max. 13,851 13,614 Pitch diameter External thread min. 13,769 13,530 Basic pitch diameter 13,876 13,640 max. 13,767 13,512 Internal thread min. 13,589 13,335 max. 13,482 13,208 Minor diameter External thread min. 13,437 13,157 aThe screw threads 9/16 40 UNS and 0,555 36 UNS u

35、sed for the connectors are based on ANSI B1.1. The diameter/pitch combinations specified in this International Standard are not, however, included in ANSI B1.1; the necessary thread characteristics are therefore specified in this table.7 Test methods 7.1 Dimensions Using measuring devices such as a

36、gauge, dial indicator, etc. with an accuracy of 0,01 mm for linear dimensions or 1 for angles, measure and record the dimensions shown in Figures 1, 2, 3 and 4. 7.2 Resistance to reprocessing Subject the test pieces to 250 reprocessing cycles using the parameters defined by the manufacturer in the i

37、nstructions for use. After the final sterilization cycle, inspect the sterilized items visually. There shall be no visible signs of deterioration or corrosion. Submit the sterilized items to the test procedures specified in 5.3. All requirements shall be met. DIN EN ISO 9168:2009-10 EN ISO 9168:2009

38、 (E) 11Annex A (informative) Performance and general design A.1 General Hose connectors should be comfortable for the operator to use and easy to manipulate. The outside surface of the hose connectors should be easy to clean and particular attention should be given to providing secure gripping surfa

39、ces for operator manipulation. In order to reduce glare, highly polished surfaces should be avoided. A.2 Construction and layout The construction of hose connectors should provide for their safe and reliable operation. If field-repairable, the hose connectors should be capable of being easily disass

40、embled and reassembled for maintenance and repair utilizing either readily available tools or special tools supplied by the manufacturer. DIN EN ISO 9168:2009-10 EN ISO 9168:2009 (E) 12Bibliography 1 ISO 7785-1, Dental handpieces Part 1: High-speed air turbine handpieces 2 ISO 13294, Dental handpiec

41、es Dental air-motors 3 ISO 13402, Surgical and dental hand instruments Determination of resistance against autoclaving, corrosion and thermal exposure 4 ISO 15606, Dental handpieces Air-powered scalers and scaler tips 5 ISO 17664, Sterilization of medical devices Information to be provided by the manufacturer for the reprocessing of resterilizable medical devices 6 ANSI B1.1, Unified Inch Screw Threads (UN and UNR Thread Form) DIN EN ISO 9168:2009-10 EN ISO 9168:2009 (E) 13