BS EN ISO 9168-2009 Dentistry - Hose connectors for air driven dental handpieces《牙科 气动牙科手持吸液器软管连结器》.pdf

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1、BS EN ISO9168:2009ICS 11.060.20NO COPYING WITHOUT BSI PERMISSION EXCEPT AS PERMITTED BY COPYRIGHT LAWBRITISH STANDARDDentistry Hoseconnectors forair driven dentalhandpieces (ISO9168:2009)This British Standardwas published under theauthority of the StandardsPolicy and StrategyCommittee on 31 August20

2、09 BSI 2009ISBN 978 0 580 59581 3Amendments/corrigenda issued since publicationDate CommentsBS EN ISO 9168:2009National forewordThis British Standard is the UK implementation of EN ISO 9168:2009. Itsupersedes BS EN 29168:1994 which is withdrawn.The UK participation in its preparation was entrusted t

3、o TechnicalCommittee 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.C

4、ompliance with a British Standard cannot confer immunityfrom legal obligations.EUROPEAN STANDARDNORME EUROPENNEEUROPISCHE 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

5、 pour pices main dentaires air comprim (ISO 9168:2009)Zahnheilkunde - Schlauchanschlsse fr luftbetriebenezahnrztliche 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 cond

6、itions for giving this EuropeanStandard the status of a national standard without any alteration. Up-to-date lists and 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

7、official versions (English, French, German). A version in any other language made by translationunder the responsibility 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 Austri

8、a, Belgium, Bulgaria, 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 United Kingdom.EUROPEAN COMMITTEE

9、 FOR STANDARDIZATIONCOMIT EUROPEN DE NORMALISATIONEUROPISCHES KOMITEE FR NORMUNGManagement Centre: Avenue Marnix 17, 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: EBS EN ISO 9168:2009EN ISO 9168:

10、2009 (E) 3 Foreword This document (EN ISO 9168:2009) has been prepared by Technical Committee ISO/TC 106 “Dentistry“ in collaboration with 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 standard, eith

11、er by publication of an identical text or by endorsement, at the latest by 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/

12、or CENELEC shall not be held responsible for identifying any or all such 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, B

13、elgium, Bulgaria, 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 Kingdom. Endorsement not

14、ice The text of ISO 9168:2009 has been approved by CEN as a EN ISO 9168:2009 without any modification. BS EN ISO 9168:2009ISO 9168:2009(E) ISO 2009 All rights reserved iiiForeword ISO (the International Organization for Standardization) is a worldwide federation of national standards bodies (ISO mem

15、ber 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 technical committee has been established has the right to be represented on that committee. International organizations, governmen

16、tal and non-governmental, in liaison with ISO, also take part in the work. ISO collaborates closely with the International Electrotechnical Commission (IEC) on all matters of electrotechnical standardization. International Standards are drafted in accordance with the rules given in the ISO/IEC Direc

17、tives, Part 2. The main task of technical committees is to prepare International Standards. Draft International Standards adopted by the technical committees are circulated to the member bodies for voting. Publication as an International Standard requires approval by at least 75 % of the member bodi

18、es 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 for identifying any or all such patent rights. ISO 9168 was prepared by Technical Committee ISO/TC 106, Dentistry, Subcommittee S

19、C 4, Dental instruments. This third edition cancels and replaces the second edition (ISO 9168:1991), which has been technically revised. The following changes were made: a) requirement resistance to sterilization has been replaced by reprocessing requirement; b) language-independent figures; c) intr

20、oduction of definition for “hose connector” and updated references and Bibliography. BS EN ISO 9168:2009BS EN ISO 9168:2009INTERNATIONAL STANDARD ISO 9168:2009(E) ISO 2009 All rights reserved 1Dentistry Hose connectors for air driven dental handpieces 1 Scope This International Standard is applicabl

21、e for achieving reliable interchangeability between hoses from dental units and dental handpieces. This International Standard specifies four types of hose connector for use between air driven dental handpieces and the flexible hoses of the dental unit which supply the handpieces with water, air and

22、 light, and provide for exhaust. 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 amendments) ap

23、plies. 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 methods 3 Terms and definitions For the purposes of this document, the terms and definitions given in ISO 1942 and the followi

24、ng 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 Standard, hose connectors for air driven dental handpieces are classified into the following four types: Type 1: connector with t

25、wo 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 and electrical contacts and connection thread 0,555 36 UNS; Type 4: connector with three outlets and connection thread M12 0,5, i

26、n accordance with ISO 261. BS EN ISO 9168:2009ISO 9168:2009(E) 2 ISO 2009 All rights reserved5 Requirements 5.1 General Hose connectors for air driven dental handpieces are specific parts of dental handpieces. Requirements for dental handpieces are specified in the relevant product standards. NOTE R

27、elevant 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 specified in Figure 1, Figure 2, Figure 3 and Figure 4. The thread characteristics for Type 1, Type 2 and Type

28、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 reprocessing Hose connectors shall be capable of withstanding a minimum of 250 reprocessing cycles as define

29、d 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 instrument, shall be capable of withstanding the reprocessing procedure as given in the manufacturers instructions.

30、In this case the requirements of ISO 7494-1 are applicable. Testing shall be carried out in accordance with 7.2. BS EN ISO 9168:2009ISO 9168:2009(E) ISO 2009 All rights reserved 3Dimensions in millimetres a) Handpiece part b) Hose part Key 1 water 2 drive air 3 spray air 4 gasket 5 nut aSee Table 1

31、for thread characteristics. Figure 1 Type 1 connector BS EN ISO 9168:2009ISO 9168:2009(E) 4 ISO 2009 All rights reservedDimensions in millimetres a) Handpiece part b) Hose part Key 1 water 4 gasket 7 fibre optic 2 drive air 5 nut 3 spray air 6 exhaust aSee Table 1 for thread characteristics. Figure

32、2 Type 2 connector BS EN ISO 9168:2009ISO 9168:2009(E) ISO 2009 All rights reserved 5Dimensions in millimetres a) Handpiece part Figure 3 Type 3 connector (continued) BS EN ISO 9168:2009ISO 9168:2009(E) 6 ISO 2009 All rights reservedb) Hose part Key 1 water 2 drive air 3 spray air 4 gasket 5 nut 6 e

33、xhaust 7 electrical contacts aSee Table 1 for thread characteristics. Figure 3 Type 3 connector BS EN ISO 9168:2009ISO 9168:2009(E) ISO 2009 All rights reserved 7Dimensions in millimetres a) handpiece part b) Hose part Key 1 water 2 drive air 3 exhaust 4 gasket 5 nut Figure 4 Type 4 connector BS EN

34、ISO 9168:2009ISO 9168:2009(E) 8 ISO 2009 All rights reserved6 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 ch

35、aracteristics 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 Int

36、ernal thread 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

37、36 UNS used 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 su

38、ch as a 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

39、in the instructions 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. BS EN ISO 9168:2009ISO 9168:2009

40、(E) ISO 2009 All rights reserved 9Annex 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 prov

41、iding secure gripping surfaces 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 cap

42、able of being easily disassembled and reassembled for maintenance and repair utilizing either readily available tools or special tools supplied by the manufacturer. BS EN ISO 9168:2009ISO 9168:2009(E) 10 ISO 2009 All rights reservedBibliography 1 ISO 7785-1, Dental handpieces Part 1: High-speed air

43、turbine handpieces 2 ISO 13294, Dental handpieces 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 medic

44、al 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) BS EN ISO 9168:2009BS EN ISO9168:2009BSI GroupHeadquarters 389Chiswick High Road,London, W4 4AL, UKTel +44 (0)20 8996 9001

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