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1、BRITISH STANDARD BS EN ISO 9173-1:2006 Dentistry Extraction forceps Part 1: General requirements and test methods The European Standard EN ISO 9173-1:2006 has the status of a British Standard ICS 11.060.20 ? Licensed Copy: sheffieldun sheffieldun, na, Thu Nov 16 07:03:35 GMT+00:00 2006, Uncontrolled
2、 Copy, (c) BSI BS EN ISO 9173-1:2006 This British Standard was published under the authority of the Standards Policy and Strategy Committee on 31 July 2006 BSI 2006 ISBN 0 580 49017 3 National foreword This British Standard is the official English language version of EN ISO 9173-1:2006. It is identi
3、cal with ISO 9173-1:2006. It supersedes BS EN ISO 9173-1:1996 which is withdrawn. The UK participation in its preparation was entrusted by Technical Committee CH/106, Dentistry, to Subcommittee CH/106/4, Dental instruments, which has the responsibility to: A list of organizations represented on this
4、 subcommittee can be obtained on request to its secretary. Cross-references The British Standards which implement international or European publications referred to in this document may be found in the BSI Catalogue under the section entitled “International Standards Correspondence Index”, or by usi
5、ng the “Search” facility of the BSI Electronic Catalogue or of British Standards Online. This publication does not purport to include all the necessary provisions of a contract. Users are responsible for its correct application. Compliance with a British Standard does not of itself confer immunity f
6、rom legal obligations. aid enquirers to understand the text; present to the responsible international/European committee any enquiries on the interpretation, or proposals for change, and keep UK interests informed; monitor related international and European developments and promulgate them in the UK
7、. Summary of pages This document comprises a front cover, an inside front cover, the EN ISO title page, the EN ISO foreword page, the ISO title page, pages ii to v, a blank page, pages 1 to 4, an inside back cover and a back cover. The BSI copyright notice displayed in this document indicates when t
8、he document was last issued. Amendments issued since publication Amd. No. DateComments Licensed Copy: sheffieldun sheffieldun, na, Thu Nov 16 07:03:35 GMT+00:00 2006, Uncontrolled Copy, (c) BSI EUROPEAN STANDARD NORME EUROPENNE EUROPISCHE NORM EN ISO 9173-1 June 2006 ICS 11.060.20Supersedes EN ISO 9
9、173-1:1995 English Version Dentistry - Extraction forceps - Part 1: General requirements and test methods (ISO 9173-1:2006) Art dentaire - Daviers - Partie 1: Exigences gnrales et mthodes dessai (ISO 9173-1:2006) Zahnheilkunde - Extraktionszangen - Teil 1: Allgemeine Anforderungen und Prfverfahren (
10、ISO 9173-1:2006) This European Standard was approved by CEN on 12 May 2006. 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 national standard without any alteration. Up-to-date lists and biblio
11、graphical references concerning such national standards may be obtained on application to the Central Secretariat or to any CEN member. This European Standard exists in three official versions (English, French, German). A version in any other language made by translation under the responsibility of
12、a CEN member into its own language and notified to the Central Secretariat has the same status as the official versions. CEN members are the national standards bodies of Austria, Belgium, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, La
13、tvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland and United Kingdom. EUROPEAN COMMITTEE FOR STANDARDIZATION COMIT EUROPEN DE NORMALISATION EUROPISCHES KOMITEE FR NORMUNG Management Centre: rue de Stassart, 36 B-1050 Br
14、ussels 2006 CENAll rights of exploitation in any form and by any means reserved worldwide for CEN national Members. Ref. No. EN ISO 9173-1:2006: E Licensed Copy: sheffieldun sheffieldun, na, Thu Nov 16 07:03:35 GMT+00:00 2006, Uncontrolled Copy, (c) BSI Foreword This document (EN ISO 9173-1:2006) ha
15、s 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, either by publication of an identical text or by endorsemen
16、t, at the latest by December 2006, and conflicting national standards shall be withdrawn at the latest by December 2006. This document supersedes EN ISO 9173-1:1995. According to the CEN/CENELEC Internal Regulations, the national standards organizations of the following countries are bound to implem
17、ent this European Standard: Austria, Belgium, 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
18、Kingdom. Endorsement notice The text of ISO 9173-1:2006 has been approved by CEN as EN ISO 9173-1:2006 without any modifications. EN ISO 9173-1:2006 Licensed Copy: sheffieldun sheffieldun, na, Thu Nov 16 07:03:35 GMT+00:00 2006, Uncontrolled Copy, (c) BSI Reference number ISO 9173-1:2006(E) INTERNAT
19、IONAL STANDARD ISO 9173-1 Second edition 2006-06-01 Dentistry Extraction forceps Part 1: General requirements and test methods Art dentaire Daviers Partie 1: Exigences gnrales et mthodes dessai EN ISO 9173-1:2006 Licensed Copy: sheffieldun sheffieldun, na, Thu Nov 16 07:03:35 GMT+00:00 2006, Uncontr
20、olled Copy, (c) BSI ii Licensed Copy: sheffieldun sheffieldun, na, Thu Nov 16 07:03:35 GMT+00:00 2006, Uncontrolled Copy, (c) BSI iii Contents Page Foreword iv Introduction v 1 Scope . 1 2 Normative references. 1 3 Terms and definitions. 1 4 Requirements 2 4.1 Materials 2 4.2 Maximum overall length.
21、 2 4.3 Rockwell hardness . 2 4.4 Surface finish 2 4.5 Resistance to autoclaving . 2 4.6 Resistance to corrosion and thermal exposure 3 4.7 Joint opening/closing force. 3 5 Test methods. 3 5.1 Visual inspection 3 5.2 Resistance test 3 5.3 Joint opening/closing force. 4 6 Marking 4 EN ISO 9173-1:2006
22、Licensed Copy: sheffieldun sheffieldun, na, Thu Nov 16 07:03:35 GMT+00:00 2006, Uncontrolled Copy, (c) BSI iv Foreword ISO (the International Organization for Standardization) is a worldwide federation of national standards bodies (ISO member bodies). The work of preparing International Standards is
23、 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, governmental and non-governmental, in liaison with ISO, also take part
24、 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 Directives, Part 2. The main task of technical committees is to pr
25、epare 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 bodies casting a vote. Attention is drawn to the possibility that
26、 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 9173-1 was prepared by Technical Committee ISO/TC 106, Dentistry, Subcommittee SC 4, Dental instruments. This second edition cancels and re
27、places the first edition (ISO 9173-1:1991), which has been technically revised. The following changes have been made: a) the scope has been expanded to cover all extraction forceps; b) the descriptions of the test procedures have been improved; c) the requirements for specific forceps have been remo
28、ved and will be included in a future part of ISO 9173. ISO 9173 consists of the following parts, under the general title Dentistry Extraction forceps: Part 1: General requirements and test methods Further parts are planned. EN ISO 9173-1:2006 Licensed Copy: sheffieldun sheffieldun, na, Thu Nov 16 07
29、:03:35 GMT+00:00 2006, Uncontrolled Copy, (c) BSI v Introduction This revision of ISO 9173-1 is intended to cover all extraction forceps used in dentistry. EN ISO 9173-1:2006 Licensed Copy: sheffieldun sheffieldun, na, Thu Nov 16 07:03:35 GMT+00:00 2006, Uncontrolled Copy, (c) BSI blank Licensed Cop
30、y: sheffieldun sheffieldun, na, Thu Nov 16 07:03:35 GMT+00:00 2006, Uncontrolled Copy, (c) BSI 1 Dentistry Extraction forceps Part 1: General requirements and test methods 1 Scope This part of ISO 9173 specifies the general performance requirements for extraction forceps used in dentistry. 2 Normati
31、ve 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) applies. ISO 1942, Dentistry Vocabulary ISO
32、6508-1, Metallic materials Rockwell hardness test Part 1: Test method (scales A, B, C, D, E, F, G, H, K, N, T) ISO 7153-1, Surgical instruments Metallic materials Part 1: Stainless steel ISO 13402, Surgical and dental hand instruments Determination of resistance against autoclaving, corrosion and th
33、ermal exposure 3 Terms and definitions For the purposes of this document, the terms and definitions given in ISO 1942 and the following apply. 3.1 extraction forceps type of pincers used for the extraction of teeth 3.2 beak separation minimum gap between beak tips with the extraction forceps closed
34、3.3 overall beak length distance from beak tip to pivot centre 3.4 fastening components components of the extraction forceps used for fastening the pincers, e.g. pins, rivets and screws EN ISO 9173-1:2006 Licensed Copy: sheffieldun sheffieldun, na, Thu Nov 16 07:03:35 GMT+00:00 2006, Uncontrolled Co
35、py, (c) BSI 2 4 Requirements 4.1 Materials 4.1.1 Component parts With the exception of the fastening components, the component parts shall be made of stainless steel conforming to grade A, B or C in accordance with ISO 7153-1, or other stainless steels providing extraction forceps made of these othe
36、r steels meet the requirements of 4.2 to 4.7. 4.1.2 Fastening components The fastening components shall be made of stainless steel conforming to any of the grades specified in ISO 7153-1, or other stainless steels providing instruments made of these other steels meet the requirements of 4.2 to 4.7.
37、4.2 Maximum overall length Unless otherwise specified in the manufacturers literature, the maximum overall length of extraction forceps shall not exceed 178 mm. 4.3 Rockwell hardness The component parts of the extraction forceps, with the exception of the fastening components, shall be heat treated
38、to attain a Rockwell hardness value of 42 HRC to 52 HRC determined in accordance with ISO 6508-1. Mating surfaces on the same extraction forceps, such as those on opposite beaks, shall not vary in hardness by more than 3 units on Rockwell hardness scale C. 4.4 Surface finish 4.4.1 All surfaces All s
39、urfaces shall be free from surface defects (e.g. pores, cracks, grinding marks, residual scale, inclusions) and shall also be free from any non-functional sharp edges. Test in accordance with 5.1. 4.4.2 Beaks When the inner or crown space of the extraction forceps is serrated or textured, the serrat
40、ion or texture shall be consistent within any one pattern of extraction forceps. Test in accordance with 5.1. 4.5 Resistance to autoclaving The extraction forceps shall show no evidence of corrosion. The extraction forceps shall show no change in hardness or mechanical strength in any part, nor shal
41、l they acquire a permanent distortion set greater than 0,2 mm. Test in accordance with 5.2. NOTE Discolouration due to water marking does not constitute evidence of corrosion. EN ISO 9173-1:2006 Licensed Copy: sheffieldun sheffieldun, na, Thu Nov 16 07:03:35 GMT+00:00 2006, Uncontrolled Copy, (c) BS
42、I 3 4.6 Resistance to corrosion and thermal exposure The extraction forceps shall show no evidence of corrosion. The extraction forceps shall show no change in hardness or mechanical strength in any part, nor shall they acquire a permanent distortion set greater than 0,2 mm. Test in accordance with
43、5.2. NOTE Discolouration due to water marking does not constitute evidence of corrosion. 4.7 Joint opening/closing force The joint of the extraction forceps shall be so constructed that the extraction forceps opens and closes smoothly. The moment of force required shall be between 0,20 Nm and 0,68 N
44、m. Test in accordance with 5.3. When each handle end is gripped between the index finger and thumb of each hand, there shall be no perceptible sideways movement in any position of the joint between fully closed and a handle opening of at the most 50 mm. 5 Test methods 5.1 Visual inspection Visual in
45、spection shall be carried out under normal vision, without magnification. 5.2 Resistance test 5.2.1 Test sequence and cycles Carry out one of the following alternative tests in one continuous sequence of operations for five cycles: a) autoclave test (5.2.2) or b) boiling water and thermal exposure t
46、est (5.2.3). 5.2.2 Autoclave test Carry out the autoclave test as specified in ISO 13402. 5.2.3 Boiling water test and thermal exposure test Carry out the boiling water test and the thermal exposure test as specified in ISO 13402. 5.2.4 Removal of blemishes After completing the resistance test (5.2.
47、2 or 5.2.3), rub the extraction forceps vigorously with a soft cloth to remove blemishes. EN ISO 9173-1:2006 Licensed Copy: sheffieldun sheffieldun, na, Thu Nov 16 07:03:35 GMT+00:00 2006, Uncontrolled Copy, (c) BSI 4 5.3 Joint opening/closing force Mount the extraction forceps in a suitable apparat
48、us so that the handle opening is 50 mm. Apply a force just sufficient to close the extraction forceps fully and record the moment of this force. Repeat the test with the closed extraction forceps mounted in the test apparatus in such a manner that the beaks are opened as the force is applied and unt
49、il a handle opening of 50 mm is achieved. Again, record the moment of the force. Compare the values obtained with the limits given in 4.7. 6 Marking Each extraction forceps shall be indelibly marked with the following information: a) name of manufacturer and/or brand name; b) pattern number; c) lot number. EN ISO 9173-1:2006 Licensed Copy: sheffieldun sheffieldun, na, Thu Nov 16 07:03:35 GMT+00:00 2006, Uncontrolled Copy, (c) BSI blank Licensed Copy: sheffieldun