EN ISO 7551-1998 en Dental Absorbent Points《牙科吸水捻 ISO 7551-1996》.pdf

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1、BRITISH STANDARD BSENISO 7551:1998 Incorporating Amendment No.1 to BS ISO7551:1996 (which renumbers the BS ISO as BS EN ISO 7551: 1998) Dental absorbent points ICS 11.060.10BSEN ISO 7551:1998 This British Standard, having been prepared underthe directionof the Healthand Environment SectorBoard, wasp

2、ublished underthe authorityof the Standards Boardand comes into effect on 15 August1997 BSI 05-1999 ISBN 0 580 27847 6 National foreword This British Standard is the English language version of EN ISO7551:1996. It is identical with ISO7551:1996. The UK participation in its preparation was entrusted

3、to Technical Committee CH/53, Dental conservation materials, which has the responsibility to: aid enquirers to understand the text; present to the responsible international/European committee any enquiries on the interpretation, or proposals for change, and keep the UK interests informed; monitor re

4、lated international and European developments and promulgate them in the UK. A list of organizations represented on this committee can be obtained on request to its secretary. Cross-references The British Standards which implement international or European publications referred to in this document m

5、ay be found in the BSI Standards Catalogue under the section entitled “International Standards Correspondence Index”, or using the “Find” facility of the BSI Standards Electronic Catalogue. A British Standard does not purport to include all the necessary provisions of a contract. Users of British St

6、andards are responsible for their correct application. Compliance with a British Standard does not of itself confer immunity from legal obligations. Summary of pages This document comprises a front cover, an inside front cover, pagesi andii, theEN ISO title page, page2, the ISO title page, pages ii

7、to iv, pages1 to6 and aback cover. This standard has been updated (see copyright date) and may have had amendments incorporated. This will be indicated in the amendment table on the inside front cover. Amendments issued since publication Amd. No. Date Comments 10135 September 1998 Implementation of

8、a European Standard.BS EN ISO 7551:1998 BSI 05-1999 i Contents Page National foreword Inside front cover Foreword 2 Foreword iii Text of ISO7551 1ii blankEUROPEAN STANDARD NORME EUROPENNE EUROPISCHE NORM EN ISO7551 May 1998 ICS 11.060.10 Descriptors: See ISO document English version Dental absorbent

9、 points (ISO7551:1996) Cnes absorbants usage dentaire (ISO7551:1996) Zahnrztliche absorbierende Spitzen (ISO7551:1996) This European Standard was approved by CEN on25April1998. CEN members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for giving this Eu

10、ropean 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 Central Secretariat or to any CEN member. This European Standard exists in three official versions (Engli

11、sh, 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 Central Secretariat has the same status as the official versions. CEN members are the national standards bodies of Austria, Belgium, Czech Repub

12、lic, Denmark, Finland, France, Germany, Greece, Iceland, Ireland, Italy, Luxembourg, Netherlands, Norway, Portugal, Spain, Sweden, Switzerland and United Kingdom. CEN European Committee for Standardization Comit Europen de Normalisation Europisches Komitee fr Normung Central Secretariat: rue de Stas

13、sart 36, B-1050 Brussels 1998 All rights of exploitation in any form and by any means reserved worldwide for CEN national Members Ref. No. EN ISO7551:1998 EENISO 7551:1998 BSI 05-1999 2 Foreword The text of the International Standard from Technical Committee ISO TC106, Dentistry, of the Internationa

14、l Organization for Standardization (ISO) has been taken over as a European Standard by Technical Committee CEN/TC55, 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 endorseme

15、nt, at the latest by November1998, and conflicting national standards shall be withdrawn at the latest by November1998. According to CEN/CENELEC Internal Regulations, the following countries are bound to implement this European Standard: Austria, Belgium, CzechRepublic, Denmark, Finland, France, Ger

16、many, Greece, Iceland, Ireland, Italy, Luxembourg, Netherlands, Norway, Portugal, Spain, Sweden, Switzerland and the United Kingdom. Endorsement notice The text of the International Standard ISO7551:1996 has been approved by CEN as a European Standard without any modification. NOTENormative referenc

17、es to International Standards are listed in Annex ZA (normative).BSENISO7551:1998 ii BSI05-1999 Contents Page Foreword iii Introduction 1 1 Scope 1 2 Normative references 1 3 Definitions 1 4 Requirements 2 5 Sampling 4 6 Testing 4 7 Designation 5 8 Packaging 5 9 Marking 5 Annex A (informative) Bibli

18、ography 6 Annex ZA (normative) Normative references to international publications with their relevant European publications 6 Figure 1 Diagrammatic representation of absorbent points 2 Figure 2 Identification and dimensions of taper size absorbent points 4 Table 1 Diameters, size designation and col

19、our designation for standard sizes 3BSENISO7551:1998 BSI 05-1999 iii 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 normally carried out through ISO technic

20、al 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 in the work. ISO collaborates closely wi

21、th the International Electrotechnical Commission (IEC) on all matters of electrotechnical standardization. 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 least75% of th

22、e member bodies casting a vote. International Standard ISO7551 was prepared by Technical Committee ISO/TC106, Dentistry, Subcommittee SC1, Filling and restorative materials. Annex A of this International Standard is for information only. Descriptors: Dentistry, dental equipment, dental instruments,

23、absorbers (equipment), specifications, dimensions, tests, designation, size designation, colour codes, marking, packaging.iv blankBS EN ISO 7551:1998 BSI 05-1999 1 Introduction The sizes of the absorbent points specified in this International Standard have been aligned with the corresponding sizes f

24、or obturating points specified in ISO6877. Specific qualitative and quantitative requirements for freedom from biological hazard are not included in this International Standard, but it is recommended that in assessing possible or toxicological hazards, reference should be made to ISO7405. Dental abs

25、orbent points are used in root-canal therapy to dry root canals or to carry medicaments into the root canal. They are therefore made of fine-grade absorbent material with a close texture to give an essentially smooth lint-free surface. To enable insertion into a prepared root canal, the absorbent po

26、int must have some rigidity, be essentially straight and circular in cross-section. 1 Scope This International Standard specifies requirements and test methods for nonmedicated absorbent points used in endodontic procedures. The requirements apply to absorbent points which have been sterilized once

27、in a manner approved by the manufacturer. Dental absorbent points include standard points and taper size points. This International Standard does not specify requirements or test methods for sterility and/or freedom from biological hazard of dental absorbent points. 2 Normative references The follow

28、ing standards contain provisions which, through reference in this text, constitute provisions of this International Standard. At the time of publication, the editions indicated were valid. All standards are subject to revision, and parties to agreements based on this International Standard are encou

29、raged to investigate the possibility of applying the most recent editions of the standards indicated below. Members of IEC and ISO maintain registers of currently valid International Standards. ISO3630-1:1992, Dental root-canal instruments Part1: Files, reamers, barbed broaches, rasps, paste carrier

30、s, explorers and cotton broaches. ISO6360-1:1985, Dental rotary instruments Number coding system Part1: General characteristics. 3 Definitions For the purposes of this International Standard, the following definitions apply. 3.1 point entire dental absorbent point 3.2 tip narrow end of a dental abso

31、rbent point 3.3 unit pack smallest pack distributed which contains one or more dental absorbent points of one or more sizes 3.4 standard absorbent point absorbent point with standardized dimensions and a standardized taper of0,02mm per millimetre of length 3.5 taper size absorbent point absorbent po

32、int with dimensions and taper at the discretion of the manufacturerBSENISO 7551:1998 2 BSI 05-1999 4 Requirements 4.1 Dimensional requirements for standard absorbent points The dimensions of standard absorbent points shall comply with Table 1 and Figure 1. Within the dimensions specified, variations

33、 in shape and design are permitted. Testing for compliance shall be carried out in accordance with ISO3630-1:1992, subclause6.2, and in accordance with6.2 and6.3 of this International Standard. The tip shall be rounded, conical or blunt. The neck may be continuously tapered or cylindrical, or a comb

34、ination of both. The dimensions shall be as shown in Table 1. 4.2 Dimensional requirements for taper size points 4.2.1 General The dimensions of taper size points shall comply with Figure 1 and Figure 2. Within the dimensional requirements, variations in shape and design are permitted. Taper size ab

35、sorbent points may have diameters different from those in Table 1. The taper shall be uniform for the first16mm of length from the tip. Measurements shall be carried out in accordance with6.3. Figure 1 Diagrammatic representation of absorbent pointsBS EN ISO 7551:1998 BSI 05-1999 3 Table 1 Diameters

36、, size designation and colour designation for standard sizes For a taper size absorbent point, d 1is the projected diameter at the tip, expressed in hundredths of millimetres, and its designation is a three-digit number. Taper is determined by the manufacturer, expressed in thousandths of millimetre

37、s, and its designation is a two-digit number. See also7.2. To determine diameters (see Figure 1) or to test taper, follow these procedures. a) Find diameter d 1from Figure 2 based on size designation. b) Find taper ratio from Figure 2 based on taper designation as given by the manufacturer. c) Deter

38、mine diameter d 2at3mm: d 1 +3 times taper ratio. d) Determine diameter d 3at16mm: d 1 +16 times taper ratio. e) For taper size absorbent points where d 10,30mm, diameter tolerances are 0,07mm. 4.3 Absorption Absorbent points shall absorb liquid to a height of not less than10mm above the liquid leve

39、l when tested in accordance with6.4. 4.4 Disintegration Absorbent points shall not disintegrate while being immersed in water at(40 1)C for10min or during removal from the water with forceps. Evaluation shall be carried out in accordance with6.2. 4.5 Sterility Where sterility of the unopened pack is

40、 claimed, the test used by the manufacturer to substantiate this claim shall conform to the local national standard. If no local requirements exist, then testing shall conform to the United States or European Pharmacopoeia. NOTEA claim by the manufacturer that the contents of the unopened pack are s

41、terile is the responsibility of the manufacturer. This International Standard does not specify requirements or test methods for sterility. Dimensions in millimetres Nominal size designation d 1 a d 2 d 3 Colour nom. tol. nom. tol. Designation Abbreviation 015 020 025 0,15 0,20 0,25 0,21 0,26 0,31 0,

42、05 0,47 0,52 0,57 0,05 white yellow red wh yel red 030 035 040 045 050 055 060 070 080 090 100 110 120 130 140 0,30 0,35 0,40 0,45 0,50 0,55 0,60 0,70 0,80 0,90 1,00 1,10 1,20 1,30 1,40 0,36 0,41 0,46 0,51 0,56 0,61 0,66 0,76 0,86 0,96 1,06 1,16 1,26 1,36 1,46 0,07 0,62 0,67 0,72 0,77 0,82 0,87 0,92

43、 1,02 1,12 1,22 1,32 1,42 1,52 1,62 1,72 0,07 blue green black white yellow red blue green black white yellow red blue green black blu grn blk wh yel red blu grn blk wh yel red blu grn blk NOTEThe taper of0,02mm per millimetre of length shall be uniform throughout the range of sizes available. a The

44、 tolerance for d 1is not specified, d 1is intended as a referenced dimension only.Taper d3 d 2 13 - =BSENISO 7551:1998 4 BSI 05-1999 4.6 Toxicity Biological hazard is discussed in the Introduction. See also clause1. 5 Sampling Take10 individual absorbent points from retail packs at random. If all10

45、samples pass the test, the product passes. If eight or fewer samples pass, the product fails. If nine samples pass, test five additional samples. When five additional samples must be tested, all five must pass to accept the product. 6 Testing 6.1 Test conditions Carry out all tests at(23 2)C and(50

46、5)% relative humidity. Sterilize the absorbent points once, as recommended by the manufacturer, then precondition for at least24h in the test atmosphere. 6.2 Visual inspection Visually inspect at normal visual acuity. Figure 2 Identification and dimensions of taper size absorbent pointsBS EN ISO 755

47、1:1998 BSI 05-1999 5 6.3 Dimensions Measure the dimensions with a calibrated shadowgraph or other equipment capable of measuring to an accuracy of0,002mm. 6.4 Absorption Suspend the test pieces vertically in a solution of C.I. Acid Yellow23 (C.I.19140)(0,4% concentration) such that the tip is immers

48、ed to a depth of5mm while isolated from the container sides and other test pieces. Record the height to which the stain marking rises above the liquid level after60s. The reported value shall be the average result of10 test pieces, rounded to the nearest0,5mm. 7 Designation 7.1 Standard absorbent po

49、ints The designation of the size of a standard absorbent point is comprised of the nominal size designation expressed as a three-digit number in accordance with Table 1 and the specified colour or its abbreviation. 7.2 Taper size absorbent points The designation of the size of a taper size absorbent point is comprised of the designation of the diameter d 1 , expressed in hundredths of millimetres with a three-digit number, and the designation of the taper, expressed in thousandths of millimetres with a t