《BS-EN-ISO-1567-2001.pdf》由会员分享,可在线阅读,更多相关《BS-EN-ISO-1567-2001.pdf(38页珍藏版)》请在三一文库上搜索。
1、BRITISH STANDARD BS EN ISO 1567:2001 Dentistry Denture base polymers The European Standard EN ISO 1567:2000 has the status of a British Standard ICS 11.060.10 NO COPYING WITHOUT BSI PERMISSION EXCEPT AS PERMITTED BY COPYRIGHT LAW Licensed Copy: sheffieldun sheffieldun, na, Thu Nov 16 06:44:31 GMT+00
2、:00 2006, Uncontrolled Copy, (c) BSI BS EN ISO 1567:2001 This British Standard, having been prepared under the direction of the Health and Environment Sector Committee, was published under the authority of the Standards Committee and comes into effect on 15 September 2001 BSI 08-2001 ISBN 0 580 3466
3、2 5 National foreword This British Standard is the official English language version of EN ISO 1567:2000. It is identical with ISO 1567:1999. It supersedes BS EN ISO 1567:1995 which is withdrawn. The UK participation in its preparation was entrusted to Technical Committee CH/51, Prosthodontic materi
4、als, which has the responsibility to: A list of organizations represented on this committee can be obtained on request to its secretary. Cross-references The British Standards which implement these international or European publications may be found in the BSI Standards Catalogue under the section e
5、ntitled “International Standards Correspondence Index”, or by 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 Standards are responsible for their correct application. Comp
6、liance with a British Standard does not of itself confer immunity from 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 the UK interests informed; monitor relate
7、d international and European developments and promulgate them in the UK. Summary of pages This document comprises a front cover, an inside front cover, the EN ISO title page, the EN ISO foreword, the ISO title page, pages ii to iv, pages 1 to 27, the annex ZA page, an inside back cover and a back co
8、ver. The BSI copyright notice displayed in this document indicates when the document was last issued. Amendments issued since publication Amd. No. DateComments Licensed Copy: sheffieldun sheffieldun, na, Thu Nov 16 06:44:31 GMT+00:00 2006, Uncontrolled Copy, (c) BSI EUROPEAN STANDARD NORME EUROPENNE
9、 EUROPISCHE NORM EN ISO 1567 April 2000 ICS 11.060.10Supersedes EN ISO 1567:1995 English version Dentistry - Denture base polymers (ISO 1567:1999) Art dentaire - Polymres pour base de prothses dentaires (ISO 1567:1999) Zahnheilkunde - Prothesenkunststoffe (ISO 1567:1999) This European Standard was a
10、pproved by CEN on 1 March 2000. 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 bibliographical references concerning such nationa
11、l 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 a CEN member into its own language and notif
12、ied to the Central Secretariat has the same status as the official versions. CEN members are the national standards bodies of Austria, Belgium, Czech Republic, Denmark, Finland, France, Germany, Greece, Iceland, Ireland, Italy, Luxembourg, Netherlands, Norway, Portugal, Spain, Sweden, Switzerland an
13、d United Kingdom. EUROPEAN COMMITTEE FOR STANDARDIZATION COMIT EUROPEN DE NORMALISATION EUROPISCHES KOMITEE FR NORMUNG Central Secretariat: rue de Stassart, 36 B-1050 Brussels 2000 CENAll rights of exploitation in any form and by any means reserved worldwide for CEN national Members. Ref. No. EN ISO
14、 1567:2000 E Licensed Copy: sheffieldun sheffieldun, na, Thu Nov 16 06:44:31 GMT+00:00 2006, Uncontrolled Copy, (c) BSI EN ISO 1567:2000 Foreword The text of the International Standard from Technical Committee ISO/TC 106 “Dentistry“ of the International Organization for Standardization (ISO) has bee
15、n taken over as an European Standard by Technical Committee CEN/TC 55 “Dentistry“, the secretariat of which is held by DIN. This European Standard replaces EN ISO 1567:1995 This European Standard shall be given the status of a national standard, either by publication of an identical text or by endor
16、sement, at the latest by October 2000, and conflicting national standards shall be withdrawn at the latest by October 2000. According to the CEN/CENELEC Internal Regulations, the national standards organizations of the following countries are bound to implement this European Standard: Austria, Belgi
17、um, Czech Republic, Denmark, Finland, France, Germany, Greece, Iceland, Ireland, Italy, Luxembourg, Netherlands, Norway, Portugal, Spain, Sweden, Switzerland and the United Kingdom. Endorsement notice The text of the International Standard ISO 1567:1999 has been approved by CEN as a European Standar
18、d without any modification. NOTE: Normative references to International Standards are listed in annex ZA (normative). Licensed Copy: sheffieldun sheffieldun, na, Thu Nov 16 06:44:31 GMT+00:00 2006, Uncontrolled Copy, (c) BSI A Reference number ISO 1567:1999(E) INTERNATIONAL STANDARD ISO 1567 Third e
19、dition 1999-02-15 Dentistry Denture base polymers Art dentaire Polymres pour base de prothses dentaires Licensed Copy: sheffieldun sheffieldun, na, Thu Nov 16 06:44:31 GMT+00:00 2006, Uncontrolled Copy, (c) BSI OSI 9991 Athgir lls serevr.de selnUs tosiwrehe scepfi,dei trap on fo thsi cilbuptayam noi
20、 cudorper ebtu ro dezilide ni yna fomr ro yb nay msnae, lecetrinoc .rehsilbup eht morf gnitirw ni noissimrep tuohtiw ,mliforcim dna gniypocotohp gnidulcni ,lacinahcem ro noitazidradnatS rof noitazinagrO lanoitanretnI 65 elatsop esaC 02 evneG 1121-HC dnalreztiwS tenretnIhc.osiosi dnalreztiwS ni detni
21、rP ii Contents 1 Scope1 2 Normative references1 3 Definitions 2 4 Classification3 5 Requirements.3 6 Sampling.6 7 Preparation of test specimens .6 8 Test methods6 9 Requirements for labelling, marking, packaging and instructions supplied by manufacturer .22 Annex A HPLC method for determination of M
22、MA content.25 Annex B Bibliography .27 EN ISO 1567:2000 100280 ISB 2 AnAZ xen (nvitamroevitamroN )e errefneetni ot secanrp lanoitublitacisno with theier relvant uEorpean puilbcation.s.2.82.8 Licensed Copy: sheffieldun sheffieldun, na, Thu Nov 16 06:44:31 GMT+00:00 2006, Uncontrolled Copy, (c) BSI ii
23、i 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 technical committees. Each member body interested in a subject for which a
24、 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 with the International Electrotechnical Commission (IEC) on all matte
25、rs 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 least 75 % of the member bodies casting a vote. International Standard ISO 1567 w
26、as prepared by Technical Committee ISO/TC 106, Dentistry, Subcommittee SC 2, Prosthodontic materials. This third edition cancels and replaces the second edition (ISO 1567:1988), which has been technically revised. Significant differences between this third edition and the second edition are: two new
27、 categories of material (light-activated and microwave-cured) have been added as Type 4 and Type 5 to Classification (clause 4); requirements and tests previously identified as transverse deflection properties are now identified as “flexural strength“ (5.2.7 and 8.5.3.5) and “flexural modulus“ (5.2.
28、8 and 8.5.3.5); the determination of flexural strength and flexural modulus require force per unit area calculations; a requirement and tests for residual methyl methacrylate monomer content (5.2.10 and 8.7) have been added. Annex A forms an integral part of this International Standard. Annex B is f
29、or information only. EN ISO 1567:2000 100280 ISB 3 Licensed Copy: sheffieldun sheffieldun, na, Thu Nov 16 06:44:31 GMT+00:00 2006, Uncontrolled Copy, (c) BSI iv Introduction Specific qualitative and quantitative requirements for freedom from biological hazard are not included in this International S
30、tandard, but it is recommended that, in assessing possible biological or toxicological hazards, reference be made to ISO 10993-1 and ISO 7405. EN ISO 1567:2000 100280 ISB 4 Licensed Copy: sheffieldun sheffieldun, na, Thu Nov 16 06:44:31 GMT+00:00 2006, Uncontrolled Copy, (c) BSI Dentistry Denture ba
31、se polymers 1 Scope 1.1 This International Standard classifies denture base polymers and copolymers and specifies their requirements. It also specifies the test methods to be used in determining compliance with these requirements. It further specifies requirements with respect to packaging and marki
32、ng the products and to the instructions to be supplied for use of these materials. 1.2 Although this International Standard does not require manufacturers to declare details of the composition, attention is drawn to the fact that some national or international authorities require such details to be
33、provided. 1.3 This International Standard applies to denture base polymers such as those listed below. a) Poly(acrylic acid esters); b) poly(substituted acrylic acid esters); c) poly(vinyl esters); d) polystyrene; e) rubber-modified poly(methacrylic acid esters); f) polycarbonates; g) polysulfones;
34、h) poly(dimethacrylic acid esters); i) polyacetals (polyoxymethylene); j) copolymers or mixtures of the polymers listed in a) through i). 2 Normative references The following standards contain provisions which, through reference in this text, constitute provisions of this International Standard. At
35、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 encouraged to investigate the possibility of applying the most recent editions of the standards indicated below. Members of IEC and IS
36、O maintain registers of currently valid International Standards. ISO 463: 1), Geometrical product specifications (GPS) Dimensional measuring instruments: Dial gauges Design and metrological requirements. ISO 1942-1:1989, Dental vocabulary Part 1: General and clinical terms. 1) To be published. (Revi
37、sion of ISO 463:1988) EN ISO 1567:2000 100280 ISB 1 EN ISO 1567:2000 1 Licensed Copy: sheffieldun sheffieldun, na, Thu Nov 16 06:44:31 GMT+00:00 2006, Uncontrolled Copy, (c) BSI ISO 1942-2:1989, Dental vocabulary Part 2: Dental materials. ISO 1942-5:1989, Dental vocabulary Part 5: Terms associated w
38、ith testing. ISO 3336:1993, Dentistry Synthetic polymer teeth. ISO 3696:1987, Water for analytical laboratory use Specification and test methods. ISO 7491:1985, Dental materials Determination of colour stability of dental polymeric materials. ISO 8601:1988, Data elements and interchange formats Info
39、rmation interchange Representation of dates and times. 3 Definitions For the purposes of this International Standard, the following definitions apply. 3.1 autopolymerizable polymers products having polymerization initiated by chemical means and not requiring application of verifiable temperatures ab
40、ove 65 C to complete the process 3.2 capsulated material material consisting of two or more components supplied in a container which keeps them separated until the time they are mixed together and dispensed for use directly from the container 3.3 denture artificial substitute for missing natural tee
41、th and adjacent tissues, to include also any additions needed for optimum function 3.4 denture base that part of a denture which rests on soft tissue foundations and to which teeth are added 3.5 heat-polymerizable polymer product requiring application of verifiable temperatures above 65 C to complet
42、e polymerization 3.6 immediate container container which is in direct contact with the denture base materials 3.7 liquid monomeric fluid to be mixed with polymeric particles to form a mouldable dough or fluid resin mixture used for forming denture bases 3.8 outer packaging labelled container or wrap
43、ping within which other containers are packed 3.9 packing of a denture the act of filling a denture base mould with a material (using a compression, pour or injection technique) to form a denture base EN ISO 1567:2000 100280 ISB 2 EN ISO 1567:2000 2 Licensed Copy: sheffieldun sheffieldun, na, Thu No
44、v 16 06:44:31 GMT+00:00 2006, Uncontrolled Copy, (c) BSI 3.10 initial packing time time after mixing, or other preparation, at which a denture base material mixture first reaches packing consistency 3.11 final packing time the last time, after reaching the initial packing time, at which a denture ba
45、se material mixture retains packing consistency 3.12 processing procedure of preparing a solid denture base polymer plate and/or specimen by polymerization or injection moulding 3.13 thermoplastic, adj. characteristic of a hard polymeric material that allows it to be softened by application of heat
46、to make it mouldable, and then return to the hardened state upon cooling 3.14 translucency capacity of a body of material to allow the passage of light, yet diffusing the light so as not to render objects lying beyond the body clearly visible 4 Classification Denture base polymers covered by this In
47、ternational Standard are categorized into the following Types and Classes: Type 1 :Heat-polymerizable polymers Class 1 :Powder and liquid Class 2 :Plastic cake Type 2 :Autopolymerizable polymers Class 1 :Powder and liquid Class 2 :Powder and liquid pour-type resins Type 3 :Thermoplastic blank or pow
48、der Type 4 :Light-activated materials Type 5 :Microwave cured materials 5 Requirements 5.1 Unpolymerized material 5.1.1 Liquid component 5.1.1.1 General The liquid shall consist essentially of monomeric material compatible with the powder. EN ISO 1567:2000 100280 ISB 3 EN ISO 1567:2000 3 Licensed Co
49、py: sheffieldun sheffieldun, na, Thu Nov 16 06:44:31 GMT+00:00 2006, Uncontrolled Copy, (c) BSI 5.1.1.2 Homogeneity The liquid shall be free of deposit or sediment that can be observed by visual inspection (8.1). 5.1.2 Solid components The solid or semisolid components shall be free of extraneous material that can be observed by visual inspection (8.1). 5.1.3 Packing plasticity When Type 1 Class 1, Type 1 Class 2, Type 2 Class 1, Type 2 Class 2, Type 4 and Type 5 materials are tested in accordance with 8.2, at the
链接地址:https://www.31doc.com/p-3744029.html