EN ISO 10139-1-2005 en Dentistry - Soft lining materials for removable dentures - Part 1 Materials for short-term use《牙科学 活动义齿软衬材料 第1部分 短期材料 ISO 10139-1-2005 代替EN 30139-1-1994》.pdf

1、BRITISH STANDARD BS EN ISO 10139-1:2005 Dentistry Soft lining materials for removable dentures Part 1: Materials for short-term use The European Standard EN ISO 10139-1:2005 has the status of a British Standard ICS 11.060.10 BS EN ISO 10139-1:2005 This British Standard was published under the author

2、ity of the Standards Policy and Strategy Committee on 2 November 2005 BSI 2 November 2005 National foreword The UK participation in its preparation was entrusted by Technical Committee CH/106, Dentistry, to Subcommittee CH/106/2, Prosthodontic materials, which has the responsibility to: aid enquirer

3、s 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. A list of organizations represent

4、ed on this 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”,

5、 or by using 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

6、immunity from legal obligations. 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 10, an inside back cover and a back cover. The BSI copyright notice displayed i

7、n this document indicates when the document was last issued. Amendments issued since publication Amd. No. Date Comments This British Standard is the official English language version of EN ISO 10139-1:2005. It is identical with ISO 10139-1:2005. It supersedes BS EN 30139-1:1994 which is withdrawn. I

8、SBN 0 580 46590 X EUROPEAN STANDARD NORME EUROPENNE EUROPISCHE NORM EN ISO 10139-1 February 2005 ICS 11.060.10 Supersedes EN 30139-1:1994 English version Dentistry - Soft lining materials for removable dentures - Part 1: Materials for short-term use (ISO 10139-1:2005) Art dentaire - Produits souples

9、 pour intrados de prothses dentaires amovibles - Partie 1: Produits pour usage court terme (ISO 10139-1:2005) Zahnheilkunde -Weichbleibende Unterftterungswerkstoffe fr Prothesen - Teil 1: Werkstoffe fr kurzzeitige Anwendungen (ISO 10139-1:2005) This European Standard was approved by CEN on 3 Februar

10、y 2005. 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 national standards may be obtai

11、ned 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 notified to the Central Secre

12、tariat 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, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Por

13、tugal, 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 Brussels 2005 CEN All rights of exploitation in any form and by any means reser

14、ved worldwide for CEN national Members. Ref. No. EN ISO 10139-1:2005: E Foreword This document (EN ISO 10139-1:2005) 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

15、 Standard shall be given the status of a national standard, either by publication of an identical text or by endorsement, at the latest by August 2005, and conflicting national standards shall be withdrawn at the latest by August 2005. This document supersedes EN 30139-1:1994. According to the CEN/C

16、ENELEC Internal Regulations, the national standards organizations of the following countries are bound to implement this European Standard: Austria, Belgium, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, M

17、alta, Netherlands, Norway, Poland, Portugal, Slovakia, Slovenia, Spain, Sweden, Switzerland and United Kingdom. Endorsement notice The text of ISO 10139-1:2005 has been approved by CEN as EN ISO 10139-1:2005 without any modifications. EN ISO 10139-1:2005 Reference number ISO 10139-1:2005(E)INTERNATI

18、ONAL STANDARD ISO 10139-1 Second edition 2005-02-15 Dentistry Soft lining materials for removable dentures Part 1: Materials for short-term use Art dentaire Produits souples pour intrados de prothses dentaires amovibles Partie 1: Produits pour usage court terme EN ISO 10139-1:2005ii EN ISO 10139-1:2

19、005 iiiContents Page Foreword iv Introduction v 1 Scope 1 2 Normative references . 1 3 Terms and definitions. 1 4 Classification. 1 4.1 Types 1 4.2 Classes. 2 5 Requirements 2 5.1 Development of elastic recovery. 2 5.2 Change in compliance with age as measured by depth of penetration 2 6 Sampling 3

20、7 Test methods. 3 7.1 Ambient conditions for testing 3 7.2 Measurement of elastic recovery 3 7.3 Test of compliance as measured by depth of penetration . 5 8 Requirement for labelling, marking and instructions supplied by the manufacturer 8 8.1 Packaging 8 8.2 Marking 8 8.3 Manufacturers instruction

21、s for use 9 Bibliography . 10 EN ISO 10139-1:2005 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 normally carried out through ISO technical committees. E

22、ach 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 with the Internati

23、onal 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 prepare International Standards. Draft International Standa

24、rds 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 some of the elements of this document may be the subject

25、 of patent rights. ISO shall not be held responsible for identifying any or all such patent rights. ISO 10139-1 was prepared by Technical Committee ISO/TC 106, Dentistry, Subcommittee SC 2, Prosthodontic materials. This second edition cancels and replaces the first edition (ISO 10139-1:1991), which

26、has been technically revised. ISO 10139 consists of the following parts, under the general title Dentistry Soft lining materials for removable dentures: Part 1: Materials for short-term use Part 2: Materials for long-term use vIntroduction Clinically, short-term denture-lining materials are used com

27、monly as tissue conditioners and as temporary soft lining materials. It is believed that their use as functional impression materials is now less common. Therefore, the tests are designed to cover the more common usages. It is recognized that the short-term material, when used as a tissue conditione

28、r, is commonly changed every few days with the aim of returning the mucosa to a healthy condition as quickly as possible. As a temporary soft lining, the material is commonly placed in immediate dentures and in dentures that need to be modified as part of implant treatment. Therefore the specificati

29、on has been so designed to necessitate that a material exhibit the required properties over a 7-d period. It is of course recognized that there are a number of clinical situations where it is appropriate to retain the soft lining in the denture for periods longer than 7 d. It is also recognized that

30、 manufacturers may wish to provide more than one set of times, temperatures, proportions and procedures to mix or prepare the material properly in order that the material can satisfy the requirements of more than one type or class. In its earliest stage, the soft lining material is usually removed f

31、rom the mouth so that it can be adjusted and tidied. If the material attains a particular level of elastic recovery, removal from the mouth will not result in unacceptable distortion. Therefore, denture lining materials for short-term use are classified in this part of ISO 10139 according to the tim

32、e at which 10 % elastic recovery is established. (When stating the time at which 10 % elastic recovery is established, the manufacturer is to take, as zero time, the end of mixing.) The other classification is related to initial compliance. Although it is not claimed that any particular time at whic

33、h 10 % elastic recovery is attained or level of compliance is superior to another, these classifications are intended to assist clinicians who will now have more information with which to make an informed choice. In an attempt to establish some degree of harmony with the procedures used to evaluate

34、related dental materials, the displacement rheometer, which is used to measure the setting characteristics of elastomeric impression materials, has been adopted to measure elastic recovery of the short-term soft lining materials (ISO 4823:2000). This method supersedes the consistency test. This part

35、 of ISO 10139 does not include specific qualitative and quantitative requirements for freedom from biological hazard. When possible biological or toxicological hazards need to be assessed, refer to ISO 7405 (see the Bibliography). EN ISO 10139-1:2005blank1Dentistry Soft lining materials for removabl

36、e dentures Part 1: Materials for short-term use 1 Scope This part of ISO 10139 specifies requirements for the physical properties, test methods, packaging, marking and manufacturers instructions for denture lining materials suitable for short-term use. 2 Normative references The following referenced

37、 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 3696, Water for analytical laboratory use Specification and test meth

38、ods 3 Terms and definitions For the purposes of this document, the following terms and definitions apply. 3.1 tissue conditioning material soft lining material, placed in the fitting surface of a denture, that is intended to be in contact with the denture-supporting mucosa, commonly for a period of

39、up to 7 d, with the aim of assisting its return to a healthy condition 3.2 temporary soft lining material for dentures soft lining material for dentures that is intended to be used for a limited period to improve fit, retention and comfort 4 Classification 4.1 Types Materials for short-term use shal

40、l be classified into the following types according to development of elastic recovery (see 5.1) as determined in accordance with 7.2: Type A: allows short time before removal from the mouth (5 min or less than 5 min); Type B: allows extended time before removal from the mouth (more than 5 min). EN I

41、SO 10139-1:20052 4.2 Classes The materials shall be further subdivided into classes according to their initial compliance as measured by initial resistance to indentation (see 5.2) determined in accordance with 7.3: Class 1: high initial compliance; Class 2: low initial compliance. 5 Requirements 5.

42、1 Development of elastic recovery When specimens are subjected to the displacement rheometer test in accordance with 7.2, two of the three specimens of the material shall conform to the requirement for the relevant type as shown in Table 1. If only one specimen meets the requirement, the material sh

43、all be deemed not to conform to this part of ISO 10139. Table 1 Development of elastic recovery Time at which 10 % recovery is attained at test carried out at 37 C t Type min A t u 5 B t 5 5.2 Change in compliance with age as measured by depth of penetration 5.2.1 Depth of penetration at 2 h When 2-

44、h old test specimens are subjected to the depth of penetration test in accordance with 7.3, two of the three specimens of the material shall conform to the requirements of the particular class as shown in Table 2. If only one specimen meets the requirement, the material shall be deemed not to confor

45、m to this part of ISO 10139. Table 2 Depth of penetration Depth of penetration at 2 h Class mm 1 W 1,5 2 1,5 5.2.2 Depth of penetration at 7 d The depth of penetration at 7 d shall be no less than 0,5 mm. If only one specimen meets this requirement the material shall be deemed not to conform to this

46、 part of ISO 10139. EN ISO 10139-1:200536 Sampling The test sample shall consist of a retail package, or packages, from the same batch. 7 Test methods 7.1 Ambient conditions for testing All tests shall be conducted at (23 1) C unless othewise stated. 7.2 Measurement of elastic recovery 7.2.1 Apparat

47、us 7.2.1.1 Displacement rheometer (see Figure 1). Key 1 LVDT support 6 plate aligning and locking pins 2 flat head assembly screws 7 perforated test plate 3 LVDT core 8 slotted test specimen pedestal 4 core carrier rod 9 instrument base 5 sliding polymer blocks 10 glide track Figure 1 Displacement r

48、heometer NOTE See ISO 4823:2000 for further figures which contain full details and dimensions of the displacement rheometer. No lubricants shall be used in attempts to reduce friction between the bearing surfaces (5) and (10) of Figure 1 of the test instrument. Before using the instrument, the follo

49、wing procedure to determine whether the friction between bearing areas of the instrument is within acceptable limits shall be used. a) Detach the linear variable displacement transducer (LVDT) core carrier rod (4) of Figure 1 from the sliding polymer blocks (5) of Figure 1. b) Clean and dry the bearing surfaces and examine them for defects that can be detected by touch (burrs, nicks, etc). Eliminate any such defects. c) Seat the sl