The document provides an overview of ISO, the International Organization for Standardization, which establishes international standards. It then summarizes ISO 9917-2, which sets requirements and test methods for resin-modified dental cements that set through both chemical and light-activated polymerization reactions. The standard was prepared by ISO Technical Committee 106 on dentistry and is intended to harmonize test methods for these resin-modified cements with other related dental material standards.
The document provides an overview of ISO, the International Organization for Standardization, which establishes international standards. It then summarizes ISO 9917-2, which sets requirements and test methods for resin-modified dental cements that set through both chemical and light-activated polymerization reactions. The standard was prepared by ISO Technical Committee 106 on dentistry and is intended to harmonize test methods for these resin-modified cements with other related dental material standards.
The document provides an overview of ISO, the International Organization for Standardization, which establishes international standards. It then summarizes ISO 9917-2, which sets requirements and test methods for resin-modified dental cements that set through both chemical and light-activated polymerization reactions. The standard was prepared by ISO Technical Committee 106 on dentistry and is intended to harmonize test methods for these resin-modified cements with other related dental material standards.
The document provides an overview of ISO, the International Organization for Standardization, which establishes international standards. It then summarizes ISO 9917-2, which sets requirements and test methods for resin-modified dental cements that set through both chemical and light-activated polymerization reactions. The standard was prepared by ISO Technical Committee 106 on dentistry and is intended to harmonize test methods for these resin-modified cements with other related dental material standards.
Download as DOCX, PDF, TXT or read online from Scribd
Download as docx, pdf, or txt
You are on page 1/ 3
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 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 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 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 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 9917-2 was prepared by Technical Committee ISO/TC 106, Dentistry, Subcommittee SC 1, Filling and restorative materials. This second edition cancels and replaces the first edition (ISO 9917-2:1998), which has been technically revised by the inclusion of resin-modified cements which set by both chemically activated and light-activated polymerization. ISO 9917 consists of the following parts, under the general title Dentistry Water-based cements:
Part 1: Powder/liquid acid-base cements
Part 2: Resin-modified cements
Introduction This part of ISO 9917 has been prepared in order to present the requirements and test methods for cements in which setting is achieved by a combination of an acid-base reaction and polymerization. The polymerization component of the reaction may be activated by mixing different components or through application of energy from an external source. As far as possible, test methods employed within this part of ISO 9917 have been harmonized with those used in ISO 4049 and ISO 9917-1. Specific qualitative and quantitative requirements for freedom from biological hazard are not included in this part of ISO 9917, but it is recommended that reference be made to ISO 109931 and ISO 7405 when assessing possible biological or toxicological hazards.
1 Scope This part of ISO 9917 specifies requirements and test methods for dental cements that are intended for luting, base or lining and restoration purposes and for which the materials are water-based and set
by multiple reactions in which setting is achieved by a combination of an acid-base reaction and
polymerization. EXAMPLE Conventional glass polyalkenoate cements are normally formed by reacting an ion-leachable aluminosilicate glass with a polyalkenoic acid in an aqueous environment. Materials that fall within the scope of this part of ISO 9917 will normally be able to effect setting by such an aqueous acid-base type reaction but in addition will be able to undergo setting by polymerization. NOTE Attention of manufacturers and test laboratories is drawn to the closely-related International Standards ISO 4049 and ISO 9917-1. Consideration should be given as to which is the most appropriate International Standard by which to evaluate any individual product.
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) applies.
ISO 1942, Dentistry Vocabulary
ISO 3665:1996, Photography Intra-oral dental radiographic film Specification
ISO 3696, Water for analytical laboratory use Specification and test methods
ISO 7491, Dental materials Determination of colour stability
ISO 8601, Data elements and interchange formats Information interchange
Representation of dates and times
3 Terms and definitions
For the purposes of this document, the terms and definitions given in ISO 1942 and the following apply. 3.1 mixing time that part of the working time required in order to obtain a satisfactory mix of the components Note 1 to entry: Materials that fall within the scope of this part of ISO 9917 include materials that require mixing and single component materials that do not require mixing. 3.2 working time period of time, measured from start of mixing (if required), during which it is possible to manipulate the material without an adverse effect on its properties Note 1 to entry: Working time is determined in the absence of activating radiation, if required for activation for Class 3 materials (seeClause 4). 3.3
setting time period of time, from start of mix, until the completion of set, as defined by the ability of the material to support an indenter under a known load 3.4 outer pack form of packaging used to combine a number of single dose containers or capsules 3.5 outermost packaging form of packaging used to combine material and additional items, including instructions for use and any proportioning or mixing devices that are supplied with the material
