YY 1042-2003 Dentistry - Polymer-based filling, restorative and luting materials
1 Scope
This standard specifies requirements for dental polymer-based filling and restorative materials and polymer-based luting materials used in dentistry. It is supplied in a form suitable for mechanical mixing, hand-mixing, or intra-oral and extra-oral external energy activation, and intended for use primarily for the direct or indirect restoration of cavities in the teeth.
The luting materials covered by this standard are intended for use in the cementing or fixation of restorations and appliances such as inlays, onlays, veneers, crowns and bridges.
This standard does not cover requirements for polymeric materials intended for veneering indirectly restoration metal sub-frames (see ISO 10477) and materials intended to prevent caries (see ISO 6874).
2 Normative references
The following normative documents contain provisions which, through reference in this text, constitute provisions of this standard. For dated references, subsequent amendments (excluding corrections), or revisions, of any of these publications do not apply to this standard. However, parties to agreements based on this standard are encouraged to investigate the possibility of applying the most recent editions of the normative documents indicated below. For undated references, the latest edition applies.
ISO 3665: 1996 Photography - Intra-oral dental radiographic film - Specification
ISO 7491: 1999 Dental materials - Determination of colour stability of dental materials
3 Terms and definitions
For the purposes of this standard, the following term and definition apply:
3.1
opaquer luting material
intensely pigmented polymer-based luting material intended to mask underlying tooth structure
3.2
opaque
shade of a polymer-based restorative material intended to be less translucent than a non-opaque shade
4 Classification
For the purposes of this standard, dental polymer-based restorative materials are categorized as one of the following types.
a) Type I: polymer-based filling and restorative materials claimed by the manufacturer as suitable for restorations involving occlusal surfaces;
b) Type II: all other polymer-based filling and restorative materials.
Note: It is not necessary to classify polymer-based luting materials into types.
The three classes of dental polymer-based filling, restorative and luting materials are as follows.
——Class I: materials whose setting is effected by mixing an initiator and activator ("self-setting" materials).
Foreword i
1 Scope
2 Normative references
3 Terms and definitions
4 Classification
5 Requirements
6 Sampling
7 Test methods and inspection rules
8 Packaging, marking and information to be supplied by the manufacturer
Annex A (Informative) Technical differences and their causes between this standard and ISO 4049: 2000
Bibliography
