Standards Development

Scope

This document specifies the requirements for the dimensions of various endodontic obturating materials, and the radiopacity for preformed polymeric-coated, polymeric points, preformed polymeric-coated, thermoplastic obturating materials, or combinations of the above used for obturation of a root canal system. It also specifies numerical and colour-coding systems for designating the sizes of a preformed endodontic obturating points, a method for determining the melt mass-flow rate for injection material, and the requirements for marking, labelling, packaging, and the instructions for use.

Dental endodontic obturating points are marketed as sterilized or non-sterilized. Sterility is not included in this document and any claim that the product is sterile is the responsibility of the manufacturer (see Table 2).

Clause 7 specifies the labelling and packaging needed, including the instructions for use. A claim by the manufacturer that the contents of the unopened pack are sterile is the responsibility of the manufacturer (see Table 3). This document does not specify requirements or test methods for sterility.

NOTE 1 Reference to applicable national regulations can be made.

Reference is made to internationally accepted pharmacopoeia.

NOTE 2 National requirements can apply.

Standards on methods of validating sterilization processes are also available: ISO 11137-1, ISO 11137-2 and ISO 11137-3.

This document does not apply to instruments or apparatus used in conjunction with thermoplastic obturating materials (obturating material that become plastic with heat). This document is not applicable to materials for support of a coronal restoration.