ISO 6877:2021 PDF

Scope: This document establishes the specifications for the dimensions of various endodontic obturating materials including preformed metal, preformed polymeric-coated metal, polymeric points, thermoplastic obturating material or combinations of the above, suitable for use in the obturation of the root canal system. This document also specifies numerical systems and a colour-coding system for designating the sizes of preformed endodontic obturating points. Dental endodontic obturating points are marketed sterilized or non-sterilized. This document covers the physical attributes expected of such products as supplied. Sterility is not included in this document, and any claim that the product is sterile is the responsibility of the manufacturer (see Table 3). Clause 7 specifies the labelling needed, including the instructions for use. This document does not apply to instruments or apparatus used in conjunction with thermoplastic obturating materials (obturating material that deform with heat). This document is not applicable to materials for support of a coronal restoration.

ISO 6877:2021 Referenced Document

ISO 13116 Dentistry - Test Method for Determining Radio-Opacity of Materials
ISO 15223-1 Medical devices-Symbols to be used with information to be supplied by the manufacturer-Part 1: General requirements
ISO 1942 Dentistry — Vocabulary — Amendment 1
ISO 3630-1 Dentistry — Endodontic instruments — Part 1: General requirements