What is ISO 6877 about?
ISO 6877 addresses dentistry and 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. ISO 6877 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. ISO 6877 covers the physical attributes expected of such products as supplied.
Sterility is not included in ISO 6877, 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.
ISO 6877 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.
Who is ISO 6877 for?
ISO 6877 on dentistry is applicable to-
- Manufacturers of endodontic obturating materials for dentistry purposes
- Medical laboratories
- Research facilities
- Healthcare centres
Why should you use ISO 6877?
Endodontic obturating material is a substance intended as a definitive product to fill a prepared root canal system, usually a combination of points and endodontic sealer.
Using ISO 6877 guidelines will help you understand specifications and dimensions of various endodontic obturating materials including preformed metal suitable for use in the obturation of the root canal system which will improve the quality standards and will ensure the patients' health and safety.
What’s changed since the last update?
BS EN ISO 6877:2021 supersedes ISO 6877:2006, which has been withdrawn. BS EN ISO 6877:2021 has some technical changes with respect to ISO 6877:2006, these include:
- Use of “endodontic” rather than “root canal” for the terminology
- Inclusion of points having a non-uniform taper
- Inclusion of thermoplastic materials not in the form of a point
- Standardization to the use of D, d3 and d16 for measurements of endodontic points at the projection of the tip, 3 mm, or 16 mm from the tip of a point
- Harmonization of D, d3 and d16 with the ISO 3630 series
- Reconsidering tests methods