ISO/AWI 24277

Dentistry — Orthodontic Clear Aligner Materials

Scope

This document specifies requirements and test methods for materials used in the production of orthodontic clear aligners along with packaging and labelling requirements. This standard includes materials that are thermoformed into clear aligners, as well as materials that are used to additively manufacture clear aligners.
This document does not specify qualitative and quantitative requirements for the evaluation of biocompatibility; which are covered in ANSI/ADA Standard No. 41, ISO 10993-1, ISO 7405 and ISO 4049.