Standards Development

Scope

This document is intended to provide a process for design and development of synthetic anatomical bone models for use in testing of implants involving digital model of the bone.

The anatomical source of synthetic model can be digital data from CT scanning, or other reference information such as from cadaver, statistical shape data.

Purpose

This document is intended to provide a guidance to establish the design and development process of the bone models, in particular, to clarify the verification of the model fitness to its intended specifications and documentation in the product report. This document is useful for the model producer and model users, because it defines the terms that are necessary to describe the synthetic models and provides a suggested set of characteristics that can be useful in specifying the model. From the bone model users’ viewpoint, the product report harmonized to this document will help them to find a bone model of their need, and to perform the validation of the test results obtained by using the model. And for the bone model producers, this document will help them to justify their products’ specifications and to clarify the boundary of responsibility sharing between the producer and the user: model producer’s role should cover until the verification, while the validation is a task of the model user.