本标准提供了一个框架，用于评估建立计算模型可信度的已完成V&V活动的相关性和充分性。可信度应与计算模型作为支持决策的设备性能、功能特性和/或安全性证据的依赖程度以及该决策不正确的后果相称。该标准将帮助用户传达已完成V&V活动的价值，并建立支持决策的计算模型的相关可信度。它还增强了其他提出V&V方法的标准，如ASME V&V 10和ASME V&V 20。因此，本手册适用于熟悉V&V术语的从业者。它没有提供一种结合用户专业知识或建模者谱系的方法，也没有描述建立特定应用和/或设备可信度所需的特定V&V活动和严格程度。 相反，本标准为从业者提供了一个框架，以使用合理的工程判断进行评估。它不是一个循序渐进的指南，也不是为了提供建立模型可信度的定量方法。虽然该框架是专门为医疗设备开发的，但V&V 40小组委员会认为该标准具有足够的通用性，可以应用于其他学科。

This Standard provides a framework for assessing the relevance and adequacy of completed V&V activities that establish credibility of a computational model. The credibility should be commensurate with the degree to which the computational model is relied on as evidence of device performance, functional characteristic, and/or safety to support a decision, and the consequences of that decision being incorrect.This Standard will help users communicate the value of the completed V&V activities and establish the associated credibility of the computational model to support a decision. It also augments other standards that present V&V methodologies, such as ASME V&V 10 and ASME V&V 20. Therefore, it is intended for the practitioner who is familiar with V&V terminology. It does not present a method for incorporating user expertise or modeler pedigree, nor does it describe the specific V&V activities and rigor that are needed to establish credibility for a particular application and/or device. Instead, this Standard presents a framework for the practitioner to make that assessment using sound engineering judgment. It is not a step-by-step guide, nor is it intended to present a quantitative method for establishing model credibility. While the framework was developed specifically for medical devices, the V&V 40 Subcommittee considers this Standard to be general enough to be applied to other disciplines.