本文件提供了设计和评估一次性成人失禁吸收产品的指南和要求。它提供了创建数据收集工具的指导方针和要求。特别是，它提供了一个框架，用于引出和记录用户及其护理人员对产品可接受性的看法。此外，还描述了产品日记，它可以帮助量化产品使用的一些参数，如磨损时间、产品吸收的尿液质量以及任何泄漏的严重程度。 本文件不包括基于统计参数的产品之间的直接比较，也不提供测量产品临床疗效的指南；可在ISO 14155中获得。

This document provides guidelines and requirements for designing and conducting an evaluation of single-use adult incontinence absorbing products. It provides guidelines and requirements on creating data collection tools. In particular, it provides a framework for eliciting and recording the views of users and their carers on the acceptability of products. In addition, a product diary is described which can help to quantify some parameters of product use, such as wear times, the mass of urine absorbed by the product and the severity of any leakage from it. This document does not cover direct comparison between products based on statistical parameters, neither does it provide guidelines on measuring the clinical efficacy of products; that is available in ISO 14155.