标准摘要
[中文适用范围]： 本文件提供了设计和进行一次性成人失禁吸收产品评估的指南和要求。它提供了创建数据收集工具的指南和要求。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，它有助于量化产品使用的某些参数，例如佩戴时间、产品吸收的尿液量以及产品泄漏的严重程度。本文件不涉及基于统计参数的产品直接比较，也不提供测量产品临床功效的指南；该指南可在 ISO 14155 中找到。 [外文原描述]： 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.
英文名称Absorbent incontinence products for urine and/or faeces — Basic principles for evaluation of single-use adult products from the perspective of users and caregivers