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现行 ISO 16021:2024
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Absorbent incontinence products for urine and/or faeces — Basic principles for evaluation of single-use adult products from the perspective of users and caregivers 用于尿液和/或粪便的吸收性失禁产品——从使用者和护理人员的角度评价一次性成人产品的基本原则
发布日期: 2024-03-26
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,描述了产品日记,其可以帮助量化产品使用的一些参数,例如磨损次数、产品吸收的尿液质量以及任何泄漏的严重程度。 本文件不涵盖基于统计参数的产品之间的直接比较,也不提供关于衡量产品临床疗效的指南;ISO中有吗?14155.

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.

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归口单位: ISO/TC 173/SC 3
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