ISO 16021:2024 pdf download Absorbent incontinence products for urine and/or faeces - Basic principles for evaluation of single-use adult products from the perspective of users and caregivers 尿和/或粪便的吸收性失禁产品 - 从使用者和护理者的角度评价一次性成人产品的基本原则

ISO 16021:2024 pdf download,Absorbent incontinence products for urine and/or faeces - Basic principles for evaluation of single-use adult products from the perspective of users and caregivers.
尿和/或粪便的吸收性失禁产品 - 从使用者和护理者的角度评价一次性成人产品的基本原则.
This document ISO 16021:2024 provides basic principles for conducting user evaluations of single-use,body-worn urine-absorbing products for adult incontinent users,their caregivers,or both.It gives guidance for users orcaregivers in evaluating products in actual use and can be used for comparing products.EDANA has provideduseful guidelines on the evaluation of baby diapers many of which apply equally to absorbent products foradult incontinence.Whether a user evaluation or a clinical investigation is planned,it is important to checkif ethics committee approval will be required.
The comparison of user evaluation data obtained from evaluating several products is statistically complexand highly dependent upon the information desired from the evaluation,the differences between or amongproducts,and the size of the user population used in the evaluation,to mention only three important factors.Direct comparison between products based on statistical parameters is not covered by this document.
This document ISO 16021:2024 is based upon an extensive body of data and experimentation on the ways in which evaluationof incontinence products by users can be done to gain useful information on the acceptability of products fora variety of purposes.Selected references are given in the Bibliography as an aid to the user of this documentin applying it to particular situations of interest.
本文件提供了对成人尿失禁使用者、其照护者或两者使用的一次性、身体使用的尿吸收产品进行用户评估的基本原则。它为用户或护理人员在实际使用中评估产品提供指导，并可用于产品比较。EDANA为婴儿尿布的评估提供了有用的指导方针，其中许多同样适用于成人尿失禁的吸收性产品。无论是计划进行用户评估还是临床研究，检查是否需要伦理委员会的批准是很重要的。
通过评估几个产品获得的用户评估数据的比较在统计上是复杂的，并且高度依赖于评估所需的信息，产品之间的差异，以及评估中使用的用户群体的大小，仅举三个重要因素。本文档不包括基于统计参数的产品之间的直接比较。
本文件是基于广泛的数据和实验的方式，其中用户评价失禁产品可以做，以获得有用的信息，对各种用途的产品的可接受性。参考书目中给出了一些参考文献，以帮助本文档的用户将其应用于感兴趣的特定情况。