Abstract

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.

Begin

2022-03-28

WI

00293084

Planned document number

DIN EN ISO 16021

Project number

06302155

Responsible national committee

NA 176-06-09 AA - Aids for ostomy and incontinence  

Responsible european committee

CEN/TC 293 - Assistive products and accessibility  

Responsible international committee

ISO/TC 173/SC 3/WG 2 - Urinary absorbing aids  

draft standard

Urine-absorbing products - Basic principles for evaluation of single-use adult-incontinence products from the perspective of users and caregivers (ISO/DIS 16021:2023); German and English version prEN ISO 16021:2023
2023-05
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previous edition(s)

Urine absorbing aids - Basic principles for evaluation of single-use adult-incontinence-absorbing aids from the perspective of users and caregivers (ISO 16021:2000); German version EN ISO 16021:2000
2001-02

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