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prSSH EN ISO 16021:2024

Absorbent incontinence products for urine and/or faeces - Basic principles for evaluation of single-use adult products from the perspective of users and caregivers (ISO 16021:2024)

General information

40.20     Feb 10, 2025

40.60    May 6, 2025

DPS

DPS/KT 205

European Norm

11.180.20  

Scope

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.

Life cycle

PREVIOUSLY

PUBLISHED
SSH EN ISO 16021:2005

NOW

IN_DEVELOPMENT
prSSH EN ISO 16021:2024
40.20 DIS ballot initiated: 12 weeks
Feb 10, 2025

Related project

Adopted from EN ISO 16021:2024 IDENTICAL

Adopted from ISO 16021:2024 IDENTICAL

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