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>UNE standards>UNE 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) (Endorsed by Asociación Española de Normalización in May of 2024.)
in stockReleased: 2024-05-01
UNE 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) (Endorsed by Asociación Española de Normalización in May of 2024.)

UNE 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) (Endorsed by Asociación Española de Normalización in May of 2024.)

Ayudas para la absorción de orina. Principios básicos para la evaluación de los absorbentes de incontinencia de un solo uso para adultos desde la perspectiva de los usuarios y cuidadores. (ISO 16021:2024) (Ratificada por la Asociación Española de Normalización en mayo de 2024.)

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Standard number:UNE EN ISO 16021:2024
Pages:21
Released:2024-05-01
Status:Standard
DESCRIPTION

UNE EN ISO 16021:2024

This document provides guidelines for designing and conducting an evaluation of single-use adult incontinence absorbing products. It provides guidance 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 guidance on measuring the clinical efficacy of products: that is available in ISO 14155 Clinical investigation of medical devices for human subjects Good clinical practice.