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BS EN ISO 16021:2024

BS EN ISO 16021:2024

$102.76

Absorbent incontinence products for urine and/or faeces. Basic principles for evaluation of single-use adult products from the perspective of users and caregivers

Published By Publication Date Number of Pages
BSI 2024 20
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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.

PDF Catalog

PDF Pages PDF Title
2 undefined
10 4.1 Questionnaires
4.2 Selection of products
4.3 Selection of users
11 4.4 Sample size
4.5 ​Evaluation period
4.6 Product evaluation strategy
5.1 Data requirements
12 5.2 Demographic data
5.3 Product evaluation data
5.3.1 Product evaluation questionnaire
13 5.3.2 Product diary
5.4 Product description data
5.5 Other documentation
6.1 Pilot studies
6.2 Preparations
14 7.1 Demographic data
7.2 Product performance data
7.2.1 Product evaluation questionnaire
7.2.2 Product change diary
7.3 User withdrawal
15 7.4 Product description data
7.5 Other documentation

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BS EN ISO 16021:2024
$102.76