NF EN ISO 16021, S96-632 (04/2024)

This document provides guidelines and requirements for the design and conduct of an evaluation of single-use absorbent products for adult incontinence. It provides guidelines and requirements for creating data collection tools. In particular, it provides a framework for selecting and recording the opinions that users and caregivers may express regarding the acceptability of products. Additionally, a product log is described. It makes it possible to quantify the parameters of use of the product, in particular the duration of use, the mass of urine absorbed by the product and the severity of any leaks. This document does not cover direct comparison between products based on statistical parameters. It also does not provide guidance on measuring the clinical effectiveness of products. These are available in ISO 14155.
(Automatic translation from French)