DIN EN ISO 16021:2024-08

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. This document (EN ISO 16021:2024) has been prepared by Technical Committee ISO/TC 173 "Assistive products" in collaboration with Technical Committee CEN/TC 293 "Assistive products and accessibility", the secretariat of which is held by SIS (Sweden). The responsible German committee is Working Committee NA 176-06-09 AA "Inkontinenzhilfen und Stomaversorgung" ("Aids for ostomy and incontinence") at DIN Standards Committee Health Technologies (NAGesuTech).