DANSK DSF/PREN ISO 16021 PDF

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.