BS EN ISO 16021:2001 PDF

1   Scope This International Standard provides guidelines for designing and conducting a user evaluation of single-use adult- incontinence-absorbing aids. 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 product performance. In addition, an optional approach for establishing the leakage performance and wear times of products and the mass of urine in them is described. This International Standard does not cover direct comparison between products based on statistical parameters.