EUROLAB laboratory provides testing and compliance services within the scope of ISO 16021 standard. Developed by the International Standards Organization (ISO), the ISO 16021 standard provides guidelines for designing and conducting user evaluation of disposable adult incontinence absorbent aids. Provides guidance on creating data collection tools.
In particular, it provides a framework for uncovering and recording users' and their caregivers' views on product performance. In addition, an optional approach is described to determine the leakage performance and wear times of products and the mass of urine in them.
This International Standard does not cover direct comparison between products based on statistical parameters.
This International Standard provides basic principles for conducting user evaluation of disposable, body-worn absorbent aids by adult incontinence users, their caregivers, or both. It provides guidance in understanding product performance in actual use and can therefore be used when making purchase or reimbursement decisions, or both, among a variety of products with varying performance characteristics.
The focus of this International Standard is on the fundamental principles that must be considered for the evaluation of a single product in actual use. Where multiple products are to be evaluated, the recommended procedure should be applied to each, although the precise evaluation protocol used will vary depending on the unique characteristics of each product, the user population used for evaluation, or both.
Comparing user evaluation data from the evaluation of several products is statistically complex and highly dependent on the information requested from the evaluation, the differences between or between products, and the size of the user population used in the evaluation, to mention only three important factors. . Direct comparison between products based on statistical parameters is not covered by this International Standard.
It is important for those wishing to make statistically robust comparisons between different products to consult a medical statistician for advice on, for example, the number of evaluation subjects they should recruit and randomizing the order of evaluation of different products.
This International Standard is based on a comprehensive body of data and experiments on how users can evaluate incontinence products to obtain useful information about product performance for a variety of purposes. Selected references are provided in the Bibliography to assist the user of this International Standard in applying it to situations of special interest.
Among the services provided by our organization within the framework of material testing services, there are also ISO 16021 standard tests. Do not hesitate to contact our laboratory EUROLAB for your testing and certification requests.
To get an appointment, to get more detailed information or to request an evaluation, you can ask us to fill in our form and reach you.
EUROLABreporting and certification activities, United Accreditation Foundation (UAF), Turkish Accreditation Agency (TÜRKAK) ve Enterprise Accreditation Foundation (EAF) based on the accreditation provided by the accreditation body. The Enterprise Accreditation Foundation (EAF) accreditation body is also a signatory of the United Nations (UN GLOBAL COMPACT) organization.
