Overview
ISO 16021:2024 - "Absorbent incontinence products for urine and/or faeces - Basic principles for evaluation of single-use adult products from the perspective of users and caregivers" - provides guidance for designing and conducting user-centered evaluations of single‑use adult absorbent incontinence products. The standard focuses on eliciting and recording the views of users and caregivers, defines data‑collection tools (questionnaires, product diaries) and sets out principles for recruitment, study duration and documentation. It does not cover direct statistical comparisons between products or clinical efficacy testing (see ISO 14155 for clinical investigations).
Key Topics and Requirements
- Evaluation protocol design
- Use clear inclusion/exclusion criteria, define objectives and record protocol decisions in the evaluation report.
- Consider ethics committee approval where applicable.
- Questionnaires and data‑gathering tools
- Structured product‑evaluation questionnaires to capture acceptability, comfort and handling.
- Demographic and background data (age, mobility, incontinence severity).
- Product diary
- Defined framework to quantify wear times, mass of urine absorbed and severity/frequency of leakage.
- Selection of products and users
- Select products from multiple production batches to reduce batch bias.
- Match product absorbency to user incontinence severity; avoid mixing institutional and home settings or independent and caregiver‑managed users in the same evaluation.
- Sample size and evaluation period
- Choose sample size based on intended use of data and resources; consult a statistician for robust comparative studies.
- Typical evaluation period: one to two weeks per product to allow acclimatization without loss of interest.
- Procedures
- Pilot studies recommended; document preparations, data collection, user withdrawal and final evaluation report content.
Applications and Who Uses It
ISO 16021:2024 is practical for:
- Product developers and manufacturers conducting user acceptability studies for single‑use adult absorbent products.
- Quality assurance and regulatory teams preparing non‑clinical usability evidence.
- Clinical researchers and health‑care providers planning user trials or real‑world evaluations focused on acceptability and caregiver handling.
- Purchasing managers and procurement specialists evaluating products from the perspective of end users and carers.
Practical benefits include improved product design decisions, evidence to support usability claims, and repeatable methods to collect real‑world user feedback.
Related Standards
- ISO 14155 - clinical investigations of medical devices (clinical efficacy).
- ISO 22748 - terminology and product-type guidance for absorbent incontinence products.
- EDANA guidance on diaper evaluation is also referenced for methodological parallels.
Keywords: ISO 16021:2024, absorbent incontinence products, single‑use adult products, user evaluation, caregiver evaluation, product diary, product evaluation questionnaire.