Overview
EN 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 planning and conducting user-centred evaluations of single‑use, body‑worn adult absorbent incontinence products. The standard focuses on eliciting and recording the views of users and caregivers and describes practical data‑collection tools, including a product diary to quantify parameters such as wear time, mass of urine absorbed and severity of leakage. It does not prescribe statistical product comparisons or clinical efficacy testing (see ISO 14155 for clinical investigations).
Key topics and requirements
- Evaluation protocol design: Guidance on creating repeatable, ethical user-evaluation protocols and data collection plans.
- Questionnaires and data tools: Requirements for developing product evaluation questionnaires and structured data‑gathering instruments targeted at users and caregivers.
- Product diary: A standardized diary format to record key use parameters (wear times, absorbed mass, leakage events) to support practical, quantitative observation.
- Participant selection: Considerations for selecting products, user groups and caregivers, and defining an appropriate evaluation period.
- Pilot studies and preparations: Recommendations to validate questionnaires and procedures before full trials.
- Data collection and reporting: Clear sections for demographic data, product performance data, user withdrawal tracking and producing a comprehensive evaluation report.
- Ethics and harmonization: Notes on ethics committee approval where required and terminology harmonized with related ISO standards (e.g., ISO 22748).
Practical applications
This standard is practical for:
- Manufacturers and product designers conducting usability and acceptability testing during product development.
- Clinical researchers and usability teams running user‑based trials focusing on acceptability and user/caregiver feedback.
- Procurement and healthcare providers assessing suitability of products for specific patient groups.
- Regulatory and quality teams documenting user-evaluation methods as part of post‑market surveillance or usability evidence.
- Care organisations and caregivers seeking structured approaches to capture real-world product performance.
Related standards
- ISO 14155 - Clinical investigations of medical devices (for clinical efficacy testing).
- ISO 22748 - Related terminology alignment for assistive products.
EN ISO 16021:2024 helps standardize how user and caregiver perspectives are collected and documented for single‑use adult absorbent incontinence products, improving product development, procurement decisions and real‑world evidence collection.
