ISO 16021:2024 PDF

Absorbent incontinence products for urine and/or faeces — Basic principles for evaluation of single-use adult products from the perspective of users and caregivers

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Title (English):

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

Document status:: Active
Format:: Electronic (PDF)
Number of pages:: 11
Publication date:: March 26, 2024
Edition:: ISO IS 16021 edition 2 version 1
ICS:: 11.180.20

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Description (English):

This document provides guidelines and requirements for designing and conducting an evaluation of single-use adult incontinence absorbing products. It provides guidelines and requirements 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 guidelines on measuring the clinical efficacy of products; that is available in ISO 14155.

Technical details

Technical committee: ISO/TC 173/SC 3 - Aids for ostomy and incontinence
SKU: ISO 16021:2024

Abstract

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.

Related standards

Mentioned in the description and other ISO standards

Abstract

Overview

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.

ISO 16021:2024 PDF

Technical details

Abstract

Overview

Key Topics and Requirements

Applications and Who Uses It

Related Standards

Related standards

Abstract

Overview

Key Topics and Requirements

Applications and Who Uses It

Related Standards

Related standards

Clinical investigation of medical devices for human subjects - Good clinical practice (ISO 14155:2026)

Absorbent incontinence products for urine and/or faeces - Product type names and illustrations (ISO 22748:202…

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