Overview
EN ISO 15621:2026 provides general guidelines for evaluating absorbent incontinence products for managing urine, faeces, or both. Applicable to products for both adults and children, this international standard offers a framework for assessment, ensuring consistent quality and suitability in products designed for urinary and/or faecal incontinence. Developed by CEN and ISO, the standard provides context for various evaluation procedures and testing methodologies. It addresses essential user, product, and usage-related factors, making it a valuable reference for healthcare professionals, caregivers, manufacturers, and end users.
Key Topics
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User-related Factors
- Quality of life improvement through effective incontinence management
- Independence vs. the need for caregiver assistance when choosing and using products
- Specifics of incontinence (type, frequency, volume, day/night use)
- End user characteristics-body size, shape, mobility, manual dexterity, age, and cognitive function
- Matching product to the user’s activities (e.g., exercise, travel, work)
- Individual preferences and needs, emphasizing the importance of offering product choice and trials
- Ease of product handling for users and caregivers
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Product-related Factors
- Freedom from both liquid and odour leakage
- Product absorption capacity, acquisition speed, retention capacity, and rewet properties
- Comfort and fit tailored to user anatomy and daily routine
- Skin health considerations, including materials that minimize irritation and maintain dryness
- Product discretion and ease of wearing under clothing
- Suitability for men, women, or unisex needs
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Usage-related Factors
- Ergonomics for both users and caregivers-how easy the product is to apply or change
- Information and instructions supplied with the product
- Laundry and disposal facilities, and sustainable, environmentally conscious design
- Emphasis on product safety and total cost of ownership
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Evaluation Methods
- Laboratory testing (absorption, leakage)
- In-use trials with end users for practical assessment
- Combined approaches for comprehensive evaluation
- Interpreting results and ensuring appropriate sample sizes
Applications
EN ISO 15621:2026 is widely applicable across various sectors:
- Healthcare Providers: Guides selection and procurement of suitable incontinence aids for hospitals, nursing homes, and long-term care facilities.
- Manufacturers & Suppliers: Offers a standardized method for product evaluation, quality assurance, and product development focused on user needs.
- Caregivers & End Users: Helps identify products that best meet individual needs, ensuring comfort, reliability, and dignity.
- Policy Makers & Insurers: Assists in benchmarking product performance and cost-effectiveness for public and private healthcare systems.
- Testing Laboratories: Acts as a reference document for standardizing incontinence product tests and interpreting their results.
Related Standards
EN ISO 15621:2026 references and aligns with several other key standards in the field of assistive products for incontinence:
- ISO 22748: Product type names and illustrations for absorbent incontinence products
- ISO 11948-1: Laboratory test for determining the absorption capacity of incontinence products
- ISO 6658: Sensory analysis methodologies, relevant for odour evaluation
- ISO 16021: Guidelines for user trials and practical testing
- ISO 9999: International classification of assistive products for persons with disability
By following these guidelines and related standards, stakeholders ensure that absorbent incontinence products are selected and evaluated based on safety, efficacy, user comfort, and overall quality, supporting dignity and quality of life for people managing incontinence.