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ISO/TR 25555:2024 — Ageing Societies — Accessibility and Usability for Home Healthcare Products
Design considerations for safe, accessible, and user-friendly home healthcare products serving older adults and non-professional caregivers
1. The Challenge of Home Healthcare in Rapidly Ageing Societies
As populations age rapidly worldwide, healthcare activities are increasingly shifting from professional medical facilities to home environments. This transition, known as home healthcare, aims to provide quality of life that includes independence, autonomy, safety, and security for older persons. ISO/TR 25555:2024 addresses the critical challenge that many older adults and non-professional caregivers now use medical and non-medical products designed primarily for professional healthcare settings, creating accessibility and usability gaps that can compromise safety and effectiveness.
The standard was developed by ISO/TC 314 (Ageing societies) and consolidates information from existing international standards, regional guidelines, and empirical feedback from home healthcare product users. Its primary goal is to make relevant design information easily accessible in a single reference document. The standard covers three interrelated domains: the products themselves, the services associated with their use, and the environments in which they are used.
Unlike medical facilities where trained professionals are continuously available, home healthcare environments often lack expert supervision. Products, services, and environments must therefore be designed for use by individuals with a wide range of physical, sensory, and cognitive abilities, including those with no formal medical training.
2. Accessibility and Usability Considerations
2.1 General Design Principles
ISO/TR 25555 organizes accessibility and usability considerations across four dimensions: products, related services, environments, and the interactions between them. The general principles include safety and security, cleanliness and sterilization, independence and autonomy of care recipients, and universal accessibility. The standard emphasizes that these principles must be considered throughout the entire product lifecycle, not merely during initial design. Post-market surveillance and feedback collection from actual home users should inform continuous improvement cycles.
| Consideration Area | Key Requirements | Design Implications |
|---|---|---|
| Safety & Security | Prevent misuse, reduce hazards for non-professional users | Fail-safe mechanisms, clear warnings, locking features |
| Cleanliness & Sterilization | Avoid infection risks across varied user populations | Easy-to-clean surfaces, disposable components, zoning |
| Independence & Autonomy | Enable self-care by care recipients where possible | Single-handed operation, clear feedback, adjustable interfaces |
| Accessibility | Accommodate widest range of physical/sensory/cognitive abilities | Large controls, high-contrast displays, tactile indicators |
2.2 Product-Specific Considerations
Operation considerations include physical interaction (force required, grip design, reachability), visual interfaces (display readability, icon comprehension), auditory feedback (alarm volume and pitch appropriate for older users who may have hearing loss), and cognitive load (simplified workflows, error prevention). Information and marking requirements address label legibility, multilingual instructions, pictogram effectiveness, and the need for large-format, high-contrast documentation. The standard emphasizes that even simple design changes, such as increasing button size and contrast, can dramatically improve usability for older adults with reduced dexterity and vision.
A key insight from the standard is that the concept of “user” encompasses three distinct groups: healthcare professionals, formal and informal caregivers, and care recipients themselves. Each group has different needs, capabilities, and contexts of use. A product that works well for a nurse may be entirely unsuitable for an older adult with arthritis and vision impairment.
3. Engineering Design Insights for Inclusive Home Healthcare
3.1 Environmental Considerations
The standard dedicates significant attention to the use environment — a critical but often overlooked aspect of home healthcare. Lighting must be adequate for task performance but not cause glare for users with visual sensitivity. Sound environments should minimize background noise that can mask important auditory alarms while ensuring alarm signals are audible. Thermal and air quality considerations address the needs of users with reduced thermoregulatory capacity and respiratory conditions. These environmental factors are defined in Clause 7 of the standard with specific guidance for each parameter, including recommended illumination levels and maximum background noise levels.
3.2 Service-Related Considerations
Services related to home healthcare products — including installation, maintenance, training, and technical support — are addressed in Clause 6. The standard emphasizes that service design must account for the fact that the person installing or maintaining equipment may be different from the daily user, and that service personnel should be trained in communicating with older adults and non-professional caregivers. Remote monitoring and telehealth integration are identified as emerging service models that can significantly improve the effectiveness of home healthcare while reducing the burden on formal care systems.
3.3 Major Product Categories
Annex A of the standard provides a comprehensive classification of major home healthcare products and their users, while Annex B offers specific product examples. These annexes serve as practical checklists for product designers and regulators working in the home healthcare space. The classification covers mobility aids, monitoring devices, treatment equipment, daily living aids, and communication systems — each with specific accessibility requirements.
For product development engineers, the most actionable insight from ISO/TR 25555 is its structured compilation of existing accessibility standards. Instead of searching across dozens of documents, designers can use this technical report as a single-entry reference that cross-references the most relevant provisions from standards across medical devices, consumer products, and information technology.
4. Frequently Asked Questions
Q1: How does ISO/TR 25555 relate to existing medical device standards like IEC 60601?
A: The standard complements medical device safety standards by focusing specifically on the home healthcare context. While IEC 60601 addresses basic safety and essential performance of medical electrical equipment, ISO/TR 25555 addresses the broader usability and accessibility challenges that arise when such equipment is used by non-professionals in uncontrolled home environments.
A: The standard complements medical device safety standards by focusing specifically on the home healthcare context. While IEC 60601 addresses basic safety and essential performance of medical electrical equipment, ISO/TR 25555 addresses the broader usability and accessibility challenges that arise when such equipment is used by non-professionals in uncontrolled home environments.
Q2: Is ISO/TR 25555 applicable to smart home and IoT healthcare products?
A: Yes. Although published in 2024, the standard’s principles are technology-neutral and applicable to digital health products including telemedicine platforms, wearable sensors, and smart home monitoring systems. The accessibility and usability considerations for interfaces, alarms, and user feedback apply equally to digital and physical products.
A: Yes. Although published in 2024, the standard’s principles are technology-neutral and applicable to digital health products including telemedicine platforms, wearable sensors, and smart home monitoring systems. The accessibility and usability considerations for interfaces, alarms, and user feedback apply equally to digital and physical products.
Q3: How can manufacturers validate that their products meet the standard’s recommendations?
A: The standard recommends user-centered design processes including usability testing with representative users (older adults, caregivers with varying levels of experience), contextual inquiry in actual home environments, and iterative design based on user feedback. Reference to ISO 9241-210 (human-centered design) and IEC 62366 (usability engineering for medical devices) provides additional methodological guidance.
A: The standard recommends user-centered design processes including usability testing with representative users (older adults, caregivers with varying levels of experience), contextual inquiry in actual home environments, and iterative design based on user feedback. Reference to ISO 9241-210 (human-centered design) and IEC 62366 (usability engineering for medical devices) provides additional methodological guidance.
Q4: Does the standard differentiate between different types of care recipients?
A: Yes. The standard recognizes that care recipients have widely varying needs based on their specific conditions (e.g., mobility impairment, visual impairment, cognitive decline, chronic disease). The general considerations are designed to be inclusive of this diversity, and the annexes provide further granularity on product-specific user groups.
A: Yes. The standard recognizes that care recipients have widely varying needs based on their specific conditions (e.g., mobility impairment, visual impairment, cognitive decline, chronic disease). The general considerations are designed to be inclusive of this diversity, and the annexes provide further granularity on product-specific user groups.
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