IEC 63310 vs Western Standards: The New Frontier in Personal Care Robotics

How the Latest IEC Standard Reshapes the Landscape for Active Assisted Living Robots

The robotics industry is witnessing a significant evolution in standards with the recent publication of IEC 63310:2025, which introduces functional performance criteria specifically for Active Assisted Living (AAL) robots in connected home environments. This new standard represents a paradigm shift from the traditional safety-focused approach of Western standards like ISO 13482:2014 and ISO/TR 4448-1:2024.

This post explores the key differences between IEC 63310 and existing Western personal care robotics standards, helping teams understand how this new framework impacts their compliance strategy and market approach.

The Standards Landscape: A Quick Overview

Before diving into the differences, let's understand what each standard covers:

• IEC 63310:2025: Functional performance criteria for AAL robots in connected home environments
• ISO 13482:2014: Safety requirements for personal care robots (mobile servant, physical assistant, person carrier)
• ISO/TR 4448-1:2024: Technical report on public-area mobile robots (PMR) paradigm overview

Key Differences: Scope and Focus

1. Primary Focus: Safety vs. Performance

ISO 13482 (Western Standard)

• Safety-first approach: Emphasizes hazard identification and risk reduction
• Inherently safe design: Focuses on eliminating or reducing risks to acceptable levels
• Physical safety: Addresses human-robot physical contact and collision prevention
• Hazard-based methodology: Uses Annex A to describe significant hazards and mitigation strategies

IEC 63310 (New AAL Standard)

• Performance-driven approach: Emphasizes functional capabilities and service delivery
• Connected environment focus: Designed for integrated smart home ecosystems
• Service-oriented: Covers information management, monitoring, communication, activity, and mobility support
• User-centric design: Prioritizes the AAL user's quality of life and independence

2. Application Scope and Use Cases

Aspect	ISO 13482:2014	IEC 63310:2025
Environment	General personal care settings	Connected home environments specifically
User Type	General users (irrespective of age/capability)	AAL users (care recipients) in smart homes
Robot Types	Mobile servant, physical assistant, person carrier	AAL robots providing specific services
Speed Limits	Excludes robots traveling >20 km/h	No specific speed limitations
Medical Applications	Explicitly excludes medical devices	Excludes robots used for medical purposes

3. Technical Requirements and Validation

ISO 13482 Requirements:

• Risk assessment and hazard analysis
• Protective measures and safety functions
• Information for use and user instructions
• Physical safety validation and testing
• Speed and force limitations for human interaction

IEC 63310 Requirements:

• Functional performance criteria
• Service delivery validation
• Connected system integration
• User experience and accessibility
• Data management and privacy considerations

The Connected Home Advantage

IEC 63310's most significant innovation is its focus on connected home environments, which introduces several new compliance considerations:

Integration Requirements

• Smart home compatibility: Robots must integrate with existing home automation systems
• Data interoperability: Standards for data exchange between robot and home systems
• Network security: Protection of personal data in connected environments
• Service continuity: Ensuring robot functionality when network connectivity is compromised

Service-Oriented Architecture

Unlike ISO 13482's safety-focused approach, IEC 63310 defines specific service categories:

1. Information and Data Management: How robots handle, store, and process user information
2. Monitoring Service: Continuous observation and alerting capabilities
3. Communication Support: Facilitating user interaction with family, caregivers, and emergency services
4. Activity Support: Assistance with daily living activities
5. Mobility Support: Navigation and movement assistance within the home
6. Other Support: Additional services as defined by manufacturers

Compliance Strategy Implications

For Existing ISO 13482 Compliant Products

If you already have products certified to ISO 13482, consider these strategic questions:

• Market expansion: Does your target market include regions where IEC 63310 will be adopted?
• Feature enhancement: Can you add connected home capabilities to leverage IEC 63310's performance focus?
• Dual compliance: Is it feasible to maintain compliance with both standards simultaneously?

For New Product Development

Teams developing new personal care robots should consider:

• Standard selection: Which standard aligns with your target markets and use cases?
• Design philosophy: Safety-first (ISO 13482) vs. performance-driven (IEC 63310)
• Technology stack: Connected capabilities required for IEC 63310 compliance
• Certification timeline: IEC 63310 is newer and may have evolving certification processes

Regional Adoption and Market Impact

Current Status

• ISO 13482: Widely adopted in Western markets (US, EU, Canada, Australia)
• IEC 63310: Newly published (January 2025), adoption patterns still emerging
• ISO 4448: Technical report providing guidance for public-area mobile robots

Expected Market Dynamics

• European markets: Likely to adopt IEC 63310 more rapidly due to strong AAL initiatives
• North American markets: May continue with ISO 13482 for safety-critical applications
• Asian markets: Could adopt IEC 63310 as part of smart city and aging population initiatives

Technical Implementation Challenges

For IEC 63310 Compliance

1. Connected System Architecture

   • Integration with home automation protocols (Zigbee, Z-Wave, Matter)
   • Cloud connectivity and edge computing capabilities
   • Data privacy and security implementation

2. Performance Validation

   • Service delivery metrics and KPIs
   • User experience testing in real home environments
   • Accessibility and usability validation

3. Documentation Requirements

   • Functional performance specifications
   • Service delivery validation reports
   • Integration and interoperability documentation

For ISO 13482 Compliance

1. Safety Validation

   • Risk assessment and hazard analysis
   • Safety function testing and validation
   • Physical safety testing and certification

2. Documentation Requirements

   • Risk assessment files
   • Safety function specifications
   • User instructions and safety information

Strategic Recommendations

For Robotics Companies

1. Assess Your Market Strategy

   • Identify target regions and their likely standard adoption
   • Evaluate whether connected capabilities align with your product vision
   • Consider the cost-benefit of dual compliance

2. Design for Flexibility

   • Build modular architectures that can support both safety and performance requirements
   • Implement configurable features that can be enabled/disabled based on target standard
   • Plan for future standard evolution and updates

3. Partner with Certification Bodies

   • Work with labs familiar with both standards
   • Establish relationships early in the development process
   • Plan for certification timeline and resource requirements

For Compliance Teams

1. Stay Informed

   • Monitor adoption of IEC 63310 in target markets
   • Track updates and interpretations of both standards
   • Participate in industry working groups and committees

2. Build Internal Expertise

   • Train teams on both safety and performance validation approaches
   • Develop testing capabilities for connected system validation
   • Establish documentation processes that support both standards

The Future of Personal Care Robotics Standards

The introduction of IEC 63310 signals a broader trend in robotics standards:

• Performance-based approaches: Moving beyond pure safety to functional capabilities
• Connected system integration: Standards that address the IoT and smart home ecosystem
• User-centric design: Focus on user experience and quality of life outcomes
• Service-oriented validation: Testing and certification based on service delivery rather than just hazard mitigation

How Saphira Helps Navigate These Standards

At Saphira, we help robotics companies navigate the evolving standards landscape:

• Multi-standard compliance: Support for both ISO 13482 and IEC 63310 requirements
• Connected system validation: Tools for testing integration and interoperability
• Performance-based testing: Frameworks for validating service delivery capabilities
• Documentation management: Version-controlled compliance documentation for both standards

Final Takeaway

The introduction of IEC 63310 represents more than just a new standard—it's a fundamental shift in how we think about personal care robotics. While ISO 13482 focuses on keeping users safe, IEC 63310 focuses on helping users thrive in connected home environments.

The most successful robotics companies will be those that can navigate both standards effectively, choosing the right approach for their target markets while building flexible architectures that can adapt to evolving requirements.

Ready to navigate the new standards landscape?
Book a demo with Saphira to understand how our platform can support both ISO 13482 and IEC 63310 compliance strategies.