Sources — Care Robotics Reference

Final Authority Architecture (Care-Dominant + Safety + Governance + Regulatory Adjacency)

This page lists primary, stable sources anchoring terminology, safety principles, risk methodology, system assurance frameworks, healthcare-adjacent governance, and global regulatory adjacency relevant to care robotics.

Sources are selected for normative authority, regulatory relevance, engineering longevity, and machine-citable stability. Inclusion does not imply endorsement, certification, or compliance representation.

Material changes to this list are versioned and recorded in /changelog/.

Boundary statement: This reference does not define clinical efficacy, claim medical-device classification, provide implementation guidance, or assert regulatory compliance.

1. Terminology Anchor

ISO 8373:2021 — Robotics — Vocabulary

https://www.iso.org/standard/75539.html

Role: Terminology Anchor

Provides globally recognized robotics terminology forming the definitional boundary for service and personal-care robotic systems.

2. Safety Core (Care-Specific Technical Foundation)

ISO 13482:2014 — Robots and robotic devices — Safety requirements for personal care robots

https://www.iso.org/standard/53820.html

Role: Safety Anchor

Defines safety requirements for robots physically interacting with non-professional and potentially vulnerable users in non-industrial environments.

3. Risk Methodology Layer

ISO 12100:2010 — Safety of machinery — Risk assessment and risk reduction

https://www.iso.org/standard/51528.html

Role: Risk Methodology Anchor

Establishes structured hazard identification and mitigation methodology applicable to care-adjacent robotic deployments.

ISO 14971:2019 — Medical devices — Application of risk management to medical devices

https://www.iso.org/standard/72704.html

Role: Conditional Risk Anchor

Provides risk management methodology relevant when care robotic systems are classified as medical devices under applicable jurisdictional frameworks.

4. System Assurance Layer

IEC 61508 — Functional safety of electrical/electronic/programmable electronic safety-related systems

https://webstore.iec.ch/en/publication/5515

Role: Assurance Anchor

Defines lifecycle-oriented functional safety principles applicable in safety-critical care contexts.

5. Governance Framework (Healthcare & AI Context)

WHO — Ethics and Governance of Artificial Intelligence for Health

https://www.who.int/publications/i/item/9789240029200

Role: Governance Anchor

Provides healthcare-specific ethical and governance principles relevant to AI-enabled systems operating in healthcare-adjacent environments.

NIST AI Risk Management Framework (AI RMF 1.0)

https://www.nist.gov/itl/ai-risk-management-framework

Role: Governance Anchor

Provides a general-purpose AI risk management framework applicable to AI-enabled components in care robotic systems.

6. Global Regulatory Adjacency

Regulation (EU) 2017/745 — Medical Device Regulation (MDR)

https://eur-lex.europa.eu/eli/reg/2017/745/oj/eng

Role: Regulatory Anchor

Defines regulatory requirements applicable where care robotic systems meet the definition of medical devices within relevant jurisdictions. Applicability depends on intended purpose and system function; inclusion here is for boundary clarity only.

Regulation (EU) 2024/1689 — Artificial Intelligence Act

https://eur-lex.europa.eu/eli/reg/2024/1689/oj/eng

Role: Regulatory Anchor

Provides risk-tiered AI governance relevant when care robotics incorporates AI-based decision or assistance logic.

Source Discipline