ISO 10218 series on industrial robot safety (2025 editions)

Compare each existing robot model clause by clause against the 2011 and 2025 requirements, list the clauses requiring redesign, revalidation or documentation updates only, and produce a migration plan and schedule. For models already sold abroad, define the cut-off between continuing to declare against the 2011 edition and upgrading to the 2025 edition, and state the standard edition and year consistently in customer specifications and tender documents.

Applies when

Manufacturers of industrial robots and cobots and suppliers of robot safety components.

Evidence to retain

• · Clause-level gap analysis between the 2011 and 2025 editions
• · Migration plan with owners, milestones and the list of affected models
• · Revalidation test plan and results
• · Agreed wording for the standard edition cited in external specifications and tenders

Estimated first-time effort: 15–45 person-days (estimate, not a commitment)

Robot conformity is not application conformity: under ISO 10218-2 the specific application and robot cell — end-effector, workpiece, peripheral equipment, guarding and safety devices, and human access routes — must be risk assessed at integration level, safeguarding measures and the collaborative operation mode must be determined, and every use restriction listed by the robot manufacturer in its declaration of incorporation must be implemented or substituted.

Applies when

Chinese robot companies performing integration abroad and their local integration partners; turnkey line suppliers carry the highest exposure.

Evidence to retain

• · Robot cell integration risk assessment report with layout drawings and human access analysis
• · Safety function inventory with performance level (PL/SIL) justification
• · Item-by-item record showing how the robot declaration of incorporation restrictions were implemented
• · Rationale for the collaborative operation mode chosen and the speed, separation or force limit parameters used

Estimated first-time effort: 10–30 person-days (estimate, not a commitment)

ISO 10218-1 does not apply to underwater, law-enforcement, military (defence), airborne or space robots, nor to medical robots, healthcare robots, prosthetics and other aids for the physically impaired, service robots, consumer products, or equipment lifting or transporting people. Before claiming ISO 10218 conformity externally, verify the product falls inside the scope, avoid unsustainable conformity claims for embodied-AI service, delivery or companion robots, and define a separate standards and safety-argument route for those categories.

Applies when

Companies selling both industrial robots and service or embodied-AI robots, and the marketing and pre-sales teams citing standards in collateral and tenders.

Evidence to retain

• · Mapping of product categories to standard scope
• · Review record (legal/compliance sign-off) for external conformity claims
• · Alternative standards and safety-argument route documented for out-of-scope categories

Estimated first-time effort: 2–6 person-days (estimate, not a commitment)