PTENES
MODULE 1.3

📋 ISO 10218:2025 — The New Era of HRC Safety

The first revision since 2011 rewrites the foundation of industrial robotics standards. The concept of a “collaborative robot” as a category disappears, TS 15066 is absorbed, cybersecurity becomes a physical safety requirement, and the Class I / Class II classification is introduced. Understanding this standard is the dividing line between installing safely and facing legal action.

6
Topics
50
Minutes
Basic
Level
Theory
Type
Risk Analysis by application 1 · Monitored Stop (SMS) 2 · Manual Guided (HG) 3 · Speed and Separation (SSM) 4 · Power and Force (PFL) Operation collaborative

Illustrative diagram: the standard does not certify the robot; it certifies the application. The 4 modes derive from a single risk assessment.

Detailed content

1

📅 First Revision Since 2011

A ISO 10218:2025 replaces the 2011 version and is the first revision in 14 years. During that time, industrial robotics changed in nature: cobots, AMRs, embedded AI, and cyberattacks on the factory floor arrived. Published in Q1 2025, the standard incorporates all of this and redefines what it means to "work alongside a robot."

2011

ISO 10218:2011 — Parts 1 and 2

The era of the caged robot

An industrial robot is a dangerous machine that operates behind fences. Human-robot collaboration was the exception, not the rule. Cobots were still in the lab.

2016

ISO/TS 15066 — Technical Specification

Force and pressure limits

A separate document that defined biomechanical force and pressure limits for collaboration. It was the reference, but it did not have full standards status.

2025

ISO 10218:2025 — The consolidation

The era of collaborative operations

Incorporates TS 15066, eliminates "cobot" as a category, integrates cybersecurity, and creates Class I / Class II. A 3-year transition period to revalidate existing installations.

📊 Why this matters now

  • 14 years - time between the two revisions of the standard
  • 3 years - transition period to revalidate installations
  • Q1 2025 - official publication of the new version
  • Shortage - robotic safety professionals are rare and in high demand

Key concepts

2025 review

Replaces the 2011 version

TS 15066

Incorporated into the standard

"Cobot" eliminated

Stops being a category

3-year transition

Revalidation deadline

2

🚫 “Collaborative robot” eliminated as a category

The standard's most profound change is conceptual: there is no longer such a thing as a "collaborative robot" as a type of robot. Any robot can operate collaboratively, as long as the application meet the safety requirements. Risk analysis shifts its focus from the machine to its actual use.

🎯 The paradigm shift

The question has changed. Before: “Is this robot collaborative?” Now: “Does this application operate safely and collaboratively?”

  • •The focus shifts away from the equipment and toward task, layout, and interaction.
  • •A “heavy” robot can run in collaborative mode if the application limits speed and force.
  • •A “lightweight” cobot can be dangerous if the tool at its tip can cut or puncture.

✗ Old logic (2011)

  • ✗"Collaborative robot" as a product category
  • ✗Risk assessment focused on the machine
  • ✗Buying the cobot already took care of "safety"
  • ✗Marketing sold “safe robot by design”

✓ New logic (2025)

  • ✓"Collaborative operation" as a mode of use
  • ✓Risk assessment for the complete application
  • ✓Safety depends on the robot + tool + task + environment
  • ✓Shared integrator/employer responsibility

💡 Practical Tip

When a vendor says “this is a collaborative robot, so it’s already safe,” correct them mentally: no robot is safe on its own. What is (or isn’t) safe is the application. Always ask for the cell’s risk assessment, not the arm’s datasheet.

Key concepts

Collaborative operation

Mode, not type of robot

Risk per application

Assesses use, not the machine

Tools matter

The end effector changes the risk

Class I vs II

New classification of systems

3

📐 ISO/TS 15066 absorbed — PFL and SSM integrated

O Technical Specification 15066 — which defined force and pressure limits for collaboration — ceased to be a separate document and was absorbed by ISO 10218:2025. As a result, the four collaborative modes gain full regulatory requirements, more rigorous and integrated. PFL and SSM, in particular, now have verifiable and auditable limits.

1 · SMS — Safety-rated Monitored Stop

The robot stops when a human enters the collaborative zone and resumes only when they leave. A safety-rated stop, not a power shutdown.

2 · HG — Hand Guiding

The operator physically guides the robot, hand over hand, using a guiding device with a safety function. Used for teach-in and assisted movement.

3 · SSM — Speed and Separation Monitoring

Sensors maintain a minimum safe distance; the robot slows down as the human approaches and stops if the separation falls below the limit.

4 · PFL — Power and Force Limiting

Human contact is permitted, but force and pressure stay below the biomechanical limits of the former TS 15066. This mode depends most on the robot hardware.

📏 TS 15066 (PFL) legacy

Biomechanical limits by body region remain a normative reference within ISO 10218:2025:

body_region    pressure_limit   force_limit
face / skull   not allowed    not allowed
hands / fingers     more restrictive  low
torso / abdomen intermediate   intermediate
legs / thighs   more permissive  higher

Illustrative table of the PFL logic — exact values by region are specified in the standard. Each region has its own pressure/force pair.

💡 Practical Tip

A cell can combine modes over time: SSM while the robot works alone, transitioning to PFL or SMS when a human enters. Documenting this transition in the risk assessment is where most audits find gaps.

Key concepts

SMS

Monitored stop

Hand Guiding

Manual operation

SSM

Speed and separation

PFL

Limited power and force

4

🔒 Cybersecurity = Physical Safety

For the first time, cybersecurity becomes a physical safety requirement into a robotics standard. The logic is straightforward: an attack that changes the force parameters of a cobot, or disables a separation sensor, is no longer an “IT problem” and becomes an risk of injury. Safety and security converge.

🚨 Compliance and risk alert

A network-connected cobot with remotely accessible force parameters is, under ISO 10218:2025, a physical security vulnerability. If an attacker raises the force limits, the robot stops being PFL-safe without any operator noticing.

  • ⚠Safety-rated parameters should never be writable without strong authentication.
  • ⚠The cell's OT network must be segmented from the corporate (IT) network.
  • ⚠Parameter change logs become legal evidence in the event of an accident.

🔗 IT / OT convergence

Two worlds that used to be separate now intersect within the same robotic cell:

  • •IT (Information Technology): networks, authentication, encryption, patch management.
  • •OT (Operational Technology): PLCs, robot controllers, safety sensors.
  • •Defense-in-depth: multiple layers — network segmentation, access control, monitoring.
  • •IEC 62443: industrial cybersecurity standard used as a complementary reference.

🧩 What Changes for the Professional

  • New competency - robotic safety professionals now need to understand cyber.
  • IEC 62443 - complementary reference for the industrial security layer.
  • Attacks on safety-rated parameters - they become documented physical risk vectors.

Key concepts

IT/OT convergence

Networks and the factory floor

Safety-rated

Protected parameters

Defense-in-depth

Multiple layers

IEC 62443

Industrial cyber reference

5

⚙️ Class I vs Class II

The standard establishes a new classification for robotic systems. Class I are systems with safety functions inherent (force sensors, built-in speed limits). Class II are systems that depend on external protective devices to be safe. Getting the class wrong means applying the wrong requirements — and being held responsible for it.

Class I — Built-in safety

  • ✓Safety functions inherent to the system
  • ✓Integrated force sensors and speed limits
  • ✓Less reliance on external protection
  • ✓Risk assessment focused on the system configuration

Class II — Add-on safety

  • •Depends on external protective devices
  • •Fences, area scanners, light curtains
  • •Greater integration complexity and cost
  • •Risk assessment focused on additional devices

💡 Practical Tip

The class changes the cost. A Class II system requires fences, scanners, and light curtains — all of which weigh on the integration budget. Classifying too low exposes the worker; classifying too high adds unnecessary cost. The correct class comes from the risk assessment, not intuition.

⚖️ Legal risk

Misclassifying can mean inadequate compliance. In the event of an accident, the classification recorded in the safety project is the first document that experts and authorities examine. A Class II cell treated as Class I is documented negligence.

Key concepts

Class I

Inherent safety

Class II

External Protection

Integration cost

Class II costs more

Correct class

Falls outside the risk assessment

6

🔄 Impact on Revalidation — Existing Cobots

Cobots installed under the ISO 10218:2011 need to be revalidated against the new standard within the transition period of 3 years. Keeping the old certificate isn’t enough. Each existing cell becomes a gap analysis project—and that’s exactly where massive demand for safety assessment professionals emerges.

1

Cell inventory

What Exists Today Under the 2011 Standard

Map all robotic installations certified under the old version and their commissioning dates.

2

Gap analysis against the new standard

Where the cell falls short of 2025

Compare the current configuration with Class I/II, updated collaborative modes, and cybersecurity requirements.

3

Risk assessment revalidation

Estimated cost: EUR 5-15k per cell

Update the risk assessment, address gaps, and reissue the compliance documentation within 3 years.

📈 The market opportunity

  • EUR 5-15k - Estimated revalidation cost per cell
  • 3 years - window in which the entire installed base needs to be reassessed
  • Immediate demand - Each existing cell generates a safety assessment project
  • Labor shortage - those who master the new standard enter a hot market

Key concepts

3-year transition

Revalidation deadline

Gap analysis

2011 vs. 2025

EUR 5-15k

Cost per cell

Job market

Immediate demand

✅ Module Summary

✓
First revision since 2011 - ISO 10218:2025 incorporates 14 years of evolution and TS 15066, with a 3-year transition period.
✓
"Collaborative robot" eliminated - Collaborative operation is possible; risk assessment shifts from the machine to the application.
✓
4 collaborative modes - SMS, Hand Guiding, SSM, and PFL, now with integrated regulatory requirements.
✓
Cybersecurity = physical safety - IT/OT convergence and IEC 62443 as a complementary reference.
✓
Class I vs Class II - built-in vs. add-on safety; the class defines requirements, cost, and legal risk.
✓
Mandatory revalidation - Each existing cell becomes a gap analysis project (EUR 5-15k), generating immediate demand.

Next Module:

1.4 - 🧠 The Psychology of Resistance: Why Humans Reject Robots