ISO 10218:2025 robot safety and what absorbed ISO/TS 15066

Hugues Orgitello updated 7 Oct 2026 16 min read

ISO 10218-1:2025 (the robot) and ISO 10218-2:2025 (the application and the cell) were published on 5 February 2025 and are cited in the EU Official Journal since 7 September 2026. ISO 10218-2:2025 took in most of ISO/TS 15066: the collaborative requirements, the biomechanical limits (Annex M) and the measurement method (Annex N). The TS itself is still listed by ISO, flagged for revision.

TL;DR:

• ISO 10218-1:2025 (edition 3) and ISO 10218-2:2025 (edition 2) replaced the 2011 editions on 5 February 2025.
• ISO/TS 15066:2016 is not withdrawn: ISO lists it at stage 90.92 (to be revised), with ISO/AWI 15066-1 on biomechanical thresholds as its successor project.
• EN ISO 10218-1:2025 and -2:2025 are harmonised under the Machinery Directive by Decision (EU) 2026/2015; the 2011 editions remain cited until 20 January 2027.
• ISO 10218-1:2025 adds robot Class I and Class II, cybersecurity requirements and a normative table of required PL or SIL per safety function.

Industrial robots placed on the EU market are machinery within the meaning of Directive 2006/42/EC, then Regulation (EU) 2023/1230 from 20 January 2027. The safety reference is the ISO 10218 series: part 1 for the robot manufacturer, part 2 for the integrator of the robot application and cell. This guide sets out what the 2025 editions changed, where the content of ISO/TS 15066 went, the functional safety chain through ISO 13849-1 or IEC 62061, the EU harmonisation dates, the US route under ANSI/A3 R15.06-2025, mobile robots under ISO 3691-4, EMC and cybersecurity, and the readings that the texts contradict.

Dated timeline: ISO 10218, ISO/TS 15066 and the EU citations

Date	Event	Source
4 February 2016	ISO/TS 15066:2016 published (edition 1, 33 pages)	ISO Open Data
2 August 2023	Decision (EU) 2023/1586 lists EN ISO 10218-1:2011 and EN ISO 10218-2:2011 under Directive 2006/42/EC (rows 223 and 224)	OJ L 194
13 May 2024	Decision (EU) 2024/1329 adds EN ISO 3691-4:2023 and EN ISO 13849-1:2023	EUR-Lex
5 February 2025	ISO 10218-1:2025 (edition 3, 95 pages) and ISO 10218-2:2025 (edition 2, 223 pages) published	ISO Open Data
September 2025	ANSI/A3 R15.06-2025 Parts 1 and 2, US national adoption of ISO 10218-1 and -2:2025	A3, via trade press
January 2026	ANSI/A3 R15.06-3-2025, US-developed Part 3 for users of robot cells	A3, via trade press
7 September 2026	Decision (EU) 2026/2015 (of 4 September 2026) adds EN ISO 10218-1:2025 and EN ISO 10218-2:2025 as rows 223a and 224a; the 2011 rows are not withdrawn	OJ L series 2026/2015
20 January 2027	Regulation (EU) 2023/1230 applies, Directive 2006/42/EC and Decision (EU) 2023/1586 are repealed	Regulation, Decision (EU) 2026/2015 Article 2

The ISO catalogue links ISO/TS 15066:2016 to two successor projects: ISO/AWI 15066-1, Robotics, physical contact with robots, Part 1: Biomechanical thresholds and data (stage 20.00), and ISO/PWI 15066, Robotics, collaborative applications (preliminary work item).

Scope: robot, application, cell

Object	Standard	Who declares conformity in the EU
Industrial robot (manipulator and controller), addressed as an incomplete machine	ISO 10218-1:2025	Robot manufacturer, declaration of incorporation
Robot application (robot, end-effector, workpiece, task program and supporting machines)	ISO 10218-2:2025	Integrator, EU declaration of conformity
Robot cell (one or more applications with their safeguarding and spaces)	ISO 10218-2:2025	Integrator, EU declaration of conformity

The 2025 edition of part 2 moves from the 2011 notion of "robot system" to "robot application", which also takes in the workpiece, the task program and the machines that support the task. A bare robot sold without an application is supplied as partly completed machinery under Annex II 1 B of Directive 2006/42/EC (Annex V, Part B, of Regulation (EU) 2023/1230), with a declaration of incorporation and assembly instructions. The integrator who builds the cell becomes the manufacturer of the final machinery and affixes the CE marking. The EU framework is detailed in the Machinery Directive guide.

Both parts exclude underwater, law enforcement, military, airborne and space, medical and healthcare uses, prosthetics, service robots with public access, consumer products and lifting or transporting people. Part 1 states it does not apply to robots manufactured before its publication date.

What changed in 2025: a clause map

The ISO texts are paywalled. The clause references below follow the published clause-by-clause review of both editions by Hartmann et al. (VSB Technical University of Ostrava), listed in the sources.

Topic	2011 editions	2025 editions
Cybersecurity	Not addressed	Part 1 clause 5.1.16: cyber threat assessment, protected interfaces, user authentication, encrypted protocols where the threat assessment calls for them; part 2 clause 7.5.23: cybersecurity information for the user
Robot classes	None	Part 1 clause 5.1.17: Class I (manipulator mass up to 10 kg, force up to 50 N, speed up to 250 mm/s), everything else Class II; Class I test method in normative Annex E
Required PL or SIL	Default PL d, category 3	Part 1 normative Annex C, per safety function: PL d or SIL 2 for Class II, PL b or SIL 1 for Class I
Safety parameters	Not addressed	Part 1 clause 5.3.5: setting of safety parameters with checksums and identifiers; clause 5.3.6: safety communication
EMC of safety functions	General clause	Part 1 clause 5.3.7: EMC tied to ISO 13849-1:2023 or IEC 62061:2021
Motion limiting	Safety-rated soft axis and space limiting	Software and dynamic limiting (part 1, 5.7.4 and 5.7.5)
Collaborative operation	Short clause listing four methods, details in ISO/TS 15066	Part 2 clause 5.14; SSM in 5.14.5 with formulas in normative Annex L; PFL in 5.14.6
Biomechanical limits	ISO/TS 15066 Annex A	Part 2 informative Annex M
Force and pressure measurement	ISO/TS 15066	Part 2 informative Annex N, with measurement required by clause 6.3.3
End-effectors, manual load stations	Not covered	Part 2 Annexes I and J (drawn from ISO/TR 20218-1 and -2)
EU annex	General Annex ZA	Annex ZA moved to the front, with a clause-by-clause mapping to Directive 2006/42/EC

ISO 10218-1: the robot itself

ISO 10218-1 sets the requirements the robot manufacturer designs into the product: inherently safe design, protective measures and information for use. The 2025 edition restructures the safety functions (protective stop, emergency stop, monitored standstill, speed monitoring, software and dynamic limits, enabling device) and assigns their required performance in Annex C instead of a single default.

Operating modes

The standard distinguishes manual reduced speed, manual high speed and automatic modes, each with activation conditions and the functions that must be active. Reduced speed is capped at 250 mm/s, the same figure as the 2011 edition. Mode selection is restricted to authorised personnel, and the teach pendant carries an enabling device with three positions.

ISO 10218-2: the application and the cell

ISO 10218-2 addresses the integrator, who combines the robot, end-effector, workpiece, safeguarding and layout into a single machine, then performs an application-level risk assessment under ISO 12100.

Safeguarding hierarchy

1. Inherent design: layout that puts hazardous motion out of reach, limited spaces.
2. Safeguarding: fixed and movable interlocked guards per EN ISO 14120 and EN ISO 14119, light curtains and scanners per IEC 61496 (IEC 61496-3 for scanners), pressure-sensitive mats and edges.
3. Information for use: procedures, training, signage.

Safety distances

Where light curtains, scanners or mats trigger the protective stop, EN ISO 13855 governs the minimum distance between the detection zone and the hazard, computed from the approach speed and the overall stopping time. EN ISO 13855:2024 joined the EU list in Decision (EU) 2026/2015 next to the 2010 edition. A heavier end-effector lengthens the stopping time, so the distance has to be recomputed after any tool change.

Validation file

The integrator validates the cell before placing it on the market: layout with spaces and safeguarding, ISO 12100 risk assessment, list of safety functions with required and achieved PL or SIL, functional tests of each function, stopping time and distance under worst-case payload and speed, and, for PFL, force and pressure measurements per Annex N of ISO 10218-2:2025.

Collaborative operation: four methods

Method	Principle
Safety-rated monitored stop (monitored standstill in 2025 terminology)	Robot motion stops while a person is in the collaborative space and resumes when the person leaves
Hand guiding	The operator moves the robot through a guiding device with an enabling function
Speed and separation monitoring (SSM)	The robot keeps a protective separation distance from the person, slowing or stopping as the distance shrinks; formulas in ISO 10218-2:2025 Annex L
Power and force limiting (PFL)	Contact can occur, but force and pressure stay below the limits set through the risk assessment

ISO 10218-2:2025 treats collaboration as a property of the application, not of the robot. A PFL-capable robot moving a heavy or sharp tool at full speed is not a collaborative application.

PFL biomechanical limits

ISO/TS 15066 Annex A (now ISO 10218-2:2025 Annex M, still informative) gives pressure limits per body area and force limits per body region, over a body model of 29 body areas grouped into 12 regions, for two contact types:

• Quasi-static contact (clamping): the body part is trapped and cannot recoil.
• Transient contact (impact): the body part can recoil after the impact.

In the TS, transient values are derived from the quasi-static ones by a multiplier, and the skull, forehead and face carry no transient value because contact with the head is to be prevented (clause 5.5.5.3). The normative duty in the TS was clause 5.5.5.5, which required limits to be established through the risk assessment. Footnote a to Table A.2 attributes the values to a single pain-onset study at the University of Mainz and expects them to change as research advances. The 2025 text keeps the annex informative while making force and pressure measurement a validation requirement.

What Performance Level do robot safety functions need?

ISO 13849-1 rates safety-related parts of control systems by Performance Level (PL a to PL e), built from category, MTTFD, diagnostic coverage and common cause failure measures. IEC 62061 expresses the same result as a SIL (1 to 3). EN ISO 13849-1:2023 is cited in the EU since Decision (EU) 2024/1329; EN IEC 62061:2021 and its A1:2024 are cited, the amendment by Decision (EU) 2026/2015.

Under ISO 10218-1:2011 the default was PL d with category 3. Under the 2025 edition, normative Annex C sets the required performance per safety function and per robot class (PL d or SIL 2 for Class II, PL b or SIL 1 for Class I, per the review cited above). The integrator still derives the required level for application functions from the ISO 12100 risk assessment and verifies the achieved level with ISO 13849-2 or IEC 62061.

The two methods side by side are compared in the IEC 62061 and ISO 13849 guide; the underlying framework is in the IEC 61508 and SIL guide, and the automotive counterpart in the ISO 26262 guide.

See also

• Solar PV modules: IEC 61730 safety and IEC 61215 performance
• CPR (305/2011) and EN 50575 cable reaction-to-fire
• HAC: Hearing Aid Compatibility (FCC 20.19, C63.19)
• EN 50332: acoustic safety of music players + headphones

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EN ISO 10218 under the Machinery Directive and Regulation

Since 7 September 2026, EN ISO 10218-1:2025 and EN ISO 10218-2:2025 give presumption of conformity with the Annex I requirements of Directive 2006/42/EC that they cover. Decision (EU) 2026/2015 inserted them as new rows without deleting the 2011 rows, so a manufacturer can rely on either edition until 20 January 2027. On that date Article 2 of the same decision repeals Decision (EU) 2023/1586 entirely, together with the Directive.

Presumption under Regulation (EU) 2023/1230 then depends on a new implementing decision listing standards against the Regulation. As of 7 October 2026 the Commission page on machinery standards lists only decisions under the Directive. Check the OJEU list at the date of placing on the market.

Both parts are type-C standards in the ISO 12100 typology: they cover one machine category and refer to type-A (ISO 12100) and type-B standards (ISO 13849-1, IEC 62061, IEC 61496, EN ISO 13855, EN ISO 14119, EN ISO 14120, EN ISO 13850) for transversal topics.

Regulation (EU) 2023/1230 requirements that reach a robot cell

Provision	What it requires
Annex III, 1.1.6 (f) and (g)	Human-machine interface adapted to operators, including for machinery with self-evolving behaviour operating with varying autonomy
Annex III, 1.1.9	Protection against corruption: connecting another device must not create a hazard, and hardware giving access to safety-critical software must be protected and log interventions
Annex III, 1.2.1 (a)	Control systems withstand reasonably foreseeable malicious attempts from third parties leading to a hazardous situation
Annex III, 1.2.1 (d)	Limits of safety functions set in the risk assessment, no modification of settings that could lead to hazards, including during a learning phase
Annex III, 1.3.7	Contact risks and psychological stress addressed for human-machine coexistence in a shared space and for human-machine interaction
Annex I, Part A, points 5 and 6	Safety components, and embedded systems, with self-evolving behaviour using machine learning that ensure safety functions
Article 25(2)	For Part A categories: EU type-examination (B+C), full quality assurance (H) or unit verification (G), no module A

A robot whose safety functions use conventional, non-learning software is not in Annex I, Part A on that ground: recital 55 limits third-party assessment to systems with self-evolving behaviour using machine learning.

US route: ANSI/A3 R15.06-2025

In the United States, ANSI/A3 R15.06-2025 replaced ANSI/RIA R15.06-2012. Parts 1 and 2 are the national adoption of ISO 10218-1:2025 and ISO 10218-2:2025; Part 3 (ANSI/A3 R15.06-3-2025), for users of robot cells, was developed in the United States and published by A3 in January 2026. A3 describes the 2025 edition as consolidating the ISO/TS 15066 guidance, which the earlier US technical report RIA TR R15.606-2016 had adopted.

Aspect	EU	US
Legal status	Harmonised standard, presumption of conformity	Voluntary consensus standard
Robot and cell	EN ISO 10218-1 and -2:2025 (2011 still cited until 20 January 2027)	ANSI/A3 R15.06-2025 Parts 1 and 2
User requirements	Not in ISO 10218; workplace law of each Member State	ANSI/A3 R15.06-3-2025
Mobile robots	EN ISO 3691-4:2023	ANSI/A3 R15.08 series

Mobile robots and mobile manipulators

Both parts of ISO 10218:2025 exclude the hazards of mobility when a robot or manipulator is fixed to or integrated with a driverless industrial truck or a mobile platform.

Standard	Scope	Status
ISO 3691-4:2023	Driverless industrial trucks and their systems	Edition 2, cited in the EU by Decision (EU) 2024/1329; a third edition is at DIS stage at ISO
ANSI/A3 R15.08	Industrial mobile robots, US	Multi-part series (robot, integration, users)

For a mobile manipulator, the integrator applies ISO 10218 for the arm and ISO 3691-4 (or R15.08 in the US) for the platform, with one risk assessment under ISO 12100 that covers arm and platform moving together.

EMC and cybersecurity

EMC

Industrial robots fall under the EMC Directive 2014/30/EU, typically assessed against EN IEC 61000-6-2 (immunity) and EN IEC 61000-6-4 (emission) for industrial environments. These generic standards check that the equipment keeps working; they do not demonstrate that a safety function stays safe under disturbance. ISO 10218-1:2025 addresses that separately by tying EMC of safety functions to ISO 13849-1:2023 or IEC 62061:2021. See the EMC Directive guide and the CE versus FCC EMC guide.

Cybersecurity

ISO 10218-1:2025 now requires a cyber threat assessment and protection of interfaces, and ISO 10218-2:2025 requires cybersecurity information for the user. For the method, the IEC 62443 series structures requirements by role: 62443-2-1 and 2-4 for operator and service provider programmes, 62443-3-3 for system requirements and security levels, 62443-4-1 and 4-2 for product development and components (see the IEC 62443 guide).

From 20 January 2027, Regulation (EU) 2023/1230 Annex III sections 1.1.9 and 1.2.1 apply. The Cyber Resilience Act, Regulation (EU) 2024/2847, applies its reporting obligations from 11 September 2026 and in full from 11 December 2027. For robots with a radio module, the Radio Equipment Directive 2014/53/EU applies, with Article 3(3)(d), (e) and (f) in force since 1 August 2025.

Risk assessment under ISO 12100

The integrator follows the three steps of ISO 12100, also covered in the Machinery Directive guide:

1. Hazard identification for every lifecycle phase (commissioning, operation, teaching, fault clearance, cleaning, maintenance, dismantling).
2. Risk estimation: severity, frequency and duration of exposure, possibility of avoiding harm.
3. Risk evaluation and reduction by the design hierarchy, then re-estimation.

For each safety function, the risk graph of ISO 13849-1 Annex A maps severity, exposure and avoidance onto a required PL; ISO 13849-2 covers validation.

End-of-arm tooling: a recurring blind spot

The end-effector is chosen and integrated by the system builder, and ISO 10218-2:2025 now covers it in Annex I. A tool change affects:

• Mass and inertia: stopping time, therefore safety distances.
• Geometry: contact area, therefore pressure for a given force in PFL.
• Sharp or hot surfaces: hazards outside the original contact assessment.
• Energised tooling (electric, pneumatic, hydraulic): pinching, ejection, heat in the collaborative space.

A change-management procedure that triggers partial re-validation on every tool change, and tool versions recorded in the technical file, are the practical mitigation.

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Common pitfalls

Pitfall	Consequence	Mitigation
PFL force and pressure not measured under worst-case payload	Limits exceeded in production	Measure per ISO 10218-2:2025 Annex N at maximum payload and speed
Tool change after commissioning without re-assessment	Previously valid PFL analysis no longer holds	Partial re-validation on every tool change
Safety distance computed without the loaded stopping time	Person reaches the hazard before the robot stops	Measure stopping time with the real tool, recompute per EN ISO 13855
Safety parameters changed without a record	Achieved PL or SIL no longer demonstrated	Use the checksum and identifier mechanisms of the controller, repeat validation tests
Fenceless cell relying on procedures alone	Risk reduction hierarchy not respected	Add SSM, PFL or protective devices, redo the risk assessment
Conveyor interface ignored	Trapping or shearing at the cell boundary	Apply EN 619 for the conveyor side within the cell risk assessment
Arm and platform motion assessed separately	Combined motion defeats both sets of safety functions	One ISO 12100 assessment for the mobile manipulator
Declaration of conformity planned on a 2011 edition after 20 January 2027	Directive list repealed, presumption only through the Regulation list	Check the Regulation list at the date of placing on the market

Claims the texts contradict

Common claim (including earlier versions of this page)	What the texts say
"ISO/TS 15066 was withdrawn when ISO 10218:2025 came out"	ISO still lists ISO/TS 15066:2016 as published at stage 90.92, to be revised; successor projects are ISO/AWI 15066-1 and ISO/PWI 15066
"ISO/TS 15066 Annex A is still where the biomechanical tables live"	ISO 10218-2:2025 carries them as informative Annex M, with the measurement method in Annex N
"Citing the 2011 edition after the 2025 OJ update loses presumption"	Decision (EU) 2026/2015 added the 2025 rows without withdrawing the 2011 rows; both stand until 20 January 2027
"The EN adoption of ISO 10218:2025 is still expected"	EN ISO 10218-1:2025 and -2:2025 exist and are cited since 7 September 2026
"ISO 10218-1 calls for PL d category 3"	That was the 2011 default; the 2025 edition sets performance per function and per robot class in Annex C
"In the US the reference is ANSI/RIA R15.06-2012"	Replaced by ANSI/A3 R15.06-2025, with a new Part 3 for users
"ISO 3691-4 replaced EN 1525 in the EU"	Neither Decision (EU) 2023/1586 nor its amendments list EN 1525; EN ISO 3691-4:2023 was added by Decision (EU) 2024/1329
"Industrial robots using AI fall into the high-risk annex"	Only safety components or embedded systems with self-evolving machine learning behaviour that ensure safety functions (Annex I, Part A, points 5 and 6)
"EN 61326-3-1 is the EMC standard for robot safety I/O"	EN 61326-3-1 is written for measurement, control and laboratory equipment; ISO 10218-1:2025 ties EMC of safety functions to ISO 13849-1 or IEC 62061

The spilma glossary defines the key terms (cobot, PFL, SSM, hand guiding, PLr, SIL, partly completed machinery, declaration of incorporation).

Going further

• Machinery Directive 2006/42/EC and Regulation (EU) 2023/1230: the EU CE marking framework into which ISO 10218 fits.
• Decision (EU) 2026/2015: the September 2026 machinery standards update: the decision that cited EN ISO 10218-1 and -2:2025.
• IEC 62061 and ISO 13849: the two functional safety methods for machinery.
• IEC 61508 and SIL: the foundational functional safety framework behind ISO 13849-1 and IEC 62061.
• ISO 26262 automotive functional safety: the neighbouring sector application.
• IEC 61010 laboratory and measurement equipment safety: the safety standard for lab and measurement equipment that often surrounds a robotic cell.
• IEC 62443 industrial cybersecurity: the method behind the cybersecurity clauses.
• Cyber Resilience Act: horizontal cybersecurity baseline for connected robots.
• EMC Directive 2014/30/EU and CE versus FCC EMC: EMC for a robot placed on the EU and US markets.

Sources

Sources & references

1. ISO 10218-1:2025, Robotics, safety requirements, part 1, industrial robots, ISO www.iso.org/standard/73933.html
2. ISO 10218-2:2025, Robotics, safety requirements, part 2, industrial robot applications and robot cells, ISO www.iso.org/standard/73934.html
3. ISO/TS 15066:2016, Robots and robotic devices, collaborative robots (stage 90.92, to be revised), ISO www.iso.org/standard/62996.html
4. ISO/AWI 15066-1, Robotics, physical contact with robots, part 1, biomechanical thresholds and data, ISO www.iso.org/standard/91522.html
5. ISO Open Data, deliverables metadata (publication dates, editions, stages, replaced-by links), ISO www.iso.org/open-data.html
6. Commission Implementing Decision (EU) 2026/2015 citing EN ISO 10218-1:2025 and EN ISO 10218-2:2025, EUR-Lex eur-lex.europa.eu/eli/dec_impl/2026/2015/oj
7. Commission Implementing Decision (EU) 2023/1586, harmonised standards for machinery, EUR-Lex eur-lex.europa.eu/eli/dec_impl/2023/1586/oj
8. Commission Implementing Decision (EU) 2024/1329 citing EN ISO 3691-4:2023 and EN ISO 13849-1:2023, EUR-Lex eur-lex.europa.eu/eli/dec_impl/2024/1329/oj
9. Regulation (EU) 2023/1230 on machinery, EUR-Lex eur-lex.europa.eu/eli/reg/2023/1230/oj
10. Harmonised standards for machinery, list of implementing decisions, European Commission single-market-economy.ec.europa.eu/single-market/goods/european-standards/harmonised-standards/machinery-md_en
11. Hartmann et al., Comparative analysis of ISO 10218-1/2 (2011 vs 2025) and integration of ISO/TS 15066 (secondary, preprint), arXiv arxiv.org/abs/2602.17822
12. A3 publishes ANSI/A3 R15.06-2025 (secondary, trade press report of the A3 announcement), Robotics 24/7 www.robotics247.com/article/a3_publishes_ansi_a3_r15.06_2025_american_national_standard_for_industrial_robots_and_robot_systems_safety_requirements
13. A3 releases Part 3 of ANSI/A3 R15.06-2025 (secondary, trade press report), Robotics 24/7 www.robotics247.com/article/a3-releases-part-3-of-ansi-a3-r15.06-2025-robot-safety-standard
14. ISO 12100:2010, Safety of machinery, general principles for design, ISO www.iso.org/standard/51528.html
15. ISO 13849-1:2023, Safety-related parts of control systems, ISO www.iso.org/standard/73481.html
16. IEC 62061:2021, Functional safety of safety-related control systems, IEC webstore.iec.ch/publication/59927
17. ISO 3691-4:2023, Industrial trucks, driverless industrial trucks and their systems, ISO www.iso.org/standard/83545.html