MITSUBISHI ELECTRIC Changes for the Better

Changes to ISO 10218 – How to avoid getting into trouble with safety?

03.11.20257 minut branja

In recent years, industrial robots have achieved unprecedented speed, precision and advanced control capabilities. Along with this development, the forces and torques they can generate are also increasing, which directly affects operator safety. It is this progress that has forced changes in standards to better reflect the current capabilities of robots and provide effective protection for the people working with them. The new regulations also aim to provide automation system integrators with clear guidelines for the implementation of modern solutions.

Below we publish a commentary by Jacek Taczała, FA Product Manager Industrial Robots at Mitsubishi Electric, on key changes in the ISO 10218 standard.

The new version of ISO 10218 is not only an update of the document, but also a new approach to industrial robot safety. In this article, I share my perspective and suggest what to look out for to ensure that your applications comply with the new safety requirements.

The previous version of the standard had been in force since 2011. After 14 years, we now have a new update that introduces a number of significant changes.

New division of robots

Robot Class Mass  Max F [N] Max V [mm/s]
Class I≤10≤50≤250
Class II >10>50>250

Class I robots are considered less risky, while class II robots pose a potentially higher risk.

Key conclusions:
  • The classification applies to design parameters, not the application itself.
  • Even a Class I robot can be dangerous in poor working conditions.
  • For Class I, safety measures may be simplified if the application is indeed low risk.

Where can Class I robots actually be used?

The standard itself indicates that when implementing a Class I robot, less stringent safety measures can be expected, but only on condition that the entire application remains completely safe for users. This means that despite the simplification of requirements, the emphasis on operator protection remains a priority.

Class I robots pose a challenge not only for manufacturers and system integrators, but also for end users. This is a new opportunity that allows manipulators to be used in additional processes – where previously devices not classified as robots were used.

Possible applications for Class I robots will be in:

  • Pharmaceutical and laboratory industry
    Handling test tubes, plates, pipettes or vials – light details and low operating speeds translate into greater safety. Examples include dispensing, mixing or placing samples in incubators.
  • Electronics and precision assembly
    Assembly of SMD components, testing of PCBs, placement of small components. Limited speed (up to 250 mm/s) is sufficient for many assembly and inspection operations.
  • Quality control and sorting of light products
    Visual inspection of details using a camera in combination with a robot, or sorting of lightweight components.
  • Educational and R&D applications
    Teaching robots at universities and training centres – limited energy and force ensure a higher level of safety during training.
  • Light logistics and warehouses
    Pick & place applications for cosmetics packaging.

However, it is worth noting that limitations in terms of strength and speed clearly indicate that Class I robots will not be used in a large number of processes in industries such as automotive (and I do not mean only OEMs but also TIER subcontractors), metallurgy or furniture manufacturing. However, they can be an alternative to simple pneumatic manipulators where greater flexibility is required.

Functional safety

The change I focused on in particular was functional safety. In the world of robotics, where we strive to have industrial robots work closely with people, we will take into account safety functions such as SLP, SLS, SS1 and SS2. The latest ISO 10218-1:2025 and ISO 10218-2:2025 standards introduce clear, measurable guidelines that are of great importance, especially in collaborative applications where humans and robots work side by side.

ISO 10218-1 and ISO 10218-2 – what is what?

  • ISO 10218-1 focuses on the safety of the robot itself as a device – i.e. what safety functions the manufacturer must provide in the hardware and software standard.
  • ISO 10218-2 focuses on the integration of the robot into the system and application – how to design work zones, which safety functions are required, optional or conditional depending on the risk and type of application.

Safety functions – classification in ISO 10218-2

In Annex C of ISO 10218-2:2025, safety functions are now clearly classified:

  • Required – mandatory functions, e.g. Emergency Stop. They must meet a specific level of reliability (SIL/PL).
  • Optional – functions that increase safety but depend on the application, e.g. speed reduction in areas where the robot may come close to the operator.
  • Conditional – functions required only in specific scenarios, e.g. monitored standstill, i.e. control of the complete stop of the robot arm in collaborative applications.

What does this mean in practice for an integrator?

  • Designing safety zones – the standard requires that each zone be assessed in terms of risk and the safety functions that need to be implemented
  • Configuring robot functions – the integrator must know which functions are mandatory, which can be implemented for additional safety, and which depend on the operating scenario
  • Safety level monitoring – SIL/PL required for each function provides clear guidelines for the design of safety systems and system integration.

Standardised security features, clear classification into required/optional/conditional, and easy configuration of features by the integrator provide a real competitive advantage.

Practical examples of safety features

  • Emergency Stop – a classic, but now with a specific PL/SIL level.
  • Speed and Separation Monitoring – dynamic speed reduction when the operator approaches.
  • Monitored Standstill – a requirement in applications where the operator feeds in details manually or works in a close access zone.

For robotic application integrators, the new standards are not an obstacle – they are a tool:

  • They allow you to conveniently design safety zones and assess risks.
  • They clearly define which functions must be implemented and which are additional for operator safety.
  • They facilitate the selection and configuration of robots – knowing which functions have the required SIL/PL level allows you to select the appropriate safety modules and software.

This change is a clear step towards promoting the use of industrial robots working closely with people, while ensuring maximum safety for them. On the other hand, in applications without an operator present, robots can operate at maximum efficiency and productivity, which also reduces the energy consumption of the entire robotised section. This is a positive direction, which will replace today's cobots blocked by mechanical guards.

Cybersecurity – a new obligation in robotics

Robotic systems are increasingly being integrated with OT/IT networks, the cloud, and even ERP systems – for example, for fixed asset management. Mitsubishi Electric robots can be connected to the cloud, allowing you to monitor the condition of the robot, the wear and tear of service parts and mechanical components. We do this by connecting the robots to the ME2Robot system, where we monitor the condition and wear and tear of the robot.

The latest version of ISO 10218 introduces a requirement for protection against unauthorised access, tampering and network attacks. These standards refer to the IEC 62443 standard, which specifies security measures for industrial control systems. The purpose of these provisions is to protect robotic systems from digital threats that could lead to failure or pose a risk to people.

Risk assessment and cybersecurity measures

The standard imposes an obligation to conduct a cybersecurity risk assessment. If the analysis shows that there is a security risk, appropriate protective measures must be implemented. These may include, among others:

  • The ability to disable access to communication ports, e.g. TCP/UDP,
  • Change TCP/UDP port numbers in logical connections,
  • Authenticated security configuration protection,the ability to change default settings such as user names, passwords, IP addresses, and authentication settings,
  • The use of encrypted and authenticated communication protocols.

The standard also refers to other standards and guidelines:

  • ISO/TR 22100-4:2018 – guidelines on IT security aspects and ISO 12100:2010,
  • IEC TS 63074:2023 – information on functional safety,
  • IEC 62443-3-2:2020 – assessment of system safety-related risks,
  • IEC 62443-3-3:2013 – information on the safety of industrial communication networks.

Implementing these requirements not only protects robotic systems from digital threats, but also ensures safe and reliable operation in increasingly integrated industrial environments. Risk assessment and cybersecurity measures.

Integration with ISO/TS 15066 – the end of the term ‘cobot’

The requirements previously contained in ISO/TS 15066 have been incorporated into ISO 10218. The term ‘collaborative robot’ (Cobot) is no longer used; instead, the following concepts have been introduced:

  • Collaborative task – part of a robot sequence in which both the robot application and the operator(s) are located in the same protective area
  • Collaborative application – an application containing one or more collaborative tasks

Benefits of integration:

  • All safety requirements in one standard.
  • Easier implementation of both industrial and collaborative robots.
  • Market consolidation and clear criteria for designing collaborative applications.

Does this mean that there will be fewer cobots on the market? Not at all. The new standard does not reduce the number of collaborative robots on the market, but rather introduces clear guidelines on how to properly implement applications in which a robot collaborates with an operator. If, in an application, the operator does not directly feed components or work in the robot's immediate vicinity, different safety functions are required than in the case of full human-robot collaboration.

There are many examples on the market where cobots, which today would no longer be defined as ‘cobots’ in the standard, are fenced off with mechanical barriers. This is not a mistake – applications can be designed this way – but this solution limits the speed of the system. So far, cobots available on the market, even with the force control function disabled, do not reach the same speed as industrial robots. The changes to the standard bring order to application design and clearly define where force and torque control functions should be used when robots work with humans.

New design and operational requirements

Detailed requirements for manufacturers and integrators have been added:

  • Design: materials, stability, fault tolerance, TCP/payload configuration.
  • Operation: standardised operating instructions, guidelines for faults, cyber security.
  • New stopping and monitoring functions: stopping distance limiting, monitored standstill.

Why?

  • Reduced risk of collisions and uncontrolled movements.
  • Clear failure handling procedures and minimisation of human error.
  • Precise settings improve operator safety and product protection.

Safety testing and validation

New testing methods have been introduced, including:

  • FMPM (Force per Manipulator) for Class I,
  • Annex H – measurement of stopping time and distance.

This eliminates interpretative uncertainty and provides consistent validation tools.

ISO 10218:2025 – practical conclusions for manufacturers, integrators and users

  • For manufacturers: greater investment in certified safety features and cyber protection.
  • For integrators: greater responsibility for the entire application (tools, details, environment).
  • For users: greater certainty of compliance with minimum requirements.
  • For the world of robotics: openness to the work of operators with industrial robots – taking advantage of their high efficiency, with the standard indicating which safety tools must be implemented to ensure operator safety.


The new ISO 10218 is not just about ‘safe robots’ but ‘safe robotic applications’.

Area ISO 10218:2011 ISO 10218:2025 Comment
Scope Focused on robots and robotic systems, excluding cybersecurity and cobots. Extended: robots, collaborative applications, cybersecurity, entire application (robot + EOAT + environment).The transition from ‘safe robot’ to ‘safe robotic application’. This is due to the new robots that have appeared on the market.
Terminology „Collaborative robot”, „safety-rated monitored stop”. „Collaborative application”, „monitored standstill”, elastyczne „safeguarded space”. Focus on the application, not just the machine with the robot
Classification of robots  No division. Class I and Class II robots have been introduced.It allows you to tailor security requirements to the level of risk.
Functional safety (FS) General reference to categories according to EN ISO 13849, without specific requirements.Clear requirements: e.g. PL d / Cat. 3, SIL 2, PFHd < 4.43×10⁻⁷. Annex C and D: list of mandatory and optional functions. A significant convenience for manufacturers and integrators – no more grey areas of interpretation.
Cyber security No requirements.New chapter: protection against attacks, IEC 62443, access control, integrity checks.An absolute novelty – the necessity of IT/OT integration. This is very important, for example, in relation to the ME2Robot application for monitoring robots.
Collaborative use (coboty)Separate specification ISO/TS 15066, not included in the main standard.Content from TS 15066 integrated: modes described (hand guiding, SSM, PFL).Simplification – the integrator does not need to refer to a separate document.
EOAT (end-of-arm tooling)General indications, supplemented by TR 20218 reports.Requirements transferred to the main standard (e.g. tool protection, gripper forces).No more fragmented documentation – clear rules in a single standard.
Operating instructions and documentationFocused mainly on installation and maintenance.Extended to include: cybersecurity, emergency procedures, payload, TCP, manual scenarios.The manufacturer must provide more practical data.
Testing and validation No uniform methods – interpretation depends on the manufacturer.Annex E, Annex H – standard methods for measuring forces, distances and stopping times.Standardisation of the testing process, easier compliance validation.
Risk analysis General requirement in accordance with ISO 12100.Detailed methods, with references to compatible applications and EOAT.The integrator has a clear process, not just a general recommendation.
Emergency stop (E-Stop) Mandatory, but with a narrower definition.Extended – various types of standstill, monitored standstill, isolated circuits.Greater precision and safety during start-up/breakdown.
Approach to human–robot collaboration Emphasis on separation (physical barriers).Acceptance of cooperation, defined methods of risk mitigation in cooperating applications.The standard specifies that it is important for the operator's safety not to press on the cobot/robot – in fact, it does not define a cobot.
Integrators Requirements for the robotic system, but largely left open to interpretation.ISO 10218-2:2025 emphasises the entirety of the application, EOAT, objects, environment, and manual interactions.The integrator has greater responsibility and clear guidelines.
Transitional period None (2011 → in force since publication)Transitional period expected until 2027.Companies have time to adapt, but they need to plan now and familiarise themselves with the changes.

Jacek Taczała

FA Product Manager Industrial Robots

Teme