ISO/DIS 12100.3

ISO/DIS 12100.3 / DIS ballot initiated 20.07.2026

ID 26621 | Update 21.07.2026 / Preview attached

ISO/DIS 12100.3
Safety of machinery - General principles for design - Risk assessment and risk reduction

Status: Under development
Stage: DIS ballot initiated: 12 weeks [40.20] 20.07.2026
Edition: 2
Number of pages: 94

This Draft International Standard is in the enquiry phase with ISO members.

ISO 12100:2010 specifies basic terminology, principles and a methodology for achieving safety in the design of machinery.

It specifies principles of risk assessment and risk reduction to help designers in achieving this objective. These principles are based on knowledge and experience of the design, use, incidents, accidents and risks associated with machinery. Procedures are described for identifying hazards and estimating and evaluating risks during relevant phases of the machine life cycle, and for the elimination of hazards or sufficient risk reduction. Guidance is given on the documentation and verification of the risk assessment and risk reduction process.

ISO 12100:2010 is also intended to be used as a basis for the preparation of type-B or type-C safety standards.

It does not deal with risk and/or damage to domestic animals, property or the environment.

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Life cycle 20.07.2026

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Preview ISO/DIS 12100.3
Safety of machinery - General principles for design - Risk assessment and risk reduction

Foreword

ISO (the International Organization for Standardization) is a worldwide federation of national standards bodies (ISO member bodies). The work of preparing International Standards is normally carried out through ISO technical committees. Each member body interested in a subject for which a technical committee has been established has the right to be represented on that committee. International organizations, governmental and non-governmental, in liaison with ISO, also take part in the work. ISO collaborates closely with the International Electrotechnical Commission (IEC) on all matters of electrotechnical standardization.

The procedures used to develop this document and those intended for its further maintenance are described in the ISO/IEC Directives, Part 1. In particular, the different approval criteria needed for the different types of ISO document should be noted. This document was drafted in accordance with the editorial rules of the ISO/IEC Directives, Part 2 (see www.iso.org/directives).

ISO draws attention to the possibility that the implementation of this document may involve the use of (a) patent(s). ISO takes no position concerning the evidence, validity or applicability of any claimed patent rights in respect thereof. As of the date of publication of this document, ISO had not received notice of (a) patent(s) which may be required to implement this document. However, implementers are cautioned that this may not represent the latest information, which may be obtained from the patent database available at www.iso.org/patents. ISO shall not be held responsible for identifying any or all such patent rights.

Any trade name used in this document is information given for the convenience of users and does not constitute an endorsement.

For an explanation of the voluntary nature of standards, the meaning of ISO specific terms and expressions related to conformity assessment, as well as information about ISO's adherence to the World Trade Organization (WTO) principles in the Technical Barriers to Trade (TBT), see www.iso.org/iso/foreword.html.

This document was prepared by Technical Committee ISO/TC 199, Safety of machinery, in collaboration with the European Committee for Standardization (CEN) Technical Committee CEN/TC 114, Safety of machinery, in accordance with the Agreement on technical cooperation between ISO and CEN (Vienna Agreement).

This second edition of ISO 12100 cancels and replaces ISO 12100:2010, ISO/TR 22100-1:2021 and ISO/TR 22100-2:2013.

The main changes are as follows:

- the Scope has been modified;
- additional normative references were added to Clause 2;
- terms and definitions have been modified in Clause 3;
- new Figure 1 added, and Figure 4 from previous edition deleted;
- requirements for control systems moved to 6.3.5;
- reference to self-evolving behaviour of applied artificial intelligence added to 5.4.3, b) 7);
- new subclause “Hygiene aspects” added as 6.2.14;
- subclause “Safeguarding to reduce emissions” shortened on general aspects only;
- subclause on “Software aspects” completely rewritten;
- updates made to requirements for guards and protective devices (6.3.2);
- new subclauses “Indirect control” and “Remote software updates” added as 6.3.5.11 and 6.3.5.12, respectively;
- new subclause “Cybersecurity and protection against corruption” added as 6.3.5.17;
- ISO/TR 22100-1 and ISO/TR 22100-2 incorporated as new Annexes C and D.

In addition to text written in the official ISO languages (English, French, Russian), this document gives text in German. This text is published under the responsibility of the member body for Germany (DIN) and is given for information only. Only the text given in the official languages can be considered as ISO text. Any feedback or questions on this document should be directed to the user’s national standards body. A complete listing of these bodies can be found at www.iso.org/members.html.

Introduction

The primary purpose of this document is to provide designers with an overall framework and guidance for decisions during the development of machinery to enable them to design machines that are adequately safe for their intended use. It also provides a strategy for standards developers and will assist in the preparation of consistent and appropriate type-B and type-C standards.

The concept of safety of machinery considers the ability of a machine to perform its intended function(s) during its lifecycle where risk has been adequately reduced.

This document is the basis for a set of standards which has the following structure:

a) type-A standards (basic safety standards) giving basic concepts, principles for design, and general aspects that can be applied to all machinery;
b) type-B standards (generic safety standards) dealing with one safety aspect or one or more type(s) of safeguard that can be used across a wide range of machinery:
- type-B1 standards on particular safety aspects (e.g. safety distances, surface temperature, noise);
- type-B2 standards on safeguards (e.g. two-hand control devices, interlocking devices, pressure-sensitive devices, guards);
c) type-C standards (machine safety standards) dealing with detailed safety requirements for a particular machine or group of machines.

This document is a type-A standard.

This document is of relevance, in particular, for the following stakeholder groups representing the market players with regard to machinery safety:

- machine manufacturers (small, medium and large enterprises);
- health and safety bodies (regulators, accident prevention organizations, market surveillance);

Others can be affected by the level of machinery safety achieved with the means of the document by the above-mentioned stakeholder groups:

- machine users/employers (small, medium and large enterprises);
- machine users/employees (e.g. trade unions, organizations for people with special needs);
- service providers, e.g. for maintenance (small, medium and large enterprises);
- consumers (in case of machinery intended for use by consumers).

The above-mentioned stakeholder groups have been given the possibility to participate in the drafting process of this document.

When a type-C standard deviates from one or more technical provisions dealt with by this document or by a type-B standard, the type-C standard takes precedence.

It is desirable that this document be referred to in training courses and manuals to convey basic terminology and general design methods to designers.

ISO/IEC Guide 51 has been taken into account as far as practicable at the time of drafting of this document.

A trilingual lookup and index of specific terms and expressions used in this document is given in Annex E.

1 Scope

This document defines basic terminology and specifies principles and a methodology for safety in the design of machinery. It specifies principles of risk assessment and risk reduction to help designers in achieving this objective. These principles are based on knowledge and experience of the design, use, incidents, accidents and risks associated with machinery. Procedures are described for identifying hazards and estimating and evaluating risks during relevant phases of the machine lifecycle, and for the elimination of hazards or the provision of adequate risk reduction. Guidance is given on the documentation and verification of the risk assessment and risk reduction process.

This document covers principal implications on machinery safety in case of implementation of artificial intelligence/machine learning, and vulnerability to cyber threats and data corruption regarding their impact on safety. It specifies generic measures to address both aspects.

Safety of machinery includes hygiene aspects.

This document is also intended to be used as a basis for the preparation of type-B or type-C safety standards.

This document covers neither risk nor damage to domestic animals, property or the environment.

NOTE 1 While this document refers to risks of harm to persons, the risk assessment process set out in this document can be equally effective in assessing other types of risks such as damage to domestic animals, property or the environment.

NOTE 2 Annex B gives, in separate tables, examples of hazards, hazardous situations and hazardous events, in order to clarify these concepts and assist the designer in the process of hazard identification.

NOTE 3 The practical use of a number of methods for each stage of risk assessment is described in ISO/TR 14121-2.

NOTE 4 As used in this document, the designer of a machine can include the manufacturer, integrator, supplier, or the user in case of safety-relevant modifications.

NOTE 5 This document can also be used for existing machinery.

2 Normative referencesThe following documents are referred to in the text in such a way that some or all of their content constitutes requirements of this document. For dated references, only the edition cited applies. For undated references, the latest edition of the reference document (including any amendments) applies.

ISO/DIS 12895-2:2025 Safety of machinery - Identification of whole body access and prevention of associated risk(s)

ISO 13849-1:2023 Safety of machinery - Safety-related parts of control systems - Part 1: General principles for design

ISO 20607 Safety of machinery - Instruction handbook - General drafting principles

3 Terms and definitionsFor the purposes of this document, the following terms and definitions apply.

ISO and IEC maintain terminology databases for use in standardization at the following addresses:

- ISO Online browsing platform: available at https://www.iso.org/obp

- IEC Electropedia: available at https://www.electropedia.org/

3.1

machinery

machine

assembly, fitted with or intended to be fitted with a drive system other than directly applied human or animal effort, consisting of linked parts or components, at least one of which moves, and which are joined together for a specific application

Note 1 to entry: The term “machinery” can include an assembly of machines, which achieves the same purpose, when they are arranged and controlled to function as an integral whole.

Note 2 to entry: Annex A provides a general schematic representation of a machine.

3.2

reliability

ability of a machine or its components or equipment to perform a required function under specified conditions and for a given period of time without failing

3.3

maintainability

characteristic of a machine that allows it to be kept in a state which enables it to fulfil its function under conditions of intended use, or to be restored to such a state

3.4

usability

characteristic of a machine that allows it to be easily used including properties or characteristics that enable its function(s) to be easily understood

3.5

harm

physical injury or damage to health

3.6

hazard

potential source of harm

Note 1 to entry: The term “hazard” can be qualified in order to define its origin (e.g. mechanical hazard, electrical hazard) or the nature of the potential harm (e.g. electric shock hazard, cutting hazard, toxic hazard, fire hazard).

Note 2 to entry: The hazard envisaged by this definition either:

- is permanently present during the intended use of the machine (e.g. motion of hazardous moving elements, electric arc during a welding phase, unhealthy posture, noise emission, high temperature); or

- can appear unexpectedly (e.g. explosion, crushing hazard as a consequence of an unintended/unexpected start-up, ejection as a consequence of a breakage, fall as a consequence of acceleration/deceleration).

3.7

significant hazard

hazard which has been identified as associated with the machine and which requires specific action to eliminate or to reduce its risk in accordance with the risk assessment

Note 1 to entry: This term is included as basic terminology for type-B and type-C standards.

Note 2 to entry: The prior term "relevant hazard" is included as being a significant hazard.

3.8

hazardous event

event that can cause harm

Note 1 to entry: A hazardous event can occur over a short period of time or over an extended period of time.

3.9

hazardous situation

circumstance in which a person is exposed to at least one hazard

Note 1 to entry: The exposure can result in harm immediately or over a period of time.

3.10

hazard zone

danger zone

any space either within or around machinery, or both, in which a person can be exposed to a hazard

3.11

risk

combination of the probability of occurrence of harm and the severity of that harm

3.12

residual risk

risk remaining after risk reduction measures have been implemented

Note 1 to entry: This document distinguishes:

- the residual risk after risk reduction measures have been implemented by the designer;

- the residual risk remaining after all risk reduction measures by the designer and the user have been implemented.

Note 2 to entry: See also Figure 3.

3.13

risk estimation

defining likely severity of harm and probability of its occurrence

3.14

risk analysis

combination of the specification of the limits of the machine, hazard identification and risk estimation

3.15

risk evaluation

procedure based on the risk analysis to determine whether further risk reduction is required

[SOURCE: ISO/IEC Guide 51:2014, 3.12, modified - The wording “tolerable risk has been exceeded” has been replaced with “further risk reduction is required”.]

3.16

risk assessment

overall process comprising a risk analysis and a risk evaluation

Note 1 to entry: See Figure 1.

3.17

risk reduction measure

DEPRECATED:protective measure

action or means to eliminate hazards or reduce risks

Note 1 to entry: See Figure 2 and Figure 3.

3.18

complementary risk reduction measure

risk reduction measure used in conjunction with inherently safe design, safeguarding or information for use to enhance risk reduction

3.19

tolerable risk

acceptable risk

adequately reduced risk

level of risk that is accepted in a given context based on the current values of society at a minimum in accordance with legal requirements

Note 1 to entry: Tolerable risk usually refers to the level at which further technologically, functionally and financially feasible risk reduction measures or additional expenditure(s) of resources will not result in significant reduction in risk.

Note 2 to entry: Criteria for determining when adequately reduced risk is achieved are given in 5.6.2.

3.20

inherently safe design

risk reduction measure which either eliminates hazards or reduces the risks associated with hazards by changing the design or operating characteristics of the machine without the use of guards or protective devices

Note 1 to entry: See 6.2.

3.21

safeguarding

risk reduction measure using safeguards to protect persons from the hazards which cannot reasonably be eliminated or risks which cannot be sufficiently reduced by inherently safe design

Note 1 to entry: See 6.3.

3.22

information for use

risk reduction measure consisting of details used separately or in combination, to convey information to the user

Note 1 to entry: See 6.4.

Note 2 to entry: Details of information of use can comprise e.g. of text, words, signs, signals, symbols, diagrams, photos.

3.23

intended use

use of a machine in accordance with the information for use

3.24

reasonably foreseeable misuse

use of a machine in a way not intended by the designer, but which can result from readily predictable human behaviour

3.25

task

specific activity performed by one or more persons on, or in the vicinity of, the machine during its lifecycle

3.26

safeguard

guard or protective device

3.27

guard

physical barrier, designed as part of the machine to provide protection

Note 1 to entry: A guard acts either:

- alone, in which case it is only effective when “closed” (for a movable guard) or “securely held in place” (for a fixed guard); or

- in conjunction with an interlocking device with or without guard locking, in which case protection is ensured whatever the position of the guard.

Note 2 to entry: Depending on its construction, a guard may be described as, for example, casing, shield, cover, screen, door, enclosure.

Note 3 to entry: The terms for types of guards are defined in 3.27.1 to 3.27.6. See also 6.3.3.2 and ISO 14120 for more information about types of guards and their requirements.

3.27.1

fixed guard

guard affixed in such a manner (e.g. by screws, nuts, welding) that it can only be opened or removed by the use of tools or by destruction of the affixing means

3.27.2

movable guard

guard which can be opened without the use of tools

3.27.3

adjustable guard

fixed or movable guard which is adjustable as a whole or which incorporates adjustable part(s)

3.27.4

interlocking guard

guard associated with an interlocking device, such that, together with the control system of the machine,

- prevents the operation of the hazardous machine functions associated with the guard until the guard is closed;

- and, if the guard is opened while hazardous machine functions are operating, a command to bring the machine to a safe state is given

Note 1 to entry: An interlocking guard can contain/be equipped with one or more interlocking devices. These interlocking devices can also be of different types.

Note 2 to entry: The generation of the command to bring the machine to a safe state when the guard is open does not apply to guards locked with a trapped key interlocking system.

Note 3 to entry: ISO 14119 gives detailed provisions.

3.27.5

interlocking guard with guard locking

guard associated with an interlocking device and a guard locking device so that, together with the control system of the machine, the following functions are performed:

- the hazardous machine functions associated with the guard cannot operate until the guard is closed and locked;

- the guard remains closed and locked until the risk due to the hazardous machine functions associated with the guard has ceased;

- when the guard is closed and locked, the hazardous machine functions associated with the guard can operate (the closure and locking of the guard do not by themselves start the hazardous machine functions)

Note 1 to entry: ISO 14119 gives detailed provisions.

3.27.6

interlocking guard with a start function

control guard

interlocking guard which, once it has reached its closed position, gives a command to initiate the hazardous machine function(s) without the use of a separate start control

Note 1 to entry: See 6.3.3.2.5 for detailed provisions on the conditions of use.

3.28

protective device

safeguard other than a guard

Note 1 to entry: Examples of types of protective devices are 3.28.1 to 3.28.8.

3.28.1

interlocking device

interlock

mechanical, electrical or other type of device, the purpose of which is to prevent the operation of hazardous machine functions under specified conditions (generally as long as a guard is not closed)

Note 1 to entry: ISO 14119 gives detailed provisions.

3.28.2

enabling control device

additional manually operated device used in conjunction with a start control and which, when continuously actuated, allows a machine to function

3.28.3

hold-to-run control device

control device which initiates and maintains machine functions only as long as the manual control (actuator) is actuated

3.28.4

two-hand control device

control device which requires simultaneous actuation by both hands in order to initiate and to maintain hazardous machine functions, thus providing a risk reduction measure only for the person who actuates it

Note 1 to entry: ISO 13851 gives detailed provisions.

3.28.5

sensitive protective equipment

SPE

equipment for detecting persons or parts of persons which generates a signal to the control system to reduce risk to the persons detected

Note 1 to entry: The signal can be generated when a person or part of a person goes beyond a predetermined limit, for example, enters a hazard zone (tripping) or when a person is detected in a predetermined zone (presence sensing), or in both cases.

3.28.6

active optoelectronic protective device

AOPD

device whose sensing function is performed by optoelectronic emitting and receiving elements detecting the interruption of optical radiation, generated within the device, by an opaque object present in the specified detection zone

Note 1 to entry: The IEC 61496 series gives detailed provisions.

3.28.7

limiting device

device which prevents a machine or hazardous machine condition(s) from exceeding a designed limit (e.g. space limit, pressure limit, load moment limit, speed limit)

3.28.8

mechanical restraint device

device that forms a mechanical obstacle which by its design prevents hazardous movement(s)

Note 1 to entry: Examples for mechanical obstacles are wedges, spindles, struts, slide locks, safety blocks, scotch (pins).

3.28.9

limited movement control device

control device, a single actuation of which, together with the control system of the machine, permits only a limited amount of travel of a machine element

Note 1 to entry: Limited movement control devices include jog controls, step-by-step controls, inching controls, pulse controls, feed controls, and similar devices.

3.29

impeding device

physical obstacle (e.g. low barrier, rail) which, without totally preventing access to a hazard zone, reduces the probability of access to this zone by offering an obstruction to free access

3.30

safety function

function of a machine whose failure can result in an immediate increase of the risk(s)

3.31

unexpected start-up

unintended start-up

start-up which, because of its unanticipated nature, generates a risk to persons

Note 1 to entry: For example, this can be caused by:

- a start command which is the result of a failure in or an external influence on the control system;
- a start command generated by inopportune action on a start control or other parts of the machine such as a sensor or a power control element;
- restoration of the power supply after an interruption;
- external/internal influences (e.g. gravity, wind, self-ignition in internal combustion engines) on parts of the machine.

Note 2 to entry: Machine start-up during normal sequence of an automatic cycle is not unintended, but can be considered as being unexpected from the point of view of the operator. Prevention of hazardous situations in this case involves the use of safeguarding (see 6.3).

[SOURCE: ISO 14118:2017, 3.2, modified - The word “unexpected” has been replaced by “unanticipated”. In Note 2 to entry “hazardous events” has been replaced by “hazardous situations”.]

3.32

fault

fault of an item

inability to perform as required, due to an internal state

Note 1 to entry: A fault of an item results from a failure, either of the item itself, or from a deficiency in an earlier stage of the lifecycle, such as specification, design, manufacture or maintenance.

Note 2 to entry: Qualifiers, such as specification, design, manufacture, maintenance or misuse, can be used to indicate the cause of a fault.

Note 3 to entry: The type of fault can be associated with the type of associated failure, e.g. wear-out fault and wear-out failure.

Note 4 to entry: The adjective “faulty” designates an item having one or more faults.

[SOURCE: IEC 60050-192:2015, 192-04-01, modified – In Note 1 to entry the former cross-reference to latent fault has been deleted. In Note 2 and Note 3 to entry “may” have been changed to “can”.]

3.33

failure

failure of an item

loss of ability to perform as required

Note 1 to entry: A failure of an item is an event that results in a fault of that item.

Note 2 to entry: Qualifiers, such as catastrophic, critical, major, minor, marginal and insignificant, can be used to categorize failures in accordance with the severity of consequences, the choice and definitions of severity criteria depending upon the field of application.

Note 3 to entry: Qualifiers, such as misuse, mishandling and weakness, can be used to categorize failures in accordance with the cause of failure.

[SOURCE: IEC 60050-192:2015, 192-03-01, modified – In Note 1 to entry the former cross-reference to fault has been deleted. In Note 2 and Note 3 to entry “may” have been changed to “can”.]

3.34

common cause failures

failures of multiple items, which would otherwise be considered independent of one another, resulting from a single cause

Note 1 to entry: Common cause failures can also be common mode failures.

Note 2 to entry: The potential for common cause failures reduces the effectiveness of system redundancy.

[SOURCE: IEC 60050-192:2015, 192-03-18, modified – In Note 1 to entry the former cross-reference to common mode failures has been deleted.]

3.38

emergency stop

emergency stop function

function which is intended to

- avert arising or reduce existing hazards to persons, and

- be initiated by a single human action

Note 1 to entry: ISO 13850 gives detailed provisions.

Note 2 to entry: Emergency stop can also be used to avert or reduce damage to machinery or to work in progress.

3.39

emission value

numerical value quantifying an emission generated by a machine (e.g. noise, vibration, hazardous substances, radiation)

Note 1 to entry: Emission values are part of the information on the properties of a machine and are used as a basis for risk assessment.

Note 2 to entry: The term “emission value” is different from “exposure value”, which quantifies the exposure of persons to emissions when the machine is in use. Exposure values can be estimated using the emission values.

Note 3 to entry: Emission values are preferably measured and their associated uncertainties determined by means of standardized methods (e.g. to allow comparison between similar machines).

3.40

cybersecurity

measures to protect a machine control system against unauthorized access or attack that can result in a hazardous situation

Note 1 to entry: Damage or changes can be made to the machine control system hardware, software or information, as well as from disruption or misdirection of the intended function.

Note 2 to entry: Cybersecurity is covering both, information technology security (IT security, e.g. ISO/IEC 27000 and further documents belonging to this family of standards) and operational technology (OT, e.g. IEC 62443 series).

3.41

remote access

process of communicating with one or more device on the machinery from another network or from a terminal device which is not permanently connected, physically or logically, to the device(s)

3.42

indirect control

process where parameters can be changed and machine functions can be initiated, stopped or modified from a location where the operator has no direct line of sight of the controlled machine parts

Note 1 to entry: The term indirect control should not be confused with cableless control.

3.43

remote programming

process where active programs can be created, modified or tested from a location where the operator has no direct line of sight of the controlled machine parts

Note 1 to entry: Remote programming can apply to safety-related or non-safety-related portions of the program.

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[11] ISO 10075-2, Ergonomic principles related to mental workload - Part 2: Design principles

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[51] IEC 62443 (all parts), Security for industrial automation and control systems

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[53] IEC/IEEE 82079-1, Preparation of information for use (instructions for use) of products - Part 1: Principles and general requirements

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[55] EN 1299, Mechanical vibration and shock - Vibration isolation of machines - Information for the application of source isolation

[56] EN 1672-2, Food processing machinery - Basic concepts - Part 2: Hygiene and cleanability requirements

[57] EN 12198-1, Safety of machinery - Assessment and reduction of risks arising from radiation emitted by machinery - Part 1: General principles

[58] EN 12198-3, Safety of machinery - Assessment and reduction of risks arising from radiation emitted by machinery - Part 3: Reduction of radiation by attenuation or screening

[59] EN 12786, Safety of machinery - Requirements for the drafting of the vibration clauses of safety standards

[60] EN 13861, Safety of machinery - Guidance for the application of ergonomics standards in the design of machinery

[61] prEN 50742:2026, Safety of machinery -Protection against corruption

Not referenced documents

[62] inter noise 2021 “Sell and Buy Quiet – the extended concept to reduce noise (at work and at home)”, Washington D.C.

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Fonte: ISO

Collegati