prEN ISO 12100
(Main)Safety of machinery - General principles for design - Risk assessment and risk reduction (ISO/DIS 12100:2025)
Safety of machinery - General principles for design - Risk assessment and risk reduction (ISO/DIS 12100:2025)
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.
Sicherheit von Maschinen - Allgemeine Gestaltungsleitsätze - Risikobeurteilung und Risikominderung (ISO/DIS 12100:2025)
Sécurité des machines - Principes généraux de conception - Appréciation du risque et réduction du risque (ISO/DIS 12100:2025)
L'ISO 12100:2010 spécifie la terminologie de base, les principes et une méthodologie en vue d'assurer la sécurité dans la conception des machines. Elle spécifie les principes de l'appréciation du risque et de la réduction du risque pour aider les concepteurs à atteindre cet objectif. Ces principes sont fondés sur la connaissance et l'expérience de la conception, de l'utilisation, des incidents, des accidents et des risques associés aux machines. Des procédures sont décrites pour identifier les phénomènes dangereux, et estimer et évaluer les risques au cours des phases pertinentes du cycle de vie des machines, ainsi que pour supprimer les phénomènes dangereux ou ariiver à réduire suffisamment les risques. Des lignes directrices sont fournies sur la documentation et la vérification du processus d'appréciation du risque et de réduction du risque.
L'ISO 12100:2010 est également destinée à servir de document de base pour l'élaboration des normes de sécurité de type B ou de type C.
Elle ne traite pas des risques et/ou des dommages causés aux animaux domestiques, aux biens ou à l'environnement.
Varnost strojev - Splošna načela načrtovanja - Ocena tveganja in zmanjšanje tveganja (ISO/DIS 12100:2025)
General Information
- Status
- Not Published
- Publication Date
- 25-Apr-2027
- Technical Committee
- CEN/TC 114 - Safety of machinery
- Current Stage
- 4060 - Closure of enquiry - Enquiry
- Start Date
- 23-Dec-2025
- Completion Date
- 23-Dec-2025
Relations
- Effective Date
- 06-Dec-2023
Overview
prEN ISO 12100, titled Safety of machinery - General principles for design - Risk assessment and risk reduction (ISO/DIS 12100:2025), is a critical international standard published by CEN. It updates the original ISO 12100:2010 standard and provides foundational terminology, principles, and methodologies for ensuring machinery safety through effective design processes. This draft international standard focuses on applying systematic risk assessment and risk reduction practices throughout the machinery lifecycle.
The standard addresses the identification of hazards, evaluation and estimation of risks, and the implementation of risk control measures, supporting machinery manufacturers and designers in delivering safer equipment. It does not cover risks related to domestic animals, property, or environmental damage. Additionally, ISO 12100 serves as a basis for developing more specific type-B and type-C safety standards.
Key Topics
Risk Assessment Strategy
Covers structured procedures to identify hazards, estimate risks, and evaluate their significance during all phases of machine use.Hazard Identification
Focuses on analyzing human-machine interactions, possible operating states, and foreseeable misuse scenarios to uncover potential dangers.Risk Estimation and Evaluation
Guides how to quantify risk by considering severity, exposure, and frequency of hazardous events, and then determining if risk reduction is adequate.Risk Reduction Principles
Details approaches including inherently safe design, safeguarding with guards and protective devices, automation to limit human exposure, and ergonomic considerations.Information for Use
Emphasizes the importance of clear manuals, warnings, markings, signals, and pictograms to help users operate machinery safely.Documentation and Verification
Specifies requirements for thorough record-keeping of risk assessments and implemented risk reduction measures to ensure traceability and compliance.Annexes Providing Practical Tools
Includes schematic examples, hazard illustrations, relationships to related standards such as ISO 13849-1, and compliance mapping to EU Directives and Regulations.
Applications
prEN ISO 12100:2025 is essential for:
Machine Designers and Manufacturers:
To integrate risk-based safety approaches in developing new machinery, minimizing hazards from inception through to operation.Safety Engineers and Risk Assessors:
For structuring comprehensive risk analyses according to internationally recognized best practices.Regulatory and Compliance Professionals:
To understand the technical foundations referenced by legal frameworks such as the EU Machinery Directive 2006/42/EC and Regulation (EU) 2023/1230.Standard Developers:
Serving as a core reference in the creation of more detailed type-B and type-C machinery safety standards.
Utilizing this standard significantly contributes to safer machine operations, reduces accident rates, and enhances overall industrial safety culture.
Related Standards
ISO 13849-1:
Covers safety-related parts of control systems and complements ISO 12100 by addressing the design and validation of control safety functions.Type-B and Type-C Safety Standards:
More specific standards for certain machinery types or safety aspects that build upon the general principles outlined in ISO 12100.EU Machinery Directive 2006/42/EC:
European regulatory framework requiring compliance with risk assessment and reduction principles as detailed in ISO 12100.Regulation (EU) 2023/1230:
Provides updated legal requirements linked to machinery safety harmonized with ISO 12100 principles.
Adopting prEN ISO 12100:2025 helps businesses align with global best practices in machinery safety by embedding robust risk assessment and mitigation techniques into design and manufacturing processes. This contributes to safer workplaces, regulatory compliance, and reduced liability from machinery-related hazards.
Frequently Asked Questions
prEN ISO 12100 is a draft published by the European Committee for Standardization (CEN). Its full title is "Safety of machinery - General principles for design - Risk assessment and risk reduction (ISO/DIS 12100:2025)". This standard covers: 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.
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.
prEN ISO 12100 is classified under the following ICS (International Classification for Standards) categories: 13.110 - Safety of machinery. The ICS classification helps identify the subject area and facilitates finding related standards.
prEN ISO 12100 has the following relationships with other standards: It is inter standard links to EN ISO 12100:2010. Understanding these relationships helps ensure you are using the most current and applicable version of the standard.
prEN ISO 12100 is associated with the following European legislation: EU Directives/Regulations: 2006/42/EC, 2023/1230; Standardization Mandates: M/396, M/605. When a standard is cited in the Official Journal of the European Union, products manufactured in conformity with it benefit from a presumption of conformity with the essential requirements of the corresponding EU directive or regulation.
You can purchase prEN ISO 12100 directly from iTeh Standards. The document is available in PDF format and is delivered instantly after payment. Add the standard to your cart and complete the secure checkout process. iTeh Standards is an authorized distributor of CEN standards.
Standards Content (Sample)
SLOVENSKI STANDARD
01-februar-2025
Varnost strojev - Splošna načela načrtovanja - Ocena tveganja in zmanjšanje
tveganja (ISO/DIS 12100:2024)
Safety of machinery - General principles for design - Risk assessment and risk reduction
(ISO/DIS 12100:2024)
Sicherheit von Maschinen - Allgemeine Gestaltungsleitsätze - Risikobeurteilung und
Risikominderung (ISO/DIS 12100:2024)
Sécurité des machines - Principes généraux de conception - Appréciation du risque et
réduction du risque (ISO/DIS 12100:2024)
Ta slovenski standard je istoveten z: prEN ISO 12100
ICS:
13.110 Varnost strojev Safety of machinery
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
DRAFT
International
Standard
ISO/DIS 12100
ISO/TC 199
Safety of machinery — General
Secretariat: DIN
principles for design — Risk
Voting begins on:
assessment and risk reduction
2024-12-13
Sécurité des machines — Principes généraux de conception —
Voting terminates on:
Appréciation du risque et réduction du risque
2025-03-07
ICS: 13.110
THIS DOCUMENT IS A DRAFT CIRCULATED
FOR COMMENTS AND APPROVAL. IT
IS THEREFORE SUBJECT TO CHANGE
AND MAY NOT BE REFERRED TO AS AN
INTERNATIONAL STANDARD UNTIL
PUBLISHED AS SUCH.
This document is circulated as received from the committee secretariat.
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Reference number
ISO/DIS 12100:2024(en)
DRAFT
ISO/DIS 12100:2024(en)
International
Standard
ISO/DIS 12100
ISO/TC 199
Safety of machinery — General
Secretariat: DIN
principles for design — Risk
Voting begins on:
assessment and risk reduction
Sécurité des machines — Principes généraux de conception —
Voting terminates on:
Appréciation du risque et réduction du risque
ICS: 13.110
THIS DOCUMENT IS A DRAFT CIRCULATED
FOR COMMENTS AND APPROVAL. IT
IS THEREFORE SUBJECT TO CHANGE
AND MAY NOT BE REFERRED TO AS AN
INTERNATIONAL STANDARD UNTIL
PUBLISHED AS SUCH.
This document is circulated as received from the committee secretariat.
IN ADDITION TO THEIR EVALUATION AS
BEING ACCEPTABLE FOR INDUSTRIAL,
© ISO 2024
TECHNOLOGICAL, COMMERCIAL AND
USER PURPOSES, DRAFT INTERNATIONAL
All rights reserved. Unless otherwise specified, or required in the context of its implementation, no part of this publication may
STANDARDS MAY ON OCCASION HAVE TO
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Published in Switzerland Reference number
ISO/DIS 12100:2024(en)
ii
ISO/DIS 12100:2024(en)
Contents Page
Foreword .v
Introduction .vi
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 2
4 Strategy for risk assessment and risk reduction . 9
5 Risk assessment . 14
5.1 General .14
5.2 Information for risk assessment . 15
5.3 Determination of limits of machinery .16
5.3.1 General .16
5.3.2 Use limits .16
5.3.3 Space limits .16
5.3.4 Time limits .17
5.3.5 Other limits .17
5.4 Hazard identification .17
5.5 Risk estimation .19
5.5.1 General .19
5.5.2 Elements of risk .19
5.5.3 Aspects to be considered during risk estimation .21
5.6 Risk evaluation . 23
5.6.1 General . 23
5.6.2 Adequate risk reduction . 23
5.6.3 Comparison of risks . 23
6 Risk reduction .24
6.1 General .24
6.2 Inherently safe design .24
6.2.1 General .24
6.2.2 Consideration of geometrical factors and physical aspects . 25
6.2.3 Taking into account general technical knowledge of machine design . 26
6.2.4 Choice of appropriate technology . 26
6.2.5 Applying principle of positive mechanical action .27
6.2.6 Provisions for stability .27
6.2.7 Provisions for maintainability .27
6.2.8 Observing ergonomics principles . 28
6.2.9 Electrical hazards. 29
6.2.10 Pneumatic and hydraulic hazards . 29
6.2.11 Limiting exposure to hazards through reliability of equipment . 29
6.2.12 Limiting exposure to hazards through mechanization or automation of loading
(feeding) / unloading (removal) operations . 29
6.2.13 Limiting exposure to hazards through location of setting and maintenance
points outside danger zones . 30
6.2.14 Hygiene aspects. 30
6.3 Safeguarding and complementary risk reduction measures . 30
6.3.1 General . 30
6.3.2 Selection and implementation of guards and protective devices . 30
6.3.3 Requirements for design of guards and protective devices .31
6.3.4 Safeguarding to reduce emissions . 34
6.3.5 Design of control systems . 34
6.3.6 Complementary risk reduction measures .41
6.4 Information for use .43
6.4.1 General requirements .43
6.4.2 Location and nature of information for use .43
iii
ISO/DIS 12100:2024(en)
6.4.3 Signals and warning devices . 44
6.4.4 Markings, signs (pictograms) and written warnings . 44
6.4.5 Accompanying documents (in particular — instruction handbook) .45
7 Documentation of risk assessment and risk reduction . 47
Annex A (informative) Schematic representation of a machine .49
Annex B (informative) Examples of hazards, hazardous situations and hazardous events .50
Annex C (informative) Using the system of type-A, type-B and type-C standards to design a
machine to achieve a level of tolerable risk by adequate risk reduction . 61
Annex D (informative) How this document relates to ISO 13849-1 .65
Annex E (informative) Trilingual lookup and index of specific terms and expressions used in
this document .70
Annex ZA (informative) Relationship between this European Standard and the essential
requirements of Directive 2006/42/EC aimed to be covered .83
Annex ZB (informative) Relationship between this European Standard and the essential
requirements of Regulation (EU) 2023/1230 aimed to be covered .84
Annex ZC (informative) Relation of this document to the Machinery Directive 2006/42/EC .85
Annex ZD (informative) Relation of this document to the Regulation (EU) 2023/1230 .86
Bibliography .87
iv
ISO/DIS 12100:2024(en)
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 documents 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).
Attention is drawn to the possibility that some of the elements of this document may be the subject of patent
rights. ISO shall not be held responsible for identifying any or all such patent rights. Details of any patent
rights identified during the development of the document will be in the Introduction and/or on the ISO list of
patent declarations received (see www.iso.org/patents).
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.
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.
This second edition cancels and replaces the first edition (ISO 12100:2010) which has been technically
revised as well as ISO/TR 22100-1:2021 and ISO/TR 22100-2:2013, the technical content of which have been
incorporated.
The main changes are as follows:
— new second paragraph and new Note 3 added to Scope;
— ISO 20607, IEC 61508-3 and IEC 62061 additionally referenced normatively;
— terms and definitions: “relevant hazard” (former 3.7), “ failure to danger” (former 3.32) and “comparative
emission data” (former 3.42) deleted; “tolerable risk” and “cybersecurity” added; term “risk reduction
measure” introduced to replace deprecated term “protective measure” and definition of “risk evaluation”
adjusted to ISO/IEC Guide 51;
— new Figure 1 additionally added;
— requirements for control systems moved to 6.3.6;
— reference to evolving behaviour of applied artificial intelligence added to 5.4, b) 2);
— Figure 4 replaced by new Figure 5;
— 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;
— new subclause “Cybersecurity and protection against corruption” added as 6.3.5.15;
— ISO/TR 22100-1 and ISO/TR 22100-2 incorporated as new Annexes C and D.
v
ISO/DIS 12100:2024(en)
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 life cycle 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 organisations, 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.
vi
DRAFT International Standard ISO/DIS 12100:2024(en)
Safety of machinery — General principles for design — Risk
assessment and risk reduction
1 Scope
This document 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 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 against cybersecurity attacks / 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.
It does not cover risk and/or 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.
2 Normative references
The 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 referenced document (including any amendments) applies.
ISO 20607, Safety of machinery — Instruction handbook — General drafting principles
1)
IEC 60204-1:2021 , Safety of machinery — Electrical equipment of machines — Part 1: General requirements
IEC 61508-3, Functional safety of electrical/electronic/programmable electronic safety-related systems —
Part 3: Software requirements
IEC 62061, Safety of machinery — Functional safety of safety-related electrical, electronic and programmable
electronic control systems
1) i.e. Edition 6.1 which combines IEC 60204-1:2016 and Amendment 1, AMD 1:2021.
ISO/DIS 12100:2024(en)
3 Terms and definitions
For the purposes of this document, the following terms and definitions apply.
ISO and IEC maintain terminological 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
an 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” also covers an assembly of machines which, in order to achieve the same end,
are arranged and controlled so that they 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
ability of a machine to be maintained 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
ability of a machine 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 (for example, mechanical hazard,
electrical hazard) or the nature of the potential harm (for example, 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 (for example, motion of hazardous moving elements,
electric arc during a welding phase, unhealthy posture, noise emission, high temperature), or
— can appear unexpectedly (for example, 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 by the
designer to eliminate or to reduce the risk according to the risk assessment
Note 1 to entry: This term is included as basic terminology for type-B and type-C standards.
ISO/DIS 12100:2024(en)
Note 2 to entry: The deprecated term ‘relevant’ 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 within and/or around machinery 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, definition 3.12, modified – The wording “tolerable risk has been exceeded”
has been replaced with “further risk reduction required”.]
3.16
risk assessment
overall process comprising a risk analysis and a risk evaluation
Note 1 to entry: See Figure 1.
3.17
adequate risk reduction
risk reduction that is at least in accordance with legal requirements, taking into consideration the current
state of the art
Note 1 to entry: Criteria for determining when adequate risk reduction is achieved are given in 5.6.2.
ISO/DIS 12100:2024(en)
3.18
risk reduction measure
DEPRECATED: protective measure
action or means to eliminate hazards or reduce risks
Note 1 to entry: See Figure 2.
3.19
tolerable risk
acceptable risk
level of risk that is accepted in a given context based on the current values of society
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: A similar phrase used in some ISO standards is “the risk has been adequately reduced”.
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 communication links (for example, text, words, signs, signals, symbols,
diagrams) used separately or in combination, to convey information to the user
Note 1 to entry: See 6.4.
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 life cycle
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 may act 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
ISO/DIS 12100:2024(en)
— 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, enclosing guard.
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 types
of guards and their requirements.
3.27.1
fixed guard
guard affixed in such a manner (for example, 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 (a stop command) 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 (stop) 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, and
— 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.
ISO/DIS 12100:2024(en)
3.27.6
interlocking guard with a start function
control guard
special form of 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)
3.28.2
enabling 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 an appropriate 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 (space
limit, pressure limit, load moment limit, speed limit etc.)
ISO/DIS 12100:2024(en)
3.28.8
mechanical restraint device
device which introduces into a mechanism a mechanical obstacle (for example, wedge, spindle, strut, slide
locks, safety blocks, scotch (pin)) which by virtue of its own span, can prevent any hazardous movement
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
3.29
impeding device
any physical obstacle (low barrier, rail, etc.) 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
any start-up which, because of its unexpected 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 (gravity, wind, self-ignition in internal combustion engines, etc.) 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 measures (see 6.3).
[SOURCE: ISO 14118:2017, definition 3.2, modified – The word “any” has been added at the begin of the
definition. In the second sentence of Note 2 to entry “hazardous events” has been replaced by “hazardous
situations”.]
3.32
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 life cycle, such as specification, design, manufacture or maintenance. See latent fault (192-04-08).
Note 2 to entry: Qualifiers, such as specification, design, manufacture, maintenance or misuse, may be used to indicate
the cause of a fault.
Note 3 to entry: The type of fault may 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]
ISO/DIS 12100:2024(en)
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: see fault (192-04-01).
Note 2 to entry: Qualifiers, such as catastrophic, critical, major, minor, marginal and insignificant, may be used to
categorize failures according to 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, may be used to categorize failures according to
the cause of failure.
[SOURCE: IEC 60050-192:2015, 192-03-01]
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 (192-03-19).
Note 2 to entry: The potential for common cause failures reduces the effectiveness of system redundancy.
[SOURCE: IEC 60050-192:2015, 192-03-18]
3.35
common mode failures
common mode failures (within a system), pl
failures of different items characterized by the same failure mode
Note 1 to entry: Common mode failures may have different causes.
Note 2 to entry: Common mode failures can also be common cause failures (192-03-18).
Note 3 to entry: The potential for common mode failures reduces the effectiveness of system redundancy.
[SOURCE: IEC 60050-192:2015, 192-03-19]
3.36
malfunction
failure of a machine to perform an intended function
Note 1 to entry: See 5.4, item b) 2) for examples.
3.37
emergency situation
hazardous situation needing to be urgently ended or averted
Note 1 to entry: An emergency situation can arise
— during normal operation of the machine (for example, due to human interaction, or as a result of external
influences), or
— as a consequence of a malfunction or failure of any part of the machine.
3.38
emergency operation
all actions and functions intended to end or avert an emergency situation
ISO/DIS 12100:2024(en)
3.39
emergency stop
emergency stop function
function which is intended to
— avert arising or reduce existing hazards to persons, damage to machinery or to work in progress, and
— be initiated by a single human action
Note 1 to entry: ISO 13850 gives detailed provisions.
3.40
emission value
numerical value quantifying an emission generated by a machine (for example, 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” ought not to be confused with “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 (for example, to allow comparison between similar machines).
3.41
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) and operational
technology (OT). See also ISO 23806.
4 Strategy for risk assessment and risk reduction
To implement risk assessment and risk reduction, the following actions shall be taken, in the order given
(see Figure 1 and Figure 2):
Determine the limits of the machinery, which include the intended use and any reasonably foreseeable
misuse thereof
NOTE 1 Any misuse of a machine which is illegal or not readily predictable human behaviour is outside the scope of
a risk assessment. However, cybersecurity attacks with potential impacts to safety should be considered.
a) identify the hazards and
...
SLOVENSKI STANDARD
01-december-2025
Varnost strojev - Splošna načela načrtovanja - Ocena tveganja in zmanjšanje
tveganja (ISO/DIS 12100:2025)
Safety of machinery - General principles for design - Risk assessment and risk reduction
(ISO/DIS 12100:2025)
Sicherheit von Maschinen - Allgemeine Gestaltungsleitsätze - Risikobeurteilung und
Risikominderung (ISO/DIS 12100:2025)
Sécurité des machines - Principes généraux de conception - Appréciation du risque et
réduction du risque (ISO/DIS 12100:2025)
Ta slovenski standard je istoveten z: prEN ISO 12100
ICS:
13.110 Varnost strojev Safety of machinery
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
DRAFT
International
Standard
ISO/DIS 12100.2
ISO/TC 199
Safety of machinery — General
Secretariat: DIN
principles for design — Risk
Voting begins on:
assessment and risk reduction
2025-10-28
Sécurité des machines — Principes généraux de conception —
Voting terminates on:
Appréciation du risque et réduction du risque
2025-12-23
ICS: 13.110
THIS DOCUMENT IS A DRAFT CIRCULATED
FOR COMMENTS AND APPROVAL. IT
IS THEREFORE SUBJECT TO CHANGE
AND MAY NOT BE REFERRED TO AS AN
INTERNATIONAL STANDARD UNTIL
PUBLISHED AS SUCH.
This document is circulated as received from the committee secretariat.
IN ADDITION TO THEIR EVALUATION AS
BEING ACCEPTABLE FOR INDUSTRIAL,
TECHNOLOGICAL, COMMERCIAL AND
USER PURPOSES, DRAFT INTERNATIONAL
STANDARDS MAY ON OCCASION HAVE TO
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POTENTIAL TO BECOME STANDARDS TO
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NATIONAL REGULATIONS.
RECIPIENTS OF THIS DRAFT ARE INVITED
TO SUBMIT, WITH THEIR COMMENTS,
NOTIFICATION OF ANY RELEVANT PATENT
RIGHTS OF WHICH THEY ARE AWARE AND TO
PROVIDE SUPPORTING DOCUMENTATION.
Reference number
ISO/DIS 12100.2:2025(en)
DRAFT
ISO/DIS 12100.2:2025(en)
International
Standard
ISO/DIS 12100.2
ISO/TC 199
Safety of machinery — General
Secretariat: DIN
principles for design — Risk
Voting begins on:
assessment and risk reduction
Sécurité des machines — Principes généraux de conception —
Voting terminates on:
Appréciation du risque et réduction du risque
ICS: 13.110
THIS DOCUMENT IS A DRAFT CIRCULATED
FOR COMMENTS AND APPROVAL. IT
IS THEREFORE SUBJECT TO CHANGE
AND MAY NOT BE REFERRED TO AS AN
INTERNATIONAL STANDARD UNTIL
PUBLISHED AS SUCH.
This document is circulated as received from the committee secretariat.
IN ADDITION TO THEIR EVALUATION AS
BEING ACCEPTABLE FOR INDUSTRIAL,
© ISO 2025
TECHNOLOGICAL, COMMERCIAL AND
USER PURPOSES, DRAFT INTERNATIONAL
All rights reserved. Unless otherwise specified, or required in the context of its implementation, no part of this publication may
STANDARDS MAY ON OCCASION HAVE TO
ISO/CEN PARALLEL PROCESSING
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Published in Switzerland Reference number
ISO/DIS 12100.2:2025(en)
ii
ISO/DIS 12100.2:2025(en)
Contents Page
Foreword .v
Introduction .vii
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 1
4 Strategy for risk assessment and risk reduction . 9
5 Risk assessment . 14
5.1 General .14
5.2 Information for risk assessment .14
5.3 Determination of the limits of machinery . 15
5.3.1 General . 15
5.3.2 Use limits .16
5.3.3 Space limits .16
5.3.4 Time limits .16
5.3.5 Other limits .17
5.4 Hazard identification .17
5.4.1 General .17
5.4.2 Human interaction with machinery during the life cycle of the machine .17
5.4.3 Possible states of the machine .18
5.4.4 Unintended behaviour of the operator or reasonably foreseeable misuse of the
machine .18
5.5 Risk estimation .19
5.5.1 General .19
5.5.2 Elements of risk .19
5.5.3 Aspects to be considered during risk estimation .21
5.6 Risk evaluation . 23
5.6.1 General . 23
5.6.2 Adequate risk reduction . 23
5.6.3 Comparison of risks .24
6 Risk reduction .24
6.1 General .24
6.2 Inherently safe design . 25
6.2.1 General . 25
6.2.2 Consideration of geometrical factors and physical aspects . 25
6.2.3 Taking into account general technical knowledge of machine design . 26
6.2.4 Choice of appropriate technology .27
6.2.5 Applying principle of positive mechanical action . 28
6.2.6 Provisions for stability . 28
6.2.7 Provisions for maintainability . 28
6.2.8 Observing ergonomics principles . 28
6.2.9 Electrical hazards. 29
6.2.10 Pneumatic and hydraulic hazards . 30
6.2.11 Limiting exposure to hazards through reliability of equipment . 30
6.2.12 Limiting exposure to hazards through mechanization or automation of loading
(feeding) or unloading (removal) operations . 30
6.2.13 Limiting exposure to hazards through location of setting and maintenance
points outside hazard zones .31
6.2.14 Hygiene aspects.31
6.2.15 Noise .31
6.2.16 Vibration .31
6.3 Safeguarding and complementary risk reduction measures .31
6.3.1 General .31
6.3.2 Selection and implementation of guards and protective devices .31
iii
ISO/DIS 12100.2:2025(en)
6.3.3 Requirements for design of guards and protective devices . 35
6.3.4 Safeguarding to reduce emissions . 38
6.3.5 Design of control systems . 39
6.3.6 Complementary risk reduction measures . 46
6.3.7 Risk reduction measures for stability . 48
6.3.8 Other protective devices . 49
6.4 Information for use . 49
6.4.1 General requirements . 49
6.4.2 Location and nature of information for use . 50
6.4.3 Signals and warning devices . 50
6.4.4 Markings, signs (pictograms) and written warnings .51
6.4.5 Accompanying documents (in particular — instruction handbook) .52
7 Documentation of risk assessment and risk reduction .54
Annex A (informative) Schematic representation of a machine .56
Annex B (informative) Examples of hazards, hazardous situations and hazardous events .57
Annex C (informative) Using the system of type-A, type-B and type-C standards to design a
machine to achieve tolerable risk by adequate risk reduction .68
Annex D (informative) How this document relates to ISO 13849-1 .72
Annex E (informative) Trilingual lookup and index of specific terms and expressions used in
this document .77
Annex ZA (informative) Relationship between this European Standard and the essential
requirements of Directive 2006/42/EC aimed to be covered .90
Annex ZB (informative) Relationship between this European Standard and the essential
requirements of Regulation (EU) 2023/1230 aimed to be covered .91
Annex ZC (informative) Relation of this document to the Machinery Directive 2006/42/EC .92
Annex ZD (informative) Relation of this document to the Regulation (EU) 2023/1230 .93
Bibliography .94
iv
ISO/DIS 12100.2:2025(en)
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 replaced by a new Figure 5;
— requirements for control systems moved to 6.3.5;
— reference to self-evolving behaviour of applied artificial intelligence added to 5.4, b) 2);
— 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 “Remote 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 6.3.5.15;
— ISO/TR 22100-1 and ISO/TR 22100-2 incorporated as new Annexes C and D.
v
ISO/DIS 12100.2:2025(en)
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.
vi
ISO/DIS 12100.2:2025(en)
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 life cycle 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.
vii
DRAFT International Standard ISO/DIS 12100.2:2025(en)
Safety of machinery — General principles for design — Risk
assessment and risk reduction
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 life cycle, 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 against 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.
It does neither cover risk nor damage, or both, 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.
2 Normative references
The 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 referenced document (including any amendments) applies.
ISO 13849-1:2023, Safety of machinery — Safety-related parts of control systems — Part 1: General principles
for design
ISO/TR 14121-2, Safety of machinery — Risk assessment — Part 2: Practical guidance and examples of methods
ISO 20607, Safety of machinery — Instruction handbook — General drafting principles
IEC 60204-1:2021, Safety of machinery — Electrical equipment of machines — Part 1: General requirements
3 Terms and definitions
For the purposes of this document, the following terms and definitions apply.
ISO/DIS 12100.2:2025(en)
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 a machine ss 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.
ISO/DIS 12100.2:2025(en)
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.
ISO/DIS 12100.2:2025(en)
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 (e.g., text, words, signs, signals, symbols, diagrams, photos)
used separately or in combination, to convey information to the user
Note 1 to entry: See 6.4.
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 life cycle
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 may act 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
ISO/DIS 12100.2:2025(en)
— 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; and
— 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.
ISO/DIS 12100.2:2025(en)
3.27.6
interlocking guard with a start function
control guard
special form of 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 an appropriate 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)
ISO/DIS 12100.2:2025(en)
3.28.8
mechanical restraint device
device which introduces into a mechanism a mechanical obstacle [e.g. wedge, spindle, strut, slide locks,
safety blocks, scotch (pin)] which by its design can prevent any hazardous movement(s) of such mechanism
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 life cycle, 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”.]
ISO/DIS 12100.2:2025(en)
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.]
3.35
common mode failures
common mode failures within a system
failures of different items characterized by the same failure mode
Note 1 to entry: Common mode failures can have different causes.
Note 2 to entry: Common mode failures can also be co
...
Die Standardisierung gemäß prEN ISO 12100:2025 bietet eine umfassende Grundlage für die Sicherheit von Maschinen und behandelt zentrale Aspekte der Risikobewertung und Risikominderung. Die Norm spezifiziert grundlegende Terminologien und Prinzipien, die notwendig sind, um Sicherheit in der Maschinenkonstruktion zu gewährleisten. Besonders hervorzuheben ist die strukturierte Methodik, die es Designern ermöglicht, die Sicherheit während des gesamten Lebenszyklus einer Maschine zu berücksichtigen. Ein wesentlicher Stärke der prEN ISO 12100:2025 liegt in der detaillierten Beschreibung der Verfahren zur Identifikation von Gefahren sowie zur Schätzung und Bewertung von Risiken. Diese Vorgehensweise ist essenziell, um Risiken frühzeitig zu erkennen und geeignete Maßnahmen zur Risikominderung zu implementieren. Die Norm basiert auf umfassendem Wissen und Erfahrungen in Bezug auf Maschinen, wodurch sie sehr relevant für aktuelle Designs ist. Ein weiterer positiver Aspekt der Norm ist die Betonung der Dokumentation und Verifizierung des gesamten Risikobewertungs- und Risikominderungsprozesses. Diese Dokumentation ist wichtig, um Transparenz zu gewährleisten und den Nachweis für die Einhaltung von Sicherheitsstandards zu erbringen. Die prEN ISO 12100:2025 stellt auch eine wertvolle Referenz für die Entwicklung von Typ-B- und Typ-C-Sicherheitsnormen dar, wodurch ihre Relevanz in der praktischen Anwendung noch steigt. Zusammenfassend lässt sich sagen, dass die prEN ISO 12100:2025 mit ihren klaren Richtlinien und robusten Prinzipien einen unverzichtbaren Beitrag zur Sicherheit von Maschinen in der heutigen Industrie leistet und somit für Designer und Hersteller von höchster Bedeutung ist.
ISO 12100:2010은 기계 디자인에서의 안전성을 확보하기 위해 필요한 기본 용어, 원칙 및 방법론을 구체적으로 규정하고 있습니다. 이 표준의 주된 목적은 기계 설계자들이 안전한 디자인을 달성할 수 있도록 지원하기 위해 리스크 평가 및 리스크 감소의 원칙을 제시하는 것입니다. 이러한 원칙은 기계에 대한 설계, 사용, 사건, 사고 및 관련 리스크에 대한 지식과 경험에 기반하고 있습니다. ISO 12100는 기계의 생애 주기와 관련된 단계에서 위험 요소를 식별하고, 리스크를 추정 및 평가하는 절차를 상세히 설명합니다. 위험 요소를 제거하거나 충족할 만한 수준으로 리스크를 감소시키기 위한 방법도 포함되어 있습니다. 이 표준은 리스크 평가 및 리스크 감소 과정의 문서화와 검증에 대한 지침을 제공하여, 사용자들이 체계적으로 안전성을 관리할 수 있도록 돕습니다. 또한 ISO 12100:2010은 B형 또는 C형 안전 표준을 작성하는 기반으로 사용될 수 있도록 설계되었습니다. 이것은 제조업체와 설계자가 기본적으로 참고해야 할 중요한 자료로 기능하며, 안전한 기계 설계를 위한 기본 틀을 제공합니다. 다만, 이 표준은 가정용 동물, 재산 또는 환경에 대한 리스크나 손상 문제는 다루고 있지 않습니다. ISO 12100:2010의 강점은 기계 설계와 관련된 전반적인 위험 관리 절차를 체계화하여, 설계자들이 보다 안전한 기계를 설계할 수 있도록 권장한다는 점입니다. 기계의 안전성 확보에 대한 명확한 원칙과 실용적인 접근 방법을 제공함으로써, 이 표준은 현재 및 미래의 기계 안전 기준의 중요한 기초로 자리잡고 있습니다. 기계 설계에서의 리스크 평가와 감소의 실천적 지침을 통해, 관련 산업에 있어 더욱 높은 안전성을 추구할 수 있게 합니다.
The standard prEN ISO 12100:2024, titled "Safety of machinery - General principles for design - Risk assessment and risk reduction," provides a comprehensive framework for ensuring the safety of machinery during the design phase. Its core objective is to establish foundational terminology, principles, and methodologies related to risk assessment and risk reduction, which are crucial for any design engineer looking to enhance safety standards. One of the strengths of ISO 12100:2010 is its emphasis on evidence-based methodologies grounded in the knowledge and experience of past machinery design incidents and accidents. By integrating a systematic approach to identifying hazards, estimating risks, and evaluating them throughout the machine life cycle, the standard fosters a proactive safety culture. This methodology not only aids designers in the elimination of hazards but ensures that sufficient risk reduction principles are applied, which is paramount in today’s manufacturing environment. The standard's guiding principles provide clarity on the documentation and verification processes associated with risk assessment and reduction. This feature highlights its relevance, as effective documentation is essential for tracking safety measures, ensuring compliance, and facilitating future improvements. Moreover, the standard serves as a pivotal foundation for the formulation of type-B and type-C safety standards, thus reinforcing its importance in the broader context of machinery safety. Although prEN ISO 12100:2024 lays out comprehensive practices for machinery safety design, it's noteworthy that it does not encompass risks or damages relevant to domestic animals, property, or the environment. This focused scope allows for a more concentrated approach to machinery safety without diluting efforts into adjacent areas. Overall, the prEN ISO 12100:2024 standard is an essential tool for designers striving to meet safety benchmarks within machinery development. Its robust principles and structured methodology provide a valuable resource that enhances the overall safety and reliability of machinery in various industrial applications.
prEN ISO 12100は、機械の安全性の設計に関する重要な原則を定義しており、リスク評価やリスク低減のための方法論を提供します。この標準は、機械の設計、使用、事故、リスクに関する知識と経験に基づいて、設計者が安全性を実現するための原則を明示しています。 この文書の強みは、機械ライフサイクルの関連フェーズにおける危険の特定とリスクの評価に関する手続きが詳細に記載されている点にあります。これは、設計者がリスクを適切に評価し、危険を排除または十分なリスク低減を図るための有効な手段となります。また、リスク評価およびリスク低減プロセスの文書化と検証に関する指針も提供されており、実践的な部分でも非常に有用です。 さらに、ISO 12100:2010は、タイプBまたはタイプCの安全基準を策定するための基礎としても利用されることを意図しています。これにより、機械の安全性を高めるための標準化が進むことが期待されます。なお、この文書は、家庭動物、財産、環境に対するリスクや損害については取り扱っていないことも明確にされています。 総じて、prEN ISO 12100は、機械の安全性を達成するための信頼性の高いガイドラインを提供しており、その適用範囲および内容の明確さから、設計者や業界の専門家にとって非常に重要な標準として位置付けられています。この標準は、機械の設計時におけるリスク管理の重要性を再認識させるものであり、その意義は今後ますます高まるでしょう。
Le document standard prEN ISO 12100 se révèle être une référence fondamentale pour la sécurité des machines. Son champ d'application, précisé dans la norme ISO 12100:2010, établit des terminologies, des principes et une méthodologie essentiels pour garantir la sécurité lors de la conception de machines. Parmi ses points forts, la norme souligne des principes de l'évaluation des risques et de la réduction des risques, qui constituent des outils cruciaux pour les concepteurs visant à atteindre des niveaux de sécurité appropriés. En s'appuyant sur des connaissances et des expériences antérieures concernant la conception, l'utilisation, ainsi que les incidents et accidents impliquant des machines, prEN ISO 12100 offre une approche bien étayée pour identifier les dangers et évaluer les risques durant les différentes phases du cycle de vie des machines. De plus, le document propose des procédures claires pour l'élimination des dangers ou la réduction suffisante des risques. L'importance de la documentation et de la vérification des processus d'évaluation des risques et de réduction des risques est également un aspect essentiel abordé dans cette norme, ce qui renforce son utilité pour les concepteurs. La norme est pertinente non seulement en tant que document autonome, mais elle sert également de base solide pour la préparation de normes de sécurité de type B ou C. Toutefois, il convient de noter que prEN ISO 12100 ne traite pas des risques ou des dommages pouvant toucher les animaux domestiques, les biens ou l'environnement, ce qui limite son champ d'application à des contextes bien définis. En somme, la norme prEN ISO 12100 s'affirme comme un outil indispensable pour les professionnels de la conception de machines, favorisant ainsi une culture de sécurité proactive et rigoureuse dans l'industrie.
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