ISO/DIS 12100 Draft 2024

ISO/DIS 12100 Safety of machinery - General principles for design - Risk assessment and risk reduction

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.

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.