ISO/TC 199/WG 5 - General principles for the design of machinery and risk assessment

This document provides assistance to the designer/manufacturer of machinery and related components as to how the system of existing type-A, type-B and type-C machinery safety standards should be applied in order to design a machine to achieve a level of tolerable risk by adequate risk reduction. This document explains the general principles of ISO 12100 and how this type-A standard is used for practical cases in conjunction with type-B and type-C machinery safety standards. This document provides assistance to standards-writing committees on how ISO 12100 and type-B and type-C standards relate and explains their function in the risk assessment and risk reduction process according to ISO 12100. This document includes an overview of existing categories of type-B standards to assist standards readers and writers to navigate the many standards.

This document addresses how artificial intelligence machine learning can impact the safety of machinery and machinery systems. This document describes how hazards being associated with artificial intelligence (AI) applications machine learning in machinery or machinery systems, and designed to act within specific limits, can be considered in the risk assessment process. This document is not applicable to machinery or machinery systems with AI applications machine learning designed to act beyond specified limits that can result in unpredictable effects. This document does not address safety systems with AI, for example, safety-related sensors and other safety-related parts of control systems.

This document specifies requirements for the machine manufacturer for preparation of the safety-relevant parts of an instruction handbook for machinery. This document: — provides further specifications to the general requirements on information for use given in ISO 12100:2010, 6.4.5; and — deals with the safety-related content, the corresponding structure and presentation of the instruction handbook, taking into account all phases of the life cycle of the machine. NOTE 1 The strategy for risk reduction at the machine is given in ISO 12100:2010, Clause 6, and includes inherently safe design measures, safeguarding and complementary risk reduction measures as well as information for use. NOTE 2 Annex A contains a correspondence table between ISO 12100:2010, 6.4, and this document. NOTE 3 Information for conception and preparation of instructions in general is available in IEC/IEEE 82079-1. This document establishes the principles which are indispensable to provide information on residual risks. This document does not address requirements for declaration of noise and vibration emissions. This document is not applicable to machinery manufactured before the date of its publication.

This document gives machine manufacturers guidance on potential security aspects in relation to safety of machinery when putting a machine into service or placing on the market for the first time. It provides essential information to identify and address IT-security threats which can influence safety of machinery. This document gives guidance but does not provide detailed specifications on how to address IT-security aspects which can influence safety of machinery. This document does not address the bypass or defeat of risk reduction measures through physical manipulation.

ISO/TR 22100-2:2013 describes the general relationship between ISO 12100 and ISO 13849‑1 used to reduce the risk of harm. It focuses on the use of safety-related parts of control systems in relation to risk assessment and the risk reduction process.

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/TR 22100-1:2015 provides assistance to the designer/manufacturer of machinery and related components as to how the system of existing type-A, type-B and type-C machinery safety standards should be applied in order to design a machine to achieve a level of tolerable risk by adequate risk reduction. It explains the general principles of ISO 12100 and how this type-A standard should be used for practical cases in conjunction with type-B and type-C machinery safety standards. ISO/TR 22100-1:2015 provides assistance to standards writing committees on how ISO 12100 and type-B and type-C standards relate and explains their function in the risk assessment and risk reduction process according to ISO 12100. It includes an overview of existing categories of type-B standards to assist standards readers and writers to navigate the many standards.