ISO 12100:2010

Overview

ISO 12100:2010 - "Safety of machinery - General principles for design - Risk assessment and risk reduction" is a Type‑A international standard that provides fundamental terminology, principles and a structured methodology for achieving safety in machinery design. It sets out the strategy for risk assessment and risk reduction across the machine life cycle, and serves as a baseline for developing type‑B and type‑C machinery safety standards. Note: ISO 12100:2010 does not cover risks to domestic animals, property or the environment.

Key topics and requirements

• Risk assessment framework: Procedures for hazard identification, risk estimation and risk evaluation during relevant life‑cycle phases (see Clause 5).
• Risk reduction strategy: Hierarchy of measures to eliminate hazards or reduce risks to an acceptable level, including inherently safe design, safeguarding and complementary protective measures (Clause 6).
• Design principles: Guidance on applying ergonomic principles, maintainability, stability, appropriate technology selection and positive mechanical action to reduce hazards.
• Control system considerations: Requirements for applying inherently safe measures to electrical, pneumatic, hydraulic and control systems and for limiting exposure through reliability and automation.
• Safeguarding and protective devices: Selection, implementation and design expectations for guards, interlocks, protective devices and emission controls.
• Information for use and documentation: Requirements for signals, markings, instruction handbooks and verification/documentation of the risk assessment and risk reduction process (Clauses 6.4 and 7).
• Supporting content: Annex B provides examples of hazards and hazardous events to assist hazard identification; normative references include IEC 60204‑1.

Practical applications and users

ISO 12100 is used to:

• Guide machine designers and product development teams in incorporating safety from concept through decommissioning.
• Support safety engineers and risk assessors performing hazard identification, risk estimation and risk evaluation.
• Provide a foundation for standards developers preparing type‑B (generic) and type‑C (machine‑specific) safety standards.
• Assist compliance and conformity assessors, regulatory bodies and technical auditors in evaluating documented risk assessments and risk‑reduction measures. Typical applications include design reviews, selection of guards and safety devices, specification of control‑system safety functions, ergonomic and maintainability assessments, and preparation of user documentation and warning labels.

Related standards

• IEC 60204‑1 (Safety of machinery - Electrical equipment of machines) is referenced as indispensable.
• ISO/IEC Guide 51 concepts were considered in drafting ISO 12100.
• ISO 12100 consolidates earlier documents ISO 12100‑1, ISO 12100‑2 and ISO 14121‑1.

Keywords: ISO 12100, machinery safety, risk assessment, risk reduction, hazard identification, machine design, safeguarding, safety standards.