Overview
SIST EN ISO 12100:2011 (identical to EN ISO 12100:2010 / ISO 12100:2010) defines general principles for the design of machinery with the aim of achieving safety through a structured process of risk assessment and risk reduction. It provides basic terminology, a risk assessment strategy and a methodology to identify hazards, estimate and evaluate risks across relevant phases of the machine life cycle, and then eliminate hazards or reduce risks to acceptable levels. The standard also covers documentation and verification of the risk assessment and reduction process. It is intended as the foundational document for preparing type-B and type-C machinery safety standards.
Key topics and requirements
- Fundamental terminology and definitions used in machinery safety and risk management.
- Strategy for risk assessment and risk reduction, including scope and limits (use, space, time) for machinery.
- Hazard identification and methods for identifying hazardous situations and hazardous events during design, operation, maintenance and disposal.
- Risk estimation and evaluation - procedures to assess severity and probability and determine whether risks are adequately reduced.
- Risk reduction hierarchy emphasizing inherently safe design measures first, then safeguarding and complementary protective measures.
- Design considerations such as geometry, stability, maintainability, ergonomics, electrical and fluid-power hazards, and safe control-system design.
- Safeguarding: selection, implementation and requirements for guards, protective devices, signals, markings and warnings.
- Information for use: requirements for instruction handbooks, labels, pictograms and other user information.
- Documentation and verification of the entire risk assessment and risk reduction process for traceability and compliance.
Practical applications and users
Who uses ISO 12100?
- Machine designers and OEMs applying safe-by-design principles.
- Safety engineers conducting formal risk assessments and developing risk reduction measures.
- Compliance and regulatory teams demonstrating conformity with the EU Machinery Directive (2006/42/EC).
- Standards developers producing type-B and type-C machine-specific safety standards.
- Test laboratories, certification bodies and notified bodies assessing machine safety.
- Maintenance planners, procurement specialists and end-users seeking documented safety information.
Typical uses:
- Embedding safety early in the design lifecycle.
- Preparing technical documentation and declarations of conformity.
- Selecting guards, interlocks and safety-related control measures.
- Producing instruction manuals and safety markings.
Related standards
- Consolidates and replaces earlier parts (ISO 12100-1/-2 and ISO 14121-1).
- Serves as the basis for type-B and type-C machinery safety standards.
- Harmonizes with EN adoption (EN ISO 12100:2010) and national implementations (e.g., SIST EN ISO 12100:2011).
Note: ISO 12100 addresses human safety risks associated with machinery - it does not cover risks to domestic animals, property or the environment.