Overview
ISO/IEC Guide 51:2014 - Safety aspects - Guidelines for their inclusion in standards provides requirements and practical recommendations for drafters of standards on how to include safety aspects. Applicable to any safety concern affecting people, property or the environment, the Guide helps standards committees and other stakeholders apply a consistent, lifecycle-based approach to identifying hazards and achieving tolerable risk.
Key topics and technical requirements
- Risk terminology and definitions: Clear definitions of key terms such as hazard, hazardous event, hazardous situation, risk, residual risk, tolerable risk, and vulnerable consumer.
- Elements of risk: Guidance on assessing severity, probability, exposure, occurrence of hazardous events, and possibilities to avoid or limit harm.
- Iterative risk assessment and risk reduction (Clause 6.1): Requires an iterative process-identify users (including vulnerable consumers), intended use and reasonably foreseeable misuse, identify hazards across the product life cycle, estimate and evaluate risk, and reduce risk until tolerable.
- Hierarchy of risk-reduction measures: Emphasizes inherently safe design first, then protective measures, information for use, and organizational measures where appropriate.
- Validation and review: Calls for validation of risk reduction and periodic review of tolerable risk levels in response to technological or societal changes.
- Use of language: Recommends avoiding vague claims like “safe” and replacing them with objective descriptions (e.g., “protective helmet” vs. “safety helmet”).
Practical applications and users
- Intended for standards drafters (ISO/IEC technical committees, subcommittees, working groups) preparing new or revised standards that include safety-related clauses.
- Useful for manufacturers, designers, service providers, regulators, and policy makers as a reference for embedding safety into product, process, service or system standards.
- Helps organizations implement structured risk assessment, design safer products (inherently safe design), address reasonably foreseeable misuse, and protect vulnerable consumers across the full life cycle (design, production, distribution, use, maintenance, disposal).
Related standards
- ISO/IEC Guide 51:2014 references and complements other risk guidance such as ISO 12100 (machine safety/risk assessment), ISO 14971 (medical device risk management), and consumer-safety guidance like ISO 10377.
ISO/IEC Guide 51:2014 is an essential reference for anyone involved in standardization or product safety wanting a principled, lifecycle-based framework for including safety aspects and achieving tolerable risk.