Overview
ISO Guide 78:2012 - Safety of machinery: Rules for drafting and presentation of safety standards provides mandatory and advisory rules for the preparation, drafting and presentation of international machinery safety standards. Intended primarily for the development of type-C (machine-specific) standards and applicable to type-B (generic safety aspect or safeguard) standards, the Guide supplements the ISO/IEC Directives, Part 2 and aligns with ISO 12100 (risk assessment and risk reduction). It promotes consistency, clarity and regulatory support for machinery safety standards used worldwide.
Key topics and requirements
- Scope and purpose: Rules for drafting and revising machinery safety standards to achieve consistent quality and support national/regional technical regulations.
- Normative references: Mandatory use of ISO 12100:2010 and ISO/IEC Directives, Part 2 as foundational documents.
- Terms and definitions: Clear definitions for type‑A, type‑B (B1/B2) and type‑C standards, plus terms like relevant hazard, significant hazard, and added value.
- General principles: Standards must not contradict type‑A principles; focus on objectives rather than detailed designs; use of “risk reduction measure” synonymously with “protective measure.”
- Drafting process: Guidance on determining the need for standardization, defining scope, identifying hazards, estimating and evaluating risk, setting risk reduction objectives and specifying safety requirements.
- Format and structure: Prescribed layout elements such as Foreword, Introduction, Scope, Normative references, Terms and definitions, Safety requirements/protective measures, Verification, Information for use, and Annexes.
- Type‑B and type‑C specifics:
- Type‑B1: basic principles for safety topics and application methods.
- Type‑B2: performance requirements for safeguards and verification.
- Type‑C: comprehensive treatment of significant hazards for a machine or group of machines, reference to applicable type‑B standards, and specification of mandatory provisions.
- Annexes and support material: Includes a model format for type‑C standards, procedures when type‑B standards are missing, and guidance on documenting significant technical changes between editions.
Applications and users
ISO Guide 78:2012 is used by:
- ISO technical committees and standards authors drafting machine‑specific (type‑C) and generic (type‑B) safety standards.
- Regulatory bodies and policy-makers who adopt standards as part of technical regulations.
- Manufacturers, safety engineers and conformity assessment bodies who rely on consistent, verifiable safety standards for design, assessment and compliance.
- Consultants and legal teams referencing harmonized drafting rules when aligning standards with regional frameworks (e.g., Vienna Agreement) or UNECE recommendations.
Related standards
- ISO 12100:2010 - Safety of machinery - General principles for design - Risk assessment and risk reduction
- ISO/IEC Directives, Part 2 - Rules for the structure and drafting of International Standards
Keywords: ISO Guide 78:2012, safety of machinery, drafting safety standards, type‑C standard, type‑B standard, ISO 12100, risk reduction, machinery safety standards.
