Overview: EN ISO 14159:2008 - Safety of machinery - Hygiene requirements for the design of machinery
EN ISO 14159:2008 (ISO 14159:2002 adopted by CEN) defines hygiene requirements for the design of machinery and associated equipment used where hygiene risks to the consumer of a processed product can occur. It is a Type B standard in the ISO 12100 series and applies across sectors such as food, pharmaceuticals, biotechnology and cosmetics. The standard does not cover uncontrolled egress of microbiological agents.
Key topics and technical requirements
The standard provides a structured approach to hygienic machine design and includes:
- Scope and normative references - links to related standards (e.g., ISO 4287 surface texture; ISO 12100 safety fundamentals).
- Terms and definitions - key hygiene concepts (e.g., cleanable, cleaning in place, corrosion resistant material, crevice).
- Hazard identification - recognition of hygiene-related hazards affecting the consumer rather than operator safety.
- Hygiene requirements and measures (Clause 5) - a strategy for selecting hygiene measures (5.1) and detailed guidance on hygienic design (5.2).
- Verification and test methods (Clause 6) - methods to confirm that hygiene measures are effective.
- Documentation (Clause 7) - manufacturer’s instruction handbook, maintenance and cleaning procedures, and limitations of use.
- Informative annexes - categorization of machinery by intended use, examples of good and bad hygienic design features, and references to related standards.
Key technical considerations emphasized by EN ISO 14159:2008 include material selection (corrosion resistance), surface finish and texture, elimination of crevices and areas where product or liquids can accumulate, cleanability including cleaning-in-place (CIP) capability, and provisions for safe maintenance and disassembly for cleaning.
Practical applications and users
EN ISO 14159:2008 is used to:
- Guide machine designers and OEMs on hygienic design principles.
- Support food safety engineers, QA/QC teams, and validation specialists in demonstrating cleanability and compliance.
- Inform purchasing and regulatory teams evaluating machinery for hygienic suitability.
- Provide a compliance route to the EU Machinery Directive (2006/42/EC) and earlier 98/37/EC via Annex ZA/ZB, offering a presumption of conformity when applied within scope.
Typical applications: processing equipment, conveyors, packaging machines and associated fittings/piping where product contamination risks must be minimized.
Related standards
- ISO 12100 (Safety of machinery - basic concepts)
- ISO 4287 (Surface texture/profile)
- Sector- or machine-specific Type C standards may be required for detailed requirements in particular industries.
Adopting EN ISO 14159:2008 helps manufacturers and integrators implement hygienic design, demonstrate conformity with machinery safety and hygiene expectations, and reduce product contamination risks in consumer-facing industries.
