1 Scope
This Standard specifies hygiene requirements of machines and provides information for the intended use to be provided by the manufacturer. It applies to all types of machines and associated equipment used in applications where hygiene risks to the consumer of the product may occur.
This Standard does not cover requirements relative to the uncontrolled egress of microbiological agents from the machine.
2 Normative References
The following documents contain provisions which, through reference in this text, constitute provisions of this Standard. For dated reference, subsequent amendments to (excluding any corrigendum), or revisions of, any of these publications do not apply. However, parties to agreements based on this Standard are encouraged to investigate the possibility of applying the most recent editions of the standards indicated below. For any undated references, the latest edition of the normative document referred to applies.
GB/T 3505-2000 Geometrical Product Specifications (GPS) - Surface Texture: Profile Method - Terms, Definitions and Surface Texture Parameters (eqv ISO 4287:1997)
GB/T 15706.1-1995 Safety of Machinery - Basic Concept, General Principles for Design - Part 1: Basic Terminology, Methodology (eqv ISO/TR 12001-1:1992)
GB/T 15706.2-1995 Safety of Machinery - Basic Concepts, General Principles for Design - Part 2: Technical Principles and Specifications(eqv ISO/TR 12001-2:1992)
3 Terminologies and Definitions
For the purposes of this Standard, the following terminologies and definitions apply.
3.1
Associated equipment
All equipment associated with a machine, not defined as machinery (3.13), that is essential to the functioning of the machine for it to hygienically process a product (e.g. fittings, piping, tubing).
3.2
Foreword i
Introduction ii
1 Scope
2 Normative References
3 Terminologies and Definitions
4 Hazards
5 Hygiene Requirements and/or Measures
5.1 Strategy for Selecting Hygiene Measures
5.2 Hygienic Design
6 Verification of Hygiene Measures and Test Methods
7 Instruction Handbook, Maintenance and Cleaning
7.1 Instruction Handbook
7.2 Maintenance and Cleaning
8 Additional Information (Limitations of Use)
Appendix A (Informative) Categorization of Machinery and Associated Equipment for Intended Use
Appendix B (Informative) Examples of Qualified and Unqualified Hygienic Design Features
