ISO 14470:2011
Food irradiation — Requirements for the development, validation and routine control of the process of irradiation using ionizing radiation for the treatment of food
ISO 14470:2011 specifies requirements for the development, validation and routine control of the process of irradiation using ionizing radiation for the treatment of food, and establishes guidelines for meeting the requirements.
ISO 14470:2011 covers irradiation processes using the radionuclides 60Co or 137Cs, electron beams or X-ray generators.
The requirements given in ISO 14470:2011 are the minimum necessary to control the food irradiation process.
ISO 14470:2011 does not specify requirements for the primary production and/or harvesting, post-harvest treatment, storage and shipment, and packaging for foods that are to be irradiated. Only those aspects of the food production directly related to the irradiation process that may affect the safety or quality of the irradiated food are addressed.
ISO 14470:2011 does not specify requirements for occupational safety associated with the design and operation of irradiation facilities.
ISO 14470:2011 does not cover measuring or inspection devices that utilize ionizing radiation.
The application of ISO 14470:2011 does not exempt the user from compliance with current and applicable legislation.
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Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 Controlling the food irradiation process
4.1 Responsibility and authority
4.2 Product realization
4.3 Monitoring, measurement and analysis
4.4 Technical agreement
4.5 Documentation
5 Irradiation facilities
5.1 Design
5.2 Radiation sources
5.3 Equipment
5.4 Personnel
6 Product
6.1 Product definition
6.2 Product specification
7 Process
7.1 Process definition — Dose range
7.2 Process specification
8 Dosimetry
9 Validation
9.1 Installation qualification (IQ)
9.2 Operational qualification (OQ)
9.3 Performance qualification (PQ)
9.4 Review and approval of validation
10 Routine monitoring and control
10.1 Process parameters
10.2 Product-loading configuration
10.3 Routine dosimetry
10.4 Processing inventory control
10.5 Labelling
10.6 Process interruptions
10.7 Irradiation process records
11 Product release from irradiation process
12 Maintaining process effectiveness
12.1 Demonstration of continued effectiveness
12.2 Equipment calibration
12.3 Recalibration
12.4 Maintenance of equipment
12.5 Requalification of the irradiation process
12.6 Assessment of change
Annex A (informative) Guidelines
Bibliography
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Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 Controlling the food irradiation process
4.1 Responsibility and authority
4.2 Product realization
4.3 Monitoring, measurement and analysis
4.4 Technical agreement
4.5 Documentation
5 Irradiation facilities
5.1 Design
5.2 Radiation sources
5.3 Equipment
5.4 Personnel
6 Product
6.1 Product definition
6.2 Product specification
7 Process
7.1 Process definition — Dose range
7.2 Process specification
8 Dosimetry
9 Validation
9.1 Installation qualification (IQ)
9.2 Operational qualification (OQ)
9.3 Performance qualification (PQ)
9.4 Review and approval of validation
10 Routine monitoring and control
10.1 Process parameters
10.2 Product-loading configuration
10.3 Routine dosimetry
10.4 Processing inventory control
10.5 Labelling
10.6 Process interruptions
10.7 Irradiation process records
11 Product release from irradiation process
12 Maintaining process effectiveness
12.1 Demonstration of continued effectiveness
12.2 Equipment calibration
12.3 Recalibration
12.4 Maintenance of equipment
12.5 Requalification of the irradiation process
12.6 Assessment of change
Annex A (informative) Guidelines
Bibliography