ISO 14470 Terms and Definitions Flashcards
Absorbed Dose
Quantity of ionizing radiation energy imparted per unit mass of a specified material.
Note 1: The unit of absorbed dose is the gray (Gy) where 1 (Gy) is equivalent to the absorption of 1 J/kg.
Note 2: For the purpose of this International Standard, the term dose is used to mean “absorbed does”
ISO/IEC 11137-1:2006 4,3.1
Calibration
operation that, under specified conditions, in a first step, establishes a relation between the quantity values with measurement uncertainties provided by measurement standards and corresponding indications with associated measurements uncertainties and, in a second step, uses this information to establish a relation for obtaining a measurement result from an indication
ISO/IEC Guide 99:2007 16,2.39
Correction
action to eliminate a detected non-comformity
Note: A correction can be made in conjunction with a corrective action
ISO 9000:2005 2, 3.6.6
Corrective Action
action to eliminate the cause of a detected non-conformity or other undesirable situation.
Note 1: There can be more than one cause of non-conformity.
Note 2: Corrective action is taken to prevent recurrence whereas preventive action is taken to prevent occurrence.
Note 3: There is a distinction between correction and corrective action.
ISO 9000:2005 2, 3.6.5
cross-contamination
contamination of a material or product with another material or product
ISO 15378:2011 7,3.15
Note: Cross-contamination occurs when a product and/or raw material is contaminated directly or indirectly from another product and/or raw material through physical contact or the environment.
Customer
organization or person that receives the product.
ISO 9000:2005 2 3.3.5
Note: In the context of this international standard, the “product” is irradiation treatment supplied by an irradiator operator under specified conditions
Dose Distribution
Spatial variation in absorbed dose throughout a defined region and material, integrated over a complete treatment.
Dose Mapping
measurement of dose distribution and variability in material irradiated under defined conditions.
ISO 11137-1:2006 4, 3.10
Dose uniformity ratio
ratio of the maximum to minimum absorbed dose
Dosimeter
Device having a reproducible, measurable response to radiation, which can be used to measure the absorbed dose in a given system.
ISO 11137-1:2006 4, 3.11
Dosimetry
measurement of absorbed dose by the use of dosimeters.
ISO 11137-1:2006 4 3.12
Dosimetry System
interrelated elements used for determining absorbed dose, including dosimeters, instruments, associated reference standards and procedures for their use.
ISO 11137-1:2006 5 3.1
Food irradiation
processing of food by ionizing radiation
Food safety
concept that food will not cause harm to the consumer when it is prepared and/or eaten according to its intended use.
ISO 22000:2005, 3.1
Good Manufacturing Practice (GMP)
combination of manufacturing and quality procedures aimed at ensuring that products are consistently manufactured to their specifications, and to avoid contamination of the product by internal or ecternal sources.
Installation Qualification (IQ)
process of obtaining and documenting evidence that equipment has been provided and installed in accordance with its specification.
ISO 11137-1:2006 4, 3.16
irradiation container
holder in which product is transported through the irradiator.
Note: The holder can be a carrier, cart, tray, product carton, pallet or other container.
ISO 11137-1:2006 4, 3.17
Irradiation Facility
Established where the irradiation Process is performed
Note 1 Irradiation facilities can consist of an irradiator, shipping and receiving docks, storage zones for irradiated and non-irradiated food, conveyor system, safety systems and the infrastructure for personnel and facility services including record control (generation, updating, control and file).
Note 2 There are different types of irradiation facilities depending on the irradiation type, the conveyor system, the radiation source, the operating mode, among others.
irradiator
assembly that provides for safe and reliable irradiation processing, including the source of radiation, conveyor and source mechanisms, safety devices, and biological shield.
irradiator operator
company or body responsible for irradiation of product
non-conformity
non-fulfillment of a requirement
operational qualification
process of obtaining and documenting evidence that installed equipment operates within predetermined limits when used in accordance with its operational procedures.
performance qualification
process of obtaining and documenting evidence that the equipment, as installed and operated in accordance with operational procedures, consistently performs in accordance with predetermined criteria and thereby yields product meeting its specification.
preventive action
action to eliminate the cause of a potential non-conformity or other undesirable potential situation.
Note 1 There can be more than one cause for a potential non-conformity
Note 2 Preventive action is taken to prevent occurrence whereas corrective action is taken to prevent recurrence.
