ISO 14470 Terms and Definitions

Question 1

Absorbed Dose

Answer 1

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

Question 2

Calibration

Answer 2

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

Question 3

Correction

Answer 3

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

Question 4

Corrective Action

Answer 4

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

Question 5

cross-contamination

Answer 5

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.

Question 6

Customer

Answer 6

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

Question 7

Dose Distribution

Answer 7

Spatial variation in absorbed dose throughout a defined region and material, integrated over a complete treatment.

Question 8

Dose Mapping

Answer 8

measurement of dose distribution and variability in material irradiated under defined conditions.

ISO 11137-1:2006 4, 3.10

Question 9

Dose uniformity ratio

Answer 9

ratio of the maximum to minimum absorbed dose

Question 10

Dosimeter

Answer 10

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

Question 11

Dosimetry

Answer 11

measurement of absorbed dose by the use of dosimeters.

ISO 11137-1:2006 4 3.12

Question 12

Dosimetry System

Answer 12

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

Question 13

Food irradiation

Answer 13

processing of food by ionizing radiation

Question 14

Food safety

Answer 14

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

Question 15

Good Manufacturing Practice (GMP)

Answer 15

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.

Question 16

Installation Qualification (IQ)

Answer 16

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

Question 17

irradiation container

Answer 17

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

Question 18

Irradiation Facility

Answer 18

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.

Question 19

irradiator

Answer 19

assembly that provides for safe and reliable irradiation processing, including the source of radiation, conveyor and source mechanisms, safety devices, and biological shield.

Question 20

irradiator operator

Answer 20

company or body responsible for irradiation of product

Question 21

non-conformity

Answer 21

non-fulfillment of a requirement

Question 22

operational qualification

Answer 22

process of obtaining and documenting evidence that installed equipment operates within predetermined limits when used in accordance with its operational procedures.

Question 23

performance qualification

Answer 23

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.

Question 24

preventive action

Answer 24

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.

Question 25

process interruption

Answer 25

intentional or unintentional stoppage of irradiation process.