ISO 11137-1:2006 ヘルスケア製品の滅菌—放射線—パート1：医療機器の滅菌プロセスの開発、検証、および日常的な管理の要件 | ページ 6

3.1

absorbed dose

dose

quantity of ionizing radiation energy imparted per unit mass of a specified material

Note 1 to entry: The unit of absorbed dose is the gray (Gy) where 1 Gy is equivalent to the absorption of 1 J/kg.

Note 2 to entry: For the purposes of this part of ISO 11137, the term dose is used to mean “absorbed dose”.

3.2

bioburden

population of viable microorganisms on or in the product and/or sterile barrier system

[SOURCE: ISO/TS 11139:2006]

3.3

biological indicator

test system containing viable microorganisms providing a defined resistance to a specified sterilization process

[SOURCE: ISO/TS 11139:2006]

3.4

calibration

set of operations that establish, under specified conditions, the relationship between values of a quantity indicated by a measuring instrument or measuring system, or values represented by a material measure or a reference material, and the corresponding values realized by standards

[SOURCE: VIM:1993, definition 6.11]

3.5

change control

assessment and determination of the appropriateness of a proposed alteration to product or procedure

[SOURCE: ISO/TS 11139:2006]

3.6

correction

action to eliminate a detected nonconformity

Note 1 to entry: A correction can be made in conjunction with corrective action (3.7) .

[SOURCE: ISO 9000:2005]

3.7

corrective action

action to eliminate the cause of a detected nonconformity or other undesirable situation

Note 1 to entry: There can be more than one cause for a nonconformity.

Note 2 to entry: Corrective action is taken to prevent recurrence whereas “preventive action” (3.24) is taken to prevent occurrence.

Note 3 to entry: There is a distinction between correction and corrective action.

[SOURCE: ISO 9000:2005]

3.8

D value

D₁₀ value

time or radiation dose required to achieve inactivation of 90 % of a population of the test microorganism under stated conditions

Note 1 to entry: For the purpose of the ISO 11137 series, the D value refers to the radiation dose necessary to achieve the 90 % reduction.

[SOURCE: ISO/TS 11139:2006]

3.9

development

act of elaborating a specification

[SOURCE: ISO/TS 11139:2006]

3.10

dose mapping

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

3.11

dosimeter

device having a reproducible, measurable response to radiation, which can be used to measure the absorbed dose in a given system

[SOURCE: ISO/TS 11139:2006]

3.12

dosimetry

measurement of absorbed dose by the use of dosimeters

3.13

establish

determine by theoretical evaluation and confirm by experimentation

[SOURCE: ISO/TS 11139:2006]

3.14

fault

one or more of the process parameters lying outside of its/their specified tolerance(s)

[SOURCE: ISO/TS 11139:2006]

3.15

health care product(s)

medical device(s), including in vitro diagnostic medical device(s), or medicinal product(s), including biopharmaceutical(s)

[SOURCE: ISO/TS 11139:2006]

3.16

installation qualification

IQ

process of obtaining and documenting evidence that equipment has been provided and installed in accordance with its specification

[SOURCE: ISO/TS 11139:2006]

3.17

irradiation container

holder in which product is transported through the irradiator

Note 1 to entry: The holder can be a carrier, cart, tray, product carton, pallet or other container.

3.18

irradiator operator

company or body responsible for irradiation of product

3.19

maximum acceptable dose

dose given in the process specification as the highest dose that can be applied to a defined product without compromising safety, quality or performance

3.20

medical device

[SOURCE: ISO 13485:2003]

Note 1 to entry: This definition from ISO 13485:2003 has been developed by the Global Harmonization Task Force (GHTF 2002).

3.21

microorganism

entity of microscopic size, encompassing bacteria, fungi, protozoa and viruses

Note 1 to entry: A specific standard might not require demonstration of the effectiveness of the sterilization process in inactivating all types of microorganisms, identified in the definition above, for validation and/or routine control of the sterilization process.

[SOURCE: ISO/TS 11139:2006]

3.22

operational qualification

OQ

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

[SOURCE: ISO/TS 11139:2006]

3.23

performance qualification

PQ

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

[SOURCE: ISO/TS 11139:2006]

3.24

preventive action

action to eliminate the cause of a potential nonconformity or other undesirable potential situation

Note 1 to entry: There can be more than one cause for a potential nonconformity.

Note 2 to entry: Preventive action is taken to prevent occurrence whereas “corrective action” (3.7) is taken to prevent recurrence.

[SOURCE: ISO 9000:2005]

3.25

primary manufacturer

body responsible for the design and manufacture of a medical device, together with the safety and performance of that medical device when placed on the market

3.26

process interruption

intentional or unintentional stoppage of the irradiation process

3.27

process parameter

specified value for a process variable

Note 1 to entry: The specification for a sterilization process includes the process parameters and their tolerances.

[SOURCE: ISO/TS 11139:2006]

3.28

process variable

condition within a sterilization process, changes in which alter microbicidal effectiveness

3.29

processing category

group of different product that can be sterilized together

Note 1 to entry: Processing categories can be based on, for instance, composition, density or dose requirements.

3.30

product

result of a process

[SOURCE: ISO 9000:2005]

Note 1 to entry: For the purposes of sterilization standards, product is tangible and can be raw material(s), intermediate(s), sub-assembly(ies) or health care product(s).

3.31

product family

group of different product that can be given the same sterilization dose

3.32

requalification

repetition of part of validation for the purpose of confirming the continued acceptability of a specified process

[SOURCE: ISO/TS 11139:2006]

3.33

services

supplies from an external source, needed for the function of equipment

3.34

specification

approved document stipulating requirements

3.35

specify

stipulate in detail within an approved document

[SOURCE: ISO/TS 11139:2006]

3.36

sterile

free from viable microorganisms

[SOURCE: ISO/TS 11139:2006]

3.37

sterility

state of being free from viable microorganisms

Note 1 to entry: In practice, no such absolute statement regarding the absence of microorganisms can be proven (see sterilization) 3.39 .

[SOURCE: ISO/TS 11139:2006]

3.38

sterility assurance level

SAL

probability of a single viable microorganism occurring on an item after sterilization

Note 1 to entry: The term SAL takes a quantitative value, generally 10^–6 or 10^–3. When applying this quantitative value to assurance of sterility, an SAL of 10^–6 has a lower value but provides greater assurance of sterility than an SAL of 10^–3.

[SOURCE: ISO/TS 11139:2006]

3.39

sterilization

validated process used to render product free from viable microorganisms

Note 1 to entry: In a sterilization process, the nature of microbial inactivation is exponential and thus the survival of a microorganism on an individual item can be expressed in terms of probability. While this probability can be reduced to a very low number it can never be reduced to zero [see “sterility assurance level” (3.38) ].

[SOURCE: ISO/TS 11139:2006]

3.40

sterilization dose

minimum dose to achieve the specified requirements for sterility

3.41

sterilization process

series of actions or operations needed to achieve the specified requirements for sterility

Note 1 to entry: This series of actions includes pretreatment of product (if necessary), exposure under defined conditions to the sterilizing agent and any necessary post treatment. The sterilization process does not include any cleaning, disinfection or packaging operations that precede sterilization.

[SOURCE: ISO/TS 11139:2006]

3.42

sterilizing agent

physical or chemical entity, or combination of entities having sufficient microbicidal activity to achieve sterility under defined conditions

[SOURCE: ISO/TS 11139:2006]

3.43

test for sterility

technical operation defined in an official pharmacopoeia performed on product following exposure to a sterilization process

[SOURCE: ISO/TS 11139:2006]

3.44

test of sterility

technical operation performed as part of development, validation or requalification to determine the presence or absence of viable microorganisms on product or portions thereof

[SOURCE: ISO/TS 11139:2006]

3.45

transit dose

dose absorbed during travel of product or source to or from the non-irradiation to the irradiation position

3.46

uncertainty of measurement

parameter, associated with the result of a measurement, that characterizes the dispersion of values that could reasonably be attributed to the measurand

[SOURCE: VIM 1993]

3.47

validation

documented procedure for obtaining, recording and interpreting the results required to establish that a process will consistently yield product complying with predetermined specifications

[SOURCE: ISO/TS 11139:2006]