ISO 18472:2018 ヘルスケア製品の滅菌—生物学的および化学的指標—試験装置 | ページ 6

3.1

biological indicator

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

[SOURCE:ISO 11139:2018, 3.29]

3.2

calibration

operation that, under specified conditions, in a first step, establishes a relation between the quantity values with measurement uncertainties provided by the measurement standards and corresponding indications with associated measurement uncertainties and, in a second step, uses this information to establish a relation for obtaining a measurement result from an indication

[SOURCE:ISO/IEC Guide 99:2007, 2.39, modified — NOTE 1, 2, and 3 have been deleted.]

3.3

chemical indicator

test system that reveals change in one or more pre-specified process variables based on a chemical or physical change resulting from exposure to a process

[SOURCE:ISO 11139:2018, 3.43]

3.4

come-down period

<resistometer> time elapsed from the termination of the exposure period to an established null reaction point

[SOURCE:ISO 11139:2018, 3.56]

3.5

come-up period

<resistometer> time elapsed from the introduction of the sterilizing agent to the attainment of the specified conditions

[SOURCE:ISO 11139:2018, 3.57]

3.6

indicator exposure period

duration between the initial attainment to the termination of the specified exposure conditions

[SOURCE:ISO 11139:2018, 3.140]

3.7

measurement accuracy

closeness of the agreement between a measured quantity value and a true quantity value of a measurand

Note 1 to entry: “Accuracy” is a qualitative concept.

Note 2 to entry: The term “precision” should not be used for “accuracy”.

[SOURCE:ISO/IEC Guide 99:2007, 2.13, modified — The terms “accuracy of measurement” and “accuracy” have been deleted. NOTE 1 and 2 have been modified. NOTE 3 has been deleted.]

3.8

measurement precision

closeness of agreement between indications or measured quantity values obtained by replicate measurements on the same or similar objects under specified conditions

Note 1 to entry: Measurement precision is usually expressed numerically by measures of imprecision, such as standard deviation, variance, or coefficient of variation under the specified conditions of measurement.

Note 2 to entry: The ‘specified conditions’ can be, for example, repeatability conditions of measurement, intermediate precision conditions of measurement, or reproducibility conditions of measurement.

Note 3 to entry: Measurement precision is used to define “measurement repeatability”, “intermediate measurement precision”, and “measurement reproducibility”.

Note 4 to entry: Sometimes “measurement precision” is erroneously used to mean measurement accuracy.

[SOURCE:ISO/IEC Guide 99:2007, 2.15, modified — The term “precision” has been deleted. The NOTEs have been modified.]

3.9

null reaction point

terminating set of conditions that have no significant effect on the indicator

3.10

record , verb

<data> collect, store and make accessible

[SOURCE:ISO 11139:2018, 3.223]

3.11

reference standard

measurement standard designated for the calibration of other measurement standards for quantities of a given kind in a given organization or at a given location

[SOURCE:ISO/IEC Guide 99:2007, 5.6, modified — The term name has been simplified.]

3.12

resistometer

test equipment designed to create specified combinations of the physical and/or chemical parameters of a sterilization process

[SOURCE:ISO 11139:2018, 3.233]

3.13

response time

τ₉₀

<sensor> period required for a 90 % change in sensor output when exposed to a step change in the variable being measured

Note 1 to entry: It may be necessary to determine the sensor response time using a faster data sampling rate than the minimum for the equipment specified in this document. Documentary evidence from the sensor manufacturer's stated response time is equally acceptable as proof of conformance.

[SOURCE:ISO 11139:2018, 3.234, modified — Note 1 to entry has been added.]

3.14

saturated steam

water vapour in a state of equilibrium between its liquid and gas phases

[SOURCE:ISO 11139:2018, 3.241]

3.15

stabilization period

elapsed time from the attainment of the minimum specified exposure conditions until the end of the specified time to achieve steady state conditions

[SOURCE:ISO 11139:2018, 3.261]

3.16

steady state period

<indicator> portion of the exposure period which begins after the stabilization period and terminates at the end of the exposure period

[SOURCE:ISO 11139:2018, 3.266]

3.17

sterilant

chemical or combination of chemicals used to generate a sterilizing agent

[SOURCE:ISO 11139:2018, 3.268]