ISO/TS 5973:2024 レーザー回折測定 — グッドプラクティス | ページ 6

3.1

absorption

reduction of intensity of a light beam not due to scattering (3.14)

[SOURCE:ISO 13320:2020, 3.1.1]

3.2

accuracy

closeness of agreement between a test result or measurement result and the true value

Note 1 to entry: In practice, the accepted reference value is substituted for the true value.

Note 2 to entry: The term “accuracy”, when applied to a set of test or measurement results, involves a combination of random components and a common systematic error or bias component.

Note 3 to entry: Accuracy refers to a combination of trueness and precision (3.8) .

[SOURCE:ISO 3534-2:2006, 3.3.1]

3.3

intermediate precision

precision (3.8) under intermediate precision conditions/reproducibility conditions (3.4)

Note 1 to entry: Reproducibility is an alternative term for intermediate precision used in a specific case where a comparison of different instruments in different locations is required.

[SOURCE:ISO 3534‐2:2006, 3.3.15, modified — Note 1 to entry has been added.]

3.4

intermediate precision conditions

<laser diffraction>measurement conditions where independent test results or measurement results are obtained on different laser diffraction instruments and in different test or measurement facilities, with different operators using the same prescribed method

Note 1 to entry: There are four elements to the operating condition: time, calibration, operator and equipment. Tests involving varying the first three are technically intermediate precision (3.8) tests, most notably when the operator is changed, however when the equipment location is varied then it is a reproducibility test.

Note 2 to entry: Method transfer between sites is a test of reproducibility. The conditions described above would be termed reproducibility conditions in this case.

[SOURCE:ISO 13320:2020, 3.1.11, modified — the conditions to different equipment and measurement facilities have been expanded.]

3.5

multiple scattering

consecutive scattering (3.14) of light by more than one particle, causing a scattering pattern (3.15) that is no longer the sum of the patterns from all individual particles

[SOURCE:ISO 13320:2020, 3.1.12]

3.6

transmission

<particle size analysis> fraction of incident light that remains un-attenuated by the particles

Note 1 to entry: Transmission can be expressed as a percentage.

Note 2 to entry: When expressed as fractions, obscuration (3.7) plus transmission equals unity.

[SOURCE:ISO 13320:2020, 3.1.29]

3.7

obscuration

fraction of incident light that is attenuated due to extinction [ scattering (3.14) and/or absorption (3.1) ] by particles

Note 1 to entry: Obscuration can be expressed as a percentage.

Note 2 to entry: When expressed as fractions, obscuration plus transmission (3.6) equals unity.

[SOURCE:ISO 8130-13:2019, 3.1, modified — words “percentage” and “during a laser diffraction measurement” have been removed from the definition and Notes 1 and 2 to entry have added.]

3.8

precision

closeness of agreement between independent test/measurement results obtained under stipulated conditions

Note 1 to entry: Precision depends only on the distribution of random errors and does not relate to the true value or the specified value.

Note 2 to entry: The measure of precision is usually expressed in terms of imprecision and computed as a standard deviation of the test results. Less precision is reflected by a larger standard deviation.

Note 3 to entry: Quantitative measures of precision depend critically on the stipulated conditions. Repeatability conditions (3.10) and reproducibility conditions are particular sets of extreme stipulated conditions.

[SOURCE:ISO 3534-2:2006, 3.3.4, modified —"measurement results" has been removed from Note 2 to entry.]

3.9

repeatability

precision (3.8) under repeatability conditions (3.10)

Note 1 to entry: Repeatability can be expressed quantitatively in terms of the stability characteristics of the particulates in the dispersing medium (3.17) .

[SOURCE:ISO 3534‐2:2006, 3.3.5, modified —"dispersion characteristics of the results" has been replaced with"particulates in the dispersing medium" in Note 1 to entry.]

3.10

repeatability conditions

observation conditions where independent test/measurement results are obtained with the same method on identical test/measurement items in the same test or measuring facility by the same operator using the same equipment within short intervals of time

[SOURCE:ISO 3534‐2:2006, 3.3.6]

3.11

instrument repeatability

closeness of agreement between multiple measurement results of a given property in the same aliquot of a sample under repeatability conditions (3.10)

Note 1 to entry: The variability includes the variability from only the instrument itself.

3.12

method repeatability

closeness of agreement between multiple measurement results of a given property in different aliquots of a sample, executed by the same operator using the same instrument under identical conditions within a short period of time

Note 1 to entry: Various pharmaceutical monographs dictate the measurement of six separate preparations.

Note 2 to entry: The variability includes the variabilities of the sub sampling technique, the sampled material, the sample handling when adding the sample to the instrument and the instrument itself.

Note 3 to entry: Method repeatability is usually determined as standard deviation of a number of measurement results

[SOURCE:ISO 13320:2020, 3.1.22, modified —"the sample handling when adding the sample to the instrument" has been added to Note 2 to entry, and Notes 1 and 3 to entry have been added.]

3.13

optical properties

refractive index and absorption parameters used in the analysis of the sample

3.14

scattering

change in propagation of light at the interface of two media having different optical properties (3.13)

[SOURCE:ISO 13320:2020, 3.1.23]

3.15

scattering pattern

angular pattern of light intensity, I(θ), or spatial pattern of light intensity, I(r), originating from scattering (3.14) , or the related readings of energy values taking into account the sensitivity and the geometry of the detector elements

[SOURCE:ISO 13320:2020, 3.1.25, modified with addition of “readings of”]

3.16

single scattering

scattering (3.14) whereby the contribution of a single member of a particle population to the total scattering pattern (3.15) remains independent of the other members of the population

[SOURCE:ISO 13320:2020, 3.1.26]

3.17

dispersing medium

liquid or gas used to suspend particles during measurement that reduces their concentration for measurement

Note 1 to entry: For measurements in liquid, the term"diluent" is often used as a synonym for dispersing medium.