ISO/TS 4807:2022 粒子サイズ測定の参考資料—要件の仕様 | ページ 5

3.1

kind of quantity

aspect common to mutually comparable quantities

Note 1 to entry: The division of ‘quantity’ according to ‘kind of quantity’ is to some extent arbitrary.

Note 2 to entry: Quantities of the same kind within a given system of quantities have the same quantity dimension. However, quantities of the same dimension are not necessarily of the same kind.

[SOURCE:ISO/IEC Guide 99:2007, 1.2, modified — Note 3 to entry and EXAMPLES 2 and 3 have been deleted.]

3.2

measurand

quantity intended to be measured

Note 1 to entry: The specification of a measurand requires knowledge of the kind of quantity (3.1) , description of the state of the phenomenon, body, or substance carrying the quantity, including any relevant component, and the chemical entities involved.

[SOURCE:ISO/IEC Guide 99:2007, 2.3, modified — Notes 2 and 3 to entry and all the EXAMPLES have been deleted.]

3.3

operationally defined measurand

method-defined measurand

measurand (3.2) that is defined by reference to a documented and widely accepted measurement procedure to which only results obtained by the same procedure can be compared

Note 1 to entry: A term for measurands that are independent of a procedure does not exist. The term “non-operationally defined measurand” is used in this document.

[SOURCE:ISO 17034:2016, 3.7, modified — the second term has been added and Note 1 to entry has been replaced.]

3.4

metrological traceability

property of a measurement result whereby the result can be related to a reference through a documented unbroken chain of calibrations (3.12) , each contributing to the measurement uncertainty

Note 1 to entry: For this definition, a ‘reference’ can be a definition of a measurement unit through its practical realization, or a measurement procedure including the measurement unit for a non-ordinal quantity, or a measurement standard.

[SOURCE:ISO/IEC Guide 99:2007, 2.41, modified — Notes 2 to 8 to entries have been deleted.]

3.5

monomodal material

material consisting of particles where the particle size density distribution has only one maximum

Note 1 to entry: A monomodal material is not monodisperse if the width of the distribution is larger than the limits described for monodisperse mateials (3.6) .

3.6

monodisperse material

material consisting of particles with narrow particle size distribution

Note 1 to entry: For this document, a material is considered monodisperse if the width of the distribution of the number-based diameter expressed as x₉₀/x₁₀ is 1,12 or less (where x₁₀ is 10 % percentile of the cumulative particle size distribution and x₉₀ is 90 % percentile of the cumulative particle size distribution), which corresponds to a relative standard deviation of the distribution of 4,4 %. The limit 1,12 is taken from the requirements for monodisperse pickets from ISO/TS 14411-1. Such narrow size distributions are typically found in polymer latex materials.

3.7

spherical particle

particle with an aspect ratio of 0,95 or above in all three dimensions

Note 1 to entry: particles with small outgrows or that are not smooth can nevertheless fulfil this definition of sphericity.

3.8

reference material

rm

material, sufficiently homogeneous and stable with respect to one or more specified properties, which has been established to be fit for its intended use in a measurement process

Note 1 to entry: RM is a generic term comprising both certified and non-certified RMs. There is no term explicitly referring to RMs without any assigned certified value (3.10) . In this document, the term “reference material/ RM” is used for the superordinate, i.e. certified and non-certified RMs, whereas “non-certified RM” is used to explicitly refer to materials without certified values.

Note 2 to entry: Properties can be quantitative or qualitative, e.g. identity of substances or species.

Note 3 to entry: Uses may include the calibration (3.12) of a measurement system, assessment of a measurement procedure, assigning values to other materials, and quality control.

[SOURCE:ISO Guide 30:2015, 2.1.1, modified — Note 1 to entry has been expanded and Note 4 to entry has been deleted.]

3.9

certified reference material

CRM

reference material (3.8) characterized by a metrologically valid procedure for one or more specified properties, accompanied by an RM certificate that provides the value of the specified property, its associated uncertainty, and a statement of metrological traceability (3.4)

Note 1 to entry: The concept of value includes a nominal property or a qualitative attribute such as identity or sequence. Uncertainties for such attributes may be expressed as probabilities or levels of confidence.

[SOURCE:ISO Guide 30:2015, 2.1.2, modified — Notes 2 to 4 to entry have been deleted.]

3.10

certified value

value, assigned to a property of a reference material (3.8) that is accompanied by an uncertainty statement and a statement of metrological traceability (3.4) , identified as such in the RM certificate

[SOURCE:ISO Guide 30:2015, 2.2.3]

3.11

indicative value

information value

informative value

value of a quantity or property, of a reference material (3.8) , which is provided for information only

Note 1 to entry: An indicative value cannot be used as a reference in a metrological traceability (3.4) chain

[SOURCE:ISO Guide 30:2015, 2.2.4]

3.12

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 measurement uncertainties and, in a second step, uses this information to establish a relation for obtaining a measurement result from an indication.

Note 1 to entry: A calibration may be expressed by a statement, calibration function, calibration diagram, calibration curve, or calibration table. In some cases, it may consist of an additive or multiplicative correction of the indication with associated measurement uncertainty.

Note 2 to entry: Calibration should not be confused with adjustment of a measuring system, often mistakenly called “self-calibration”, nor with verification of calibration.

Note 3 to entry: Often, the first step alone in the above definition is perceived as being calibration.

[SOURCE:ISO/IEC Guide 99:2007, 2.39]

3.13

design qualification

DQ

process for verification that the proposed specification for the facility, equipment, or system meets the expectation for the intended use

[SOURCE:ISO 11139:2018, 3.220.1]

3.14

installation qualification

IQ

process of establishing by objective evidence that all key aspects of the process equipment and ancillary system installation comply with the approved specification

[SOURCE:ISO 11139:2018, 3.220.2]

3.15

performance qualification

PQ

process of establishing by objective evidence that the process, under anticipated conditions, consistently produces a product which meets all predetermined requirements

[SOURCE:ISO 11139:2018, 3.220.4]

3.16

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 11139:2018, 3.220.3]

3.17

proficiency test

evaluation of participant performance against pre-established criteria by means of interlaboratory comparisons

[SOURCE:ISO/IEC 17043:2010, 3.7, modified — Notes to entry 1 and 2 have been removed.]

3.18

statistical quality control

part of quality control in which statistical methods are used (such as estimation and tests of parameters and sampling inspection)

[SOURCE:ISO 12491:1997, 3.2, modified — the EXAMPLE has been added.]