ISO 19430:2016

DRAFT INTERNATIONAL STANDARD
ISO/DIS 19430
ISO/TC 24/SC 4 Secretariat: JISC
Voting begins on: Voting terminates on:
2015-03-23 2015-06-23
Determination of particle size distribution — Particle
tracking analysis
Détermination de la distribution granulométrique — Suivi de particule unique
ICS: 19.120
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ISO/DIS 19430:2015(E)
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PROVIDE SUPPORTING DOCUMENTATION. ISO 2015

ISO/DIS 19430:2015(E)
© ISO 2015
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ii © ISO 2015 – All rights reserved

ISO/DIS 19430:2015(E)
Contents Page
Foreword .iv
Introduction .v
1 Scope . 1
2 Normative References . 1
3 Terms and definitions . 1
4 Symbols and abbreviated terms . 4
5 Principles . 5
5.1 Key physical parameters. 5
5.2 Detection limits . 5
5.3 Measurement Accuracy . 6
6 Apparatus . 6
7 Procedure. 7
7.1 Sample preparation . 8
7.2 Instrument set-up and Initialisation . 8
7.3 Measurement . 9
7.3.1 Sample Delivery . 9
7.3.2 Sample Illumination . 9
7.3.3 Particle Imaging and Tracking . 9
7.3.4 Track Analysis .10
7.4 Results evaluation .10
7.4.1 Particle Size Evaluation .10
7.4.2 Distribution Analysis .11
7.4.3 Data Analysis and Reporting .11
8 System qualification and quality control .11
8.1 System installation requirements .11
8.2 System Maintenance .11
8.3 System Operation .12
8.4 System Qualification .12
9 Data Recording .13
10 Test report .13
Annex A (informative) Theory.15
Annex B (informative) Apparatus settings and best practice .18
Annex C (informative) Test Reporting .20
Bibliography .21
ISO/DIS 19430:2015(E)
Foreword
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ISO/TS 19430 was prepared by Technical Committee ISO/TC 24/SC 4, Particle characterization
including sieving
iv © ISO 2015 – All rights reserved

ISO/DIS 19430:2015(E)
Introduction
Regulatory, scientific and commercial requirements for nanomaterial characterization or
characterization of particulate suspensions where particle sizing and counting is required provide a
strong case for further development of techniques such as Particle Tracking Analysis (PTA), also known
[1]
as Nanoparticle Tracking Analysis (NTA). Due to the fact that PTA covers a larger size range and is
1)
more generic the term PTA will be used throughout this document to refer to NTA and PTA. For all
aims and purposes the term PTA will also mean NTA in this document.
PTA is based on measuring the diffusion movement of particles in a suspension by means of laser
illumination, imaging of scattered light, particle identification and localization, and individual particle
tracking. The hydrodynamic diameter of the individual particles is related to Brownian motion
parameters via the Stokes-Einstein equation.
In recent years the academic community working in fields such as liposomes and other drug delivery
vehicles, nanotoxicology, viruses, exosomes, protein aggregation, ink jet inks, pigment particles,
cosmetics, foodstuffs, fuel additives and fine bubbles began using the PTA technology for characterization.
[2]
An ASTM standard guide (E2834–12) was developed to give guidance to the measurement of particle
size distribution by means Nanoparticle Tracking Analysis. The present document aims to broaden the
scope of the specification and to introduce system tests for PTA operation.
This document aims to outline the theory and basic principles of the particle tracking analysis with its
limitations and advantages. It will also describe commonly used apparatus and measurement procedures
as well as system qualifications and data reporting. One of the key aspects is the meaning of the data
and its interpretation. It should be noted that the key measurand obtained from PTA measurement is
the number-based particle size distribution where the size is taken to mean hydrodynamic diameter
(3.12) of the particles in the sample. This size may be different from other sizes obtained with different
[3] [4]
techniques such as dynamic light scattering or electron microscopy.
1) NTA is the most recognised abbreviation for the technique described in this document. However the Particle
Tracking Analysis (PTA) includes the NTA in its size range of measurements.
DRAFT INTERNATIONAL STANDARD ISO/DIS 19430:2015(E)
Determination of particle size distribution — Particle
tracking analysis
1 Scope
This document provides guidance and specification for the determination of the number-based particle
size distribution of suspensions of submicron particles using particle tracking analysis methodology.
2 Normative References
The following referenced documents are indispensable for the application of this document. For dated
references, only the edition cited applies. For undated references, the latest edition of the referenced
document (including any amendments) applies.
ISO/FDIS 13322-1:2014, Particle size analysis — Image analysis methods — Part 1: Static image
analysis methods
ISO 26824:2013, Particle characterization of particulate systems — Vocabulary
3 Terms and definitions
3.1
nanoscale
size range from approximately 1 nm to 100 nm
Note 1 to entry: Properties that are not extrapolations from a larger size will typically, but not exclusively, be
exhibited in this size range. For such properties the size limits are considered approximate.
Note 2 to entry: The lower limit in this definition (approximately 1 nm) is introduced to avoid single and small
groups of atoms from being designated as nano-objects
...