ISO 13320
ISO 13320 provides the laser diffraction method reference for particle size analysis using light-scattering data in systems such as powders, sprays...
AlignedStandards
Laser Diffraction PSD: ISO 13320
ISO 13320-aligned guidance for laser diffraction PSD studies of aerosols, sprays, powders, suspensions, and formulations.
Use this standards cluster when ensemble optical particle-size data must inform method selection, formulation screening, device comparisons, batch evidence, or regulatory documentation.
Standard roster
Individual standards in this cluster
ISO 13320 is the workbook-defined citation set; ARE Labs translates it into sample presentation, optical model choices, instrument checks, PSD outputs, and report records.
Purpose & when to use
Laser diffraction PSD testing uses light-scattering behavior to estimate the particle or droplet size distribution of an ensemble sample. This Standards cluster helps teams determine when ISO 13320 is an appropriate method reference for sprays, aerosols, powders, suspensions, emulsions, or formulation systems, and when another sizing method should be selected or used alongside it:
- Spray and aerosol programs use ISO 13320 when ensemble optical PSD can support formulation screening, batch comparison, or device-performance decisions.
- Powder or suspension teams use ISO 13320 to frame sample presentation, dispersion state, concentration range, and repeatability expectations.
- Method-development studies use ISO 13320 when optical model inputs, obscuration targets, and replicate strategy need documented rationale.
- Regulatory-support packages use ISO 13320 context to connect Dv10, Dv50, Dv90, span, distribution plots, and limitations to the study objective.
Use this cluster when the question extends beyond particle size to whether laser diffraction is appropriate for the product, presentation, optical assumptions, transient behavior, and decision the data must support.
Applicable to
Built around ensemble optical sizing decisions
The cluster applies when PSD results depend on sample presentation, obscuration, optical model selection, particle shape assumptions, replicate control, and reportable distribution outputs.
Standards in this group
What each citation controls
This page is a one-citation standards cluster because the workbook and guide list ISO 13320 as the controlling reference. The summary below stays at applicability level: what the ISO method covers, how it affects ARE Labs study design, and which official publisher record was verified.
ISO
AlignedISO 13320
Particle size analysis - Laser diffraction methods
ISO 13320 provides the laser diffraction method reference for particle size analysis using light-scattering data in systems such as powders, sprays, aerosols, suspensions, emulsions, and bubbles. ARE Labs uses it to frame sample presentation, instrument qualification checks, optical assumptions, replicate strategy, and PSD reporting.
ISO official page verified 2026-05-17; ISO 13320:2020 is published, edition 2, publication date 2020-01, confirmed in 2025.
Accredited where held, aligned where followed
ARE Labs treats ISO 13320 laser diffraction PSD work as standards-aligned unless a project-specific scope review confirms a separate accreditation claim. The page does not imply ISO certification, product approval, or third-party accreditation to ISO 13320.
- ISO 13320AlignedMethod reference followed with documented setup, outputs, and limits.
Operational chain
How ARE Labs turns the standards into a study
ISO 13320 sets the method reference, but the executable study still depends on product behavior, size range, presentation state, optical assumptions, and the client decision. ARE Labs converts that source into documented method controls.
01
Fit check
Confirm ISO 13320 applicability
We review product matrix, expected size range, aerosol or spray behavior, particle shape, evaporation risk, and whether ISO 13320 is the right PSD reference.
Method-fit note02
Configuration
Set presentation and optics
ISO 13320 context guides sample presentation, obscuration target, background measurement, optical model inputs, dispersion state, and replicate strategy.
Protocol setup03
Verification
Control the instrument state
ISO 13320 alignment, background signal, instrument verification, sample stability, and run sequence are recorded so the method frame is visible.
Run log04
Adaptation
Document product-specific limits
When ISO 13320 assumptions are stressed by non-spherical particles, transient sprays, concentration effects, or evaporation, ARE Labs records the limitation and rationale.
Rationale log05
Reporting
Connect PSD data to decisions
Reports connect ISO 13320 method settings with Dv10, Dv50, Dv90, span, full distributions, replicate variability, exclusions, and comparison plots.
Review-ready reportData quality, QA/QC & documentation
Laser diffraction PSD results are useful only when the method record shows how the sample reached the measurement zone and how the distribution was processed. ARE Labs applies the ISO 13320 framework to setup checks, instrument records, run metadata, raw files, processed outputs, deviations, and QA review.
Capture method settings
ISO 13320 files link presentation mode, obscuration target, optical model, background measurement, and replicate plan to the study objective.
Record instrument readiness
ISO 13320 runs retain alignment checks, background signal, verification records, run sequence, and sample stability observations.
Retain raw and processed PSD
ISO 13320 reports preserve raw files, processed distributions, Dv10, Dv50, Dv90, span, replicate statistics, and comparison plots.
Document method boundaries
ISO 13320 assumptions are flagged when shape, evaporation, transient sprays, concentration, or presentation effects affect interpretation.
Separate alignment from claims
ISO 17025 QA review checks report language so aligned ISO 13320 use is not overstated as certification or accreditation.
Why ARE Labs
ARE Labs connects technical topics to practical study design, method selection, controlled aerosol work, and reportable evidence without turning technical pages into sales pages.
Reviewed byJamie Balarashti - Weston Schaper
QualityDocumented study records
900+Studies Performed
17+Years in operation
300+Clients supported
Common questions
These questions help formulation, device, quality, and regulatory teams determine whether laser diffraction PSD should follow ISO 13320, whether another sizing method should be used alongside it, and what records ARE Labs provides for method review, comparison studies, documented limitations, technical files, and final reporting decisions.
Q. When is ISO 13320 appropriate?
A. ISO 13320 is appropriate when laser diffraction can represent the particle or droplet system and its method assumptions fit the study decision, size range, presentation state, and sample behavior.
Q. Does ISO 13320 cover every spray?
A. No. Transient sprays, evaporation, non-spherical particles, concentration effects, and device-specific behavior may require method adaptations, paired measurements, or clearly documented limitations.
Q. What outputs are typical?
A. Reports may include Dv10, Dv50, Dv90, span, full distributions, replicate summaries, method settings, run observations, exclusions, deviations, and comparison plots.
Q. Is the work accredited to ISO 13320?
A. This page describes testing as aligned with ISO 13320. ARE Labs does not claim formal accreditation to ISO 13320 unless that status is confirmed through a project-specific scope review.
Q. How are method limits handled?
A. ARE Labs documents limitations in the protocol and report, including optical assumptions, presentation constraints, sample stability, evaporation risk, and any deviations from planned conditions.
Related services & devices
Related services & devices
Service
Particle Size Distribution (PSD) Testing
Primary route for laser diffraction, aerosol sizing, distribution outputs, and method comparison.Read more ->ServiceSpray Pattern & Plume Geometry
Adds spray-shape and plume evidence when PSD alone does not explain device behavior.Read more ->ServiceHigh-Speed Imaging & Velocimetry
Pairs transient spray imaging with PSD interpretation for short-duration events.Read more ->ServiceDose Uniformity & Emitted Dose
Connects particle-size evidence with emitted dose and product-performance records.Read more ->ServiceBreathing Simulation
Links aerosol performance to breathing profiles when device output depends on patient-use flow.Read more ->ServiceFormulation Development Support
Uses PSD evidence to compare formulations, excipients, dispersion state, and stability behavior.Read more ->DevicesMetered Dose Inhalers
Pressurized inhalers where PSD may support formulation and device comparison.Read more ->DevicesNebulizers
Jet, mesh, ultrasonic, and related systems where droplet sizing may support characterization.Read more ->DevicesPressurized Consumer Aerosols
Aerosol products where droplet or particle distributions inform performance claims.Read more ->DevicesPump Spray Products
Liquid spray products where laser diffraction may pair with plume and pattern evidence.Read more ->Related clusters
Related standards clusters
Laser diffraction PSD overlaps with inhalation sizing, spray imaging, nebulizer performance, and chamber deposition work. These routes help teams choose the neighboring standard cluster when ISO 13320 is not the only method frame.
Standards - Live