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ISO 10993-7:2026 Biological evaluation of medical devices — Part 7: Ethylene oxide sterilization residuals

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ISO 21501-1:2025

ISO 21501-1:2025 Determination of particle size distribution — Single particle light interaction methods — Part 1: Light scattering aerosol spectrometer

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This publication was last reviewed and confirmed in 2025.

Determination of particle size distribution — Single particle light interaction methods — Part 1: Light scattering aerosol spectrometer

SKU: be470cf727d8 Categories: ,

Description

This document specifies characteristics of a light scattering aerosol spectrometer (LSAS) which is used for measuring the size, number concentration and number-based size distribution of particles suspended in a gas. This document provide the calibration procedure and the validation method for aerosol spectrometers.

This document applies to:

    characterization of metered dose inhalers (MDI), dry powder inhalers (DPI) and nebulizers in pharmacy;

    production control of active agents;

    cut-off determination: impactors, cyclones and impingers;

    atmospheric aerosols: bio-aerosols, stables or composting facilities, nebulized droplets, measurements in street tunnels;

    fractional separation efficiency determination of filters.

Edition

2

Published Date

2026-06-19

Status

PUBLISHED

Pages

37

Language Detail Icon

English

Format Secure Icon

Secure PDF

Abstract

This document specifies characteristics of a light scattering aerosol spectrometer (LSAS) which is used for measuring the size, number concentration and number-based size distribution of particles suspended in a gas. This document provide the calibration procedure and the validation method for aerosol spectrometers.

This document applies to:

    characterization of metered dose inhalers (MDI), dry powder inhalers (DPI) and nebulizers in pharmacy;

    production control of active agents;

    cut-off determination: impactors, cyclones and impingers;

    atmospheric aerosols: bio-aerosols, stables or composting facilities, nebulized droplets, measurements in street tunnels;

    fractional separation efficiency determination of filters.

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