ISO 14644-12:2018 PDF

Cleanrooms and associated controlled environments — Part 12: Specifications for monitoring air cleanliness by nanoscale particle concentration

First page of standard ISO 14644-12:2018

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Title (English):

ISO 14644-12:2018

Cleanrooms and associated controlled environments — Part 12: Specifications for monitoring air cleanliness by nanoscale particle concentration

Document status:: Active
Format:: Electronic (PDF)
Number of pages:: 11
Publication date:: August 30, 2018
Edition:: ISO IS 14644 edition 1 version 1
ICS:: 13.040.35

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Description (English):

This document covers the monitoring of air cleanliness by particles in terms of concentration of airborne nanoscale particles. For monitoring purposes, only populations of particles with a lower size limit of 0.1 microns (100 nm) or less ? "nanoscale" ? are considered. The monitoring given in this document is for use mainly in "operational" states. NOTE 1 For the purposes of this document, reference is made to "nanoscale particles", which means all nano-objects having one (nanoplate), two (nanofibre) or three (nanoparticle) dimensions in the nanoscale. NOTE 2 As a consequence, the specifications for monitoring air cleanliness by nanoscale particle concentration of the cleanroom in operational state also considers process specifics, e.g., used equipment, personnel behaviour, etc. NOTE 3 Health and safety considerations are excluded from this document.

Technical details

Technical committee: ISO/TC 209 - Cleanrooms and associated controlled environments
SKU: ISO 14644-12:2018

Abstract

Overview

ISO 14644-12:2018 specifies methods and requirements for monitoring air cleanliness in cleanrooms and associated controlled environments by nanoscale particle concentration. The standard covers airborne particles with a lower size limit of 0.1 µm (100 nm) or less - defined as “nanoscale” - and is intended primarily for use in the operational state of a cleanroom, when process equipment and personnel are active. Health and safety considerations are explicitly excluded.

Key topics and technical requirements

Scope of measurement: Focus on particle number concentration of nanoscale particles (≈1–100 nm), using an equivalent diameter metric.
Reference detection method: Condensation Particle Counter (CPC) is the preferred detector; Annex A provides the CPC reference method.
Counting performance: Counting efficiency and particle size cutoff (D50 - the particle size at 50% counting efficiency) are addressed (see Annex B).
Monitoring plan elements: Establishes that monitoring should be based on a risk assessment and include:
- nanoscale particle size range to measure
- sampling time-dependence and sample volume
- sampling locations and number of samples
- criticality of process/product and clean zone layout
Calibration and traceability: Tests must be performed with calibrated instruments and documented calibration status.
Test reporting: Required report content includes test location coordinates, occupancy state, instrumentation and calibration details, lower particle size limit reported, CPC zero count rate, and a summary assessing trends and alert/action limits.

Applications and who uses this standard

ISO 14644-12 is applicable where nanoscale contamination monitoring supports process control and product quality. Typical users include:

Cleanroom operators and facility managers in microelectronics, nanotechnology, aerospace, pharmaceuticals, medical device and healthcare manufacturing
Process engineers designing contamination control and monitoring programs
Third‑party testing organizations reporting cleanroom performance in operational states
Quality and compliance teams creating risk-based monitoring plans for products sensitive to nanoscale particles

This standard is especially relevant when process-related nanoscale particles are expected (e.g., from equipment, chemical reactions or manufacturing processes), since measurements are intended to reflect operational conditions.

Related standards

ISO 14644 series (classification, test methods, monitoring plans) - notably ISO 14644-1 and ISO 14644-2 referenced for classification and monitoring plan requirements
ISO 14644-3 (historical related material on ultrafine particles)
ISO/TS 80004-2 (nanotechnologies terminology)
ISO 15900 (aerosol terminology)

Keywords: ISO 14644-12, nanoscale particle concentration, cleanrooms, monitoring air cleanliness, CPC, condensation particle counter, nanoparticle monitoring, clean zone.

Related standards

Standards mentioned in the description

Abstract

Overview

Key topics and technical requirements

Scope of measurement: Focus on particle number concentration of nanoscale particles (≈1–100 nm), using an equivalent diameter metric.
Reference detection method: Condensation Particle Counter (CPC) is the preferred detector; Annex A provides the CPC reference method.
Counting performance: Counting efficiency and particle size cutoff (D50 - the particle size at 50% counting efficiency) are addressed (see Annex B).
Monitoring plan elements: Establishes that monitoring should be based on a risk assessment and include:
- nanoscale particle size range to measure
- sampling time-dependence and sample volume
- sampling locations and number of samples
- criticality of process/product and clean zone layout
Calibration and traceability: Tests must be performed with calibrated instruments and documented calibration status.
Test reporting: Required report content includes test location coordinates, occupancy state, instrumentation and calibration details, lower particle size limit reported, CPC zero count rate, and a summary assessing trends and alert/action limits.

Applications and who uses this standard

ISO 14644-12 is applicable where nanoscale contamination monitoring supports process control and product quality. Typical users include:

Cleanroom operators and facility managers in microelectronics, nanotechnology, aerospace, pharmaceuticals, medical device and healthcare manufacturing
Process engineers designing contamination control and monitoring programs
Third‑party testing organizations reporting cleanroom performance in operational states
Quality and compliance teams creating risk-based monitoring plans for products sensitive to nanoscale particles

Related standards

ISO 14644 series (classification, test methods, monitoring plans) - notably ISO 14644-1 and ISO 14644-2 referenced for classification and monitoring plan requirements
ISO 14644-3 (historical related material on ultrafine particles)
ISO/TS 80004-2 (nanotechnologies terminology)
ISO 15900 (aerosol terminology)

Keywords: ISO 14644-12, nanoscale particle concentration, cleanrooms, monitoring air cleanliness, CPC, condensation particle counter, nanoparticle monitoring, clean zone.

ISO 14644-12:2018 PDF

Technical details

Abstract

Overview

Key topics and technical requirements

Applications and who uses this standard

Related standards

Related standards

Abstract

Overview

Key topics and technical requirements

Applications and who uses this standard

Related standards

Related standards

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