Skip to main content
Back

EVS-EN ISO 14644-14:2026

Cleanrooms and associated controlled environments - Part 14: Assessment of suitability for use of equipment by airborne particle concentration (ISO 14644-14:2026)

General information

Valid from 01.04.2026
Base Documents
ISO 14644-14:2026; EN ISO 14644-14:2026
Directives or regulations
None

Standard history

Status
Date
Type
Name
This document specifies a methodology to assess the suitability of equipment (e.g. machinery, measuring equipment, process equipment, components and tools) for use in cleanrooms and associated controlled environments, with respect to airborne particle cleanliness as specified in ISO 14644-1. Particle sizes range from 0,1 µm to equal to or larger than 5 µm (given in ISO 14644-1).
NOTE            Where regulatory agencies impose supplementary guidelines or restrictions, appropriate adaptation of the assessment methodology can be required.
This document is not applicable to the following items:

assessment of suitability with respect to biocontamination;
testing for suitability of decontamination agents and techniques;
cleanability of equipment and materials;
requirements on design of equipment and selection of materials;
physical properties of materials (e.g. electrostatic, thermal properties);
optimizing performance of equipment for specific process applications;
selection and use of statistical methods for testing;
protocols and requirements for local safety regulations.

Required fields are indicated with *

*
*
*
PDF
19.84 € incl tax
PDF redline
25.79 € incl tax
Paper
19.84 € incl tax
Browse standard from 2.48 € incl tax
Standard monitoring

Customers who bought this item also bought

Main

EVS-EN ISO 14155:2026

Clinical investigation of medical devices for human subjects - Good clinical practice (ISO 14155:2026)
Newest version Valid from 04.05.2026
Main + amendment

EVS-EN ISO 11608-1:2022+A1:2026

Needle-based injection systems for medical use - Requirements and test methods - Part 1: Needle-based injection systems (ISO 11608-1:2022 + ISO 11608-1:2022/Amd1:2026)
Newest version Valid from 18.05.2026
Main

EVS-EN ISO 10993-7:2026

Biological evaluation of medical devices - Part 7: Ethylene oxide sterilization residuals (ISO 10993-7:2026)
Newest version Valid from 02.06.2026
Main

EVS-EN ISO 20417:2026

Medical devices - Information to be supplied by the manufacturer (ISO 20417:2026)
Newest version Valid from 15.04.2026