ISCC'24 Symposium

ISO Standards

ISO Contamination Control Standards

The ISO standards on cleanrooms and associated controlled environment should be used by suppliers and customers to establish and to demonstrate contamination control with respect to contaminants of interest (particles, macro-particles, nano-particles, chemicals and micro-organisms. There should always be requirements for the air cleanliness with respect to airborne particles ≥ 0.1 µm up to ≥ 5 µm. This air cleanliness is the base for classification of a cleanroom as described in ISO 14644-1. Other airborne and surface contaminants may be added for monitoring purposes. These contaminants and the associated standards are shown in the table below. A risk assessment should be performed to determine the required cleanliness levels. Standards for design, construction and start-up of cleanrooms and separate devices may be used to establish control and the standard on measurement methods and measurement methods in the contaminant standards can be used to verify the established control. During operation, the operation and cleaning standard may be applied. To demonstrate control the contaminant standards and measurement methods should be used. In the table below an overview is given.

Contaminants Particles Macro-particles Nano-particles Chemicals Micro-organisms
Requirements 14644-1,2,9 14644-1,9,17 14644-12 14644-8,10 14698-1,2 EN17141
Establish Control
+ 14644-3,4,7,14
+ 14644-4,14

+ 14644-4,7

+ 14644-4,7,15

+ 14644-4,7
Demonstrate Control
+ 14644-3,5,13

+ 14644-3,5,13

+ 14644-5

+ 14644-5,13

+ 14644-5


ISO 14644 - Cleanrooms and associated controlled environments

ISO Part Name Year
14 644-1 Classification of air cleanliness by particle concentration 2015
14 644-2 Monitoring to provide evidence of cleanroom performance related to air cleanliness by particle concentration 2015
14 644-3 Test methods 2019
14 644-4 Design, construction and start-up 2001 (DIS 2021)
14 644-5 Cleanroom operations 2004
14 644-7 Separative devices (clean air hoods, glove boxes, isolators and minienvironments) 2004
14 644-8 Classification of air cleanliness by chemical concentration (ACC) 2013
14 644-9 Classification of surface cleanliness by particle concentration  2012
14 644-10 Classification of surface cleanliness by chemicals concentration  2013
14 644-12 Specifications for monitoring air cleanliness by nanoscale particle concentration 2018
14 644-13 Cleaning of surfaces to achieve defined levels of cleanliness in terms of particle and chemical concentrations 2017
14 644-14 Assessment of suitability for use of equipment by airborne particle concentration 2016
14 644-15 Assessment of suitability for use of equipment and material by airborne chemical and surface chemical concentration 2017
14 644-16 Energy efficiency in cleanrooms and separative devices 2019
14 644-17 Particle Deposition Rate Applications 2021


ISO 14698 - Cleanrooms and associated controlled environments -Biocontamination control

ISO Part Name Year
14 698-1 General Principles 2004
14 698-2 Evaluation & Interpretation of Biocontamination Data 2004
Replaced ISO14698 in Europe
Biocontamination – Microbial Control 2020


How to use the international cleanroom standards?