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.

Control phase/ contaminantsParticlesMacro-particlesNano-particlesChemicalsMicro-organisms
Requirements14644-1,2,914644-1,9,1714644-1214644-8,1014698-1,2
Establishment and verificationRequirements
+ 14644-3,4,7,14
Requirements
+ 14644-4,14
Requirements
+ 14644-4,7
Requirements
+ 14644-4,7,15
Requirements
+ 14644-4,7
Operation and monitoringRequirements
+ 14644-3,5,13
Requirements
+ 14644-3,5,13
Requirements
+ 14644-5
Requirements
+ 14644-5,13
Requirements
+ 14644-5

ISO 14644 - Cleanrooms and associated controlled environments

ISO PartNameYear
14 644-1Classification of air cleanliness by particle concentration2015
14 644-2Monitoring to provide evidence of cleanroom performance related to air cleanliness by particle concentration2015
14 644-3Test methods2019
14 644-4Design, construction and start-up2001 (CD 2020)
14 644-5Cleanroom operations2004
14 644-7Separative devices (clean air hoods, glove boxes, isolators and minienvironments)2004
14 644-8Classification of air cleanliness by chemical concentration (ACC)2013
14 644-9Classification of surface cleanliness by particle concentration 2012
14 644-10Classification of surface cleanliness by chemicals concentration 2013
14 644-12Specifications for monitoring air cleanliness by nanoscale particle concentration2018
14 644-13Cleaning of surfaces to achieve defined levels of cleanliness in terms of particle and chemical concentrations2017
14 644-14Assessment of suitability for use of equipment by airborne particle concentration2016
14 644-15Assessment of suitability for use of equipment and material by airborne chemical and surface chemical concentration2017
14 644-16Energy efficiency in cleanrooms and separative devices2019
14 644-17Particle Deposition Rate Applications2021

ISO 14698 - Cleanrooms and associated controlled environments -Biocontamination control

ISO PartNameYear
14 698-1General Principles2004
14 698-2Evaluation & Interpretation of Biocontamination Data2004
EN17141
Replaces 14698 in Europe
Biocontamination – Microbial cleanliness levels2020