BS EN ISO 14644-3:2019 Cleanrooms and associated controlled environments. Test methods

BS EN ISO 14644-3:2019

Cleanrooms and associated controlled environments. Test methods

Status : Current   Published : October 2019



What is this standard about?

This is the third in a multi-part series of international standards on cleanrooms and associated controlled environments which limit contamination to levels appropriate for accomplishing contamination-sensitive activities.


The standard sets out appropriate test methods for measuring the performance of a cleanroom, clean zone or associated controlled environment, including separative devices and controlled zones, together with all associated structures, air treatment systems, services and utilities.


Who is this standard for?

Industries that benefit include aerospace, microelectronics, pharmaceuticals, medical devices, healthcare, life sciences, nanotechnology, optics and food. Users will be:

  • Anyone involved in cleanroom testing
  • Quality assurance and quality control managers
  • Cleanroom operations managers
  • Cleanroom facility engineers
  • Cleanroom project engineers, designers and specifiers
  • Cleanroom facility users
  • Design professionals and consultants
  • Facility design and construction professionals


Why should you use this standard?

It provides test methods in support of the operation of cleanrooms and clean zones to meet air cleanliness classification, other cleanliness attributes and related controlled conditions.

Performance tests are specified for two types of cleanrooms and clean zones: those with unidirectional airflow and those with non-unidirectional airflow, in three possible occupancy states: as-built, at-rest and operational.

It provides the test methods, recommended test apparatus and test procedures for determining performance parameters. Where the test method is affected by the type of cleanroom or clean zone, alternative procedures are suggested. For some of the tests, several different methods and apparatus are recommended to accommodate different end-use considerations.

NOTE 1: Alternative methods not included in this document can be used by agreement between customer and supplier. Alternative methods do not necessarily provide equivalent measurements. This document doesn’t apply to the measurement of products or of processes in cleanrooms, clean zones or separative devices.

NOTE 2: This document does not purport to address safety considerations associated with its use (for example, when using hazardous materials, operations and equipment). It is the responsibility of the user of this document to establish appropriate safety and health practices and to determine the applicability of regulatory limitations prior to use.

NOTE 3: Not all cleanroom parameter test procedures are shown in this document. The procedure and apparatus for the test carried out for the air cleanliness classes by particle concentration and for macroparticles are provided in BS EN ISO 14644-1 and specifications for monitoring air cleanliness by nanoscale particle concentrations are provided in BS EN ISO 14644-12. The procedures and apparatus to characterize other parameters, of concern in cleanrooms and clean zones used for specific products or processes, are discussed elsewhere in other documents, for example, procedures for control and measurement of viable materials (BS EN ISO 14698 series), testing cleanroom functionality (BS EN ISO 14644-4), and testing of separative devices (BS EN ISO 14644-7). In addition, other standards can be considered to be applicable. Other cleanliness attribute levels can be determined using BS EN ISO 14644-8 (levels of air cleanliness by chemicals), BS EN ISO 14644-9 (levels of surface cleanliness by particle concentration) and BS EN ISO 14644-10 (levels of surface cleanliness by chemical concentration).

What’s changed in this update?

This second edition of BS EN ISO 14644-3 replaces the first edition (BS EN ISO 14644-3:2005) which has been technically revised. The main changes compared to the previous edition are:

a)       Clause B.7 (Installed filter system leakage test) has been simplified and corrected to deal with concerns over its complexity and noted errors

b)      Guidance concerning classification of air cleanliness by airborne particle concentration has been moved to BS EN ISO 14644-1

c)       The text of the whole document has been revised or clarified to make it more user-friendly

d)      A segregation test has been introduced

e)      Other test methods have been updated and expanded

Standard NumberBS EN ISO 14644-3:2019
TitleCleanrooms and associated controlled environments. Test methods
Publication Date29 October 2019
Normative References(Required to achieve compliance to this standard)No other standards are normatively referenced
Informative References(Provided for Information)EN 1822-4, SEMI E14-93, JIS B 9921, ISO 14644-10, ASTM F24-00, ISO 7726, ASTM F50-92, ASME N510-1989, ISO 5167-5, ISO 14644-12, ASTM F312-97, ISO 14644-4, ISO 14644-8, ISO 5167-4, ISO 14644-9, ASTM F1471-93, ISO 5167-2, EN 1822-2, ISO 14644-2, ISO 14644-1:2015, ISO 14644-7:2004
ReplacesPD 6609:2007, BS EN ISO 14644-3:2005
International RelationshipsEN ISO 14644-3:2019,ISO 14644-3:2019
Amended ByCorrigendum, June 2020
DescriptorsTesting conditions, Air cleaning equipment, Filtration, Particle size distribution, Environmental cleanliness, Performance testing, Clean rooms, Environment (working), Air filters, Particulate air pollutants
Title in FrenchSalles propres et environnements maîtrisés apparentés Méthodes d'essai
Title in GermanReinräume und zugehörige Reinraumbereiche Prüfverfahren
ISBN978 0 539 14318 8
File Size1.981 MB

 Your basket
Your basket is empty

Multi-user access to over 3,500 medical device standards, regulations, expert commentaries and other documents

Develop a PAS

Develop a fast-track standardization document in 9-12 months


The faster, easier way to work with standards

Tracked Changes

Understand the changes made to a standard with our new Tracked Changes version