DIN EN ISO 14644-9:2012-12

Cleanrooms and associated controlled environments provide for the control of contamination to levels appropriate for accomplishing contamination-sensitive activities. Products and processes that benefit from the control of contamination include those in such industries as aerospace, microelectronics, optics, nuclear, and life sciences (pharmaceuticals, medical devices, food, healthcare). ISO 14644-1 to ISO 14644-8 and ISO 14698-1 and ISO 14698-2 (biological contamination) deal exclusively with airborne particle and chemical contamination. Other factors, besides the classification of surface cleanliness, should be considered in the design, specification, operation and control of cleanrooms and other controlled environments. These factors are covered in some detail in other parts of ISO 14644 and ISO 14698. This part of ISO 14644 provides a classification for the determination and designation of surface cleanliness levels based on particle concentrations. This part of ISO 14644 also lists some methods of testing, as well as procedure(s) for determining the concentration of particles on surfaces. Where regulatory agencies impose supplementary guidelines or restrictions, appropriate adaptations of the testing procedures might be required. This part of ISO 14644 establishes the classification of cleanliness levels on solid surfaces by particle concentration in cleanrooms and associated controlled environment applications. Recommendations on testing and measuring methods, as well as information about surface characteristics, are given in Annexes A to D. This part of ISO 14644 applies to all solid surfaces in cleanrooms and associated controlled environments, such as walls, ceilings, floors, working environments, tools, equipment and products. The classification of surface cleanliness by particle concentration (SCP) is limited to particles between 0,05 µm and 500 µm. The following issues are not considered in this part of ISO 14644: - requirements for the cleanliness and suitability of surfaces for specific processes; - procedures for the cleaning of surfaces; - material characteristics; - references to interactive bonding forces or generation processes that are usually time-dependent and process-dependent; - selection and use of statistical methods for classification and testing; - other characteristics of particles, such as electrostatic charge, ionic charges, microbiological state, etcetera. EN ISO 14644 consists of the following parts under the main title Cleanrooms and associated controlled environments - Part 1: Classification of air cleanliness by particle concentration - Part 2: Specifications for monitoring and periodic testing to prove continued compliance with ISO 14644-1 - Part 3: Test methods - Part 4: Design, construction and start up - Part 5: Operations - Part 6: Vocabulary - Part 7: Separative devices - Part 8: Classification of air cleanliness by chemical concentration - Part 9: Classification of surface cleanliness by particle concentration - Part 10: Classification of surface cleanliness by chemical concentration Reference is also made to ISO 14698 Cleanrooms and associated controlled environments - Biocontamination control, consisting of the following parts: - Part 1: General principles and methods - Part 2: Evaluation and interpretation of biocontamination data The standard has been prepared by Technical Committee ISO/TC 209 "Cleanrooms and associated controlled environments" in collaboration with Technical Committee CEN/TC 243 "Cleanroom technology", the secretariat of which is held by BSI (United Kingdom). The committee responsible for the German version is the Heating and Ventilation Technology Standards Committee (NHRS) at DIN, the German Institute for Standardization e. V.