DIN Standards Committee Health Technologies
DIN EN ISO 14644-2
Cleanrooms and associated controlled environments - Part 2: Monitoring to provide evidence of cleanroom performance related to air cleanliness by particle concentration (ISO 14644-2:2015); German version EN ISO 14644-2:2015
Reinräume und zugehörige Reinraumbereiche - Teil 2: Überwachung zum Nachweis der Reinraumleistung bezüglich Luftreinheit anhand der Partikelkonzentration (ISO 14644-2:2015); Deutsche Fassung EN ISO 14644-2:2015
Overview
This document (EN ISO 14644-2) 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 Working Committee NA 041-02-21 AA "Reinraumtechnik (SpA CEN/TC 243 und ISO/TC 209)" ("Cleanroom technology (Mirror committee CEN/TC 243 and ISO/TC 209)") at Standards Committee Heating and Ventilation Technology and their Safety (NHRS) at DIN, the German Institute for Standardization e. V. This part of International Standard ISO 14644 provides a procedure for demonstrating continuing compliance with ISO 14644-1 and specifies minimum requirements for testing and monitoring. Any test plan should also take into account the specific operational requirements, risk assessment of the facility and its use. Cleanrooms and associated cleanroom areas provide the opportunity to monitor contamination by airborne particles to a certain, appropriate level that ensures activities in contamination-sensitive areas. Products and processes that benefit from controlled airborne contamination include those used in the aerospace, microelectronics, pharmaceutical, food, medical and healthcare industries. In addition to airborne particle cleanliness, there are many additional issues to consider in the design, specification, operation and control of cleanrooms and other associated areas. Circumstances may arise where supplementary requirements or restrictions are imposed by the relevant legislative authorities. In these cases, corresponding adjustments to the
Document: references other documents
Document: referenced in other documents
Responsible national committee
NA 041-02-21 AA - Cleanroom technology (Mirror committee CEN/TC 243 and ISO/TC 209)
Responsible european committee
CEN/TC 243 - Cleanroom technology
Responsible international committee
ISO/TC 209 - Cleanrooms and associated controlled environments
