EN ISO 14644-5 pdf download Cleanrooms and associated controlled environments – Part 5: Operations (ISO 14644-5:2004)
This part of ISO 14644 specifies basic requirements for cleanroom operations. It is intended for those planning to use and operate a cleanroom. Aspects of safety that have no direct bearing on contamination control are not considered in this part of ISO 14644 and national and local safety regulations must be observed. This document considers all classes of cleanrooms used to produce all types of products. Therefore, it is broad in application and does not address specific requirements for individual industries. Methods and programmes for routine monitoring within cleanrooms are not covered in detail in this part of ISO 14644 but reference is made to ISO 14644-2 and ISO 14644-3 for monitoring particles and ISO 14698-1 and ISO 14698-2 for monitoring micro-organisms.
2 Normative references
The following referenced documents are indispensable for the application of this document. For dated references, only the edition cited applies. For undated references, the latest edition of the referenced document (including any amendments) applies.
ISO 14644-1:1999, Cleanrooms and associated controlled environments — Part 1: Classification of air cleanliness
ISO 14644-2:2000, Cleanrooms and associated controlled environments — Part 2: Specifications for testing and monitoring to prove continued compliance with ISO 14644-1
ISO 14644-3:— 1) , Cleanrooms and associated controlled environments — Part 3: Test methods
ISO 14644-4:2001, Cleanrooms and associated controlled environments — Part 4: Design, construction and start-up
ISO 14698-1:2003, Cleanrooms and associated controlled environments — Biocontamination control — Part 1: General principles and methods
ISO 14698-2:2003, Cleanrooms and associated controlled environments — Biocontamination control — Part 2: Evaluation and interpretation of biocontamination data
3 Terms and definitions
For the purposes of this part of ISO 14644, the following terms and definitions apply.
3.1 General Terms
cleanroom used for products and processes that are sensitive to microbiological contamination
room where people entering or leaving a cleanroom put on or take off cleanroom clothing
NOTE Adapted from ISO 14644-4:2001, 3.1.
bench that is used as an aid to changing of cleanroom clothing and which provides a barrier to the tracking of floor contamination
removal, destruction or de-activation of micro-organisms on objects or surfaces
particle having an aspect (length-to-width) ratio of 10 or more
[ISO 14644-1:1999, 2.2.7]
person working in the cleanroom performing production work or carrying out process procedures
minute piece of matter with defined physical boundaries
NOTE For classification purposes refer to ISO 14644-1:1999.
persons entering the cleanroom for any purpose
equipment utilizing constructional and dynamic means to create assured levels of separation between the inside and the outside of a defined volume
EXAMPLES Some industry-specific examples of separative devices are clean air hoods, containment enclosures,gloveboxes, isolators and minienvironments.
controlled airflow through the entire cross-section of a clean zone with a steady velocity and approximately parallel airstreams
NOTE This type of airflow results in a directed transport of particles from the clean zone.
[ISO 14644-4:2001, 3.11]