ISO 14698-1:2003 pdf free download.Cleanrooms and associated controlled environments — Biocontamination control — Part 1: General principles and methods.
The principles described here are intended to promote appropriate hygienic practices. This part of ISO 14698 is one of a number of standards considering factors important for the creation of clean, controlled environments.
Hygiene has become increasingly important in many areas of modern society. In such areas, hygiene or biocontamination control methods are, or will be, used to create safe and stable products International trade in hygiene-sensitive products has greatly increased. At the same time, the use of antimicrobial agents has been reduced or forbidden, creating a need for increased biocontamination control.
This part of ISO 14698 is the first general International Standard for biocontamination control. However, many factors besides cleanliness must be considered in the design, specification, operation and control of cleanrooms and associated controlled environments.
In some circumstances, relevant regulatory agencies could impose supplementary policies or restrictions. In such situations, appropriate adaptations of the standard testing procedures might be required.
ISO 14698:2003 establishes the principles and basic methodology of a formal system of biocontamination control (Formal System) for assessing and controlling biocontamination when cleanroom technology is applied for that purpose. It specifies the methods required for monitoring risk zones in a consistent way and for applying control measures appropriate to the degree of risk involved. In zones where risk is low, it can be used for information.
Application-specific requirements are not given.Neither are fire and safety issues addressed; for these, see regulatory requirements and other national or local documentation.