BS EN ISO 14698-1:2003 – Cleanrooms and associated controlled environments — Biocontamination control — Part 1: General principles and methods
1 Scope
This part of ISO 1 4698 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. This part of ISO 1 4698 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 as a source of 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.
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 1 4644-4:2001 , Cleanrooms and associated controlled environments — Part 4: Design, construction and
start-up
ISO 1 4698-2:2003, Cleanrooms and associated controlled environments — Biocontamination control — Part 2: Evaluation and interpretation of biocontamination datam
3 Terms and definitions
For the purposes of this document, the following terms and definitions apply.
3.1 General
3.1.1
action level
level set by the user in the context of controlled environments, which, when exceeded, requires immediate intervention, including investigation of cause, and corrective action
3.1.2
alert level
level set by the user in the context of controlled environments, giving early warning of a drift from normal conditions, which, when exceeded, should result in increased attention to the process
3.1.3
bioaerosol
dispersed biological agents in a gaseous environment
3.1.4
biocontamination
contamination of materials, devices, individuals, surfaces, liquids, gases or air with viable particles
3.1.5
cleanroom
room in which the concentration of airborne particles is controlled, and which is constructed and used in a manner to minimize the introduction, generation, and retention of particles inside the room, and in which other relevant parameters e.g. temperature, humidity, and pressure, are controlled as necessary
[ISO 1 4644-1 :1 999, 2.1 .1 ] [1 ]
3.1.6
contact device
specially designed appliance holding an appropriate, sterile, culture medium with an accessible surface used for surface sampling
3.1.7
contact plate
contact device where the container is a rigid dish
BS EN ISO 14698-1:2003 – Cleanrooms and associated controlled environments — Biocontamination control — Part 1: General principles and methods