ISO 14698-1 Clean Rooms and Related Controlled Environments - Biocontamination Control - General Principles and Methods

ISO 14698-1 specifies the principles and basic methodology of a formal biocontamination control system (Formal System) to assess and control biocontamination when clean room technology is applied for this purpose. It specifies the methods necessary for the consistent monitoring of risk areas and the implementation of control measures appropriate to the relevant risk level. It can be used for informational purposes in regions where the risk is low.

Terms and definitions, the following terms and definitions apply for the purposes of this standard:

• The level of action, defined by the user in the context of controlled environments, when exceeded, requiring immediate action, including investigation of the cause and corrective action;
• Alert level is the level set by the user in the context of controlled environments, which gives early warning of deviations from normal conditions and, when exceeded, should result in greater attention to the process;
• Bioaerosol, biological agents dispersed in a gaseous medium;
• Biocontamination, contamination of materials, devices, individuals, surfaces, liquids, gases or air with living particles;
• Contact device, specially designed device that holds a suitable, sterile culture medium with an accessible surface, used for surface sampling;
• A control point is a point in a controlled environment where control is exercised and a hazard can be avoided, eliminated or reduced to acceptable levels.

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