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ISO 14698-1. ISO 14698-1 was first written in 2003. ISO 14698-1 describes the principles and basic methodology for a formal system to assess and control biocontamination, where cleanroom technology is applied, in order that biocontamination in zones at risk can be monitored in a reproducible way and appropriate control measures can be selected.
ISO 14698-1 was prepared by Technical Committee ISO/TC 209, Cleanrooms and associated controlled environments. ISO 14698 consists of the following parts, under the general title Cleanrooms and associated controlled environments — Biocontamination control:
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Ordinary room air is around class 1,000,000 or ISO 9. ISO 14644-1 and ISO 14698. ISO 14644-1 and ISO 14698 are non-governmental standards developed by the International Organization for Standardization (ISO). The former applies to clean rooms in general (see table below); the latter to cleanrooms where biocontamination may be an issue. Since ...
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.
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Sep 20, 2021 · In August 2020, the European Committee for Standardization (CEN) published EN 17141 , with the new standard superseding EN 14698-1:2003 and ISO 14698-2:2003. This process has caused some confusion as to which standard medical device manufacturers should follow in their efforts to control microorganisms in cleanrooms and controlled environments.
The ISO 14698 Series features two International Standards on Biocontamination control. ISO 14698-1, Cleanrooms and associated controlled environments--Biocontamination control, Part 1: General principles and methods, and ISO 14698-2, Cleanrooms and associated controlled environments--Biocontamination control, Part 2: Evaluation and interpretation of biocontamination data.
Both ISO 14698-1:2003 and EN 17141:2020 have performance criteria for the suitability of volumetric air samplers when used in conjunction with other elements of the standard (media section, incubation and result readings). TAble 1Comparison of standards ISO 14698-1/2:2003 eN 17141:2020 B.1 Consideration of physical and biological efficiencies
