What is EN ISO 14698-2:2018?

EN ISO 14698-2:2018 is a technical standard that specifies the methods for the biocontamination control of cleanrooms and associated controlled environments. It provides guidelines for the evaluation and interpretation of data to assess the biocontamination levels within these environments.

Importance of Biocontamination Control

Biocontamination refers to the presence of unwanted microorganisms such as bacteria, viruses, fungi, and other biological particles that can potentially contaminate products or affect the health and safety of individuals in cleanrooms and controlled environments. Controlling biocontamination is crucial in industries like pharmaceuticals, healthcare, food production, and electronics manufacturing where maintaining high levels of cleanliness and hygiene is essential.

Requirements and Guidelines

EN ISO 14698-2:2018 sets out requirements and guidelines for both the measurement and interpretation of data related to biocontamination. It covers various aspects, including sampling methods, equipment calibration, laboratory analysis, and statistical treatment of the obtained data. Compliance with this standard ensures that reliable and comparable results are obtained when evaluating biocontamination levels.

Key Changes in EN ISO 14698-2:2018

The revised version of EN ISO 14698-2:2018 includes several key changes compared to its previous edition. Notable updates include a more comprehensive approach to risk assessment, additional guidance on the use of new technologies, and improved harmonization with other relevant international standards. These changes aim to enhance the accuracy and effectiveness of biocontamination control measures for cleanrooms and controlled environments.