What is EN ISO 14698-2:2014 ?

EN ISO 14698-2:2014 is a critical standard for companies operating in industries where contamination can have a significant impact on their products, processes, or workers. The standard provides guidelines and recommendations for establishing and maintaining biocontamination control within cleanrooms and associated controlled environments.

The main purpose of EN ISO 14698-2:2014 is to minimize the risk of microorganisms present in the air and on surfaces within these environments. The standard takes into account both viable (living) and non-viable particles, which are microorganisms that can cause harm or disease in humans or the environment.

To achieve this purpose, EN ISO 14698-2:2014 establishes several key components:

Cleanroom environment design and construction: The standard outlines the physical requirements for cleanrooms, including dimensions, 通风 systems, and controls to maintain controlled environments.

Microbiological monitoring: The standard recommends the use of monitoring systems to continuously detect and measure microorganisms in the air and on surfaces.

Cleaning and disinfection: The standard provides guidelines for the cleaning and disinfection of cleanrooms to prevent the growth of microorganisms.

Personnel and equipment: The standard recommends appropriate training and protective equipment for personnel working in cleanrooms and controlled environments.

Documentation and record-keeping: The standard requires organizations to maintain records and documentation of their biocontamination control measures.

By following the recommendations outlined in EN ISO 14698-2:2014, companies can minimize the risks associated with biocontamination, ensure product quality, worker safety, and regulatory compliance. The standard is widely recognized and respected in the industry, and its implementation is often required by regulatory bodies.

In conclusion, EN ISO 14698-2:2014 is a crucial standard for companies operating in industries where biocontamination can have a significant impact on their products, processes, or workers. By following the guidelines and requirements outlined in the standard, organizations can minimize the risks associated with microorganisms, ensure product quality, worker safety, and regulatory compliance.