A Review of EN ISO 17141, ISO 14698 and Particle Measuring Systems’ Microbial Instrumentation Conformance
There are two sections to the new European standard, EN 17141:
- Normative: Those parts that are prescriptive. They should be followed to demonstrate compliance with the standard.
- Informative: Those parts that are descriptive. They aid the reader understand the concepts presented in the standard.
The normative chapters describe the establishment of microbiological control, in identifying the risks associated with environments and processes and how to ally a monitoring plan to those identified risks. Those aspects are covered in a separate technical review. The informative chapters offer guidance on how to apply the monitoring plans to meet specific regulated industrial applications. The standard is also very clear that additional regulatory requirements may be made on these industries by local and international regulatory bodies. It is the Informative Annexes E and F that identify the apparatus that can be used to measure within these applications. Guidance is given on selecting the most suitable solution for an application and verifying and/or validating their suitability.
Read this paper to learn more about:
- d50 efficiency calculations
- a comparison of ISO 14698-1/2:2003 to EN 17141:2020
- requirements of volumetric air samplers
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