What is ISO 11171:2018

ISO 11171:2018 is a professional technical standard that provides guidelines for the calibration and performance verification of particle counters. It outlines the requirements for conducting tests on liquid-borne particle counters used in various industries, including pharmaceuticals, biotechnology, and semiconductor manufacturing.

The Purpose of ISO 11171:2018

The primary purpose of ISO 11171:2018 is to ensure the accuracy and reliability of particle counting instruments. By following the guidelines set forth in this standard, manufacturers and users of particle counters can establish a consistent basis for comparing results obtained from different equipment and testing methods.

Key Features of ISO 11171:2018

ISO 11171:2018 specifies a comprehensive set of procedures for calibrating particle counters, determining their counting efficiency, and evaluating their performance characteristics. It covers topics such as calibration techniques, system integrity testing, sizing accuracy assessment, and counting efficiency determination.

The standard also defines the methods for verifying the performance of optical particle counters through the use of reference particle suspensions with known concentration and size distribution. By using these standard methods, particle counter manufacturers can validate the accuracy of their instruments, while users can assess the performance of their existing equipment.

Benefits and Implications

Compliance with ISO 11171:2018 brings several benefits to both manufacturers and users of particle counters. Firstly, it ensures consistency and comparability of test results across different laboratories and equipment. This allows for better quality control and process optimization in industries that rely on accurate particle measurements for product development and manufacturing.

Secondly, ISO 11171:2018 promotes confidence and transparency in the performance of particle counters. By adhering to the standard, manufacturers can provide reliable instruments to the market, while users can make informed decisions when selecting and evaluating particle counting equipment.

Ultimately, ISO 11171:2018 contributes to the overall improvement of product quality, process efficiency, and customer satisfaction in industries where precise control of particle contamination is critical.