With the release of a new standard for Luer connectors, many medical device manufacturers are now striving to achieve compliance with both new and legacy connectors.
With that in mind, STERIS has prepared a short white paper outlining the most important requirements to adhere to for achieving compliance with ISO 80369-7, which you can download here:
Screening for Adverse and Inhibitory Substances
Test method validation for adverse and/or inhibitory substances is important to ensure that the measurement of contamination on a device is not impacted by substances present in the test. Adverse substances and/or inhibitory substances (e.g. antimicrob
What is Bioburden Recovery Efficiency and How to Approach Lower Than Desired Recovery Results
What is Recovery Efficiency (RE)? Recovery Efficiency (RE) is an important part of the validation of the bioburden test method. It is intended to provide an assessment of the efficiency of the extraction technique to remove viable microorganisms from a
The Basics of Bioburden Testing
What is bioburden? Bioburden is the quantity and types of native bacterial and fungal flora present on or in a device, substrate, or chemical (test unit). Bioburden plays a large role in determining what is necessary to achieve sterility, and can impac
Custom laboratory and in-line test equipment.
We build a wide range of laboratory and in-line test equipment to suit our customers’ exact needs.