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:
Related TechTips
Bacterial Endotoxin Testing
Pyrogens are substances that can induce a fever response in the body, and sources can be either microbial or non-microbial. The focus of this TechTip is the testing associated with a microbial pyrogen, bacterial endotoxin. Bacterial endotoxins are memb
Biological Indicator Population Verification Test
Purpose In a sterilization process where biological indicator (BI) sterility results are used as part of product release criteria, the BIs shall be procured from an approved supplier with a minimum population of test organisms defined. The population o
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