Microbiological Testing of Medical Devices

Manufacturers of medical devices should ensure that their devices are free of harmful contamination. Not only do patients and doctors expect this, but global medical device regulations also stipulate this. A trusted partner such as TÜV SÜD can help by testing the devices for the presence of these harmful contamination at our state-of-the-art testing facilities, using advanced microbiological testing methods.

Microbiological testing of a medical device refers to tests for the presence and risk of microbial contaminants. Methods may include, but are not limited to, bioburden testing, endotoxin detection, and sterility assessments of medical devices. Further supportive testing is accomplished through environmental monitoring of the clean environment and microbial control of the entire manufacturing process.

TÜV SÜD is globally recognised for its quality and safety as a third-party one-stop testing provider. We provide a comprehensive range of medical device testing solutions required for medical devices and help manufacturers and suppliers independently meet regional and global regulatory standards.

We are a comprehensive solution for a variety of tests and most major medical device markets. We offer high-quality microbiological testing services for all types of medical devices to meet the latest requirements of global and regional regulators.

Our global medical health and services laboratory team comes from the medical and medical device industries with years of experience. Their deep expertise and experience in testing medical devices underpin our astute understanding of the medical device industry and global requirements, keeping us ahead of the latest developments and ensuring that all emerging regulatory needs are me.

 

We provide the following services to help manufacturers perform microbiological testing. These services adhere with the requirements of the International Organization for Standardization (ISO), the U.S. Food and Drug Administration (FDA), Technical Information Reports (TIR) from the Association for the Advancement of Medical Instrumentation (AAMI), the International Electrotechnical Commission (IEC), and European Standards (EN). They also include environmental monitoring and microbial control procedures.

• Bioburden Testing – ISO 11737-1, USP<71>, & ISO 11137 – Bioburden testing is conducted to quantify the microorganisms (total microbial count) found on a medical device before sterilisation.
• Sterility Testing – ISO 11737-2, ISO 11138, ISO 14161, ISO 13060 & EN 285 – Sterility testing of medical devices is required to ensure that the devices are free of viable microorganisms.
• Reprocessing Validation – ISO 17664, ANSI/AAMI ST79, ANSI/AAMI/ISO 17665; ANSI/AAMI ST98; ANSI/AAMI TIR 12; ASTM F3438-21– Validation of reprocessing instructions for cleaning, disinfection and sterilisation are performed for example typically on reusable surgical instruments to ensure devices continue to meet the performance specifications. These also help address the risks associated with reprocessing and shelf-life testing wherever required by regulators. Regulators also differ in terms of their testing requirements:

• Instead of the ISO 17664 requirements, the FDA follows its own set of guidelines and refers to the AAMI’s TIR 12 and 30
• The FDA provides manufacturers with the option of disinfection or sterilisation testing. All three steps are required by the EU
• Minimum temperature requirements for moist heat sterilisation differ between the FDA and other regulatory bodies

• Endotoxin Testing – ISO 11737-3, ANSI/AAMI ST72; USP<85>; USP<161> – Bacterial endotoxin testing is required to detect blood-harming endotoxins on the medical device.
• Biological Indicator Testing – ISO 11138 – Biological indicators are required for most sterilization validation activities.  These indicators are required to be verified before use.
• Water Testing – As part of environmental controls, water testing is necessary to ensure control. Typically endotoxin, TOC, and microbial counts are required.