Bioburden Analysis
Medical Analyses

Bioburden Analysis

    Bioburden Testing According to TS EN ISO 11737-1

    As TTS Laboratory Services, we specialize in bioburden testing and medical analyses. Bioburden testing is a critical analytical method performed according to the TS EN ISO 11737-1 standard to determine the microbial load present on a product or medical device. In medical products, bioburden testing is crucial for monitoring microbial contamination that can arise during production.


    Importance of Bioburden Testing

    By detecting contamination levels originating from raw materials, personnel contact, or environmental conditions, bioburden testing in medical products provides insight into potential sources of microbial contamination. It also helps identify variations in microbial load between different batches and is therefore recommended as a routine practice. Determining the appropriate sterilization dose level is made possible through bioburden testing.


    How Is a Bioburden Test Carried Out?

    At TTS Laboratory Services, we perform bioburden testing meticulously in line with TS EN ISO 11737-1, as part of our medical analysis services. This process aims to measure the total microbial load on products and calculate the appropriate sterilization dose. The main steps include:

    1. Sample Collection

      • Collecting an appropriate quantity of medical product samples for analysis.
    2. Extraction and Filtration

      • Extracting microorganisms in a sterile environment using a suitable method and filtering the sample to capture any microbes.
    3. Cultivation and Enumeration

      • Cultivating the microorganisms on appropriate culture media and determining their count to assess the overall microbial load.

    Benefits of Bioburden Testing

    • Helps identify contamination risks during production.
    • Facilitates effective sterilization by determining the suitable sterilization dose.
    • Ensures products meet legal and quality standards.
    • Monitors microbial differences across different batches.

    Compliance with TS EN ISO 11737-1

    The TS EN ISO 11737-1 method ensures that bioburden testing meets internationally recognized standards. This standard details the procedures, culture media, and enumeration methods to be followed during the bioburden test on medical products.


    Bioburden Testing at Our Laboratory

    At TTS Laboratory Services, we conduct bioburden testing in accordance with TS EN ISO 11737-1, supporting manufacturers with microbial load analyses. By regularly performing bioburden tests, you can better control microbial contamination levels and optimize the sterilization effectiveness of your products. Offered as part of our medical analysis and biocompatibility testing services, this testing guarantees compliance with international standards.


    Bioburden testing in accordance with TS EN ISO 11737-1 plays a critical role in determining the microbial load of medical devices and products. At TTS Laboratory Services, our expert support in bioburden testing, medical analyses, and biocompatibility assessments helps you reduce potential risks during the production process and ensures your products meet all legal and quality requirements.