Sterility Testing/ISO 11737 Series

Accurately Evaluate Sterility to Ensure Medical Safety                             

• Sterility test protocol and report compiling service.
• Regulatory support team standby for ISO 11737 compliance.
• Customized sterility testing strategies.
• One-stop medical device analysis services including other related analysis projects.
• Rigorous quality control system.
• Professional team.
• Advanced laboratory equipment.
• Timely response.

Sterility testing is an important means of determining the sterility of medical devices, focusing on the presence or absence of live microorganisms. As a core element and important evaluation index of medical device quality, it determines the reliability and safety of medical devices in clinical applications. Manufacturers are often required to provide sterility test reports during the marketing process of medical devices.

AltaNovate provides accurate and efficient sterility testing services for medical devices in accordance with ISO 11737 standards, along with regulatory support services for market access. Contact us for any needs.

Our Service

AltaNovate offers comprehensive sterility testing services for diverse medical devices following the ISO 11737 standard, involving sterility checks, microbial enumeration, and sterilization validation. Every step is strictly executed per the standard norms, guaranteeing the precision and credibility of test outcomes.

Sterility Check: Sterility check, by specific methods, detect viable microorganisms in sterilized medical devices. It's the final step for product release. Based on ISO 11737 - 2, it ensures device safety and averts patient infections and adverse events.

Bioburden Testing: Bioburden refers to the microorganisms present on a product, raw material, or surface. It is of significant importance in the quality control of medical devices. The bioburden testing, which adheres to the ISO 11737 - 1 standard, is carried out to identify the populations of viable microorganisms on a product before sterilization.

Sterilization Validation: Sterilization validation is key to ensuring the effectiveness and consistency of medical device sterilization. Authorities like the FDA, China, and the EU have set related requirements. Based on ISO 11737 - 3, it uses physical, chemical, and bio-indicator tests to assess the sterilization process and reach the necessary sterility assurance level.

AltaNovate is your top choice for medical device analysis! We provide one-stop analysis services covering biocompatibility testing, sterility testing, mechanical testing, etc. Regardless of the type of your medical device and the specific testing service it requires, we are capable of offering customized testing solutions. Contact us now for free initial consultations and customized analysis.

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