Medical Device Sterilization Standards

What are medical device sterilization standards?

Manufacturers of medical devices must ensure that their products are free from microorganisms (especially pathogenic types) and other infectious substances such as endotoxins that could transmit infectious diseases to patients and healthcare workers. This requirement applies to sterile single use medical devices, as well as to certain device types that are intended to be made ready for use by processor after suitable (re-)processing.

Requirements for the development, validation and routine control of sterilization processes for medical devices and other healthcare products are described in the international standards. To ensure the validated processes comply with regulatory requirements (including international ISO sterilization standards), TÜV SÜD conducts conformity assessments, evaluating them for adherence to standards such as:

► ISO 11135 for ethylene oxide
► ISO 11137 for radiation
► ISO 17664 for information to be provided by manufacturer to the processor regarding cleaning, disinfection and sterilization processes
► ISO 17665 for moist heat
► ISO 11607 for sterile packaging

Why medical device sterilization standards are important for manufacturers?

All sterilization processes must be validated and controlled to ensure the effectiveness of the sterilization process. The same situation applies for reusabe medical devices in relation to their instructions for reprocessing. This can pose several challenges to manufacturers. The science of sterilization is complex and needs expertise in several technical areas such as microbiology, chemistry and engineering.

The medical device sterilization standards are extensive, and it can be difficult to predict how different regulatory authorities will interpret each standard. Regulatory requirements can change in the light of new scientific information. These and other issues can slow down the product approvals and certification process. All of this necessitates a trusted third party such as TÜV SÜD to assess sterilization processes complying with international standards and regulatory requirements.

How TÜV SÜD can assess your medical device for compliance with sterilization standards?

TÜV SÜD provides manufacturers with in-depth expertise in assessment of sterile manufacturing (including sterile packaging) and sterilization process validation and monitoring of routine processes. This expertise spans all medical types of medical devices and is recognised by regulatory authorities worldwide. This includes review of sterilization process related documentation for regulatory compliance, on-site assessments of sterilization processes to verify the equipment conformity for the applied process, and audits of quality management systems. We also assess instructions in the IFU for safe (re-)processing of reusable medical devices and validations thereof.

Our experts are also well-versed in standard and regulatory requirements all over the world. We are a trusted service provider to companies ranging from global manufacturers to regional and local firms.

What our medical device sterilization service includes

Submission Forms on Completeness (only valid for TÜV SÜD Product Service GmbH) – detailed forms guiding through the applicable biological safety standards with reference to specific clauses which assure that regulative requirements are covered by data. Manufacturers do a self-assessment by checking the data for their sterile and reprocessable medical devices for regulatory compliance against detailed forms formulated by TÜV SÜD Product Service experts. The submission forms neutrally reflect the state-of-the-art requirements and enable manufacturers to review their documentation for compliance in a well-structured and efficient manner prior to submission.

Get Started with TÜV SÜD

Request our assessment services for your medical device sterilization compliance. Start your journey with us.

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