Sterilization Practices Control and Validation for Medical Devices

Sterilization Processes for Medical Devices - ISO 11135, ISO 11137, ISO 17665 and ISO 17664

Manufacturers of nearly all medical devices must ensure that their products are free from bacteria and other substances that could transmit infectious diseases to patients and healthcare workers. This requirement applies to single-use medical devices and certain device types that are reusable after suitable reprocessing. Industrial sterilization procedures can involve using various chemicals and techniques, including gamma irradiation, moist heat, and ethylene oxide. However, all sterilization processes must be controlled and validated to ensure the effectiveness of the sterilization process. The same situation applies to reusable medical devices concerning their instructions for reprocessing.

Requirements for the development, validation, and routine control of sterilization processes for medical devices and other healthcare products are described within the international standards ISO 11135 (for ethylene oxide), ISO 11137 (for radiation), and ISO 17665 (for moist heat). In summary, an effective sterilization process includes comprehensive documentation of a manufacturer’s validation protocols and reports, along with related laboratory compliance data. For sterilization procedures involving reprocessing (ISO 17664), a comprehensive risk management assessment must be completed. This documentation becomes part of the product dossier or technical documentation, which is generally required for medical device approvals worldwide and placement on the market.

Medical device manufacturers often face several issues in implementing and maintaining appropriate sterilization processes and controls. The science of sterilization is complex and requires expertise in microbiology, chemistry, and engineering. Standards applicable to the control and validation of industrial sterilization processes are extensive and can be difficult to determine how a given standard’s requirements will be interpreted by regulatory authorities during the conformity assessment process. In addition, regulatory requirements applicable to sterilization processes and validation can change in light of new scientific information. These and other issues can slow the regulatory review and approval process for medical device manufacturers.

Why Choose TÜV SÜD

TÜV SÜD Product Service provides global medical device manufacturers with services for the assessment of sterilization and sterile packaging processes, including services for safe reprocessing of reusable devices according to international standards. This includes on-site assessments of sterilization processes, review of sterilization documentation for regulatory compliance, and audits of quality management systems.

Our Services at a Glance

• Submission forms - Manufacturers can save time and money by checking the data for their sterile and reprocessable medical devices for regulatory compliance against checklists formulated by TÜV SÜD Product Service experts. The checklists are neutrally reflecting the state-of-the-art requirements and enable manufacturers to review in a well structured and efficient manner, their documentation prior to submission.
• GLP-compliant biocompatibility evaluations - TÜV SÜD laboratories conduct biocompatibility tests in compliance with GLP Principles.
• Other testing and certification services - In addition to services for testing of sterilization and sterile packaging processes, TÜV SÜD Product Service can also provide compliance testing for medical devices in accordance with other relevant regulations and standards.

Questionnaire Examples

Packaging Review Questionnaire

Reprocessing Review Questionnaire ISO 17664

Sterilization Review Questionnaire Moist Heat EN ISO 17665-1

Sterilization Review Questionnaire Ethylene Oxide

Sterilization Review Questionnaire Irradiation

Tyvek® Transition Checklist

Your Benefits at a Glance

• Global support - In addition to in-depth expertise in effective sterilization processes and controls, TÜV SÜD Product Service has expertise in regulations and requirements applicable to medical devices, regardless of where they are sold.
• Recognized medical device expertise - TÜV SÜD Product Service is one of the largest EU Notified Body in the world. TÜV SÜD Product Service is recognized by regulatory authorities around the world for its extensive experience with all types of medical devices.
• Expert partnership - TÜV SÜD Product Service has a long record of technical and regulatory expertise for medical devices, and is a trusted partner to companies ranging from global manufacturers to regional and local research and development firms

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