ISO 14644 医療機器のクリーンルーム環境(英語)

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Sterilisation processes for medical devices - ISO 11135, ISO 11137 and ISO 17665

Manufacturers of most types of 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, as well as to certain device types that can be reused after suitable reprocessing. Industrial sterilisation processes can involve the use of various chemicals and techniques, including gamma irradiation, moist heat and ethylene oxide. However, all sterilisation processes must be controlled and independently validated to ensure the effectiveness of the sterilisation process.

Sterilisation processes

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

Medical device manufacturers often face a number of issues in implementing and maintaining appropriate sterilisation process and controls. The science of sterilisation is complex and requires expertise in a number of technical areas, such as microbiology, chemistry and engineering. Standards applicable to the control and validation of industrial sterilisation processes are extensive, and it can be difficult to determine in advance how a given standard’s requirements will be interpreted by regulatory authorities during the conformity assessment process. In addition, regulatory requirements applicable to sterilisation 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 testing of sterilisation and sterile packaging processes, including services for safe reprocessing of reusable devices according to international standards. This includes on-site assessments of sterilisation processes, review of sterilisation documentation prior to submission to regulatory authorities 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 enable manufacturers to review in a well structured and efficient manner, their own data based on applicable state of the art requirements.
  • Cleanroom/ISO 14644 expertise - TÜV SÜD is a single source for manufacturers of medical devices. In addition, TÜV SÜD Industry Service’s Clean Cert Program provides support in the design, construction and testing of cleanrooms.
  • Product safety testing and certification - TÜV SÜD Product Service is an EU Notified Body for medical devices, and is recognised by other regulatory agencies throughout the world for its extensive experience with a broad range of medical devices.
  • GLP-compliant biocompatibility evaluations - TÜV SÜD laboratories conduct biocompatibility tests in compliance with GLP Principles.
  • FDA 510(k) third party review service - TÜV SÜD Product Service has participated in the FDA 510(k) third-party review program since its inception in 1996, and offers third-party submission reviews for over 600 devices. TÜV SÜD Product Service medical device experts maintain close contact with FDA reviewers to ensure that issues are promptly addressed, resulting in a more efficient review process and timely product clearance.
  • Other testing and certification services - In addition to services for testing of sterilisation and sterile packaging processes, TÜV SÜD Product Service can also provide compliance testing for medical devices in accordance with other relevant regulations and standards.

Questionaire Samples

Packaging Review Questionnaire

Reprocessing ISO 17664

Sterilisation Review Questionnaire EN ISO 17665-1

Sterilisation Review Questionnaire ETO

Sterilisation Review Questionnaire Irradiation

Tyvek® Transition Checklist

Your benefits at a glance

  • Recognised medical device expertise - TÜV SÜD Product Service is the largest EU Notified Body in the world. With a Regulatory Foreign Affairs and Clinical Centre of Excellence, TÜV SÜD Product Service is recognised by regulatory authorities around the world for its extensive experience with all types of medical devices.
  • Global support - In addition to in-depth expertise in effective sterilisation processes and controls, TÜV SÜD Product Service has expertise in regulations and requirements applicable to medical devices, regardless of where they are sold. 
  • 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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