Foryou Medical Participated in Drafting the New National Standard for Radiation Sterilization of Medical Products

From late November to early December, the State Administration for Market Regulation and the Standardization Administration of China successively released a series of national standards concerning the radiation sterilization of medical products.

These include:
GB 18280.1-2025 Sterilization of Health Care Products — Radiation — Part 1: Requirements for the Development, Validation and Routine Control of a Sterilization Process for Medical Devices. (Effective Date: January 1, 2029)
GB/T 18280.2-2025 Sterilization of Health Care Products — Radiation — Part 2: Establishing the Sterilization Dose. (Effective Date: July 1, 2027)
GB/T 18280.3-2025 Sterilization of Health Care Products — Radiation — Part 3: Guidance on Dosimetric Aspects of Development, Validation and Routine Control. (Effective Date: July 1, 2027)

According to the latest data from the National Standard Information Public Service Platform, these national standards were officially published on December 2.

The standards fall under the purview and are to be implemented by the National Technical Committee for Sterilization Technology and Equipment of Standardization, with the National Medical Products Administration serving as the competent authority.

The newly released GB 18280.1-2025 standard is a mandatory national standard. Its content is directly relevant to the compliant operation of medical device manufacturers, sterilization service providers, and related enterprises. This standard comprehensively covers the development, validation, and routine control of the radiation sterilization process for medical devices, providing the industry with systematic technical guidance and normative requirements. Upon implementation, it will fully replace the previous 2015 edition, further strengthening the management of sterilization quality for medical products.

The core drafting work for these standards brought together multiple specialized institutions and enterprises from within the industry, including irradiation equipment manufacturers, irradiation technology service providers, and medical device product companies. Huizhou Foryou Medical Devices Co., Ltd., as one of the primary drafting units, participated deeply in the compilation and revision of the standards. As a significant enterprise in the field of radiation sterilization technology, the company integrated its years of practical experience accumulated in medical device manufacturing, sterilization validation, and quality control into the standard-setting process.

The release and implementation of the new standards will have a profound impact on the medical product radiation sterilization industry. This series of standards provides unified specifications and clear requirements for medical device manufacturers, sterilization service providers, and regulatory bodies. Furthermore, it offers guidance on dosimetric aspects for development, validation, and routine control, supplying enterprises with detailed technical instructions for implementing radiation sterilization processes.

The new edition of the standards is more comprehensive and systematic compared to the 2015 version, reflecting the technological advancements and elevated management standards within China's medical product sterilization sector. With the full implementation of these standards, the medical product radiation sterilization industry is poised to enter a more standardized and regulated phase of development. This holds significant importance for ensuring the safety and efficacy of medical products and safeguarding public health.

With over two decades of dedicated experience in the industry, Foryou Medical has transformed from a follower of national  standards into a definer of them. This is an honor and, more importantly, a responsibility.

Foryou Medical will continue to leverage technological innovation as its engine, collaborating with industry peers to jointly advance China's medical sterilization endeavors into a new era characterized by greater safety and higher efficiency.

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