In June 2026, hydrogen-oxygen medicine reached a milestone moment: at the 18th Straits Forum · Health and Wellness Sub-forum, witnessed by Academician Zhong Nanshan and more than a hundred medical experts from both sides of the Strait as well as Hong Kong and Macao, the group standard General Specification for Clinical Application of Hydrogen-Oxygen Mixed Gas Inhalation Therapy (T/CRHA 316—2026) was officially released.
The standard was proposed by the Respiratory Medicine Professional Committee of the Chinese Research Hospital Association, and jointly led in drafting by the National Center for Respiratory Medicine (the First Affiliated Hospital of Guangzhou Medical University), Peking Union Medical College Hospital, and Shanghai Asclepius Meditec Co., Ltd., with more than 20 renowned Class III Grade A hospitals nationwide, including Zhongshan Hospital of Fudan University, Xiangya Hospital of Central South University, and Peking University First Hospital, participating in compilation. The standard clearly defines the clinical applicable scenarios, operating norms, and safety boundaries of hydrogen-oxygen inhalation therapy, filling an industry gap and marking hydrogen-oxygen medicine's entry into a new stage of standardization, regulation, and long-term development.
Approval announcement and group-standard cover issued by the Chinese Research Hospital Association (official document, retained in original Chinese).
Class III Medical Device Certification: The “Hard Threshold” for Purchasing
Guided by the General Specification for Clinical Application of Hydrogen-Oxygen Mixed Gas Inhalation Therapy, the first “safety ruler” for choosing a hydrogen-oxygen machine is qualification certification.
Hydrogen-oxygen inhalation devices fall into the highest risk category of the National Medical Products Administration classification, Class III medical devices, under the same regulatory level as cardiac stents and artificial joints. Currently, in the “Medical Device Query” section of the NMPA official website, only two registration numbers can be found for hydrogen-oxygen inhalation devices—“国械注准20203080066” and “国械注准20233081929”—with the registrant in both being Shanghai Asclepius Meditec Co., Ltd. This means the Asclepius hydrogen-oxygen machine is currently the only hydrogen-oxygen inhalation device in China holding the NMPA Class III medical device registration certificate, with its safety, efficacy, and quality having passed strict national review and clinical validation.
No Alkali Added, No PFAS Proton Membrane: Core Technology Eliminates Long-Term Hazards
The industry standard defines the safety boundaries of hydrogen-oxygen inhalation therapy, but a product's safety ultimately returns to the hydrogen-production technology itself.
At the special session on the General Specification for Clinical Application of Hydrogen-Oxygen Mixed Gas Inhalation Therapy, experts pointed out in particular that the mainstream water-electrolysis technologies on the market today all have clear defects: the liquid-electrolyte process uses industrial strong alkali that is readily inhaled into the airways with the gas and burns the respiratory tract; the proton exchange membrane (PFAS-type) used in the solid-conduction process is a forever chemical that is hard to degrade, may cause long-term human toxicity, and the EU has already issued related restriction and ban regulations.
Asclepius Meditec's hydrogen-oxygen machines explicitly do not adopt industrial hydrogen-production technology, avoiding the safety hazards of traditional alkaline water electrolysis (AEC) and proton exchange membrane electrolysis (PEM, also called SPE). Asclepius Meditec's exclusively developed alkaline biocompatible conduction technology breaks through the two technical thresholds of AEC conductive-liquid electrolysis and PEM ion-membrane electrolysis, realizing a medical-grade electrolysis solution that “uses no membrane and adds no alkali,” avoiding at the source the two major hazards of airway burns and toxic-substance accumulation, and safeguarding use safety.
Uphold Evidence-Based Medicine, Let the Data Speak
Academician Zhong Nanshan emphasized that, for hydrogen-oxygen medicine to achieve long-term healthy development, it must uphold the core of evidence-based medicine, supporting the practical application of the technology with rigorous, sufficient clinical research data, and adhere to regulation first and standards leading.
Behind compliant products lies solid evidence-based medical accumulation; Asclepius Meditec's products have gone through years of R&D and multicenter clinical validation and cooperate deeply with top domestic hospitals and academician teams. At the same time, Asclepius holds 505 global patents, 107 papers (92 in SCI), and 10 National Natural Science Foundation projects; these weighty data are strong proof of its technical strength and clinical value.
Faced with hydrogen-oxygen machines of mixed quality on the market, consumers must not follow trends blindly. Mastering these three “safety rulers”—looking for Class III medical device qualification, avoiding strong-alkali and PEM-membrane technology, and valuing evidence-based medical data—lets you choose a truly safe, reassuring hydrogen-oxygen machine and let frontier medical achievements genuinely benefit health.
