At the Special Session on Hydrogen-Oxygen Medicine Development of the 18th Straits Forum Health and Wellness Sub-forum, industrial representatives and academic experts recognized that the release of the group standard General Specifications for Clinical Application of Hydrogen-Oxygen Mixture Inhalation Therapy will provide strong support through standardization into the sustainable and orderly development of the hydrogen-oxygen medicine industry.
Academician Zhong Nanshan of the Chinese Academy of Engineering pointed out in the keynote speech that standardized clinical operating protocols and a comprehensive industrial standard system should be established to rectify irregular industry practices and address development gaps in the field, thus pushing hydrogen-oxygen medicine to transition from empirical exploration to a new stage of standardized, evidence-based and regulated development.
In the past, there existed non-standard market practices where modified industrial hydrogen-generation equipment were sold as home-use medical devices. Such products lack biocompatibility testing and explosion-proof safety validation, carrying potential safety risks. In his speech, Academician Zhong Nanshan highlighted this critical issue and stressed the need to rectify non-compliant practices to address gaps in industry development. Participating experts noted that the absence of unified standards not only impairs clinical outcomes but also damages the overall reputation of the industry. Therefore, the introduction of industrial standards has become an urgent priority for the healthy development of the industry.
The newly released group standard draws clear legal and safety boundaries for the whole industry. It explicitly defines equipment requirements, safety requirements and clinical application scenarios and scope for hydrogen-oxygen inhalation therapy, and mandates that all relevant devices must hold appropriate medical device registration qualifications.
Aligned with national standardization principles, the document clarifies applicable clinical scenarios, operating procedures and usage limits of hydrogen-oxygen inhalation therapy, providing authoritative guidelines for the standardized and safe clinical application of this cutting-edge medical technology. Compliant enterprises such as Shanghai Asclepius Meditec with Class III medical device registration certifications will gain greater market competitiveness, while non-compliant manufacturers will be phased out, realizing market-driven optimization and consolidation.
In accordance with the Measures for the Administration of Group Standards of the Chinese Research Hospital Association, the association approves and publishes including General Specifications for Clinical Application of Hydrogen-Oxygen Mixture Inhalation Therapy (T/CRHA 316—2026). Release Date: June 12, 2026 Implementation Date: June 18, 2026
As one of the three co-leading drafting organizations of the group standard, Shanghai Asclepius Meditec has demonstrated the safety and effectiveness of its technical pathway through proprietary membrane-free, alkali-free innovative electrolysis technology and the world’s first Class III medical device registration certificate for hydrogen-oxygen generators.
The Asclepius hydrogen-oxygen generator is the world’s first hydrogen -oxygen inhalation device registered as a Class III medical device by NMPA (Registration No.: NMPA 20203080066). It obtained expanded approval for home -care use in 2023 (Registration No.: NMPA 20233081929), making China’s first Class III active hydrogen medical device approved for home-care use (Source: NMPA Medical Device Database). From product standards and quality control criteria to service standards, the company meets the requirements of the group standard, establishing an industry benchmark for orderly development (Sources: Asclepius Official Website; National Intellectual Property Administration Patent Retrieval System).
Academician Zhong Nanshan stated that after years of independent research and iterative innovation, China has built comprehensive scientific research, clinical application and industrial support framework for hydrogen-oxygen medicine. Domestic compliant medical devices are continuously upgraded toward lightweight and intelligent technologies, with large-scale and systematic clinical application outcomes ranking among the world’s leading levels (Source: People’s Daily Central Kitchen Health 37°C Studio Report). He hoped to take the release of this standard as a new starting point to further consolidate China’s leading position in hydrogen-oxygen medicine and bring safe and standardized hydrogen-oxygen therapy to more patients (Source: Transcript of Academician Zhong Nanshan’s speech at the special session).
A The standard sets clear safety and technical baselines, phasing out non-compliant products and opportunistic manufacturers. It helps compliant enterprises gain competitive advantages and facilitates the promoting market optimization and eliminating non-compliant products across the industry.
As one of the co-leading drafting organizations and a compliant industry benchmark enterprise, Asclepius innovative membrane-free, alkali-free electrolysis technology and Class III medical device qualifications establish benchmarks for product safety and service quality for the whole industry.
A The standard provides solid support for safe clinical application and orderly industrial growth, ensuring this cutting-edge therapy can benefit wider populations within a safe and regulated framework.
