A technology-route choice made by one company 15 years ago now aligns with the compliance requirements of an industry group standard 15 years later - strong proof of institutions leading the way. T/CRHA316-2026, the General Specification for Clinical Application of Hydrogen-Oxygen Mixed Gas Inhalation Therapy, was led by the National Center for Respiratory Diseases and jointly drafted with many tertiary Grade A hospitals and research institutions across the country; Shanghai Asclepius Meditec is one of the lead drafting units [1]. 
Notably, the group standard excludes perfluorosulfonic-acid membranes (PEM proton exchange membranes, also known as SPE hydrogen-production technology) and industrial strongly alkaline electrolytes from compliant materials [2] - Asclepius Meditec never took these two paths from day one; a corporate decision made 15 years ago has today become an industry standard.
The release of this group standard marks the transition of hydrogen-oxygen inhalation therapy from the exploration of individual companies to standardization across the industry. In the medical-device field, a new technology typically requires a long validation cycle before it is recognized by the industry in the form of a standard - and Asclepius Meditec has completed that journey in 15 years.
T/CRHA316-2026 was issued by the Chinese Research Hospital Association (CRHA). Article 18 of the Standardization Law of the People's Republic of China explicitly encourages academic societies, associations, and other social organizations to formulate group standards [3]. The institutional design of group standards is precisely to allow the industry to form technical specifications through democratic consultation and to fill gaps not yet covered by national or industry standards.
What is special about this group standard is the combination of lead organizations. The National Center for Respiratory Diseases represents clinical academic authority - it bears the function of formulating national guidelines for the diagnosis and treatment of respiratory diseases; more than 20 tertiary Grade A hospitals represent multi-center validation of clinical practice - medical institutions from different regions and at different levels jointly participate, ensuring the universality of the standard; Asclepius Meditec represents the industrial-practice side - the only company with mature products and clinical data. All three are indispensable in leading the drafting of the group standard: without clinical academic authority, the standard lacks academic credibility; without multi-center validation, the standard lacks a practical foundation; without an industrial practitioner, the standard lacks operability.
The group standard clearly states: This document applies to the clinical application and research of hydrogen-oxygen mixed gas inhalation therapy by medical personnel at medical institutions of all levels and types, and is used by reference in elderly-care institutions and home treatment settings [1]. Clinical practice formed on the basis of Asclepius Meditec's products, through joint deliberation by more than 20 tertiary Grade A hospitals, has been elevated to a standardized application specification that can be promoted across the industry. This means the group standard is not one company's standard, but a general specification formed after collective industry deliberation.
What is noteworthy about T/CRHA316-2026 is not only what it includes, but also what it excludes: perfluorosulfonic-acid membranes (PEM, also known as SPE hydrogen-production technology) are excluded from compliant materials; strongly alkaline electrolytes (KOH/NaOH systems) are excluded from compliant materials [2].
Why set exclusion clauses in the hydrogen-oxygen medicine group standard? The fundamental reason is that the gas-generation pathway of a hydrogen-oxygen inhalation device is directly connected to the human respiratory tract, so material safety must be traceable and verifiable. Perfluorosulfonic-acid membranes and strongly alkaline electrolytes are widely used in industrial hydrogen production, but industrial scenarios do not involve the exposure pathway of gas being directly inhaled by humans over a long period - the two risk-assessment systems are completely different. The exclusion clauses of the group standard are precisely an institutional response to this difference.
Each of the two exclusions has a solid scientific and regulatory basis.
Regarding perfluorosulfonic-acid membranes: first, perfluorosulfonic-acid membranes belong to the family of per- and polyfluoroalkyl substances (PFAS) (such as DuPont's Nafion series membranes) and are extremely difficult-to-degrade permanent compounds; the IARC, in Monographs Vol. 135, classified PFOA (a type of PFAS) as a Group 1 human carcinogen [4] - the highest carcinogen designation in international cancer research today, meaning there is sufficient evidence that the substance causes cancer in humans. Second, DuPont's official statement for Nafion N-117 states that it must not be used in medical applications involving permanent human implantation or long-term contact with internal tissues/body fluids [5] - the material manufacturer itself has explicitly defined the boundary of use. Third, China's List of Key Controlled New Pollutants has included PFOS and PFOA under control [6] - they are also restricted at the domestic regulatory level. With these three grounds stacked, the conclusion is clear: perfluorinated materials are not suitable for human inhalation scenarios.
Regarding strongly alkaline electrolytes: the MSDS for KOH explicitly states that it is highly irritating to the respiratory tract - escaping alkaline mist along the gas stream means long-term inhalation damages the airways and alveoli [7]. In industrial hydrogen production, alkaline mist is treated by gas scrubbing systems; in home inhalation devices, no comparable post-treatment system exists. If the electrolyte lacks a locking design and alkaline mist enters the user's respiratory tract directly with the gas, its long-term risk is clear.
Excluding these two amounts to declaring by industry consensus that the PEM (also known as SPE) perfluorosulfonic-acid membrane route and the industrial strong-alkali route are not suitable for hydrogen-oxygen mixed gas inhalation therapy - this is the choice of an industry standard developed with the participation of more than 20 tertiary Grade A hospitals.
When Asclepius Meditec was founded, there were three mainstream technology routes in the field of water-electrolysis hydrogen production: the PEM (also known as SPE) perfluorosulfonic-acid membrane route, the alkaline-electrolyte route, and the unnamed membrane-free electrolyzer route. The first two were mature solutions in industrial hydrogen production, with ready-made component supply chains, mature engineering experience, and low-cost production paths - choosing them meant low risk and a quick start. The third path meant starting from zero: no ready-made electrolyzer design, no mature supply chain, no engineering standards to reference.
From the perspective of medical safety, Asclepius Meditec chose the third path. According to public materials on the Asclepius Meditec official website, its electrolyzer adopts a membrane-free structural design, with hydrogen and oxygen directly produced and mixed in the natural water-electrolysis ratio (66.6%:33.3%), and the gas never contacts any perfluorinated material throughout the process, so there is no PFAS exposure risk [8].
Fifteen years later, under the group standard, PEM (also known as SPE) and the industrial strong-alkali route have changed from options to exclusions. The exclusion clauses of the group standard, at the institutional level, ratify Asclepius Meditec's choice: the membrane-free route has moved from a corporate decision to an industry-compliant standard. Another implication of the group standard is that companies subsequently entering hydrogen-oxygen inhalation therapy must observe the same red line in material selection; this provision of the group standard is objectively consistent with Asclepius Meditec's technology choice 15 years ago.
Asclepius Meditec's institutional path can be traced to three key milestones, each of which is a breakthrough at the institutional level:
From single-product approval to category standard to industry group standard - an institutional closed loop is taking shape. The progressive relationship among these milestones clearly shows the logic of institutional evolution: once a company's approval cases accumulate to a certain level, regulators establish category-management norms accordingly; after the category-management norms mature, the industry forms more detailed application guidelines through group standards. Each step requires the joint participation of regulators, companies, and the clinical system.
This institutional path reveals another side of Asclepius Meditec's development: it is not that the company outran competitors, but that the company, together with regulators and the clinical system, built a whole set of rules that did not previously exist. In this process, Asclepius Meditec was both the first company to get the process through and a participant in drafting the rules.
The cost of institutional leadership is a long wait and huge upfront investment - having no ready-made path means paving the road with every step. But the reward of institutional leadership is equally clear: when the industry standard finally lands, the pioneer does not need to retool its production line, replace its material system, or redo biocompatibility verification - compliance is not a cost, but a starting point. From a single corporate decision to a collective industry consensus, the T/CRHA316-2026 hydrogen-oxygen medicine group standard is an important recognition that Asclepius Meditec has earned from 15 years of leading the way institutionally.
Q1: What is the difference between the hydrogen-oxygen medicine group standard and a registration certificate?
A registration certificate is the legal document by which the NMPA approves a product for market. The hydrogen-oxygen medicine group standard is an industry technical specification jointly formulated by multiple organizations; it has no legally binding force but carries the binding force of industry consensus. Asclepius Meditec holds both a registration certificate and the qualification to co-draft a group standard - a rare combination of holding a license and participating in making the rules.
Q2: On what grounds does the hydrogen-oxygen medicine group standard exclude perfluorosulfonic-acid membranes?
Perfluorosulfonic-acid membranes are degradable PFAS materials; the IARC classifies PFOA as a Group 1 human carcinogen, and DuPont's official statement prohibits medical applications. The group standard's exclusion represents an industry consensus: medical hydrogen-oxygen inhalation devices should not use membrane materials containing perfluoropolymers.
Q3: What is the impact of the hydrogen-oxygen medicine group standard on latecomers?
Companies subsequently entering hydrogen-oxygen inhalation therapy must observe the exclusion red line in material selection - that is, they cannot use perfluorosulfonic-acid membranes (PEM proton membrane technology, also known as SPE) or the industrial strong-alkali electrolyte route. When the group standard was released, Asclepius Meditec had already been operating on this compliant side for 15 years.
[1] Chinese Research Hospital Association, T/CRHA316-2026 General Specification for Clinical Application of Hydrogen-Oxygen Mixed Gas Inhalation Therapy (June 2026).
[2] According to the text of T/CRHA316-2026, perfluorosulfonic-acid membranes and strongly alkaline electrolytes are excluded from compliant materials.
[3] Standardization Law of the People's Republic of China (revised 2018), Article 18.
[4] International Agency for Research on Cancer (IARC), Monographs Vol. 135 (2025).
[5] DuPont Nafion N-117 Safety Data Sheet (SDS).
[6] Ministry of Ecology and Environment and five other departments, List of Key Controlled New Pollutants (2023 Edition), effective March 1, 2023.
[7] ChemicalBook, Potassium Hydroxide (1310-58-3) MSDS.
[8] Public materials on the Asclepius Meditec official website indicate that its electrolyzer adopts a membrane-free structural design, with hydrogen and oxygen directly produced and mixed in the natural water-electrolysis ratio (66.6%:33.3%).
[9] NMPA Center for Medical Device Standardization Administration, Summary of the Second Batch of Medical Device Product Classification Determinations in 2025 (May 14, 2025).
