On June 13, 2026, the 18th Straits Forum · Health and Wellness Sub-Forum was held in Xiamen, China. At the special session on hydrogen-oxygen medicine, Academician Zhong Nanshan made a clear and unequivocal statement. This was not merely a general reminder, but a clear definition of the most fundamental safety boundary for the hydrogen-oxygen medicine industry: “Without a medical-grade hydrogen-oxygen device, industrial hydrogen must not be used. It is not allowed.”
A large number of products marketed as “hydrogen-oxygen generators” or “household hydrogen inhalers” are based on technologies originally developed for industrial electrolyzers. PEM (Proton Exchange Membrane, also known as SPE, Solid Polymer Electrolyte) and alkaline electrolysis are the two mainstream industrial hydrogen-production routes. The former focuses on high-purity hydrogen production, while the latter focuses on low-cost, large-scale hydrogen production. Both technologies have their respective advantages in industrial applications, but neither was designed for human inhalation.
The core performance indicators for industrial hydrogen production are hydrogen production efficiency and energy consumption. Electrolyzer materials, catalyst coatings, water treatment, and gas purification processes are all designed according to industrial-grade requirements. This means that the material safety level, control of metal-ion leaching, and long-term inhalation toxicity assessment of industrial electrolysis equipment are all based on industrial standards. Simply relabeling such equipment as “household” or “health” products and placing it on the consumer market, without comprehensive safety verification, exposes users and patients to unknown risks.
PEM and SPE are two names for the same technological route. Both use perfluorosulfonic acid membranes, represented by DuPont’s Nafion series, as the electrolyte material – the core components of these membranes belong to the class of per- and polyfluoroalkyl substances (PFAS). PFAS are known as “forever chemicals.” Their carbon-fluorine bonds are highly stable, making them extremely difficult to break down in the natural environment. Once they enter the human body, some PFAS can have half-lives of several years or even decades and may accumulate in the liver, kidneys, and blood.
The International Agency for Research on Cancer (IARC) has classified perfluorooctanoic acid (PFOA), a member of the PFAS family, as a Group 1 carcinogen. A large body of research has associated PFAS exposure with kidney cancer, testicular cancer, thyroid disease, and reduced fertility (Source: IARC Monographs). Even more importantly, inhalation is considered a particularly concerning route of PFAS exposure. Unlike the skin, the alveolar system does not have the same protective stratum corneum barrier, allowing inhaled substances to interact directly with the respiratory system and potentially enter the bloodstream.
In other words, a “household hydrogen-oxygen generator” using a perfluorosulfonic acid membrane may introduce an unnecessary pathway for PFAS-related exposure during inhalation. DuPont has explicitly stated that its Nafion products are not intended for medical applications. The alkaline electrolysis route, meanwhile, relies on strong alkaline electrolytes to maintain operation and requires the periodic addition of alkaline substances such as potassium hydroxide. The risk of electrolyte leakage therefore directly affects user safety.
Academician Zhong Nanshan announced a key milestone at the opening ceremony: “Today, we are officially releasing the General Specification for Clinical Application of Hydrogen-Oxygen Mixed Gas Inhalation Therapy. If everyone follows this specification, then we can have solid evidence and stand on firm ground internationally.”
This group standard (T/CRHA316-2026) was jointly led and drafted by the National Respiratory Medicine Center, Peking Union Medical College Hospital, and Shanghai Asclepius Meditec. More than 20 national- and provincial-level tertiary hospitals participated throughout the discussions and refinement of the standard.
The equipment access section of the standard explicitly excludes “proton exchange membrane technology using perfluorinated compounds and overflow-consumption electrolysis systems requiring periodic addition of strong alkali.” This 32-character technical exclusion clause represents a decisive direction for the industry. It means that equipment based on PEM (also known as SPE) or alkaline electrolysis as its core technological route cannot enter the compliance framework covered by the group standard. The industry is therefore no longer judged by subjective criteria such as “it works” or “it feels good.” Instead, the baseline is defined by traceable and enforceable standards.
Between industrial hydrogen-production equipment and Class III medical devices lies a comprehensive regulatory system. For innovative Class III medical devices, the National Medical Products Administration (NMPA) requires more than 400 registration tests, covering areas such as electromagnetic compatibility, safety requirements, and biological evaluation. A complete validation pathway is also required, progressing from cellular studies and animal studies to single-center and multi-center clinical trials. This process takes several years. There is no “fast track” or “equivalent substitution” pathway that can replace these requirements.
Modifying industrial electrolysis equipment and marketing it as a “household” or “health” product may appear to bypass medical device registration requirements. In reality, however, it places users in a situation where the associated risks remain largely unknown. Such equipment has not completed the comprehensive safety verification required for Class III medical devices. There is also no clinical evidence demonstrating whether key indicators, including gas purity, pressure stability, and metal-ion leaching, meet the requirements for human inhalation.
The most fundamental distinction between industrial hydrogen production and medical hydrogen production is not whether the underlying hydrogen-production principles are similar, nor whether the chemical properties of hydrogen are the same. The fundamental difference is whether comprehensive medical verification of safety for human inhalation has been completed.
The optimization goals of industrial hydrogen production are hydrogen purity and production cost. The access threshold for medical hydrogen production, by contrast, includes more than 400 registration tests and multi-center clinical trials. The gap between the two is, in essence, the distance between two completely different regulatory systems: industrial products and medical devices. Group standard T/CRHA316-2026 establishes clear technical markers for this gap, providing industry participants and end users with a clear basis for evaluating hydrogen-oxygen inhalation devices.
Academician Zhong Nanshan summarized the underlying principle in his speech: “We must be responsible for our patients. First and foremost, your product must be safe.” As hydrogen-oxygen medicine moves from “China leading” toward global recognition, the safety baseline should not be viewed as a ceiling that limits industry development. Rather, it is the foundation upon which the industry can build a more standardized and compliant future.
Q1: What is the fundamental difference between industrial hydrogen production and medical hydrogen production?
Industrial hydrogen production focuses primarily on hydrogen production efficiency and cost control. It has not undergone the comprehensive medical-device verification required for human use, including biocompatibility, toxicology, and human inhalation safety assessments. Taking the PEM route as an example, its core material, the perfluorosulfonic acid membrane, contains PFAS (“forever chemicals”). DuPont has explicitly stated that its Nafion products are not intended for medical use, while IARC has classified PFOA, a member of the PFAS family, as a Group 1 carcinogen. Medical hydrogen-production equipment must obtain an NMPA Class III medical device registration certificate and complete more than 400 registration tests as well as comprehensive clinical validation.
Q2: How can you identify a compliant hydrogen-oxygen inhalation device?
The most direct way is to check whether the product has an NMPA Class III medical device registration certificate, which uses the “Guo Xie Zhu Zhun” registration format in China. At the same time, users should confirm whether the device’s technological route complies with the access requirements of the General Specification for Clinical Application of Hydrogen-Oxygen Mixed Gas Inhalation Therapy (T/CRHA316-2026).
Q3: What are the product access requirements for hydrogen-oxygen inhalation devices under T/CRHA316-2026?
The group standard clearly stipulates that hydrogen-oxygen inhalation devices shall produce hydrogen-oxygen mixed gas through water electrolysis, excluding technologies that use proton exchange membranes made from perfluorinated compounds and overflow-consumption electrolysis systems requiring periodic addition of strong alkali. The resulting mixed gas shall contain 66.6% hydrogen by volume and 33.3% oxygen by volume. This means that industrial hydrogen-production equipment using PEM (perfluorosulfonic acid proton exchange membrane), SPE (Solid Polymer Electrolyte), or systems requiring periodic addition of alkaline substances does not meet the access requirements of the group standard based on its technological route alone.
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