February 2026 Updates: Health Care Technology Standards for Oxygen Systems & Herbal Medicines

February 2026 sees significant advancements in health care technology standards, with five new international standards released to enhance patient safety, product quality, and global market consistency. This part of our coverage highlights international specifications for transportable liquid oxygen systems as well as harmonized quality benchmarks for herbal medicines widely used in Traditional Chinese Medicine (TCM). These updates directly impact manufacturers, importers, and health providers across the health care industry, driving both innovation and compliance in a competitive, quality-centric landscape.

Overview / Introduction

Health care technology continues to evolve rapidly, with international standards playing a pivotal role in ensuring safety, efficacy, and interoperability across the sector. February 2026 brings important developments, including updated requirements for medical oxygen systems and unified quality approaches to medicinal herbs. As the use of complex equipment and natural medicines expands worldwide, comprehensive standards ensure that products meet stringent safety, purity, and performance demands—supporting both clinical outcomes and regulatory compliance.

In this article, we explore the scope, requirements, and implications of five newly published standards for health care technology. Whether your focus is equipment procurement, quality control, regulatory affairs, or product development, understanding these updates will help you navigate the new landscape and mitigate risks.

Detailed Standards Coverage

ISO 18777-1:2026 - Enhanced Safety for Liquid Oxygen Systems

Transportable liquid oxygen systems for medical use — Part 1: Common requirements and particular requirements for base units

This standard establishes critical safety, design, and performance requirements for transportable liquid oxygen systems intended for medical applications, with a primary focus on home-care scenarios. ISO 18777-1:2026 covers both base units (for storage and transfilling) and portable units, while also detailing requirements unique to base units. Stationary (pipeline-supplied) systems are excluded. Key areas include risk management, materials, usability, environmental conditions, cryogenic vessel design, interoperability, oxygen flow characteristics, and information to be provided by manufacturers.

Organizations that design, manufacture, or regulate liquid oxygen systems for home use or patient mobility must comply with these specifications. The standard integrates common European requirements, ensuring global interoperability and harmonized safety practices for oxygen delivery devices.

Key highlights:

• Mandatory risk assessment according to ISO 14971 and comprehensive usability provisions
• Design and marking specifications for vacuum-insulated cryogenic containers and transfilling devices
• Rigorous requirements for leakage, flow control, oxygen purity, electrical safety, and information supplied to users

Access the full standard:View ISO 18777-1:2026 on iTeh Standards

ISO 19661:2026 - Quality and Safety for Anemarrhena Rhizome

Traditional Chinese medicine — Anemarrhena asphodeloides rhizome

ISO 19661:2026 provides an authoritative framework for the quality, safety, and identification of Anemarrhena asphodeloides rhizome—a widely used ingredient in TCM with significant export and therapeutic value. The standard specifies criteria for macroscopic and microscopic identification, moisture and ash content, marker compound quantification, as well as limits on heavy metals and pesticide residues.

These guidelines apply to organizations growing, processing, exporting, or certifying Anemarrhena rhizome for use as a natural medicine, including both raw herbal materials and decoction pieces. Unified international criteria facilitate smoother trade and ensure patient safety by eliminating substandard or adulterated products from the supply chain.

Key highlights:

• Defined test methods for TLC (thin-layer chromatography) identification and quality markers
• Clear thresholds for moisture, total ash, and acid-insoluble ash
• Comprehensive controls for contaminants and labelling requirements

Access the full standard:View ISO 19661:2026 on iTeh Standards

ISO 24066:2026 - Harmonized Requirements for Euodia Fruit

Traditional Chinese medicine — Euodia (syn. Evodia or Tetradium) fruit

This standard addresses the long-standing variability in national requirements for Euodia fruit (wúzhūyú in Chinese), a medicinal fruit used for centuries in TCM. ISO 24066:2026 brings together best practices in quality control, including rigorous standards for morphological and chemical identification, marker compound analysis (e.g., evodiamine, rutecarpine, limonin), and thresholds for contaminants like heavy metals, sulfur dioxide, and pesticides. It sets protocols for sampling, testing, packaging, and labelling to ensure product authenticity and safety.

Key stakeholders include growers, herbal processors, pharmaceutical companies, export certifiers, and regulators involved in the international trade of natural medicines.

Key highlights:

• Standardized TLC and HPLC test methods for chemical authentication
• Maximum allowed concentrations for moisture, total ash, and ethanol-soluble extractives
• Controls for both visible and chemical contamination, with strict storage and transport requirements

Access the full standard:View ISO 24066:2026 on iTeh Standards

ISO 21315:2026 - Global Standard for Ganoderma Lucidum Fruiting Body

Traditional Chinese medicine — Ganoderma lucidum fruiting body

Updated in 2026, this second edition unifies the diverse quality requirements for Ganoderma lucidum (Lingzhi/Reishi), a prized medicinal mushroom. The standard specifies criteria for macroscopic/microscopic identification, chromatography-based chemical testing, moisture, and marker compounds, including polysaccharides and ganoderic acid A. It also prescribes limits for heavy metals and pesticide residues, and expands recommendations for water-soluble extractives.

This document supports growers, manufacturers, and quality assurance professionals in reliably demonstrating the authenticity and safety of Ganoderma products in both domestic and international trade.

Key highlights:

• Comprehensive identification protocols using TLC and HPLC
• Detailed requirements for target active constituents and purity
• Enhanced harmonization of international pharmacopoeia requirements

Access the full standard:View ISO 21315:2026 on iTeh Standards

ISO 25099:2026 - Curcuma Rhizome: Standardized Identity and Testing

Traditional Chinese medicine — Curcuma phaeocaulis, Curcuma kwangsiensis and Curcuma wenyujin rhizome

This new standard sets out unified international requirements for the identity, purity, physical characteristics, and chemical constituents of Curcuma rhizome—including the "E’zhu" types commonly used in herbal medicine. The document covers macroscopic and microscopic identification, thin-layer and high-performance liquid chromatography methods, as well as tests for essential oils, marker compounds, heavy metals, and pesticide residues.

Organizations cultivating, exporting, or regulating Curcuma rhizome gain a harmonized benchmark for trade and therapy, ensuring end users receive authentic, effective, and safe medicinal products.

Key highlights:

• Clear distinction of rhizome types by both morphological and chemical tests
• Required tests for residual sulfur dioxide, extractives, and oil content
• Enhanced traceability and quality assurance for international trade

Access the full standard:View ISO 25099:2026 on iTeh Standards

Industry Impact & Compliance

The release of these five standards marks a critical advance for stakeholders across the health care technology and traditional medicine sectors. Organizations involved in the design, production, or distribution of oxygen systems and herbal products should prioritize a thorough review and implementation of these requirements. Compliance deadlines may differ regionally, but early adoption ensures:

• Improved patient safety and therapeutic predictability
• Legal certainty and alignment with global best practices
• Fewer trade barriers and enhanced international market access
• Lower risk of product recalls or regulatory penalties

Non-compliance risks include fines, import/export delays, reputation damage, and—most importantly—potential patient harm. Integrating these new standards into procurement criteria, supplier agreements, and internal quality systems is essential for long-term operational resilience.

Technical Insights

Although the standards cover diverse products, several core principles and technical considerations emerge:

• Risk Management: All device-related standards demand rigorous hazard analysis and mitigation, particularly ISO 18777-1:2026, which explicitly aligns with ISO 14971 for medical device risk management.
• Product Characterization: All herbal standards require a combination of macroscopic, microscopic, chemical, and chromatographic analyses (TLC/HPLC) to ensure positive identification and to prevent adulteration.
• Contaminant Controls: Universal requirements are set for contaminant testing—heavy metals, pesticide residues, and, where applicable, sulfur dioxide and ash content.
• Documentation & Labelling: Each standard prescribes the information manufacturers and suppliers must provide, including clear labelling, test reports, and usage guidance.
• Testing & Verification: Implement best-practice sampling, standardized methodologies, and internal validation processes to meet new requirements and simplify certification or regulatory approvals.
• Supplier Engagement: Upstream supplier audits and shared specifications aligned to these standards are key to maintaining quality assurance across complex supply chains.

Conclusion / Next Steps

These February 2026 health care technology standards set a new global benchmark for patient safety, product consistency, and supply chain transparency. To stay ahead:

• Review the full texts of each standard relevant to your business or supply chain
• Engage with quality assurance, procurement, and compliance teams to update internal documentation, audit protocols, and supplier requirements
• Consider training staff and partners in new testing and documentation procedures
• Monitor for future amendments or related standards (e.g., updates to pipeline oxygen systems, additional TCM herbs)

Staying abreast of industry-wide standards updates is essential for all organizations aiming to maintain competitive advantage and ensure safety within international health care markets.

Explore the latest standards and industry insights at iTeh Standards. Stay informed and compliant with emerging requirements in health care technology and beyond.