March 2026: New Standards in Health Care Technology Drive Safety and Quality

The evolving landscape of health care technology received significant advancements in March 2026 with the release of five pivotal international standards. These new publications address critical aspects ranging from respiratory therapy and dental implant documentation to Traditional Chinese Medicine reference materials and pandemic response diagnostics. Developed by leading organizations such as ISO and CEN, these standards are essential for manufacturers, medical practitioners, quality managers, and regulatory professionals striving to elevate safety, performance, and compliance across clinical and research settings.

Overview

Health care technology is an industry at the crossroads of innovation and rigorous regulatory oversight. With rapid medical advances, standards play a crucial role in ensuring safety, consistent performance, interoperability, and risk mitigation. The newly published standards for March 2026 reflect continued global attention on:

• Robust safety requirements for electrical and respiratory equipment
• Consistent documentation and traceability for implantable devices
• Quality assurance in herbal medicines
• Emergency preparedness for diagnostic surges in pandemics

This article unpacks each standard’s technical focus, real-world implications, and why their adoption is increasingly critical for organizations operating or supplying within the sector.

Detailed Standards Coverage

FprEN ISO 80601-2-74 - Respiratory Humidifying Equipment Safety

Medical electrical equipment - Part 2-74: Particular requirements for basic safety and essential performance of respiratory humidifying equipment (ISO/FDIS 80601-2-74:2025)

This standard sets specialized requirements for the basic safety and essential performance of respiratory humidifiers (medical electrical equipment or ME equipment), focusing on equipment used in both hospital and home settings. The document addresses not just the humidifiers themselves but also accessories (including heated breathing tubes and controllers) whose characteristics can influence humidification therapy outcomes.

The requirements span invasive and non-invasive ventilation, nasal high-flow therapy, sleep apnea therapy, and care for tracheostomy patients. Notably, the standard distinguishes between active HMEs (devices that add heat and moisture) and passive HMEs (which simply return expired heat and moisture), directing users to additional specific standards for the latter.

Key updates in this edition include revised references, new requirements for fill connectors (to prevent misconnection hazards), and clarified system recovery requirements after power interruption or fault.

Key highlights:

• Addresses safety and performance for stand-alone and integrated humidifiers
• Details compatibility requirements for accessories (breathing tubes, controllers)
• Clarifies marking, labelling, and documentation to prevent misuse

Access the full standard:View FprEN ISO 80601-2-74 on iTeh Standards

ISO 24825:2026 - Establishment of Herbal Reference Substances in Traditional Chinese Medicine

Traditional Chinese medicine — General principles for the establishment of herbal reference substances

ISO 24825:2026 ensures global clarity and uniformity in the establishment, quality control, and supply chain management of herbal reference substances used in Traditional Chinese Medicine (TCM). The standard outlines principles for producing, testing, packaging, and transporting herbal reference materials, reference extracts, and chemical reference substances.

Manufacturers and laboratories engaged in the preparation or use of herbal reference substances for international trade will find guidance on identifying botanical origins, ensuring homogeneity and stability, and documenting analytical findings as required by major pharmacopoeias.

Its comprehensive approach harmonizes requirements with ISO 17034 and related quality management references, supporting cross-border trust and regulatory acceptance for herbal medicinal product quality control.

Key highlights:

• Defines production and documentation requirements for TCM reference substances
• Harmonizes international quality control practices across major pharmacopoeias
• Supports supply chain transparency and regulatory harmonization for herbal products

Access the full standard:View ISO 24825:2026 on iTeh Standards

FprEN ISO 80601-2-90 - Safety for Respiratory High-Flow Therapy Equipment

Medical electrical equipment - Part 2-90: Particular requirements for basic safety and essential performance of respiratory high-flow therapy equipment (ISO/FDIS 80601-2-90:2025)

This standard is dedicated to the safety and performance of high-flow respiratory therapy equipment for patients able to breathe spontaneously and in need of humidified respiratory gases—applications such as treating respiratory failure, improving oxygenation, and supporting mucociliary clearance.

It sets stringent requirements for equipment intended for both clinical and home healthcare environments, addressing:

• Alarm systems and risk management for power or gas supply interruption
• Flowrate and oxygen concentration accuracy
• Compatibility with accessories such as cannulas, masks, and humidifiers

The specification includes detailed criteria for technical documentation, labelling, operating instructions, cleaning, and maintenance, reflecting best practices for device usability and patient safety.

Key highlights:

• Essential performance and alarm requirements for high-flow therapy
• Comprehensive technical and labelling requirements
• Targeted toward manufacturers supplying hospitals and home care providers

Access the full standard:View FprEN ISO 80601-2-90 on iTeh Standards

ISO 20364:2026 - Pandemic Diagnostic Surge Management

Healthcare organization management — Pandemic response — Requirements for surging diagnostic demand

ISO 20364:2026 is a timely, strategic standard for healthcare organizations seeking resilience in pandemic response, particularly in rapidly scaling up diagnostic testing services. It provides a management framework for mitigating supply chain disruptions, protecting personnel, ensuring quality assurance, and fostering collaborative stakeholder response.

The standard recommends innovative and pragmatic solutions, such as outsourcing, task shifting, adoption of automated systems, pooled sample testing, and the use of non-medical laboratories to meet sudden increases in diagnostic demand. It also emphasizes robust risk management and continuous communication with regulatory authorities.

Key highlights:

• Pandemic surge diagnostics management framework for healthcare providers
• Quality assurance and supply chain continuity strategies
• Collaborative and dynamic response practices

Access the full standard:View ISO 20364:2026 on iTeh Standards

EN ISO 10451:2026 - Documentation and Safety for Dental Implant Systems

Dentistry - Contents of a technical file for dental implant systems (ISO 10451:2026)

EN ISO 10451:2026 specifies the technical documentation necessary to demonstrate regulatory compliance for endosseous dental implant systems—spanning implant bodies, abutments, screws, connection parts, and healing components. The standard details the requirements for:

• Device description, specification, and representative images
• Biocompatibility, design attributes, and manufacturing data
• Sterilization, packaging, labelling, and shelf-life documentation
• Post-market surveillance and clinical evaluations

Clear, comprehensive technical files not only facilitate smoother regulatory submissions but also underpin market access across different jurisdictions.

Key highlights:

• Defines core documentation for regulatory assessment of dental implant systems
• Addresses requirements for clinical evaluation and risk analysis
• Supports traceability and post-market surveillance

Access the full standard:View EN ISO 10451:2026 on iTeh Standards

Industry Impact & Compliance

Adopting these updated standards is imperative for organizations manufacturing, implementing, or procuring medical devices and health care solutions. Ensuring compliance means:

• Demonstrating alignment with global best practices and reducing the risk of adverse incidents
• Enhancing patient and end-user safety by adopting the latest tested requirements
• Facilitating cross-border trade, as international compliance is often required for market access
• Staying competitive amidst stricter regulatory scrutiny and evolving healthcare challenges, especially post-pandemic

Non-compliance may result in regulatory penalties, product recalls, or loss of trust among patients and clinical customers. Early adoption is recommended, especially before enforcement or transition deadlines.

Technical Insights

Key Technical and Quality Management Themes

1. Systemic Approach to Safety: Both respiratory standards (FprEN ISO 80601-2-74 and -2-90) integrate device and accessory requirements, highlighting the interconnectedness of medical electrical systems.
2. Thorough Documentation Requirements: EN ISO 10451:2026 demonstrates a growing emphasis on transparent, traceable technical files—the backbone of conformity assessments in device regulation.
3. Consistency in Quality Control: ISO 24825:2026 and ISO 20364:2026 both stress standardized processes for quality assurance, whether in herbal reference substance preparation or large-scale pandemic diagnostics.
4. Practical Usability and Labeling: Across all standards, usability for both professional and lay users, clear marking, and comprehensive instructions are prioritized to mitigate risk and enable correct operation.

Implementation and Certification Considerations

• Engage early with notified bodies or conformity assessment organizations to clarify documentation needs
• Train relevant staff on both technical and documentary changes introduced
• Update existing devices and processes during the transition period to maintain regulatory compliance
• Use the new standards to guide supplier audits, procurement specifications, and internal quality audits

Conclusion & Next Steps

March 2026 marks a significant milestone in health care technology with the release of these new international standards. Organizations are strongly advised to:

• Review each standard relevant to their product portfolio or operational domain
• Implement necessary process, documentation, and technical changes
• Train teams on updated requirements and maintain ongoing regulatory intelligence

Stay tuned for the next installment covering additional standards published in this dynamic sector, and consult iTeh Standards for access to authoritative, up-to-date standards necessary for your ongoing compliance and innovation.