April 2026 Update: New Standards for Respiratory Therapy Equipment and Medical Surface Disinfection

In April 2026, the international health care technology sector witnessed the release of five significant standards impacting respiratory therapy and hospital surface disinfection. These standards, developed by leading organizations such as ISO, IEC, and CEN, provide updated safety, performance, and efficacy guidelines for medical electrical equipment—including respiratory humidifiers and high-flow devices—as well as advanced protocols for surface disinfection. For medical device manufacturers, clinical engineers, infection control specialists, and compliance managers, understanding these updates is crucial for patient safety, regulatory compliance, and effective operational practices.

Overview: Raising the Bar in Health Care Technology Standards

Health care technology stands at the forefront of patient safety, device performance, and infection prevention. International standards underpin crucial aspects of product development, procurement, and clinical application—establishing a common language for manufacturers, regulators, and practitioners worldwide. This update reviews in detail newly released standards for April 2026, offering insights into:

• Enhanced requirements for respiratory humidification equipment
• Advanced performance and safety specifications for high-flow respiratory therapy devices
• Comprehensive test methods and criteria for on-site medical surface disinfection

Readers will gain clarity on scope, applicability, and the practical implications for their roles in compliance, quality management, and procurement.

Detailed Standards Coverage

ISO 80601-2-74:2026 (ISO Edition) — Advanced Requirements for Respiratory Humidifying Equipment

Medical electrical equipment — Part 2-74: Particular requirements for basic safety and essential performance of respiratory humidifying equipment

This standard establishes the essential safety and performance criteria for medical electrical (ME) respiratory humidifiers and their accessories—devices used to condition medical gases for patient therapy in both hospital and home care environments. Humidification is especially critical in invasive and non-invasive ventilation, high-flow therapy, and for tracheostomy patients, reducing complications caused by dry medical gases.

The core requirements include:

• Systematic risk management: Addressing hazards from electrical, thermal, mechanical, and user-interface issues, with compatibility across various humidification configurations.
• Accessory integration: Encompassing requirements for both integrated humidifiers and externally connected accessories such as heated breathing tubes and active heat and moisture exchangers (HMEs).
• Performance criteria: Precise limits for temperature, humidity output, and moisture content to ensure effective clinical performance without endangering patient safety.
• Testing protocols: Comprehensive regime for testing gas temperature, humidification output, and system recovery—including new requirements for fill connectors and recovery behavior.
• Labeling and documentation: Updated guidance on marking, labelling, and instructional content, following the latest IMDRF principles.

This 2026 edition supersedes the 2021 version, with enhanced normative references, additional fill connector requirements, and clarified system recovery criteria.

Industries needing to comply:

• Manufacturers and integrators of respiratory support equipment
• Clinical engineering departments in hospitals
• Home care ventilator providers
• Suppliers of humidifier accessories

Key highlights:

• Updated normative references to align with IEC 60601 series
• Extended requirements on active HMEs and accessory compatibility
• Stricter labelling and system performance recovery mandates

Access the full standard:View ISO 80601-2-74:2026 on iTeh Standards

ISO 80601-2-74:2026 (IEC Edition) — Harmonized Safety for Humidification Systems

Medical electrical equipment – Part 2-74: Particular requirements for basic safety and essential performance of respiratory humidifying equipment

The IEC edition mirrors the ISO counterpart but emphasizes interoperability and harmonization within the global regulatory landscape. It ensures that manufacturer-supplied accessories—such as heated tubes and wire controllers—meet both IEC 60601-1 and ISO 5367 requirements for comprehensive system risk mitigation.

Scope and details:

• Applicable to standalone and integrated humidifiers within equipment such as critical care and home ventilators
• Specifies risk controls for hazards from improper accessory interchangeability (such as heating connector mismatches)
• Ensures devices avoid excessive heat or moisture that might compromise airway safety
• Clarifies exclusion: Not for room humidifiers, HVAC systems, or infant chamber humidification

Target organizations:

• Equipment manufacturers exporting to markets with IEC compliance requirements
• Multinational hospital networks
• Regulatory affairs professionals

Key highlights:

• IEC harmonization for accessory and connector interoperability
• Refined accessory safety (especially for heated breathing circuits)
• New clarity on the treatment of integrated vs. standalone humidification equipment

Access the full standard:View ISO 80601-2-74:2026 on iTeh Standards

ISO 80601-2-90:2026 (IEC Edition) — Safety and Performance for High-Flow Respiratory Therapy

Medical electrical equipment - Part 2-90: Particular requirements for basic safety and essential performance of respiratory high-flow therapy equipment

This standard addresses devices delivering high-flow humidified respiratory gases, now increasingly deployed for adult and pediatric patients with acute or chronic respiratory conditions. The document encompasses stand-alone high-flow devices and those with a dedicated high-flow mode in multi-function ventilators or anesthesia systems.

Key requirements include:

• Safety controls: Requirements to prevent overheating, gas contamination, excess or inadequate oxygen delivery, and instability of medical gas supply
• Accessories and configuration: Ensures all system accessories (cannulas, masks, breathing sets, humidifiers) are compatible and evaluated together
• Performance assurance: Accurate delivery of flow and oxygen concentration under varying patient scenarios
• Cybersecurity features: New for 2026—addresses system integrity for software-managed devices and SpO2 monitoring add-ons
• Testing rigor: Protocols for alarms, emergency recovery, and system usability (with personal protective equipment in mind)

Industries and users impacted:

• Manufacturers of acute and hospital-based high-flow therapy devices
• Clinical respiratory care teams
• Biomedical equipment maintenance providers

Key highlights:

• Added cybersecurity requirements in line with evolving digital health threats
• New reference to pulse oximetry (SpO2) safety
• Practical usability controls for staff in PPE

Access the full standard:View ISO 80601-2-90:2026 on iTeh Standards

ISO 80601-2-90:2026 (ISO Edition) — Comprehensive High-Flow Therapy Device Guidance

Medical electrical equipment — Part 2-90: Particular requirements for basic safety and essential performance of respiratory high-flow therapy equipment

This ISO edition of the high-flow device standard supports both international manufacturers and health care operators in ensuring patient safety and treatment efficacy. The standard is applicable wherever devices deliver humidified respiratory gases, whether in intensive care, pediatric wards, or home-based settings. Although focused on acute and pediatric care, future ISO guidance for long-term home therapy is anticipated.

Major points:

• Applies to fully integrated systems or modular assemblies
• Risk analysis and mitigation for high-pressure/oxygen supply, infection control, heated humidifiers, and system transit use
• Accessory evaluation: from cannulas to alarm distributors
• Comprehensive marking, labelling, and documentation provisions

Who needs this standard:

• Global respiratory care equipment manufacturers
• Procurement specialists in large hospital systems
• Clinical engineering and risk management teams

Key highlights:

• Updated and harmonized references for multi-standard regulatory needs
• Explicit accessory compatibility and warning systems
• Guidance for multi-function and transportable devices

Access the full standard:View ISO 80601-2-90:2026 on iTeh Standards

EN 16615:2026 — Updated Test Method for Chemical Surface Disinfectants in Medical Settings

Chemical disinfectants and antiseptics — Quantitative test method for the evaluation of bactericidal and yeasticidal and/or fungicidal and/or tuberculocidal and/or mycobactericidal activity on non-porous surfaces with mechanical action employing wipes or mops in the medical area (4-field test) — Test method and requirements (phase 2, step 2)

This updated CEN European standard strengthens the quantitative evaluation of disinfectant efficacy on non-porous surfaces in clinical environments, focusing on disinfection via mechanical action (wiping/mopping) rather than spraying or flooding. It is pertinent for products applied in hospitals, clinics, dental care, and even supporting areas like kitchens or laundries. The test method closely mimics real-life surface cleaning scenarios, ensuring practical relevance.

Key elements:

• Four field test protocol: Simulates cleaning across four defined surface fields to accurately assess microbial reduction
• Minimum efficacy performance: Requires a minimum 5-log reduction for bacteria and 4-log for fungi/mycobacteria (under defined conditions)
• Application methods covered: Includes soaking, spraying, user- and manufacturer-impregnated wipes/mops
• Process controls: Water control included for validation, plus specification for types of wipes, contact times, interfering substances (albumin, erythrocytes)
• Result interpretation: Strict calculation of colony-forming units (cfu), multiple repetitions, and result validation

Organizations affected:

• Infection control departments
• Procurement teams sourcing disinfectants and hospital wipes
• Manufacturers of surface disinfectants, wipes, and mops

Key highlights:

• Harmonized test method for European medical surface disinfection
• Emphasis on practical, real-world cleaning scenarios
• Stricter process control and minimum test performance thresholds

Access the full standard:View EN 16615:2026 on iTeh Standards

Industry Impact & Compliance Considerations

Adoption of these new standards marks a pivotal step for manufacturers, clinical service providers, and quality managers. Here's how:

• For Manufacturers: Products must now align with the latest, more stringent requirements—especially regarding electrical safety, system recovery, thermal performance, accessory testing, and cybersecurity. Third-party certification and product documentation must reference the latest editions.
• For Clinical Facilities: High standards for device acceptance testing, routine maintenance, and staff training are necessary to meet updated requirements and maintain compliance. Infection prevention programs must validate new cleaning protocols using harmonized test methods, as prescribed in EN 16615:2026.
• Timeline: Most standards become mandatory in procurement specifications within 6–18 months of publication, subject to regulatory contexts. Early adoption is strongly advised to manage certification lead times.
• Benefits:
  • Enhanced patient safety and comfort
  • Reduced risk of device-related incidents and hospital-acquired infections
  • Streamlined audit and inspection processes
• Non-Compliance Risks:
  • Regulatory penalties and product recalls
  • Compromised patient safety
  • Barriers to market entry for non-compliant manufacturers

Technical Insights: Requirements, Implementation, and Certification

Across these standards, several technical themes and implementation tips emerge:

• Integration of Accessories: Rigorous evaluation of accessories (e.g., heated tubes, cannulas) as part of the ME system—not merely standalone—ensures holistic patient safety.
• Performance and Recovery: Updated requirements involve extended performance testing under fault and recovery scenarios, emphasizing real-world resilience.
• Alarm Systems and Usability: Devices must feature alarms for unsafe states and be operable by staff wearing gloves and protective gear.
• Documentation and Labeling: Enhanced guidelines mandate clear, durable markings per IMDRF principles and the provision of comprehensive user instructions.
• Disinfectant Test Methods: Adherence to EN 16615:2026 ensures only products with validated log reductions under defined contact times and interfering conditions are used in practice.

Best practices for implementation:

1. Perform a thorough gap analysis against existing device and disinfectant inventories
2. Update risk management files and device technical documentation to reflect new requirements
3. Engage with accredited test labs for performance and microbiological testing per the new protocols
4. Train staff in both device operation and surface disinfection validated under harmonized methods
5. Ensure procurement contracts specify compliance with the precise standard and edition

Certification:

• Seek third-party certification for devices
• Maintain compliance documentation for all accessories
• Validate cleaning protocols using the four-field test before regulatory inspections

Conclusion and Next Steps

April 2026 marks a leap forward in health care technology standards, with stringent requirements for respiratory humidification, high-flow therapy, and surfaces disinfection. To maintain excellence in patient care and regulatory readiness:

• Review which of your equipment and cleaning products are impacted
• Update procurement, risk management, and operating procedures to align with new requirements
• Initiate staff training and documentation updates ahead of regulatory deadlines

Stay ahead—explore the latest standard editions, and ensure robust, compliant, and high-performing health care environments.

Discover full details and explore more standards relevant to your sector at iTeh Standards.