Health Care Standards Summary – September 2025 Overview

Looking back at September 2025, the Health Care sector witnessed the publication of a notable international standard, further refining the safety, performance, and usability landscape for critical care equipment. The single standard showcased this month, ISO 7376-2:2025, addresses the essential requirements for video laryngoscopes (VLs)—a device category that has seen exponential adoption in medical practice. For industry professionals, quality managers, and those tasked with compliance and procurement, this overview serves as a vital retrospective: clarifying changes, identifying key impacts, and providing guidance on navigating the ever-evolving regulatory framework for medical devices.

Monthly Overview: September 2025

September 2025 was characterized by a focused but highly impactful standardization activity in the Health Care domain. The release of ISO 7376-2:2025—dedicated to video laryngoscopes—underscores a clear industry trend toward specialized guidance for advanced clinical devices. Unlike more diffuse months with multiple diverse topics, September’s publication honed in on a single, high-stakes area: airway management in critical care.

This concentration reflects two key realities: the rapidly growing integration of digital video technology into core procedures (like intubation), and the regulatory community’s intent to close gaps in device-specific requirements—especially where patient safety and operator usability are directly linked. Comparing this month’s output to historic patterns, we see an industry increasingly committed to defining robust criteria for complex, technology-driven tools, rather than updating broad generic standards. Such precision signals both the maturity and the specialization of health care device regulations in today’s environment.

Standards Published This Month

ISO 7376-2:2025 – Anaesthetic and respiratory equipment – Part 2: Video laryngoscopes

Full Standard Title: Anaesthetic and respiratory equipment – Part 2: Video laryngoscopes

Scope and Applicability: ISO 7376-2:2025 establishes comprehensive requirements for electrically powered video laryngoscopes—a class of devices now fundamental to tracheal intubation in anaesthesia and emergency medicine. The scope spans every component integral to these devices, including the handle, rigid blade, built-in light source, miniature camera, and dedicated display. It also extends to essential accessories directly tied to core function. Importantly, this standard does not apply to non-video laryngoscopes, endoscopes, surgical laryngoscopes, or third-party display screens not provided by the original manufacturer.

Key Requirements and Specifications:

• Risk Management: Mandates integrated processes for identifying hazards—particularly those unique to video interfaces (such as the risk of viewing recorded vs live images, or display obstruction by icons).
• Materials and Surfaces: All components must minimize risk of injury; rough or sharp surfaces are prohibited, and specific attention is given to external ergonomics.
• Mechanical Integrity: Prescribes minimum force thresholds for critical parts (e.g., handles, blades); includes requirements for drop testing, rigidity, and the strength of connections—reinforcing resilience in both routine and emergency scenarios.
• Illumination and Optical Performance: Sets distinct illumination and image display criteria (e.g., field of view, image latency, limiting resolution, and geometric distortion). Defines requirements for paediatric and neonatal use, reflecting sensitivity to special populations.
• System Communication and Power: Addresses electrical safety, system integration, and battery performance in compliance with IEC 60601 series and other referenced frameworks.
• Cleaning, Disinfection, and Sterilization: Demands manufacturer instructions for decontamination protocols, supporting infection control and device longevity.
• Information Supplied: Specifies what documentation, labeling, and instructions must accompany each device—essential for safe use and regulatory compliance.

Who Needs to Comply:

• Medical device manufacturers producing video laryngoscopes
• Hospitals, clinics, and emergency medical service providers procuring or maintaining such tools
• Regulatory authorities, notified bodies, and certification organizations overseeing approval and conformity assessment of airway management devices

Role in Regulatory and Industry Context: ISO 7376-2:2025 complements and extends the foundational requirements established in ISO 7376 (for non-video laryngoscopes), while interfacing with quality, safety, and usability standards including ISO 14971 (risk management), IEC 60601-1 (general medical electrical equipment), and ISO 18190 (airway devices general requirements). By specifying device-specific provisions, it fills critical regulatory gaps and promotes international harmonization for a rapidly advancing segment of clinical technology.

Notable Features:

• Introduction of minimum optical performance benchmarks, such as defined image latency thresholds (<200 ms) and geometric distortion limits (±20%).
• Defined force and mechanical tests to simulate clinical use, including drop and separation resistance.
• Special provisions for paediatric and emergency settings, avoiding a one-size-fits-all approach.
• Enhanced requirements for user instructions and risk communication, supporting both clinicians and risk managers.

Key highlights:

• Focused risk management for digital and video-specific hazards, including cybersecurity.
• Harmonized with leading international and IEC standards, emphasizing interoperability and system safety.
• Flexible compliance options, allowing validated alternative test methods under strict equivalency protocols.

Access the full standard:View ISO 7376-2:2025 on iTeh Standards

Common Themes and Industry Trends

The September 2025 publication of ISO 7376-2:2025 signaled several salient trends within the Health Care sector:

• Device-Specific Standardization: There is a clear shift toward issuing standards that address the nuanced challenges of individual device categories. Video laryngoscopes, now a mainstay in airway management, earned a dedicated benchmark—suggesting similar approaches are likely for other advanced clinical technologies.
• Emphasis on Digital Integration: The rising presence of video and imaging technology in clinical workflows is acknowledged not only in functional requirements but also in specific risk management concerns (e.g., image latency, display integrity, cybersecurity, and the risks tied to visual distractions).
• Patient-Centric Safety: By building in pediatric, neonatal, and emergency scenario requirements, the standard acknowledges diverse use contexts and patient profiles—a move toward increasingly tailored guidance.
• Strengthening of User and Risk Communication: Expanded instructions for manufacturers to supply comprehensive documentation and risk assessments reflect regulators’ desire for transparency and end-user empowerment.

Collectively, these themes reveal a sector that prizes both technological advancement and clinical safety, with standards acting as key enablers of reliable, interoperable, and innovative products.

Compliance and Implementation Considerations

For organizations affected by ISO 7376-2:2025, proactive measures are essential to both compliance and ongoing operational excellence. Key recommendations include:

• Gap Analysis: Conduct a thorough review of existing products, processes, and documentation against the explicit requirements of ISO 7376-2:2025. Pay particular attention to risk management files, mechanical design parameters, and user documentation.
• Cross-Reference to Related Standards: Ensure alignment with referenced standards (e.g., ISO 14971 for risk management, IEC 60601-1 for electrical safety), as conformance is often interdependent.
• Implementation Timeline: While the standard was published in September 2025, organizations should establish reasonable transition periods for process updates and staff training, balancing regulatory deadlines with realistic resource allocations.
• Access to Skills and Resources: Involve multidisciplinary teams—including clinical engineers, regulatory specialists, and frontline users—in both assessment and update phases.
• Documentation and Training: Update instructions for use (IFU), cleaning and maintenance protocols, and staff training programs to reflect the latest standard requirements.
• Supplier and Procurement Integration: Healthcare providers and procurement officers should request evidence of compliance from vendors and adjust purchasing policies to reference ISO 7376-2:2025 explicitly.

Conclusion: Key Takeaways from September 2025

September 2025’s Health Care standardization activity may have centered on a single document, but ISO 7376-2:2025 stands as a highly consequential benchmark for video laryngoscope safety and performance. Professionals across the healthcare spectrum—manufacturers, clinical practitioners, and compliance leaders alike—are encouraged to understand its requirements in depth.

Key recommendations:

• Prioritize a rapid, thorough review of any processes or products impacted by video laryngoscope regulations.
• Integrate the new requirements into design, procurement, and staff education cycles.
• Leverage this standard as part of broader risk and quality management strategies to enhance patient safety and operational reliability.

Staying current with such advances in health care device standardization is not simply a compliance exercise; it is a foundation for clinical excellence and patient trust. Organizations are encouraged to explore the details of ISO 7376-2:2025—and the wealth of resources available via iTeh Standards—to stay ahead in an era of technological complexity and growing regulatory scrutiny.