Monthly Roundup: Health Care Technology Standards from July 2025

Looking back at July 2025, the health care technology sector experienced a significant period of standardization, with five notable documents published across diagnostic imaging, medical gas systems, dental surgery, and equipment security. This recap provides a comprehensive analysis of these standards, highlighting the month's prevailing themes—such as advanced safety protocols, tightening security measures for hazardous materials, and ongoing harmonization with international best practices. For industry professionals—whether involved in compliance, procurement, engineering, or risk management—this overview offers essential insights into changes affecting regulatory landscapes and technology implementation.

Monthly Overview: July 2025

July 2025 demonstrated continued momentum in strengthening the foundations of health care technology worldwide. The month's standards reflected a dual focus: on one hand, pushing the capabilities of diagnostic and treatment equipment (as seen in updates for functional near-infrared spectroscopy [NIRS] and synthetic air proportioning), and on the other, systematically addressing the increasing demands for security and safe handling of medical equipment containing hazardous elements such as high-activity radioactive sources.

Publication activity this month also emphasized the integration of usability, electromagnetic compatibility, and marking requirements, signalling a broader trend toward quality and transparency. Compared to previous months, there was a pronounced emphasis on cross-discipline security, especially with the twin publication of IEC 63322, and renewed attention to harmonizing device-related standards (e.g., EN ISO 7396-3 within the medical gas pipeline ecosystem). These trends suggest a health care ecosystem that is increasingly interconnected, data-driven, and risk-aware.

Standards Published This Month

IEC 80601-2-71:2025 – Functional Near-Infrared Spectroscopy (NIRS) Equipment

Medical electrical equipment – Part 2-71: Particular requirements for the basic safety and essential performance of functional near-infrared spectroscopy (functional NIRS) equipment

IEC 80601-2-71:2025 addresses the basic safety and essential performance of functional NIRS equipment. Targeted at manufacturers and integrators of medical electrical (ME) equipment, this standard defines critical requirements and tests for devices used in non-invasive functional brain imaging and research, ensuring operator and patient safety, and guaranteeing reliable measurement under clinical conditions.

The scope is carefully delineated: while focusing on NIRS systems for the brain, it specifically excludes oximetry-focused devices (like pulse or cerebral tissue oximeters), as these are governed under separate standards. Major updates in this edition include alignment with IEC 60601-1 series, new mandates for essential performance and display legibility (especially relevant given increased PPE usage in clinical settings), and harmonized requirements for marking, labelling, and accompanying documents.

Among its notable features:

• Enhanced requirements for safety, temperature protection, and unintended radiation hazards
• Comprehensive performance test methods, including optical power, signal-to-noise ratio, and response time
• Harmonized instructions and identification protocols to improve traceability and user training
• Integration of phantom-based validation for accuracy

Access the full standard:View IEC 80601-2-71:2025 on iTeh Standards

IEC 63322:2025 – Security for ME Equipment Containing High-Activity Sealed Radioactive Sources

Security of ME equipment containing high-activity sealed radioactive sources

IEC 63322:2025 sets forth stringent security requirements for medical electrical equipment utilizing high-activity sealed radioactive sources—essential for radiotherapy and other clinical interventions. The document applies to Category 1, 2, and 3 radioactive sources as per IAEA definitions, imposing obligations on both equipment manufacturers and organizations responsible for using and storing these devices.

This standard establishes:

• Specific resistance grades and security classifications for equipment (stationary and mobile)
• Requirements for vulnerability assessments, access control systems, intrusion detection, and emergency protocols
• Comprehensive documentation and marking protocols (site security manuals, labelling)
• Test methods for physical resistance and regular compliance verification

By tightly coupling the physical security of equipment with site-level risk management, IEC 63322:2025 aims to minimize unauthorized access and reduce the risk of radiological theft or sabotage. The broader impact is a systematic, lifecycle-based approach to radioactive source security.

Key highlights:

• Dual obligations for manufacturers and site organizers
• Physical and procedural security for equipment during use, storage, and decommissioning
• Detailed resistance testing methodologies integrated with European security norms

Access the full standard:View IEC 63322:2025 on iTeh Standards

ISO 19490:2025 – Dentistry: Sinus Membrane Elevator

Dentistry – Sinus membrane elevator

ISO 19490:2025 is tailored to the dental field, delineating requirements for sinus membrane elevators—a critical surgical instrument in implantology for sinus floor lifting. The standard specifies mechanical properties, resistance to reprocessing, hardness, construction, and marking/labelling, ensuring devices meet international benchmarks for safety, reliability, and traceability.

Practices addressed include resistance to repeated sterilization, ergonomic design (for safe and effective use), and detailed instruction for use and maintenance, thereby supporting both surgical outcomes and infection control priorities.

Key highlights:

• Mandatory mechanical property benchmarks and resistance to sterilization
• Improved labelling and packaging specifications for traceability
• Detailed test methods for ensuring durability and functionality over repeated use

Access the full standard:View ISO 19490:2025 on iTeh Standards

EN ISO 7396-3:2025 – Proportioning Units for Production of Synthetic Medical Air

Medical gas pipeline systems – Part 3: Proportioning units for the production of synthetic medical air (ISO 7396-3:2025)

EN ISO 7396-3:2025 addresses the requirements for proportioning devices used to create synthetic medical air (by blending oxygen and nitrogen), a crucial resource in modern hospitals for direct therapy and to drive surgical tools. The standard covers design, operation, monitoring, marking, and shutdown systems for devices integrated into gas pipeline distribution networks.

Compatibility with ISO 7396-1 is essential, emphasizing multi-source redundancy and safety in gas distribution. The standard incorporates environmental, usability, and electromagnetic compatibility (EMC) requirements, making it suitable for evolving digital hospital environments.

Key highlights:

• Stringent criteria for gas quality, blending accuracy, leak prevention, and system redundancy
• Layered safety systems (manual/automatic shutoffs, alarms, pressure-relief systems)
• Unified requirements for EMC and electrical safety

Access the full standard:View EN ISO 7396-3:2025 on iTeh Standards

Common Themes and Industry Trends

July 2025’s standardization activity signaled several key trends for health care technology:

• Safety and Security as Core Priorities: Across all published standards, robust approaches to safety and security were foregrounded. Whether safeguarding radioactive sources or ensuring reliable physiological measurement, the bar for compliance is being consistently raised.

• Lifecycle Risk Management: The shift towards holistically managing equipment security—from manufacturing to decommissioning—was especially evident in IEC 63322. This reflects increased awareness of operational and regulatory risks.

• Alignment with International Norms: Document updates clearly prioritized harmonization with global frameworks (IEC 60601-1, ISO 7396-1, IAEA categories), facilitating international adoption and regulatory approval.

• Focus on Usability and Clarity: Revised standards (notably IEC 80601-2-71) now require clear markings, comprehensive documentation, and detailed instructions for use—supporting both user safety and traceability.

• Technology Integration: The standards for NIRS equipment and gas pipeline systems reflect trends towards smart medical devices, enhanced monitoring, and integration within larger medical systems, foreshadowing the ongoing digital transformation in health care.

Compliance and Implementation Considerations

For organizations affected by these July 2025 standards, several practical steps are recommended:

• Gap Assessments: Review current equipment, policies, and procedures against new or revised requirements. Focus on device safety, marking, and security controls.
• Training Initiatives: Update staff competencies to include new procedures for security, operation, and maintenance, reflecting revised documentation and user instructions.
• Vendor Engagement: Communicate with equipment and software suppliers to verify compliance, especially for high-activity source devices and integrating NIRS technologies.
• Upgrade Pathways: Prioritize upgrading or replacing non-conforming equipment, particularly security-critical radiological systems and gas proportioners.
• Documentation and Records: Maintain robust, accessible documentation for all equipment in the relevant scope, ensuring traceability and readiness for inspection.
• Timelines: Be mindful of transitional adoption periods; for instance, implementation is typically recommended within three years of the publication date unless otherwise required by local or national regulation.
• Utilize Resources: Access full documents, support materials, and guidance via platforms such as iTeh Standards for detailed compliance planning.

Conclusion: Key Takeaways from July 2025

July 2025’s standards activity in health care technology was defined by a dual commitment to innovation and risk reduction. The newly published and revised standards demand greater attention to device integrity (IEC 80601-2-71), robust physical and procedural security (IEC 63322), and precise control over specialized medical processes (ISO 19490, EN ISO 7396-3).

Industry professionals—be they compliance officers managing regulatory risk, engineers upgrading equipment, procurement leads ensuring traceability, or researchers advancing medical technologies—are encouraged to thoroughly review these standards. Keeping pace with evolving international expectations is essential not only for regulatory compliance but to ensure patient and workforce safety in a rapidly changing medical environment.

For a comprehensive dive into the details and to plan your next steps, explore the full standards texts on iTeh Standards. Staying informed and proactive is the best means to ensure readiness for both current challenges and future advancements in health care technology.