November 2025: Essential Health Care Technology Standards You Need to Know

Health care technology is in a continual cycle of innovation and improvement, with international standards shaping the foundation for patient safety, device reliability, and operational excellence. In November 2025, five significant new and revised standards were released—each one influencing the landscape for organizations designing, manufacturing, and utilizing medical, dental, and health care support technology. This third instalment in our four-part series examines these new standards, illuminating what’s changed, who’s impacted, and how professionals can prepare for compliance and competitive advantage.

Overview / Introduction

In a sector as mission-critical as health care technology, robust standards ensure equipment safety, effectiveness, and compliance with global best practices. International standards underpin everything from device biocompatibility to the reliability of drug delivery systems, and from portable oxygen safety to the integrity of dental materials. These benchmarks are not just compliance checklists—they drive innovation, protect patients, and streamline quality management.

In this article, you’ll discover:

• The scope and application of each newly published standard
• Key requirements and notable updates
• Practical tips for implementation and compliance
• The market and safety impact across multiple health care settings

Whether you’re a medical device manufacturer, procurement specialist, compliance officer or clinical engineer, understanding these updates is essential for risk management, product development, and patient safety.

Detailed Standards Coverage

ISO 10993-1:2025 – Biological Evaluation of Medical Devices, Part 1

Biological evaluation of medical devices — Part 1: Requirements and general principles for the evaluation of biological safety within a risk management process

ISO 10993-1:2025 refines the gold-standard framework guiding the biological evaluation of medical devices. This revision harmonizes the evaluation process with the ISO 14971 risk management standard, emphasizing an integrated, lifecycle view of biological safety—from initial concept to end-of-life decommissioning.

Scope and Key Requirements:

• Encompasses all medical devices with patient or user contact (including personal protection)
• Requires biological evaluations to be conducted within a structured risk management process
• Addresses biological risks from device constituents and tissue/device interactions
• Considers effects such as cytotoxicity, sensitization, irritation, systemic and local toxicity, genotoxicity, carcinogenicity, haemocompatibility
• Stresses the need for periodic reevaluation as devices undergo lifecycle changes
• Aligns more closely with device-specific standards (e.g., for dental or breathing devices)

Who Should Comply:

• All organizations developing, manufacturing, or distributing medical devices intended for patient or occupational health applications
• Regulatory and quality assurance professionals responsible for clinical safety assessments

Practical Implications:

• Calls for a comprehensive biological evaluation plan as part of the device’s overall risk file
• Requires gap analysis for devices tested under previous standard versions
• Mandates detailed documentation of risk controls, equivalence claims, and test justifications

Key highlights:

• Complete reorganization aligning with ISO 14971 risk management
• Improved guidance for characterizing exposure duration and identifying biological hazards
• New rationale for biological effects considered under various tissue contacts

Access the full standard:View ISO 10993-1:2025 on iTeh Standards

FprEN ISO 80369-1 – Small-Bore Connectors for Liquids and Gases

Small-bore connectors for liquids and gases in healthcare applications - Part 1: General requirements (ISO/FDIS 80369-1:2025)

Critical to patient safety, this newly updated standard provides the general interface requirements for small-bore connectors in medical devices and accessories, aimed at preventing hazardous misconnections. It covers diverse applications from respiratory and enteral to limb cuff, neural, and vascular access devices.

Scope and Key Requirements:

• Defines design requirements to minimize risk of misconnection for small-bore connectors
• Covers connectors for fluids and gases in clinical applications: respiratory, enteral, intravascular, neural, limb inflation, and others
• Requires demonstration of non-interconnectable features per clinical use
• Includes methodology for assessing and validating the non-interconnectability of connector designs

Who Should Comply:

• Device designers and manufacturers in anesthesia, infusion, respiratory therapy, vascular access, and related fields
• Clinical engineering and risk management teams

Practical Implications:

• Mandates verification testing and design safeguard review during connector development
• Manufacturers must transition away from legacy Luer connectors for non-intravascular applications
• Integrates connectors with requirements of the broader ISO/IEC 80369 series

Key highlights:

• Expanded scope to cover additional clinical applications and updated connector guidance
• Methodology for assessing and ensuring non-interconnectable designs
• Enhanced safety for patients via standardized, application-specific interfaces

Access the full standard:View FprEN ISO 80369-1 on iTeh Standards

ISO 18777-2:2025 – Portable Liquid Oxygen Systems

Transportable liquid oxygen systems for medical use - Part 2: Particular requirements for portable units

ISO 18777-2:2025 addresses the growing demand for patient independence by focusing on the performance and quality of portable liquid oxygen units used in home care and mobile settings.

Scope and Key Requirements:

• Specifies requirements unique to portable units in transportable liquid oxygen systems, especially those used by patients away from clinical supervision
• Establishes design, mechanical strength, filling connector, maximum mass, and oxygen flow control requirements
• Defines test protocols for evaporation rate and device durability

Who Should Comply:

• Manufacturers and suppliers of home-care and transportable oxygen delivery products
• Procurement specialists in hospitals and outpatient care

Practical Implications:

• Ensures reliable and safe oxygen supply during patient movement and travel
• Enhances usability and reduces device-related risks for non-professionals
• Guidance on marking, labeling, and manufacturer-supplied instructions

Key highlights:

• First edition focused on portable units, integrating with ISO 18777-1 for base units
• Includes requirements for patient refill interfaces
• Promotes patient mobility and safety in community-based oxygen therapy

Access the full standard:View ISO 18777-2:2025 on iTeh Standards

ISO/TS 4452:2025 – Reliability of Single-Use Drug Delivery Systems

Specification and demonstration of system reliability of single-use drug delivery systems

This new technical specification responds to the proliferation of disposable drug delivery systems in modern medicine, where a single-use device must deliver a critical dose with near-perfect reliability.

Scope and Key Requirements:

• Covers all single-use drug delivery systems (DDSs) with one-time-dose capability, including needle-based, needle-free, and aerosol devices
• Sets out five risk-based reliability levels linked to the severity of harm if delivery fails
• Mandates empirical and modeled demonstration of device reliability during development and manufacture
• Requires maintenance of required reliability throughout production

Who Should Comply:

• Developers and manufacturers of disposable DDSs in pharmaceutical and medical device sectors
• Quality, process validation, and risk management professionals

Practical Implications:

• Integrates reliability and capability targets into design verification
• Ensures system-level reliability, not just individual function accuracy
• Calls for robust process control, especially for high-severity-use cases

Key highlights:

• Introduction of reliability level matrix for DDS risk stratification
• Emphasizes entire product lifecycle; not just initial testing
• Aligns with usability engineering principles for comprehensive risk mitigation

Access the full standard:View ISO/TS 4452:2025 on iTeh Standards

EN ISO 6876:2025 – Dental Endodontic Sealing Materials

Dentistry - Endodontic sealing material (ISO 6876:2025)

This European/ISO harmonized standard codifies the properties and performance of sealing materials used for root canal therapy and related dental procedures, ensuring both patient safety and long-term clinical outcomes.

Scope and Key Requirements:

• Covers all materials used for conventional and specialized endodontic sealing (including orthograde and retrograde applications)
• Defines classification system for Type 1 (orthograde) and Type 2 (special purpose) materials
• Establishes requirements for appearance, flow, working time, setting time, film thickness, solubility/disintegration, and radiopacity
• Details standardized testing methodologies for material compliance

Who Should Comply:

• Manufacturers of dental endodontic materials
• Dental procurement specialists
• Regulatory and quality management teams in dental device supply

Practical Implications:

• Ensures consistent material performance for tooth preservation and procedural success
• Facilitates regulatory acceptance across EU and global markets
• Supports standardization in clinical purchasing and product selection

Key highlights:

• Replaces previous standards with expanded material classifications
• New test methods and benchmarks for disintegration and radiopacity
• Guidance referencing international regulations on sterility and packaging

Access the full standard:View EN ISO 6876:2025 on iTeh Standards

Industry Impact & Compliance

As the health care technology field accelerates, these standards reinforce quality and safety throughout the product lifecycle.

Business Impact:

• Drives higher levels of safety, efficacy, and global market acceptance for medical and dental devices
• Streamlines procurement by ensuring product comparability and regulatory compliance
• Positions organizations for smoother audits and market entry

Compliance Considerations:

• Early integration of these requirements in design and manufacturing processes is crucial
• Non-compliance can result in delayed approvals, increased adverse events, or costly product recalls
• Regular training of quality, engineering, and regulatory staff on evolving standards is essential

Adoption Timelines:

• Review and address any gaps between new requirements and existing QMS/procedures
• Allow for sufficient transition period to align with new test methods and design protocols as specified in the standards

Benefits:

• Improved patient safety and reduced clinical risks
• Simplified conformance with international regulations
• Enhanced product reliability, performance, and reputation

Risks of Non-Compliance:

• Increased regulatory scrutiny and potential market withdrawal
• Heightened risk of litigation due to adverse events
• Loss of credibility and market competitiveness

Technical Insights

Across all five standards, a few recurring technical themes emerge for organizations:

• Rigorous risk assessment and management, integrating ISO 14971 principles throughout the lifecycle
• Explicit demonstration of device and material performance (e.g., reliability matrices, test result documentation)
• Design controls to prevent hazardous interfacing or misconnections (especially for connectors and DDSs)
• Precision test methods and quantitative criteria for critical parameters (solubility, flow rates, exposure duration, connector non-interchangeability, etc.)
• Robust documentation supporting clinical safety and usability claims
• Close alignment to usability engineering (IEC 62366-1) and post-market surveillance best practices

Implementation Best Practices:

1. Map all new requirements against current design, manufacturing, and quality management protocols.
2. Update training programs and internal documentation to reflect updated terminology and processes.
3. Use statistical and modeling tools to manage reliability and process controls, especially for complex single-use devices.
4. Work closely with suppliers to ensure upstream compliance—particularly for raw materials, connectors, and system components.
5. Engage cross-disciplinary teams early (R&D, regulatory, clinical) for a holistic approach to standard adoption.

Testing and Certification:

• Leverage accredited laboratories for initial and periodic verification testing
• Ensure traceability in all material and system test reports
• Maintain readiness for third-party audits, with clear linkage from risk analysis to test results and design justifications

Conclusion / Next Steps

November 2025 brings a transformative set of updates to health care technology standards. Organizations must act proactively to interpret, implement, and integrate these requirements, ensuring not only compliance but ongoing patient safety and operational excellence.

Key Takeaways:

• These five standards set new expectations for the safety, performance, and reliability of a wide array of health care technologies
• Strategic adoption offers a pathway to smoother global market access, minimized regulatory risk, and enhanced patient trust
• Now is the time for health care technology leaders to review their product portfolios, risk management plans, and quality systems in light of these changes

Recommended Actions:

• Download and thoroughly review the full text of each standard from iTeh Standards
• Schedule cross-departmental workshops to address implementation priorities and compliance strategies
• Subscribe to standards update notifications—never miss a critical change that impacts your market or products

Explore all the latest standards and stay ahead in health care technology at standards.iteh.ai.