November 2025: New Standards Advance Safety and Performance in Health Care Technology

The landscape of health care technology is rapidly evolving, and staying up-to-date with international standards is essential for ensuring patient safety, regulatory compliance, and consistent performance of medical devices. In November 2025, five new and revised standards were published, addressing critical requirements for medical device marking, oxygen therapy equipment, sleep apnoea therapy accessories, and implant wear testing.

These updates are vital for professionals across hospitals, device manufacturing, and home care environments—providing clear guidelines, risk mitigation protocols, and harmonized requirements that will impact procurement, quality assurance, and continual improvement processes across the sector.

Overview / Introduction

Health care technology touches every area of patient care—from the MR scanners in advanced diagnostics and portable oxygen systems supporting respiratory needs, to the specialized masks used for managing sleep apnoea, and the implants restoring mobility and quality of life.

International standards are at the heart of patient safety, manufacturer accountability, and clinical effectiveness. Standards organizations like ISO, IEC, and CEN regularly review and revise guidelines to address new technologies, updated clinical evidence, and regulatory demands. This article, part one of our four-part November 2025 deep dive, summarizes the latest standards shaping the future of health care technology:

• Ensuring clear marking for MR environment safety
• Providing robust specifications for home-care oxygen solutions
• Defining critical requirements for sleep apnoea interfaces
• Detailing advanced wear testing for spinal disc prostheses

What you’ll learn:

• The scope and key requirements of each new standard
• Who must comply and why these updates matter
• Implementation best practices and compliance strategies
• How to access the complete, authoritative standards

Detailed Standards Coverage

EN IEC 62570:2025 – Marking Medical Devices for Safety in Magnetic Resonance Environments

Standard practice for marking medical devices and other items for safety in the magnetic resonance environment

Magnetic resonance (MR) imaging offers unparalleled diagnostic power, but also presents unique safety challenges due to strong electromagnetic fields. EN IEC 62570:2025 provides a harmonized approach for marking medical devices and items that may enter the MR environment.

What this standard covers:

• Establishes the required marking terms and icons for all items anticipated to enter the MR environment
• Specifies labeling content to inform users about MR compatibility, stipulating clear guidance on information to be included
• Links requirements to existing risk management (ISO 14971) and harmonizes with ASTM F2503 practices
• Excludes MR image artifact testing from mandatory sections, focusing strictly on direct safety concerns

Key requirements & specifications:

• Distinguishes between MR Safe, MR Conditional, and MR Unsafe items with clearly defined symbols
• Provides requirements for labeling regarding electromagnetic field exposure risks
• Requires instructions for users on safe use, particularly where specific conditions (static field strength, spatial gradients, radiofrequency heating, torque) must be observed
• Integrates with device risk management files
• Incorporates references to test methods for displacement force, torque, and RF heating

Who needs to comply:

• Manufacturers of medical devices that may be used in MR environments (implantables, surgical tools, accessories, and support equipment)
• Health care facilities and service providers responsible for device selection and inventory
• Quality assurance and compliance teams ensuring MR safety

Practical implications:

• Reduces potential for MR-related incidents (projectile effects, burns, interference)
• Streamlines patient workflow and supports regulatory compliance
• Facilitates uniform communication of safety parameters across global health systems

Notable changes from previous version:

• Supersedes EN 62570:2015, incorporating updated terminology and revised marking illustrations
• Greater alignment with latest ASTM and IEC requirements

Key highlights:

• Harmonized MR safety symbols and terms
• Enhanced labeling content requirements
• Integration with risk management and regulatory frameworks

Access the full standard:View EN IEC 62570:2025 on iTeh Standards

EN ISO 18777-2:2025 – Transportable Liquid Oxygen Systems for Medical Use – Portable Units

Transportable liquid oxygen systems for medical use – Part 2: Particular requirements for portable units (ISO 18777-2:2025)

Home-based oxygen therapy is critical for chronic respiratory patients. This standard sets comprehensive requirements for the design, labeling, and performance of portable medical-use liquid oxygen units.

What this standard covers:

• Applies to portable units serving as components of transportable liquid oxygen systems, designed for unsupervised use during daily activities
• Focuses on the home-care environment, supporting mobility and independent living for patients
• Details requirements for design, safety, filling systems, and user instructions

Key requirements & specifications:

• Filling port connector specifications to ensure proper, safe refilling from a base unit
• Mechanical strength, mass limits, and ergonomic considerations for portability
• Performance expectations for evaporation rates, conserving devices, conservation of oxygen during use
• Mandatory marking and clear, accessible instructions for use
• Compatibility with ISO 18777-1 general requirements for both portable and base oxygen units
• Test methods to verify durability and reliability

Who needs to comply:

• Manufacturers of portable and base liquid oxygen equipment
• Home-care equipment suppliers and service companies
• Health care procurement and maintenance teams

Practical implications:

• Enables safe, user-friendly oxygen therapy across diverse environments
• Minimizes risk of oxygen loss or device malfunction during unsupervised use
• Empowers patients to lead more active, independent lives, while maintaining clinical efficacy

Notable changes from previous edition:

• Supersedes EN ISO 18777:2009, adding updated ergonomic, technical, and safety requirements

Key highlights:

• Comprehensive safety & usability for patient-operated portable oxygen units
• Detailed marking and refilling port specifications
• Extended requirements for ergonomic design and reliability

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

ISO 17510:2025 (ISO & IEC Editions) – Sleep Apnoea Therapy: Masks and Application Accessories

Medical devices – Sleep apnoea breathing therapy – Masks and application accessories

Effective management of sleep apnoea depends on high-performance therapy masks and accessories, ensuring comfort, biocompatibility, and reliable connection to therapy devices. The new edition of ISO 17510:2025, available via both ISO and IEC, offers comprehensive requirements for these critical components.

What this standard covers:

• Applies to all masks and application accessories (e.g., nasal masks, exhaust ports, headgear) that link a patient's airway to breathing therapy equipment
• Specifies safety and essential performance requirements, with focus on interface design, materials, and integration with therapy devices
• Addresses both single-patient and multi-patient use
• Includes test specifications for comfort, leakage, rebreathing, and acoustic noise

Key requirements & specifications:

• Universal mask connector dimensions and compatibility
• Biocompatibility requirements, referencing updated ISO 18562-1 for gas pathways
• Protection against carbon dioxide rebreathing (under fault and normal conditions)
• Cleaning, disinfection, and sterilization procedures for reusable masks/accessories
• Anti-asphyxia valve performance for safety in equipment failure
• Acoustic emission limits for patient comfort
• Manufacturer’s labeling and information disclosure, including new requirements for magnets used in headgear

Who needs to comply:

• Manufacturers of CPAP, APAP, BiPAP, or other sleep apnoea device interfaces
• Distributors supplying sleep therapy equipment for clinics or home settings
• Clinical procurement and respiratory therapy professionals

Practical implications:

• Reduces risk of device-related harm, enhances compliance through improved comfort and usability
• Streamlines patient onboarding and cross-device compatibility
• Ensures up-to-date hygiene and reprocessing protocols, addressing global infection control standards

Notable changes from previous edition (ISO 17510:2015):

• Enhanced alignment with IEC 60050-880
• New disclosure requirements for magnetic components
• Revised testing and labeling to accommodate latest regulatory frameworks (IMDRF)
• Added, updated acoustic performance benchmarks
• Harmonization with latest biocompatibility requirements

Key highlights:

• Comprehensive safety and comfort guidelines
• Full biocompatibility and processing specifications
• Rigorously defined test and information supply requirements

Access the full ISO edition:View ISO 17510:2025 on iTeh Standards

Access the full IEC edition:View ISO 17510:2025 on iTeh Standards (IEC)

ISO 18192-3:2025 – Implants for Surgery: Impingement-wear Testing for Spinal Disc Prostheses

Implants for surgery – Wear of total intervertebral spinal disc prostheses – Part 3: Impingement-wear testing and corresponding environmental conditions for test of lumbar and cervical prostheses

Long-term success of spinal disc prostheses relies on robust design and validated endurance under real-world conditions. ISO 18192-3:2025 introduces rigorous test procedures for adverse impingement scenarios, simulating and evaluating the wear of both lumbar and cervical disc prostheses.

What this standard covers:

• Provides a standardized test for simulating and quantifying the effects of adverse impingement (e.g., misalignment, overload) on artificial spinal discs
• Applies to both lumbar and now, with this edition, cervical prostheses
• Outlines environmental protocols, test fluids, and biomechanical simulation

Key requirements & specifications:

• Detailed methodologies for establishing worst-case impingement conditions
• Kinematic simulation including flexion, extension, lateral bending, and combined rotations
• Strict test equipment accuracy and calibration (ISO 7500-1, ISO 23788)
• Fluid test medium composition to mimic physiological environment
• Test report content requirements and specimen handling for reproducibility
• Criteria for specimen selection, control use, and wear measurement

Who needs to comply:

• Implant manufacturers and R&D labs developing new spinal disc devices
• Testing laboratories engaged in product validation and regulatory submissions
• Orthopaedic surgeons and health systems evaluating device durability claims

Practical implications:

• Supports regulatory and clinical acceptance of spinal prostheses by demonstrating durability
• Identifies potential wear risks under extreme, real-world conditions
• Enhances the safety profile of new devices introduced to the market

Notable changes from previous edition (ISO 18192-3:2017):

• Expanded to include cervical prosthesis protocols
• Fully updated values and methods for cervical impingement testing
• Greater detail on specimen sizing, combination testing, and reporting expectations

Key highlights:

• Comprehensive impingement-wear simulation for lumbar and cervical prostheses
• Updated to reflect expanded clinical and engineering datasets
• Clear test reporting and environmental control requirements

Access the full standard:View ISO 18192-3:2025 on iTeh Standards

Industry Impact & Compliance

How These Standards Affect Businesses

These November 2025 health care technology standards redefine the operational and compliance benchmarks for professionals across medical device manufacturing, hospital procurement, and home-care delivery. Adoption drives safer products, reduces liability risk, and demonstrates adherence to global best practices.

Compliance Considerations and Timelines

• Transition periods are defined by each standard's implementation and withdrawal dates. Organizations are advised to initiate gap assessments and update documentation promptly.
• Compliance aligns with regulatory frameworks (e.g., EU MDR, US FDA, global IMDRF guidelines) and is often mandated for market access.
• Device marking and labeling updates (as in EN IEC 62570:2025) require review of current inventory and updated staff training.
• Testing and certification for new requirements (ISO 18192-3:2025, ISO 17510:2025) may require coordination with accredited labs and technical teams.

Benefits of Early Adoption

• Enhanced patient safety and clinical outcomes
• Streamlined regulatory submissions and faster market approvals
• Improved product reputation and reduced risk of recalls
• Competitive differentiation based on adherence to latest standards

Risks of Non-Compliance

• Market restrictions or legal penalties
• Increased likelihood of adverse events and liability claims
• Reputational harm and loss of customer trust

Technical Insights

Common Technical Requirements Across November 2025 Standards

• Labeling & User Information: All newly published standards emphasize clear, unambiguous labeling to inform both professionals and patients of risk factors and safe use parameters.
• Test and Verification: Uniform testing requirements ensure products meet real-world performance demands—whether simulating MR safety or implant-endurance in dynamic environments.
• Ergonomics & Usability: Especially for home-care and patient-directed devices, standards now place greater emphasis on human factors engineering and accessible design.
• Biocompatibility & Infection Control: Updated references to ISO 18562-1 and risk management frameworks help ensure components are safe for repeated human contact and are easy to clean/disinfect.

Implementation Best Practices

1. Conduct a Gap Analysis against each standard's requirements
2. Update Technical Documentation: device master records, instructions for use, labeling, risk files
3. Review Supplier and Manufacturing Controls: particularly for parts subject to new test parameters
4. Engage with Accredited Laboratories for compliance testing (e.g., wear simulation, performance verification)
5. Train Staff and Stakeholders on new marking, labeling, and handling procedures

Testing and Certification Considerations

• Ensure test equipment calibration and control conditions match the referenced ISO/IEC base standards
• Document all test outcomes and corrective actions for future audits
• Maintain detailed records supporting declarations of conformity, particularly for market authorities

Conclusion / Next Steps

November 2025 has brought critical updates to the standards portfolio for health care technology—advancing safety, efficacy, regulatory compliance, and patient-centered design. This thorough review of five cornerstone standards serves as both a technical roadmap and a call to action:

• Quality and compliance professionals: Begin immediate audits against the new requirements. Update procedures, labels, and training as needed.
• Engineers and product developers: Ensure all products in design or production meet the latest test and marking requirements.
• Procurement specialists and clinical facilities: Demand up-to-date documentation and declarations from suppliers.

Stay updated and explore the official texts: Access all the latest standards directly via iTeh Standards for authoritative guidance and implementation resources.

Explore Parts 2–4 in this series for additional November 2025 updates across the health care technology landscape.