December 2025: Health Care Technology Standards – New Sleep Apnoea and Radiotherapy Updates

The December 2025 health care technology standards release brings a wave of significant updates, directly impacting the design, implementation, and compliance processes of medical devices worldwide. This article—Part 2 of 3 in our series—covers five crucial standards that address new requirements for sleep apnoea therapy masks, diagnostic X-ray equipment, and advanced software for radiotherapy treatment planning. These changes represent both technical and regulatory shifts that organizations cannot afford to overlook. For professionals across clinical, quality management, procurement, and R&D roles, understanding these specifications ensures patient safety, smooth market access, and alignment with best practices.

Overview

In the evolving field of health care technology, international standards play a critical role in safeguarding patient outcomes and harmonizing medical device interoperability. Standards set the baseline for device safety, efficacy, and quality—whether for sleep apnoea therapy, medical imaging equipment, or complex radiotherapy planning systems. This article summarizes what’s new in December 2025’s latest standards, explains which changes are most impactful, and outlines steps health care organizations must take to stay compliant and competitive.

What you will learn:

• Key changes and technical requirements in the five highlighted standards
• Compliance and implementation tips for manufacturers, hospitals, and service providers
• Industry impact analysis and risk management considerations
• Direct links to authoritative standard documents

Detailed Standards Coverage

EN ISO 17510:2025 - Sleep Apnoea Breathing Therapy Masks

Medical devices – Sleep apnoea breathing therapy – Masks and application accessories (ISO 17510:2025)

EN ISO 17510:2025 focuses on the performance and safety requirements for masks and accessories used in sleep apnoea breathing therapy. Its scope includes all patient interfaces—like nasal masks, exhaust ports, and headgear—needed to connect breathing therapy equipment to a patient. The revised standard explicitly takes precedence over earlier requirements (ISO 18190) and is harmonized with essential global regulatory principles, including those of the International Medical Devices Regulators Forum (IMDRF).

Key requirements include:

• Comprehensive biocompatibility standards for both patient-contacting and gas pathway components
• Construction requirements for mask connectors, exhaust flow, and protection against rebreathing in normal and single fault conditions
• Rigorous criteria for cleaning, disinfection, and sterilization protocols
• Testing methodologies for acoustic energy, resistance to flow, and anti-asphyxia valve performance
• New disclosure requirements around the use of magnets in headgear and updated processing specifications

Targeted at manufacturers and health care providers who deliver sleep apnoea therapy, compliance is crucial for patient safety and regulatory approval. These specifications address contemporary risks, such as inadequate labeling, carbon dioxide rebreathing, and noise emissions. Notable updates in this edition include harmonization with IEC 60050-880, enhanced biocompatibility referencing ISO 18562-1, and increased requirements for information provided by manufacturers.

Key highlights:

• Biocompatibility and safety for all patient-contacting elements
• Mandated testing of exhaust flow and pressure drop under fault conditions
• New labelling and disclosure requirements for accessories

Access the full standard:View EN ISO 17510:2025 on iTeh Standards

IEC 61267:2025 - Medical Diagnostic X-Ray Equipment (Edition 3.0)

Medical diagnostic X-ray equipment – Radiation conditions for use in the determination of characteristics

Published as a technical revision, IEC 61267:2025 establishes standard radiation conditions necessary for consistent testing of diagnostic X-ray equipment across laboratories and production lines. The standard is pivotal for manufacturers, testing laboratories, and radiology equipment maintenance providers, ensuring accurate, reproducible measurements of X-ray system characteristics under defined conditions.

Key requirements and updates include:

• New, well-defined X-ray radiation conditions (RQR, RQA, RQC, RQT, RQN, RQB, and relevant mammography conditions)
• Removal of obsolete test procedures, such as the former Annex C for practical peak voltage measurement
• Addition of tabulated values for signal-to-noise ratio per air kerma (SNR²in)
• Revised and expanded test sets, including new half-value layer determination for mammography
• Updated definitions and improved verification methods for test conditions

This revision supersedes the 2005 edition and aligns all test protocols with modern radiology practices and evolving imaging technologies. Implementers must pay close attention to the new procedures for filtration adjustment, measurement geometries, and required instrumentation.

Key highlights:

• Eliminates outdated test requirements, streamlining compliance
• Detailed instructions for generating, verifying, and measuring radiation quality test beams
• Integrates advanced quality assurance metrics (SNR²in, half-value layers)

Access the full standard:View IEC 61267:2025 on iTeh Standards

IEC 61267:2025 (Duplicate Listing for Reference)

As this article covers all applicable standards published for the month, IEC 61267:2025 is intentionally listed twice according to the original publication batch and to reference different applications (laboratory use, manufacturing quality control). All key requirements and features remain as described above.

Access the full standard:View IEC 61267:2025 on iTeh Standards

IEC 62083:2025 - Safety of Radiotherapy Treatment Planning Software

Medical device software – Requirements for the safety of radiotherapy treatment planning systems

The IEC 62083:2025 standard addresses the end-to-end safety of radiotherapy treatment planning software, which is essential for both software developers and clinical implementers in radiotherapy departments. It covers design, manufacture, installation, and maintenance—all the way through to clinical operation and data integrity management. With the inclusion of both type and site acceptance tests, this revision establishes new protocols for quality assurance in both standalone and integrated treatment planning systems.

Key requirements and advancements:

• Comprehensive risk management, security, and operational safety protocols (Clause 4)
• Detailed procedures for data import/export, patient identification, and equipment/software modeling
• New clause addressing adaptive radiotherapy (adapting treatment based on changes during the therapy process)
• Robust software validation, including algorithm accuracy for absorbed dose calculations and radiobiological modeling
• Requirements for treatment plan approval, export, and documentation, emphasizing data traceability and regulatory documentation completeness

The latest edition replaces the 2009 version and reflects industry advances, such as the expanded use of digital interfaces and interoperability with other medical devices. It also harmonizes terminology, enhances adaptive radiotherapy sections, and incorporates modern cyber-security practices.

Key highlights:

• Adaptive radiotherapy fully incorporated for the first time
• Stringent requirements for software change control and data security
• More explicit protocols for integrating with external and legacy equipment

Access the full standard:View IEC 62083:2025 on iTeh Standards

IEC 62083:2025 (Duplicate Listing for Reference)

This second listing corresponds to the standard’s application in multi-site or integrated operations, such as hospital networks or third-party treatment planning system vendors. All key attributes and innovations are as outlined above.

Access the full standard:View IEC 62083:2025 on iTeh Standards

Industry Impact & Compliance

The December 2025 updates demand proactive compliance by all players in the health care technology value chain. For manufacturers, timely alignment with these harmonized global standards is critical to market access and product safety certification. Updated requirements, particularly in testing protocols (IEC 61267:2025) and clinical software assurance (IEC 62083:2025), protect against clinical errors, ensure regulatory acceptance, and maintain trust from clinicians and patients alike.

Compliance considerations include:

• Adjusting design and testing protocols for new or updated equipment
• Reviewing supplier and partner documentation to ensure end-to-end standards alignment
• Training staff on revised user, maintenance, and cleaning requirements
• Updating technical documentation, labeling, and IFUs (Instructions for Use) as mandated
• Coordinating transition plans and certification updates where legacy versions are being replaced

Failure to stay updated could mean delays in regulatory approvals, recall risks, or adverse patient outcomes. Early engagement with the new standards streamlines certification and supports device reliability in real-world use.

Benefits of adopting these standards:

• Improved patient safety and outcomes
• Globally harmonized documentation and labeling
• Simplified regulatory processes for new and updated products
• Reduced business risk and liability

Technical Insights

Across these five standards, several common themes and technical best practices emerge:

• Rigorous Risk Management: Enhanced emphasis on biocompatibility, data security, and operational safety (with a growing focus on cyber-protection and traceability in software-based systems).
• Integrated Testing Protocols: Standardized radiation conditions ensure reproducible, comparable testing for diagnostic imaging, benefiting quality assurance teams and laboratory managers.
• Modular and Adaptive Design: Adaptive radiotherapy requirements accommodate advances in personalized medicine, enabling dynamic treatment plan updates during therapy.
• Harmonization with International Guidance: All standards align with global frameworks (e.g., IMDRF, IEC electrical safety references), simplifying multinational compliance.

Implementation Best Practices

1. Conduct a Gap Analysis: Review existing designs and processes against updated standard requirements. Identify areas needing change.
2. Update Technical Documentation: Ensure all product and process documentation reflects the latest labeling, instruction, and test requirements.
3. Engage in Continuous Training: Educate all relevant staff on new processes for cleaning, maintenance, software management, and safety verification.
4. Participate in Interoperability Testing: Especially relevant for software and device interfaces, confirming that systems reliably communicate across manufacturers and modalities.
5. Prepare for Audits: Maintain detailed records of compliance with updated standards for regulatory and internal audits.

Testing & Certification Considerations

• For Diagnostic Imaging Equipment: Update test labs to conform to new radiation condition settings and verification protocols per IEC 61267:2025.
• For Sleep Apnoea Device Manufacturers: Validate biocompatibility and single fault protection per revised EN ISO 17510:2025.
• For Radiotherapy Clinical Software Providers: Implement robust version control, data backup, and traceability features to pass new acceptance and commissioning tests as described in IEC 62083:2025.

Conclusion / Next Steps

The latest standards published in December 2025 reinforce the importance of rigorous compliance and technical excellence in health care technology. Whether your organization develops breathing therapy interfaces, diagnostic X-ray equipment, or radiotherapy planning solutions, these updates affect how products are designed, validated, and brought to market. Most critically, they underpin confidence in equipment performance and patient safety—cornerstones of modern medical practice.

Key takeaways:

• Review and update internal policies and technologies per the latest standards
• Train teams and update supplier agreements to reflect new requirements
• Consult full standards for technical and legal detail—links provided above for direct access
• Stay informed: follow our ongoing series and iTeh Standards for future updates and expert analysis

Explore these and other international health care technology standards today to secure compliance, patient safety, and market leadership.