December 2025: New Standards Advance Health Care Technology

The health care technology sector is witnessing major progress this December 2025 with the publication of five pivotal international standards. Covering medical device safety, high-performance imaging, traditional Chinese medicine quality, and transfusion equipment, these standards set new benchmarks for device manufacturers, health care facilities, quality managers, and researchers worldwide. Staying informed and compliant is crucial as these standards influence regulatory expectations and best practices from production to patient care.

Overview / Introduction

Health care technology is at the forefront of patient safety, clinical innovation, and global health outcomes. International standards play a vital role in harmonizing requirements, defining safety and efficacy, and supporting organizations to deliver high-quality health products and services. This article details five major standards published in December 2025:

• Advancements in medical device biological evaluation
• Rigorous performance requirements for transfusion sets
• Modernized test methods for imaging systems
• Quality controls for traditional Chinese medicinal materials

By understanding these publications, professionals can ensure compliance, drive quality improvements, and position their organizations for leadership in a rapidly evolving field.

Detailed Standards Coverage

EN ISO 10993-1:2025 - Biological Evaluation of Medical Devices: Risk Management & Biological Safety

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)

The latest revision of EN ISO 10993-1:2025 sets the global agenda for biological risk management in medical device design and lifecycle management. Aligned closely with the ISO 14971 framework, this standard defines general principles and detailed requirements to ensure the biological safety of medical devices, including prototypes and in-development products, prior to clinical trials.

The scope includes all devices with direct or indirect patient contact and those intended for user protection (such as gloves and masks). It mandates comprehensive biological evaluation considering device constituents, tissue-device interactions, and lifecycle changes—from development to decommissioning (excluding environmental risks and infectious agents).

Key updates in the 2025 edition include:

• Enhanced alignment with risk management principles (ISO 14971)
• Clearer guidance on exposure duration calculations
• Expanded requirements for material characterization and identification of biological hazards
• Updated terminology reflecting tissue contact and device types

Stakeholders affected:

• Medical device manufacturers
• Clinical research organizations
• Regulatory Affairs & Risk Managers
• Quality Assurance departments
• Testing laboratories

Key highlights:

• Thorough requirements for biological risk assessment and reporting
• New guidance on the evaluation of biological effects (toxicity, genotoxicity, irritation, sensitization)
• Life cycle approach to ensure ongoing biological safety

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

prEN IEC 61675-2:2024 - Imaging Devices: Gamma Cameras Performance & Testing

Radionuclide imaging devices — Characteristics and test conditions — Part 2: Gamma cameras for planar, wholebody, and SPECT imaging

This international standard is essential for manufacturers and clinical users of nuclear medicine imaging equipment. It defines test methods, performance criteria, and documentation requirements for gamma cameras used in planar, whole-body, and single-photon emission computed tomography (SPECT) imaging.

Scope includes:

• System sensitivity and spatial resolution for planar and whole-body imaging
• SPECT system performance, accuracy, and image quality
• Requirements for pixelated semi-conductor detector-based systems

Notable changes for 2025:

• Integration of whole-body and SPECT-specific test protocols
• Harmonization with NEMA NU 1-2018
• Addition of quantitative SPECT performance and image registration tests

Stakeholders:

• Manufacturers and Quality Managers in radiological equipment
• Clinical physicists and Nuclear Medicine Technologists
• Biomedical engineers overseeing imaging systems

Key highlights:

• Comprehensive set of mandatory tests for performance verification
• Addresses both routine QA and acceptance testing
• Detailed requirements for accompanying technical documentation

Access the full standard:View prEN IEC 61675-2:2024 on iTeh Standards

ISO 22212:2025 - Traditional Chinese Medicine: Gastrodia Elata Tuber Quality

Traditional Chinese medicine — Gastrodia elata tuber

ISO 22212:2025 delivers an authoritative foundation for quality, safety, and identification of Gastrodia elata tuber, a key medicinal herb in Asian medical practice. The standard covers only cultivated or artificially propagated material, excluding wild forms, and provides:

• Minimum physical and chemical requirements
• Test methods for identification, purity, and potency
• Limits for moisture, ash, extractable content, heavy metals, pesticide residues, and sulfur dioxide
• Labelling and traceability requirements

Notable revisions (December 2025):

• Updated maximum moisture content and ash values
• Revised marker compound identification using advanced analytical methods
• Improvements to contamination and adulteration detection

Target users:

• Manufacturers and quality managers in herbal medicine
• Regulatory authorities for traditional medicine
• Importers and exporters of medicinal plant materials

Key highlights:

• Prevents adulteration and ensures product authenticity
• Mandates state-of-the-art testing and safety controls
• Supports international trade with harmonized requirements

Access the full standard:View ISO 22212:2025 on iTeh Standards

EN ISO 1135-4:2025 - Transfusion Sets: Gravity Feed Safety and Performance

Transfusion equipment for medical use — Part 4: Transfusion sets for single use, gravity feed (ISO 1135-4:2025)

EN ISO 1135-4:2025 specifies physical, chemical, and biological requirements for single-use gravity-fed transfusion sets. The aim is to ensure full compatibility with blood containers and intravenous equipment, guaranteeing safe, effective, and contamination-free transfusions across health care settings.

Key features:

• Material quality and mechanical strength criteria
• Flow rate, leakage, particulate contamination, and sterility requirements
• Enhanced labelling and packaging guidelines

What’s new for 2025:

• Updated injection site requirements to support needle-free and Luer-activated interfaces
• Improvements in protective cap design for enhanced contamination prevention
• Alignment with latest EU Medical Device Regulation (MDR) and ISO symbols

Stakeholders:

• Transfusion set manufacturers
• Health care facility procurement teams
• Clinical teams administering transfusions
• Sterilization service providers

Key highlights:

• Focused on safety and compatibility for all blood component types
• Robust chemical and biological safety requirements
• Clear manufacturing and post-production guidance

Access the full standard:View EN ISO 1135-4:2025 on iTeh Standards

EN ISO 1135-5:2025 - Pressure Infusion Transfusion Sets: Performance Standards

Transfusion equipment for medical use — Part 5: Transfusion sets for single use with pressure infusion apparatus (ISO 1135-5:2025)

Complementing Part 4, EN ISO 1135-5:2025 addresses the special requirements of pressure infusion transfusion sets—devices essential for rapid, high-volume transfusion scenarios. Designed for pressures up to 200 kPa, this standard ensures device integrity, compatibility, and safety.

Core requirements:

• Mechanical strength and leakage resistance under pressure
• Compatibility with blood/plasma containers and IV equipment
• Prohibition on platelet (thrombocyte) transfusion under pressure
• Stringent sterility, pyrogenicity, and toxicity criteria

Key 2025 updates:

• Improved volume definition for tubing and components
• Expanded requirements for needle-free injection ports
• Enhanced instructions for labelling, packaging, and tube volume determination

Target audience:

• Medical device manufacturers (infusion/transfusion)
• Hospital equipment managers
• Regulatory and procurement authorities

Key highlights:

• Detailed performance tests for pressure scenarios
• Reinforced compatibility and safety for red cell and plasma transfusions
• Clear, globally harmonized requirements for compliant product development

Access the full standard:View EN ISO 1135-5:2025 on iTeh Standards

Industry Impact & Compliance

Adoption of these standards directly impacts the quality, safety, and competitiveness of health care technology products. Key compliance and implementation considerations include:

• Regulatory readiness: New and revised standards may be referenced in national and regional regulations (e.g., EU MDR, US FDA guidances).
• Product development timers: Manufacturers must integrate updated requirements into design, verification, and validation processes before bringing new devices to market.
• Quality management: QMS and risk management systems should reflect new biological evaluation, imaging device performance, and material specifications.
• Procurement and due diligence: Health care organizations benefit from specifying compliance with these standards in contracts and supplier evaluations.

Benefits of adoption:

• Enhanced patient safety and reduced risk of adverse events
• Improved product reliability and device performance
• Facilitates international trade and market access
• Supports efficiency in regulatory submissions and product approvals

Risks of non-compliance:

• Delays or rejection in regulatory approvals
• Increased liability exposure
• Market access barriers and reputational damage

Technical Insights

Despite covering different domains, these standards share several technical commonalities:

• Comprehensive testing regimes: Each standard provides detailed test methods for physical, chemical, and biological performance.
• Quality by design: Emphasis on verifying material selection, manufacturing control, and batch traceability.
• Lifecycle management: Standards emphasize not only initial product safety but also the sustained performance over device use life.
• Documentation & traceability: Rigorous report generation and retention processes enable swift regulatory response and continuous improvement.

Implementation Best Practices

1. Gap Analysis: Compare current products and processes against new standard requirements.
2. Staff Training: Ensure technical, QA, and regulatory staff are aware of changes and their implications.
3. Supplier Management: Share standards updates upstream—require compliance from key suppliers, especially for materials and components.
4. Validation and Testing: Update validation protocols, risk assessments, and batch release specifications to align with new standards.
5. Early Engagement: Collaborate proactively with regulatory bodies, notified bodies, and certifying organizations.

Testing & Certification

• Engage accredited laboratories for specialized tests (e.g., biocompatibility, imaging system calibration).
• Ensure documented proof for performance, safety, and conformity as part of product technical files.
• Prepare for possible changes in third-party certification or auditing criteria following standard updates.

Conclusion / Next Steps

The December 2025 standards releases for health care technology represent both a challenge and an opportunity. By proactively adapting to more rigorous biological evaluation, imaging device assessments, transfusion equipment safety, and quality requirements for traditional medicine, organizations can ensure regulatory compliance, support patient safety, and gain competitive advantage.

Key Takeaways:

• Review and update policies, processes, and technical documentation in line with the latest standards.
• Engage early with quality, regulatory, and supplier partners to implement best practices.
• Stay informed on further updates—this article is part 1 of a comprehensive series covering all health care technology standards published in December 2025.

Ready to explore the full standards? Visit iTeh Standards to access authoritative, up-to-date documents and stay connected with the latest in global health care technology compliance.