January 2026: New Standards Shape Patient Safety and Quality in Health Care Technology

The start of 2026 brings significant advancements to the health care technology sector, with the publication of five impactful international standards. These standards address everything from radiation-based therapeutic equipment and pediatric medical beds to disinfection processes and traditional medicine quality controls. Whether you’re a quality manager, engineer, clinician, or procurement specialist, these January 2026 updates signal new benchmarks for safety, operational excellence, and patient care—reshaping expectations in hospitals and clinics worldwide.

Overview / Introduction

Health care technology relies on a foundation of robust international standards to ensure the safety, efficacy, and reliability of equipment, medicinal products, and care environments. With the early 2026 release of new standards in this field, organizations across the globe are prompted to re-examine compliance, procurement, and operational protocols. These documents cover critical clinical and technical aspects—from high-energy radiotherapy equipment to disinfection of reusable devices and the safety of herbal medicine packaging.

In this article, we provide an expert breakdown of each new standard, highlighting scope, requirements, implementation challenges, and practical implications to support informed decision making and enable proactive compliance.

Detailed Standards Coverage

EN IEC 60601-2-64:2026 - Safety for Light Ion Beam Medical Electrical Equipment

Medical electrical equipment - Part 2-64: Particular requirements for the basic safety and essential performance of light ion beam medical electrical equipment

This updated edition establishes rigorous safety and essential performance requirements for light ion beam medical electrical equipment used in radiotherapy. It applies to both standalone equipment and integrated systems administered by licensed operators under clinical protocols. The standard now harmonizes closely with broader IEC 60601-1 series requirements and addresses updated terminology and definitions relevant to light ion beam systems.

Notably, the 2026 revision clarifies testing requirements by distinguishing type and site tests—emphasizing the necessity for both manufacturing compliance and on-site verification. Equipment must ensure proper containment of light ion beams (energy per nucleon: 10–500 MeV/n) and feature safeguards such as interlocks to mitigate unsafe irradiation. It further includes updates to address safety regarding stray neutrons outside the irradiation field and mandates traceable instructions for quality assurance, performance checks, and operator qualifications.

Key highlights:

• Harmonization with latest general safety (IEC 60601-1:2020 amendments) and performance standards
• Expanded requirements for automated programmable subsystems and regular calibration
• New provisions for safety regarding unintended neutron exposure

Access the full standard:View EN IEC 60601-2-64:2026 on iTeh Standards

EN IEC 80601-2-89:2026 - Medical Beds for Children: Safety and Performance

Medical electrical equipment - Part 2-89: Particular requirements for the basic safety and essential performance of medical beds for children

This new standard addresses the unique safety and ergonomic needs of pediatric patients—and adults with atypical anatomy—using medical beds. Covering both electrical and manual (non-electrical) beds, the standard defines requirements for beds up to 180 cm in length (suitable for children with a body length up to 155 cm). It sets strict benchmarks for protection against electrical and mechanical hazards, entrapment, falls, and helps manufacturers ensure compliant control systems and markings.

Special attention is paid to preventing patient entrapment and optimizing side rail and panel designs according to age. The document includes annexes with inspection guidance, ergonomic recommendations, and marking protocols to support hospital implementation and ongoing maintenance.

Key highlights:

• Tailored safety and mechanistic requirements for children-specific hospital beds
• Comprehensive entrapment and stability testing, including visual markings and ergonomic controls
• Guidance for periodic inspection, user qualification, and inspection record-keeping

Access the full standard:View EN IEC 80601-2-89:2026 on iTeh Standards

ISO 24976:2026 - Pueraria Lobata Root in Traditional Chinese Medicine

Traditional Chinese medicine — Pueraria lobata root

ISO 24976:2026 codifies the global quality and safety requirements for Pueraria lobata root—a foundational material in traditional Chinese medicine (TCM), used internationally for its therapeutic properties. The standard applies to both whole medicinal roots and decoction pieces, detailing macroscopic and microscopic features, chemical marker content (notably puerarin ≥2.0%), chromatographic fingerprint methods, and specific limits for ash, moisture, heavy metals, pesticide residues, and aflatoxins.

The document is vital for quality assurance in global TCM supply chains, ensuring consistency, safety, and proper labeling/packaging for trade and clinical use. It clarifies sampling, testing, grading, and reporting, supporting traceability and regulatory compliance.

Key highlights:

• Minimum content for active marker compounds and limits for impurities
• Harmonized testing for heavy metals, pesticides, and fungal toxins
• Complete guidance from description through sampling to packaging and labeling

Access the full standard:View ISO 24976:2026 on iTeh Standards

ISO 15883-6:2026 - Washer-Disinfectors for Non-Critical Health Care Equipment

Washer-disinfectors — Part 6: Requirements and tests for washer-disinfectors employing thermal disinfection for non-critical medical devices and health care equipment

This important technical revision specifies how washer-disinfectors (WD) should be designed and tested for use on non-invasive, non-critical medical equipment in health care environments. ISO 15883-6:2026 aligns with the general WD requirements in ISO 15883-1 and updates cross-references and definitions in accordance with recent standards. The document focuses on devices that do not require automated process record-keeping, such as bed frames, bowls, wheelchairs, and cleaning carts.

Key protocols include thermal disinfection by hot water or steam, minimal disinfection assurance (A0 ≥ 60), and evidence-based performance testing for cleaning efficacy, water quality, and safety. The updated standard allows facilities to perform reliable, traceable disinfection while optimizing costs and environmental footprint for non-critical devices.

Key highlights:

• Updated scope and terminology for non-critical devices
• Defined thermal disinfection requirements and efficacy validation protocols
• Aligned with latest ISO WD standards and includes new guidance on water quality

Access the full standard:View ISO 15883-6:2026 on iTeh Standards

ISO/TS 21758:2026 - Stick-Type Packaging for Viscous Extracts in Traditional Chinese Medicine

Traditional Chinese medicine — General requirements of stick-type package for viscous extracts

This new Technical Specification defines quality and safety requirements for stick-type, single-dose packaging used with viscous extracts in the TCM sector. The focus is on material safety (combustion characteristics, limiting heavy metal release), extractable substances, foaming, pH, residue limits, and performance under standard test methods. The standard does not apply to solid dosage forms but is essential for manufacturers, packagers, and regulatory authorities overseeing liquid or semi-liquid herbal products.

Adopting ISO/TS 21758:2026 will enhance uniformity in TCM packaging, reduce contamination risk, improve consumer safety, and facilitate international commerce in viscous herbal extracts.

Key highlights:

• Safety-focused test methods for material integrity and extractables
• Performance-based packaging criteria for liquid and viscous TCM products
• Guidance aimed at international producers, distributors, and importers

Access the full standard:View ISO/TS 21758:2026 on iTeh Standards

Industry Impact & Compliance

These newly published standards represent a step-change in how health care providers and manufacturers will approach safety, efficacy, compliance, and trade. For example:

• Radiotherapy clinics and device manufacturers must implement advanced safety controls, rigorous calibration, and updated operator qualifications to meet the stringent criteria set for light ion beam therapy.
• Hospitals and pediatric units must source beds that align with strict anti-entrapment and ergonomic requirements, updating procurement specifications and maintenance procedures accordingly.
• Traditional medicine and herbal product suppliers now face globally harmonized expectations for quality, impurity limits, traceability, and packaging safety—vital for both regulatory clearance and international market access.
• Sterilization and facility managers can streamline reprocessing workflows and ensure consistent infection prevention for non-critical items, in line with recognized best practices.

Compliance timelines may depend on local adoption and regulatory harmonization. Organizations are encouraged to undertake gap analyses, update technical documentation, collaborate with accredited certification bodies, and ensure continuous professional training to support conformity. Timely adoption ensures:

• Reduced risk of adverse events
• Access to international markets
• Improved internal quality assurance
• Legal and regulatory protection
• Enhanced patient and staff confidence

Technical Insights

Common Technical Requirements

Many of these standards emphasize:

• Traceability and documentation: From equipment test results to quality certificates for raw materials and packaging.
• Hazard analysis and risk mitigation: Interlocks and mechanical safety in equipment, chemical limits in herbal products, and mechanical testing for beds.
• Performance verification: Routine calibration for therapeutic devices, efficacy testing for disinfection, and chromatographic fingerprinting in TCM.

Implementation Best Practices

• Early procurement alignment: Work with supply chain partners to ensure all products meet the latest standards and certificates are provided before installation or delivery.
• Routine staff training: Equip operations and clinical teams with the updated protocols for testing, handling, and reporting—especially where new device interface elements, risk controls, or performance standards are involved.
• Integrated quality assurance: Incorporate new requirements into your quality management system, bridging documentation, audits, and corrective action processes.
• Testing and certification: Engage accredited bodies for type and site tests (as specified in equipment standards), utilize qualified laboratories for herbal or extract testing, and maintain thorough records for regulatory review or market approval.

Certification and Documentation

• Medical equipment: Demonstrate conformity through type and site testing; maintain up-to-date calibration and inspection records.
• Traditional medicines: Keep test results for purity, contaminant levels, and compliance with marker compound thresholds.
• Packaging: Retain documentation on packaging material safety, extractable substances, and shelf stability.

Conclusion / Next Steps

The January 2026 wave of health care technology standards signals not only enhanced safeguards for patients and clinicians but also a new playing field for product quality, international trade, and operational excellence.

Key takeaways:

• Familiarize your team with the detailed requirements and guidance of these revised and new standards.
• Evaluate current inventory, processes, and suppliers for compliance gaps.
• Invest in staff education, updated documentation, and third-party certification as needed.
• Proactively liaise with regulatory bodies and standards organizations for transition guidance and future-proofing.

Ready to dive deeper?

• Download and review each new standard to guide your next compliance audit or procurement cycle.
• Monitor upcoming parts in this three-part series for even more critical updates in health care technology.

Explore the new standards in detail and stay ahead in patient safety, clinical effectiveness, and operational excellence—visit iTeh Standards for trusted, up-to-date resources.