January 2026: New Safety Standard for Transcutaneous Oxygen Monitors in Healthcare

In January 2026, the healthcare technology landscape sees a significant enhancement in patient safety and clinical accuracy with the release of the new international standard for transcutaneous partial pressure monitoring equipment. The publication of prEN IEC 80601-2-23:2024 introduces robust safety, performance, and compliance requirements that will affect device manufacturers, hospitals, and clinical practitioners worldwide. This update covers a single but critical standard, marking an important advancement in the essentials of diagnostic medical equipment safety and functionality.

Overview / Introduction

Healthcare technology continues to advance rapidly, with diagnostic equipment playing a crucial role in early detection and ongoing patient monitoring. Standards in this sector ensure that devices such as transcutaneous partial pressure monitors—used for non-invasive monitoring of oxygen or carbon dioxide levels—deliver reliable, accurate, and safe results.

By implementing the latest standards, organizations can maintain high levels of clinical safety, meet regulatory requirements, and protect patient well-being. In this article, you'll discover:

• The scope and significance of prEN IEC 80601-2-23:2024
• New and enhanced safety and performance requirements
• Practical implications for compliance
• Technical and operational insights for the health technology sector

Detailed Standards Coverage

prEN IEC 80601-2-23:2024 – Enhanced Safety for Transcutaneous Partial Pressure Monitoring Equipment

Medical electrical equipment – Part 2-23: Particular requirements for the basic safety and essential performance of transcutaneous partial pressure monitoring equipment

prEN IEC 80601-2-23:2024 sets forth comprehensive safety, electromagnetic compatibility (EMC), and essential performance criteria for transcutaneous monitoring equipment. This equipment is used extensively in critical care, neonatology, pulmonology, and anesthesiology to non-invasively monitor blood gas levels (e.g., oxygen and carbon dioxide partial pressures) through the skin. The standard is crucial for device manufacturers, clinical engineering teams, and healthcare institutions that rely on the precision and dependability of these diagnostic instruments.

This edition—superseding previous drafts and harmonizing with related standards—defines:

• Basic safety under normal and single fault conditions
• Essential performance requirements specific to skin-contact gas sensors
• Applicability of collateral standards for risk management, usability, and labeling
• Test procedures for both electrical safety and physiological accuracy

Who must comply:

• Medical device manufacturers designing or supplying transcutaneous partial pressure monitors
• Healthcare facilities purchasing or maintaining diagnostic equipment
• Quality assurance and regulatory compliance officers in clinical contexts

Practical implications: Implementing this standard helps ensure patient safety by minimizing risks such as thermal injury from heated sensors, electrical hazards, and measurement inaccuracies due to device malfunction or use errors. It also supports regulatory submissions by aligning products with internationally consensus-based criteria established by CENELEC and IEC committees.

Key highlights:

• Addresses essential performance for reliable patient monitoring during continuous usage
• Mandates risk management for skin-contact temperature and electrical safety
• Specifies test protocols for EMC and measurement accuracy, minimizing false readings or device interference

Access the full standard:View prEN IEC 80601-2-23:2024 on iTeh Standards

Industry Impact & Compliance

The release of prEN IEC 80601-2-23:2024 brings immediate and long-term implications for healthcare technology providers and users:

• Device Manufacturers: Must update product development, testing, and quality control processes to conform with new safety and performance benchmarks. This impacts R&D, design verification, risk assessment, and technical documentation for regulatory approval.
• Healthcare Facilities: Hospitals and clinics must ensure procurement of compliant devices, update maintenance protocols, and train staff in line with new requirements to manage device-related risks proactively.
• Compliance Officers: Alignment with global regulatory requirements (such as EU Medical Device Regulation and FDA guidelines) is enhanced by adopting this current standard, reducing liability and market access barriers.

Benefits of adoption:

• Improved patient safety and trust in diagnostic processes
• Streamlined conformance with international and local regulations
• Reduced risk of adverse events, recalls, and legal challenges

Non-compliance risks:

• Regulatory penalties, delay or denial of product approvals
• Increased likelihood of device-related incidents or recalls
• Reduced competitiveness in global healthcare markets

Technical Insights

Several technical requirements and considerations are central to the updated standard:

• Basic electrical safety: Reinforced insulation, leakage current limits, and single fault protection mechanisms safeguard both patients and operators.
• Accuracy and reliability: Strict protocols for calibration, device self-tests, and sensor performance ensure that measurements remain clinically actionable over extended periods.
• Heating element control: Special attention to temperature management of skin-contact sensors prevents burns and ensures comfort throughout monitoring cycles.
• EMC compliance: Equipment must withstand common electromagnetic disturbances in hospital environments, minimizing susceptibility to interference from other devices.
• User interface and alarms: Clear instructions for use, visual/audible alarms for sensor detachment, out-of-range readings, and technical faults are now mandatory.
• Risk management: Continuous risk assessment—covering device misuse, hardware/software malfunctions, and environmental factors—must be documented and tested.

Best practices for implementation:

1. Conduct gap analyses comparing current products to the new requirements
2. Update technical files and clinical evaluation reports to document risk mitigations
3. Integrate user feedback into design improvements, especially around alarm limits and sensor placement
4. Schedule regular training for clinical and maintenance staff
5. Plan for re-certification and third-party testing as part of regulatory maintenance

Testing and certification: Third-party certification bodies and notified bodies (in the EU) will require evidence that the latest standard has been applied, especially for newly developed or substantially modified devices.

Conclusion / Next Steps

The January 2026 publication of prEN IEC 80601-2-23:2024 marks a decisive step forward in the safety and reliability of transcutaneous partial pressure monitoring equipment. To remain at the forefront of patient care and regulatory compliance, manufacturers, clinical engineers, and healthcare providers should:

• Review and integrate new requirements into product lifecycles and procurement policies
• Train relevant teams on updated operational standards
• Track further updates as the standard stabilizes ahead of its 2030 target date

By taking proactive steps, organizations can ensure enhanced safety, improved outcomes, and secure their market position amid rapidly evolving healthcare technologies.

Explore and download the full prEN IEC 80601-2-23:2024 standard:Access the official document on iTeh Standards

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