HEALTH CARE TECHNOLOGY Standards Summary - May 2025 (Part 2 of 3)

Looking back at May 2025, the Health Care Technology landscape experienced a notable surge in foundational standardization. This second part of our three-part monthly retrospective captures five essential standards that underscore advances in patient safety, clinical effectiveness, device reliability, and the harmonization of regulatory requirements worldwide. From specialized connectors for neural procedures to the durability testing of lower limb prosthetics, and spanning to the declaration of ultrasonic surgical system outputs, radiation-based medical device sterilization, and gravity-feed transfusion devices, these publications reflect the sector's increasing demand for clarity, interoperability, and reproducible performance. For professionals charged with compliance, engineering, risk management, or product procurement, this overview provides essential context and highlights the implications of these relevant May 2025 publications.

Monthly Overview: May 2025

May 2025 saw a significant concentration of standardization activity in Health Care Technology, driven by multiple factors: evolving regulatory frameworks (notably in the EU), rapid innovation in medical materials and devices, and an intensified focus on risk management throughout the clinical value chain. The five standards examined here collectively represent a cross-section of the sector’s priorities: robust design and interoperability, enhanced patient safety, and support for state-of-the-art medical practice. Noteworthy is the range of coverage—from surgical equipment measurements to sterility assurance and transfusion compatibility—indicating a broad and multifaceted response to emergent healthcare challenges.

The pattern observed this month—where both international and European standards organizations participated in updated and new work—signals the industry’s commitment to aligning core practices across global markets and ensuring that local regulatory needs do not outpace universal safety and performance benchmarks. Compared to previous months, May 2025 delivered an expanded focus on highly specialized components and procedures, reinforcing the sector’s move toward interoperable, resilient, and patient-centric solutions.

Standards Published This Month

ISO 80369-6:2025 - Small Bore Connectors for Neural Applications

Small bore connectors for liquids and gases in healthcare applications – Part 6: Connectors for neural applications

ISO 80369-6:2025 establishes stringent requirements for small-bore connectors intended for use in neural applications such as anesthesia, intrathecal therapy, and cerebrospinal fluid procedures. While not addressing complete medical devices, the standard sets dimensional, mechanical, and usability requirements for connectors to prevent potentially catastrophic misconnections between incompatible medical delivery systems.

Key requirements involve:

• Non-interconnectability design criteria to mitigate cross-connection risks
• Defined mechanical properties, including tensile and flexural strength (minimum modulus of elasticity >950 MPa)
• Specific leakage and separation resistance tests, referencing both ISO 80369-20:2024 and internal annexes for test methods
• Updated terminology (e.g., 'cone' and 'socket' replacing 'male'/'female'), backward compatibility, and harmonization with emergent regional frameworks

This standard is particularly relevant for manufacturers of neural drug delivery systems, anesthesia, neurosurgical accessories, and related equipment providers, ensuring consistent patient safety across diverse clinical settings. Its adoption supports compliance with both international and regional rules targeting device safety and interoperability.

Key highlights:

• Expanded backward-compatible design tolerances and test methods
• Enhanced guidance for neural-specific safety and usability
• Alignment with contemporary risk management and usability engineering best practices

Access the full standard:View ISO 80369-6:2025 on iTeh Standards

EN ISO 22675:2025 - Prosthetics: Ankle-Foot Devices and Foot Units

Prosthetics – Testing of ankle-foot devices and foot units – Requirements and test methods (ISO 22675:2024)

This European adoption of ISO 22675:2024 represents a major update for respondents in the field of prosthetic engineering and orthotics. The standard specifies both cyclic and static testing procedures, ensuring that ankle-foot devices and foot units are rigorously evaluated for performance under loading conditions that realistically simulate a full stance phase of walking (heel strike to toe-off).

Key features include:

• Definition of test ranges and loading profiles tailored to the device’s intended use
• Specified test methods for cyclic (fatigue) loading and static (proof and ultimate strength) testing
• Alignment of test parameters to clinical realities, incorporating body mass considerations and advanced prosthetic designs
• Harmonization with EU Medical Device Regulation (MDR 2017/745), providing a presumption of conformity for strength and durability aspects

Owing to its detailed focus on realistic, reproducible performance requirements, EN ISO 22675:2025 is indispensable for manufacturers, clinical facilities, and conformity assessment bodies concerned with lower limb prostheses. The guidance ensures both the mechanical integrity and extended service life of assistive technology in demanding environments.

Key highlights:

• Comprehensive stance-phase simulation and evaluation
• Integration of new clinical and regulatory requirements
• Direct facilitation of EU MDR compliance for mechanical resilience

Access the full standard:View EN ISO 22675:2025 on iTeh Standards

IEC 61847:2025 - Ultrasonics: Surgical System Output Measurement

Ultrasonics – Surgical systems – Measurement and declaration of the basic output characteristics

IEC 61847:2025 is a substantial revision—superseding the 1998 edition—focused on measurement and manufacturer declaration of non-thermal ultrasonic output parameters for surgical systems (20 kHz–120 kHz), such as tissue fragmenters, coagulators, and debriders. This edition notably extends coverage up to 120 kHz and emphasizes hydrophone-based measurements over outdated calorimetry methods.

Manufacturers are now required to:

• Apply harmonized measurement protocols for acoustic output, vibration frequencies, and directivity
• Address systems with user-selectable vibration modes and complex output patterns
• Characterize devices with respect to cavitation-related phenomena and performance at both sub-cavitation and maximum output levels
• Provide detailed, standardized output declarations for improved purchaser and regulatory transparency

The standard targets surgical instrument engineers, device manufacturers, and quality leaders, significantly increasing the reproducibility and comparability of stated equipment performance, thereby improving procurement, safety, and risk assessment.

Key highlights:

• Expanded measurement scope (up to 120 kHz)
• Mandatory hydrophone output measurement methods
• Enhanced provisions for complex/multimodal ultrasonic devices

Access the full standard:View IEC 61847:2025 on iTeh Standards

FprEN ISO 11137-1 - Radiation Sterilization for Medical Devices

Sterilization of health care products – Radiation – Part 1: Requirements for the development, validation and routine control of a sterilization process for medical devices (ISO/FDIS 11137-1:2024)

FprEN ISO 11137-1 provides the unified international requirements for developing, validating, and routinely controlling sterilization processes for medical devices using radiation methods—including Cobalt-60, Cesium-137, electron beams, and X-rays. Although strictly focused on medical devices, its contents can apply to other healthcare products.

Critical elements of the standard:

• Detailed process requirements spanning agent characterization, dose specification, process validation, process monitoring, and ongoing control
• Alignment with ISO 13485 for quality management, emphasizing only those QMS elements necessary for effective process control
• Clarification on the non-requirement of biological indicators or pharmacopoeial sterility tests as part of validation
• Guidance on regulatory distinctions, highlighting that 'sterile' designation and occupational safety are subject to regional or national rules

The standard is essential for all organizations involved in radiation sterilization—manufacturers, contract sterilizers, and quality assurance professionals—ensuring clinical efficacy and facilitating global trade in medical devices.

Key highlights:

• Comprehensive framework for radiation process validation and control
• Integration with global regulatory references and EU MDR perspectives
• Adaptable to multiple irradiation technologies

Access the full standard:View FprEN ISO 11137-1 on iTeh Standards

ISO 1135-4:2025 - Single-Use Gravity Transfusion Sets

Transfusion equipment for medical use – Part 4: Transfusion sets for single use, gravity feed

ISO 1135-4:2025 addresses global requirements for single-use, gravity-feed transfusion sets, ensuring compatibility with blood containers, clinical equipment, and a wide range of blood components. The standard details both design and performance requirements—covering material compatibility, leak resistance, filter and tubing specifications, biocompatibility, and labeling.

Major updates in the most recent revision include:

• Updated requirements for needle-free injection ports and luer-activated connectors
• Enhanced biological safety protocols, in alignment with ISO 10993 series risk assessment standards
• Revised labeling, packaging, and sterilization provisions to reflect contemporary clinical and regulatory expectations

This standard is critical for suppliers and buyers of transfusion devices, as well as compliance officers seeking to reduce variability and risk in clinical transfusion practices across international markets.

Key highlights:

• Compatibility assurance for a broad range of blood components and containers
• Modernized safety and labeling requirements
• Global alignment for clinical procurement

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

Common Themes and Industry Trends

The May 2025 standards publications reveal several cross-cutting themes in Health Care Technology:

• Patient Safety and Misconnection Prevention: Both ISO 80369-6 and ISO 1135-4 illustrate the sector’s proactive stance on eliminating device misconnections and enhancing the safety of invasive procedures.
• Realistic Testing and Performance Validation: EN ISO 22675’s focus on cyclic testing and real-world load simulation reflects a sector-wide drive for performance validation that mirrors real clinical use.
• Transparent Measurement and Declarations: IEC 61847’s revisions ensure ultrasonic surgical devices are characterized transparently, supporting informed procurement and regulatory approval.
• Regulatory Harmonization: Several standards were updated with a view toward EU MDR alignment, enabling manufacturers to leverage harmonized presumption of conformity and smoother device approvals.
• Broad Applicability Across Critical Device Types: From prosthetics and transfusion kits to advanced surgical and sterilization systems, the standards collectively cover high-impact, high-risk areas of global healthcare delivery.

Emerging focus areas include neural safety, durability and longevity in prosthetics, reproducibility in surgical performance, and robust sterilization protocols—each supporting efforts toward improved clinical outcomes and reduced risk.

Compliance and Implementation Considerations

For organizations impacted by these standards, a structured compliance pathway is recommended:

1. Gap Analysis: Review current processes, components, and device specifications against the newly published standards. Pay special attention to any referenced harmonized test methods, labeling, or safety requirements.
2. Training and Awareness: Where applicable, update engineering, risk management, and clinical procurement staff on the new requirements—focusing on patient safety, performance reliability, and interoperability.
3. Prioritization: Standards with direct clinical safety impact, such as ISO 80369-6 (misconnection prevention) or ISO 1135-4 (transfusion safety), should be escalated for immediate review.
4. Process and Product Updates: Update design and production documentation to integrate new testing methods, definitions, and control mechanisms. For radiation sterilization (FprEN ISO 11137-1), ensure that all routine control and validation protocols are aligned.
5. Engagement with Notified Bodies and Regulators: For products seeking CE-marking or global approvals, confirm conformance with EN ISO/IEC standards where presumption of conformity is afforded.
6. Documentation and Recordkeeping: Maintain thorough records of compliance evaluations, training, and implementation actions for both legal defensibility and process improvement.

Timeline considerations:

• European standards (EN, FprEN) may have delayed enforcement periods; review transition dates and sunset clauses on previous versions.
• Contractual and procurement policies should reference the latest revision dates to reduce risk of noncompliance.

Resources:

• The iTeh Standards platform (https://standards.iteh.ai) offers up-to-date access, purchase, and document management tools for all listed standards.

Conclusion: Key Takeaways from May 2025

The five Health Care Technology standards released in May 2025 demonstrate a robust and collaborative effort to advance safety, performance, and compliance in a rapidly evolving sector. The most impactful developments addressed connector safety in neural procedures, performance durability for prosthetics, ultrasonic surgical measurement, radiation-based sterilization validation, and transfusion product compatibility.

For professionals in the sector, staying informed and promptly integrating these standards will help:

• Mitigate patient risks and ensure clinical best practices
• Facilitate regulatory approvals and maintain market access
• Support innovation while meeting international benchmarks for quality and interoperability

We strongly recommend quality managers, compliance officers, engineers, and procurement teams utilize this retrospective overview as a checklist for updating internal standards libraries and prioritizing compliance initiatives. For complete details and access to authoritative documents, visit iTeh Standards for direct links to each May 2025 publication cited in this report.