June 2026 Brings Key Updates in Health Care Technology Standards

Technological transformation continues to accelerate across the health care field, demanding rigorous approaches to risk, safety, and performance. June 2026 marks a pivotal month with five significant international standards published for health care technology. These updates deliver detailed guidance on machine learning–enabled medical device risk, innovations in ophthalmic optics coatings, advanced safety in plasma wound treatment, and standardized methods for surgical instrument measurement and testing. Collectively, the standards set new benchmarks for patient safety, device reliability, and regulatory compliance.

Overview / Introduction

Health care technology is experiencing rapid advancements, from artificial intelligence applications in medical devices to breakthrough wound care and precision surgical instruments. Standards in this sector serve as the backbone for quality assurance, patient safety, and global interoperability—elements crucial for manufacturers, clinical engineers, regulators, and procurement professionals alike.

In this article—the first in a four-part June 2026 coverage—we explore five newly published standards changing health care practice and device manufacturing. Readers will gain practical insights into:

• Critical requirements and updated compliance considerations for medical device risk, coatings, safety, and instrument quality.
• The latest methods for evaluation, measurement, and performance monitoring.
• Strategic recommendations to align operations with evolving international best practices.

Detailed Standards Coverage

CEN ISO/TS 24971-2:2026 – Machine Learning in Medical Device Risk Management

Medical devices – Guidance on the application of ISO 14971 – Part 2: Machine learning in artificial intelligence (ISO/TS 24971-2:2026)

As artificial intelligence and machine learning (ML) reshape medical device design and deployment, risk management must keep pace. CEN ISO/TS 24971-2:2026 was developed to guide manufacturers through the unique risks associated with ML-enabled medical devices (MLMD), ensuring the process defined in ISO 14971 is robustly applied to this cutting-edge technology.

This standard addresses:

• The distinctive risk profile presented by data-driven learning algorithms, including issues of transparency (the "black box" problem), data bias, and system autonomy.
• Integrated approaches for analyzing, evaluating, and controlling risks within the MLMD lifecycle, from model training and validation to post-market monitoring.
• The importance of establishing MLMD acceptance criteria up front and managing continual learning, retraining, and updating in the clinical environment.

Applicable to developers, manufacturers, and clinical implementers of ML-based medical devices (excluding those using large language models or generative AI), this guidance supports regulatory compliance and patient safety through systematic risk assessment.

Key highlights:

• Outlines comprehensive documentation requirements for risk management files in MLMD.
• Provides best practices for identifying and mitigating algorithmic bias and unintended outcomes.
• Emphasizes the need for continuous post-production monitoring and retraining safeguards.

Access the full standard:View CEN ISO/TS 24971-2:2026 on iTeh Standards

ISO 8980-4:2026 – Testing and Specifications for Spectacle Lens Coatings

Ophthalmic optics — Uncut finished spectacle lenses — Part 4: Specifications and test methods for the properties of anti-reflective coatings and hydrophobic coatings

High-performance spectacle lenses are crucial not only for vision correction but also for wearer comfort and safety. ISO 8980-4:2026 delivers updated specifications and test methodologies for anti-reflective and hydrophobic coatings on uncut finished spectacle lenses.

Key provisions include:

• Detailed optical and non-optical requirements for coatings, including luminous reflectance and mean reflectance limits, usable coating diameter, water repellency (static contact angle ≥90°), and coating durability.
• Rigorous standards for test methods, such as environmental cycling, durability through rubbing sequences, and the evaluation of hydrophobic properties via precise contact angle measurements.
• Clear procedures for calibration, specimen preparation, and performance validation—promoting product consistency and compliance for lens manufacturers and testing laboratories.

Vital for manufacturers of spectacle lenses, optical labs, procurement specialists, and quality assurance, the revised standard assures patients and providers of reliable coating performance.

Key highlights:

• Adds comprehensive test methods for hydrophobic (self-cleaning) coatings.
• Updates durability requirements to reflect real-world wear and environmental conditions.
• Aligns terminology, references, and methods with the latest international best practices for ophthalmic optics.

Access the full standard:View ISO 8980-4:2026 on iTeh Standards

IEC 60601-2-91:2026 – Safety for Non-Thermal Plasma Wound Treatment Equipment

Medical electrical equipment – Part 2-91: Particular requirements for basic safety and essential performance of non-thermal plasma wound treatment equipment

Non-thermal plasma wound treatment is a promising modality for challenging wounds and dermatological conditions. IEC 60601-2-91:2026 defines the safety and essential performance criteria for these advanced devices, focusing on unique hazards and operational profiles.

This standard includes:

• Clear criteria for electrical and mechanical safety, electromagnetic compatibility, and accurate control of plasma-related parameters (such as gas temperature and reactive species output).
• Test methods to confirm insulation, leakage currents, radiation safety, and prevention of excessive temperatures.
• Exclusion of equipment intended for haemostasis or those applying thermal effects, ensuring targeted scope.

Essential for manufacturers, clinical users, and test labs specializing in wound care technology, this standard underpins confidence in device safety, particularly in clinical environments treating chronic wounds and skin diseases.

Key highlights:

• Introduces comprehensive test protocols for monitoring plasma characteristics and operator exposure.
• Supplements and modifies general requirements in IEC 60601-1 with plasma-specific controls.
• Facilitates conformity assessment and supports regulatory submissions.

Access the full standard:View IEC 60601-2-91:2026 on iTeh Standards

ISO 7554-2:2026 – Surgical Instrument Basic Measurement Methods

Surgical instruments — Terms, measuring methods and test methods — Part 2: Methods for determination of basic measures

Precision and repeatability in surgical instruments are vital for both safety and clinical outcomes. ISO 7554-2:2026 offers foundational methods for measuring length, joint width, thickness, jaw width, and penetration depth of standard surgical instruments, excluding complex tools for neurosurgery and cardiovascular use.

The standard delivers:

• Consistent terminology and stepwise measurement rules to ensure clarity from design through quality control.
• Practical guidance for diverse instrument shapes, with exceptions documented for specific categories (e.g., those with unique anatomic adaptation).
• Clear procedures and tools for accurate unit conversions between metric and customary units.

Applicable to manufacturers, QA teams, regulators, and procurement professionals, these methods promote compatibility, traceability, and accuracy in surgical instrument procurement and inspection.

Key highlights:

• Provides harmonized measurement rules to support global supply chains.
• Specifies exceptions and alternative approaches for anatomically contoured instruments.
• Supports informed sourcing and regulatory documentation.

Access the full standard:View ISO 7554-2:2026 on iTeh Standards

ISO 7554-3:2026 – Functional and Durability Test Methods for Surgical Instruments

Surgical instruments — Terms, measuring methods and test methods — Part 3: Test methods

Functionality, durability, and surface quality are non-negotiable for surgical instruments. ISO 7554-3:2026 defines the test requirements for standard surgical tools, from scalpels and forceps to needle holders and retractors.

Key test requirements include:

• Functional testing tailored to instrument type (e.g., cutting efficacy for scalpels, elasticity for forceps, and proper fit for needle holders).
• Surface quality control—free from burrs, cracks, corrosion, or machining residue—verifiable through visual inspection and hardness testing.
• Procedures for boiling, Vickers/Rockwell hardness, and assessment of resistance to sterilization, corrosion, and thermal exposure.

The guidance does not cover instruments for neurosurgical or cardiovascular use but establishes a robust baseline for most general surgical settings.

Key highlights:

• Detailed procedures ensure every instrument is evaluated for safe, reliable performance.
• Provides harmonized methods for comparison across manufacturers and markets.
• Useful for regulatory submissions, supplier audits, and ongoing QA activities.

Access the full standard:View ISO 7554-3:2026 on iTeh Standards

Industry Impact & Compliance

Adopting these five updated standards delivers immediate and long-term benefits for organizations across the health care technology supply chain. Specific compliance considerations include:

• Quality Management Systems (QMS): Integration of new risk assessment protocols, measurement practices, and device safety checks into existing QMS frameworks will ensure ongoing regulatory alignment and certification readiness.
• Implementation Timelines: Organizations should review standard-specific transition periods, align with notified bodies, and update documentation, validation plans, and supplier requirements accordingly.
• Business Benefits: Enhanced product reliability, market confidence, and minimized recall risks yield bottom-line advantages. Early adopters of these standards are well-positioned to respond to regulatory changes and differentiate themselves through quality and compliance excellence.
• Non-compliance Risks: Failure to comply may lead to product delays, regulatory findings, patient safety events, or reputational damage. Regular training, audits, and supplier engagement are strongly recommended.

Technical Insights

Several technical themes unify these standards:

• Standardized Testing: Rigorous and harmonized test protocols underpin all five documents—from risk management in AI to coating durability and instrument function.
• Measurement Precision: Consistent definitions and methods for length, angles, reflectance, and surface analysis reduce variability and increase trust in results across geographies.
• Documentation and Traceability: Each standard emphasizes the importance of documentation—not only for compliance but for ongoing process improvement and risk mitigation.
• Implementation Best Practices:
  1. Conduct gap analyses: Identify areas where current practices diverge from newly published requirements.
  2. Train key personnel: Ensure quality, regulatory, and technical teams are familiar with the latest specifications.
  3. Update internal procedures: Adapt workflows to integrate measurement, risk management, and test methods as prescribed.
• Testing and Certification: Early engagement with accredited laboratories and certification bodies will streamline market access, especially for new medical technologies.

Conclusion / Next Steps

June 2026’s suite of newly published health care technology standards reflects the sector’s ongoing evolution—both technologically and in its approach to safety, quality, and regulatory compliance. By reviewing and adopting these authoritative specifications, organizations will future-proof products, safeguard patients, and assure customers and regulators of commitment to excellence.

Recommended actions:

• Review and integrate the relevant standards into your QMS and product development cycles.
• Engage with suppliers and testing labs early to clarify compliance expectations and timelines.
• Bookmark iTeh Standards for access to official documents and ongoing updates across all segments of health care technology standards.

Stay tuned for Parts 2–4 of our June 2026 coverage as we spotlight even more critical updates shaping the future of health care technology.