January 2026 Health Care Technology Standards: Medical Devices, Diagnostics, and Animal Health Advances

In January 2026, the field of health care technology saw the publication of five significant standards affecting everything from medical electrical equipment and life-supporting devices to advanced diagnostics—both in human and animal health. These updates, representing Part 2 of 3 in our series, mark critical advancements in quality, safety, and harmonization requirements. Organizations across the medical device, diagnostics, and veterinary sectors will need to adapt their compliance frameworks to incorporate new guidelines, essential performance benchmarks, and updated risk management protocols. This article provides expert insights into the core changes, implementation strategies, and industry implications of each new standard.

Overview

Health care technology is an ever-evolving domain where standards play a pivotal role in safeguarding patient safety, fostering innovation, and ensuring global interoperability. Well-crafted standards set the foundation for medical device and system reliability, performance, and trust. With regulatory frameworks tightening and innovation accelerating, keeping abreast of the latest standards is essential for industry professionals. This article will guide you through the technical, compliance, and strategic ramifications of the newest standards shaping health care technology in January 2026.

Detailed Standards Coverage

EN IEC 60601-2-57:2026 - Medical Electrical Equipment: Non-Laser Light Source Equipment

Medical electrical equipment - Part 2-57: Particular requirements for the basic safety and essential performance of non-laser light source equipment intended for therapeutic, diagnostic, monitoring, cosmetic and aesthetic use

This standard introduces particular requirements for the basic safety and essential performance of medical equipment utilizing non-laser optical radiation. Covering devices that operate in the 200 nm to 3,000 nm wavelength range, EN IEC 60601-2-57:2026 applies to light source equipment (LS equipment) used for therapeutic, diagnostic, monitoring, cosmetic, and aesthetic purposes (excluding laser devices).

Key Requirements & Scope

• Outlines comprehensive risk management processes in alignment with IEC 60601-1, including hazard identification, control, and monitoring of optical radiation output.
• Introduces classifications for output risk groups, including the addition of Risk Group 1C (devices with contact-based emission limitation), and stipulates safety interlocks if applicators lose contact with the patient.
• Expands on marking and labeling including emission aperture labeling, product labelling, and user instructions.
• Prescribes requirements for exposure termination controls, output uniformity, and the minimization of hazardous stray optical radiation.
• Imposes rigorous EMC (electromagnetic compatibility), mechanical, and electrical safety checks.

Applicability & Implementation

• Mandatory for manufacturers and users of non-laser medical light source equipment for human applications, including physical therapy, dermatology, diagnostic imaging, and monitoring.
• Impacts quality assurance teams, R&D, device engineers, as well as clinical procurement specialists selecting LS equipment for institutional or ambulatory practice.

Notable Changes

• Comprehensive revisions to risk group classifications and operational safeguards
• Greater detail for user documentation, with inclusion of exposure and safety output values

Key highlights:

• Enhanced risk management for optical radiation
• Specific labeling/instruction requirements for LS equipment
• Output safety controls and compliance mechanisms

Access the full standard:View EN IEC 60601-2-57:2026 on iTeh Standards

ISO 16840-6:2026 - Wheelchair Seating: Simulated Use Testing of Seat Cushions

Wheelchair seating — Part 6: Determination of changes in properties of seat cushions following simulated use

Developed to ensure durability and continued safety of seat cushions in wheelchairs, ISO 16840-6:2026 standardizes the methods for assessing the effects of ageing and wear on cushion performance.

Key Requirements & Scope

• Specifies apparatus and protocols for simulating ageing (wear-and-tear), including mechanical, thermal, and environmental stressors.
• Defines systematic test methods to measure changes in envelopment, column buckling, impact damping, pressure distribution, lateral/forward stiffness, and hysteresis, as well as cold exposure and bacterial soiling.
• Outlines documentation and reporting requirements for manufacturers to disclose performance changes and predict product lifespan.
• Accelerated ageing test procedures (e.g., 70 °C heat exposure, cyclic loading) for warranty validation and life expectancy assessment.

Applicability & Implementation

• Essential for wheelchair cushion manufacturers, testing laboratories, quality managers, and procurement officers responsible for device selection in healthcare, rehabilitation, and long-term care settings.
• Provides insurers and clinicians confidence in product claims of durability, affecting reimbursement and purchasing standards.

Notable Changes

• Expanded suite of tests simulating real-world cushion use
• Uniform methods for reporting and claims validation

Key highlights:

• Systematic simulated use methodology
• Endurance metrics tied to real-world user scenarios
• Detailed disclosure for regulatory and procurement transparency

Access the full standard:View ISO 16840-6:2026 on iTeh Standards

prEN IEC 80601-2-31:2024 - External Cardiac Pacemakers: Basic Safety and Essential Performance

Medical electrical equipment - Part 2-31: Particular requirements for the basic safety and essential performance of external cardiac pacemakers with internal power source

prEN IEC 80601-2-31:2024 sets forth the safety requirements and essential performance criteria for external cardiac pacemakers powered by internal batteries—crucial devices for managing life-threatening cardiac arrhythmias.

Key Requirements & Scope

• Details performance, safety, and labeling requirements for devices supporting single, dual, and triple-chamber pacing.
• Mandates robust fault condition assessments, including protection against electrical, mechanical, thermal, and electromagnetic hazards.
• Includes defibrillation protection, battery performance reporting, saline exposure endurance, and clarity in terminal/indicator labeling.
• Tightens requirements for immunity to electrostatic discharge (ESD) and aligns with latest electromagnetic compatibility (EMC) criteria.

Applicability & Implementation

• Relevant for manufacturers and testing bodies working on external cardiac pacemakers, clinical engineers, and hospital device managers.
• Directly informs quality assurance, regulatory submissions, and procurement evaluations of cardiac support systems.
• Ensures safer device operation in acute, perioperative, and transport environments.

Notable Changes

• Updated indicator color conventions from previous editions
• Revised battery use and saline testing protocols

Key highlights:

• Comprehensive performance and hazard protection
• Updated test and reporting for battery and indicators
• Stronger EMC and ESD requirements

Access the full standard:View prEN IEC 80601-2-31:2024 on iTeh Standards

EN 18000-1:2026 - Animal Health Diagnostics: Initial and Batch-to-Batch Control for In Vitro Diagnostic Reagents

Animal health diagnostic analyses - Control of in vitro diagnostic reagents - Part 1: Application file for the initial and the batch-to-batch control

EN 18000-1:2026 lays the foundation for regulatory harmonization in the control and approval of in vitro diagnostic reagents for animal health, facilitating recognition and mutual acceptance across countries and regulatory frameworks.

Key Requirements & Scope

• Establishes required terms, definitions, and application dossier content for initial and subsequent batch approvals.
• Mandates administrative and technical information disclosure, technical validation according to current disease-specific and generic standards, and comprehensive descriptions of product, performance, and manufacturing practices.
• Provides protocols for conformity certificates, documentation of modifications, and management of reference materials.
• Not intended for all existing reagents but prioritizes those central to infectious disease monitoring and trade regulation.

Applicability & Implementation

• Applies to veterinary diagnostics manufacturers, laboratories, and regulatory bodies overseeing disease status, trade, and health certification.
• Supports traceability, batch quality, and harmonized approval of strategic reagents across regions.

Notable Changes

• Systematizes cross-jurisdiction dossier application and batch validation
• Clarifies roles of control organizations and applicants

Key highlights:

• Comprehensive application and control file requirements
• Batch conformity certificates and modification protocols
• Supports regulatory harmonization for disease control

Access the full standard:View EN 18000-1:2026 on iTeh Standards

EN 18000-2:2026 - Animal Health Diagnostics: Immunological Technique Reagents

Animal health diagnostic analyses - Control of in vitro diagnostic reagents - Part 2: Reagents for immunological techniques

EN 18000-2:2026 complements Part 1 by specifying requirements uniquely for in vitro diagnostic reagents used in immunological analyses (e.g., ELISA, immunodiffusion) with qualitative result interpretation in animal health diagnostics.

Key Requirements & Scope

• Outlines prerequisites, including control organization capacity, access to reference materials, and definition of reagents’ regulatory/performance objectives.
• Defines applicant and control organization responsibilities in initial conformity and ongoing batch control context, covering analytical sensitivity/specificity, diagnostic panel use, interpretation methods, and reporting.
• Addresses special scenarios: multiple protocols/matrices, pooled sample verification, and batch control derogations for rare diseases.

Applicability & Implementation

• Central for laboratories and manufacturers participating in animal disease surveillance, food chain biosecurity, and trade compliance.
• Directly impacts product approvals, market access, and national/international disease program operations.

Notable Changes

• Stepwise harmonization for immunological reagent validation and batch release
• Clear demarcation of responsibilities and documentation obligations

Key highlights:

• Protocol standards for immunological diagnostic reagents
• Repeatable and transparent performance validation
• Batch control requirements adaptable to disease-specific scenarios

Access the full standard:View EN 18000-2:2026 on iTeh Standards

Industry Impact & Compliance

These five newly published standards make a profound impact across the medical and animal health technology value chain:

• Operational changes: New safety controls and performance requirements necessitate design and documentation updates, especially for manufacturers of medical electrical equipment and diagnostic reagents.
• Compliance timelines: Implementing these standards early is strategically advantageous—many regulatory bodies allow a transition, but early adopters often gain market trust and streamlined approval.
• Benefits of adoption:
  • Enhanced patient and animal safety
  • Improved device reliability and effectiveness
  • Regulatory acceptance across multiple jurisdictions (especially where harmonized dossiers and batch certificates are needed)
  • Competitive market position through innovation and compliance leadership
• Risks of non-compliance: Delays to market, denied regulatory approval, possible product recalls, or even patient safety events—particularly with life-sustaining devices—can result from failing to meet these new standards.

Technical Insights

Common Technical Requirements:

• Implementation of rigorous risk management aligned to device/test scope
• Detailed labeling and user documentation for transparency and safe operation
• Performance testing under real-world or simulated conditions (e.g., ageing, exposure, batch variation)
• Emphasis on interoperability, traceability, and responsiveness to evolving regulatory demands

Best Practices:

1. Start early with gap analysis compared to current devices, processes, and quality documentation.
2. Engage multidisciplinary teams—engineering, regulatory, laboratory, clinical, and supply chain.
3. Use accredited laboratories and validated protocols for performance/ageing tests.
4. Collaborate with notified/control bodies; document justification for exemptions or derogations.
5. Maintain comprehensive, accessible records of compliance and test results for audits or regulatory submissions.

Testing & Certification:

• Leverage established third-party and governmental laboratories for independent verification
• Document all protocol deviations and rationale, especially for rare disease contexts in animal health
• Pursue certification and conformity marks recognized by target markets

Conclusion / Next Steps

The January 2026 wave of health care technology standards demonstrates the industry’s commitment to advancing both human and animal health through rigorous international harmonization and performance assurance. Whether you are bringing a new medical device to market, maintaining a portfolio of diagnostic reagents, or procuring critical therapeutic equipment, proactively integrating these requirements will be essential.

Key takeaways:

• These standards set new benchmarks for safety, reliability, and traceability in a rapidly evolving sector.
• Early engagement, robust internal compliance systems, and strong partnerships with testing/certification bodies will expedite market access and lower regulatory risk.

Stay up-to-date on future standard releases by subscribing to notifications on iTeh Standards. Review the full texts for each standard via the links above for technical details, implementation guidance, and compliance checklists.