Health Care Technology: Five Vital Standards Released — November 2025 Updates

In November 2025, the landscape of health care technology advances with the publication of five crucial international standards. This release—marking Part 2 of our comprehensive four-part series—features essential updates for tissue engineering, medical implants, respiratory therapy equipment, and disinfection protocols. As health care systems face rising expectations for safety, efficacy, and compliance, understanding the scope and impact of these standards is critical for professionals striving for excellence in medical innovation, procurement, and regulatory adherence.

Overview

Health care technology standards play a vital role in assuring the safety, functionality, and effectiveness of medical products and systems throughout their lifecycle. These internationally harmonized requirements are fundamental for manufacturers, regulators, quality managers, and end users in ensuring that technologies consistently meet rigorous benchmarks for patient protection and clinical outcomes.

In this article, you'll discover:

• The scope and significance of five newly published health care technology standards
• Key requirements and compliance implications
• Best practices for implementation
• Technical nuances and cross-cutting considerations
• The industry impact and compliance strategies

Whether you are responsible for quality assurance, procurement, research, or compliance, this guide will support your organization's readiness for the latest international specifications.

Detailed Standards Coverage

ISO 6631:2025 - Quantification of Bovine Type I Collagen for Tissue-Engineered Medical Products

Tissue-engineered medical products — Quantification of bovine type I collagen marker peptide with liquid chromatography — Tandem mass spectrometry

ISO 6631:2025 establishes a quantitative method for identifying and measuring marker peptides of purified bovine type I collagen using advanced liquid chromatography-tandem mass spectrometry (LC-MS/MS). The standard serves as an indispensable tool for the quality control of tissue-engineered medical products (TEMPs) and other collagen-based biomaterials.

The method enables manufacturers to accurately detect bovine-specific or type I-specific collagen, even in complex samples with multiple animal sources or collagen types. While the primary focus is on type I collagen derived from bovine tissues, the protocol provides a template adaptable to other animal species or collagen types by designing suitable marker peptides and optimizing LC-MS/MS conditions.

The procedure addresses:

• Sample preparation, denaturation, trypsin digestion, and LC-MS/MS detection
• Construction of standard curves for calculation
• Criteria for experimental acceptance and reporting

Applicable to:

• Manufacturers and quality control laboratories for TEMPs
• Producers of collagen-based regeneration matrices and wound dressings
• Researchers in regenerative medicine

Key highlights:

• Highly specific quantification method minimizes cross-reactivity
• Adaptable template for sources beyond bovine type I collagen
• Essential for regulatory submission and batch release documentation

Access the full standard:View ISO 6631:2025 on iTeh Standards

ISO 7206-12:2025 - Deformation Testing for Hip Joint Prostheses

Implants for surgery — Partial and total hip joint prostheses — Part 12: Deformation test method for press-fit acetabular components

Revision ISO 7206-12:2025 specifies standardized laboratory methods for assessing the short-term deformation of press-fit acetabular components (used in non-cemented total hip replacements). The standard’s meticulous approach factors in crucial variables of implant material, design, loading conditions, and surgical implantation technique.

The method includes:

• Test setup and parameters for simulating in vivo loading scenarios
• Measurement of deformation under load and after unloading
• Reporting and justification of test specimen selection, loading directions, and observations
• Evaluation of risks related to component performance based on measured deformation
• Recommendations for additional clinical or mechanical assessment if needed

Target users:

• Orthopedic implant manufacturers and design engineers
• Regulatory bodies and notified laboratories
• Clinical evaluators and hospital procurement teams

Revisions:

• Refinement of specimen setup and test requirements
• Clarification of rotational orientation tolerances and material selection
• Expanded interpretive guidance for performance evaluation and risk analysis

Key highlights:

• Ensures implant reliability through rigorous bench testing
• Harmonized terminology and test interpretation with the latest global references
• Supports patient safety and long-term device performance assessments

Access the full standard:View ISO 7206-12:2025 on iTeh Standards

ISO 80601-2-70:2025 (ISO) - Basic Safety & Essential Performance of Sleep Apnoea Breathing Therapy Equipment

Medical electrical equipment — Part 2-70: Particular requirements for basic safety and essential performance of sleep apnoea breathing therapy equipment

This Third Edition of ISO 80601-2-70:2025 from ISO defines requirements and testing methods for sleep apnoea breathing therapy equipment—most notably, those used for patients with obstructive sleep apnoea in both professional and home health care environments.

Key elements include:

• Mandatory requirements for basic safety and essential performance under IEC 60601-1 general standards
• Applicability to home-use and clinical continuous positive airway pressure (CPAP) and bi-level PAP devices
• Specific exclusions (neonatal, critical care ventilators, anesthesia ventilators, transport devices, etc.)
• Requirements for connected accessories impacting system safety/performance
• Risk assessment for physiological function and hazards, including mechanical, electrical, and thermal protections

Applicable organizations:

• Medical device manufacturers
• Importers and distributors of home respiratory therapy devices
• Notified bodies and test laboratories

Key highlights:

• Focused on both patient/user safety and consistent therapy delivery
• Covers labelling, user instructions, maintenance, and testing specifics
• Supports global market access for sleep apnoea equipment

Access the full standard:View ISO 80601-2-70:2025 (ISO) on iTeh Standards

ISO 80601-2-70:2025 (IEC) - Basic Safety & Essential Performance of Sleep Apnoea Breathing Therapy Equipment

Medical electrical equipment — Part 2-70: Particular requirements for the basic safety and essential performance of sleep apnoea breathing therapy equipment

This edition, also formally cataloged by the IEC, is technically aligned with the ISO’s release of ISO 80601-2-70:2025, providing parallel guidance for regulatory compatibility and market acceptance across different regions.

End-users and organizations will benefit from:

• Unified requirements for testing, marking, documentation, and accessory validation
• Assurance of device safety, functional stability, and patient suitability in home and clinical settings
• Guidance for exclusion/inclusion based on intended patient populations (not for ventilator-dependent patients)
• Enhanced focus on user instructions, warnings, cleaning, and maintenance procedures

Key highlights:

• Supplies a harmonized approach for global compliance under ISO and IEC frameworks
• Covers device and system requirements for therapy stability and safety controls
• Facilitates easier cross-border approvals and product certifications

Access the full standard:View ISO 80601-2-70:2025 (IEC) on iTeh Standards

EN 17272:2020+A1:2025 - Airborne Room Disinfection via Automated Process

Chemical disinfectants and antiseptics – Methods of airborne room disinfection by automated process – Determination of bactericidal, mycobactericidal, sporicidal, fungicidal, yeasticidal, virucidal and phagocidal activities

EN 17272:2020+A1:2025 sets the gold standard for evaluating automated airborne chemical disinfection of nonporous surfaces in medical, veterinary, food, and institutional settings. The document outlines test methods designed to determine effectiveness against a comprehensive suite of pathogens—including bacteria, mycobacteria, spores, fungi, yeasts, viruses, and bacteriophages.

The standard establishes:

• Efficacy performance benchmarks for each microorganism type (defined log reductions required)
• Procedures for both efficacy and distribution testing under laboratory-similar practical conditions
• Exclusions (manual application, sprays, flooding, medical device disinfection)
• Applicability for process validation, cross-comparison, and regulatory compliance

Designed for:

• Manufacturers and system integrators of automated disinfection devices
• Clinical environmental services and infection control teams
• Food and institutional facility managers

New to the 2025 amendment:

• Updated challenge requirements
• Expanded explicit reference organisms and defined test conditions
• Cross-referenced to latest EN and ISO terminology and norms

Key highlights:

• Defines robust, reproducible efficacy testing for real-world scenarios
• Essential for infection prevention, process validation, and risk management
• Facilitates regulatory acceptance and procurement due diligence

Access the full standard:View EN 17272:2020+A1:2025 on iTeh Standards

Industry Impact & Compliance

Implementing these new and revised standards is essential for organizations to:

• Ensure product safety and function by meeting internationally harmonized requirements
• Satisfy regulatory and procurement criteria for market access and tender qualification
• Enhance patient and user confidence in devices or disinfection outcomes
• Minimize liability and reputational risk by demonstrating due diligence

Compliance strategies include:

• Early gap analysis against current practices and documentation
• Cross-functional team training and awareness
• Integration into design, validation, and quality management systems
• Timely recertification and communication with regulatory authorities

Timelines:

• Most standards take immediate effect upon publication, with transition periods as set by local authorities

Risks of non-compliance include:

• Market access denial or recall
• Delays in product development or tenders
• Safety incidents, liability exposure, and reputational harm

Technical Insights

Common technical requirements:

• Strictly defined test methods, equipment, and reporting templates
• Focus on traceability, reproducibility, and documentation integrity
• Multi-factor risk assessment and validation against clinical or field-use scenarios

Implementation best practices:

1. Conduct robust initial staff training.
2. Update laboratory protocols and quality documentation consecutively.
3. Participate in inter-laboratory comparisons or proficiency tests, where required.
4. Engage with device or system suppliers early during transition.

Testing and certification:

• Engage accredited test laboratories for device performance and product validation.
• Leverage notified bodies for conformity assessment under both ISO and European frameworks.
• Maintain a complete audit trail of sample preparation, test execution, and deviations.

Conclusion & Next Steps

In November 2025, health care technology organizations face new expectations for product performance, safety, environmental control, and regulatory conformity. Mastering the details of ISO 6631:2025, ISO 7206-12:2025, ISO/IEC 80601-2-70:2025, and EN 17272:2020+A1:2025 is a strategic imperative for market leaders.

Key takeaways:

• These standards drive advancements in device safety, quality, and patient outcomes
• Compliance ensures smooth regulatory pathways and procurement eligibility
• Comprehensive understanding equips your teams to proactively address emerging requirements

Recommendations for organizations:

• Review each standard in detail and update internal protocols accordingly
• Train key stakeholders in testing, documentation, and risk management
• Engage with notified bodies and testing partners early in your transition process

Call to Action: Explore these standards on iTeh Standards to access full requirements and stay competitive in the evolving health care technology landscape. Subscribe to our updates to ensure you never miss a critical regulatory change.