December 2025 Brings New Safety Standards for Pediatric Medical Beds & Sleep Apnoea Devices

December 2025 has introduced a significant slate of new international standards in healthcare technology, addressing essential safeguards for pediatric medical beds and sleep apnoea therapy equipment. This latest set of five standards—comprising comprehensive requirements for mechanical, electrical, and usability aspects—represents a critical update for device manufacturers, clinical engineers, procurement specialists, and quality managers throughout the medical sector. Here’s an in-depth look at what’s new, what it means for industry stakeholders, and how organizations can adapt swiftly for compliance and patient safety.

Overview / Introduction

Modern healthcare technology increasingly relies on robust international standards to guide device design, promote harmonized safety benchmarks, and protect vulnerable populations. In pediatric care and respiratory therapy—two areas where margin for error is slim—updated specifications impact everything from hospital workflows to product certification and market access.

This article reviews five newly published standards in three key themes:

• Pediatric and atypically dimensioned medical beds (IEC/ISO)
• Safety and essential performance of sleep apnoea breathing therapy equipment (CEN/ISO)

Readers will discover:

• Specific technical requirements
• Affected product categories and institutions
• Compliance and implementation strategies
• Risks and advantages
• Direct access to each full standard on iTeh Standards

Detailed Standards Coverage

IEC 80601-2-89:2025 (ISO Edition) – Basic Safety and Essential Performance of Medical Beds for Children

Medical electrical equipment – Part 2-89: Particular requirements for the basic safety and essential performance of medical beds for children

This standard, published by ISO with joint IEC input, establishes essential safety and performance requirements for medical beds designed for children and adults with atypical anatomy—ranging outside typical adult parameters. It covers both electrically operated and manual beds, including those with adjustable functionalities, up to 180 cm in length (suitable for patients up to 155 cm tall). Device types outside this scope include adult-only beds, specialty mattresses, incubators, and examination/transport stretchers.

Key requirements and coverage areas:

• Definitions for intended users and target dimensions
• Protection against electrical, mechanical, and thermal hazards
• Risk management for patient entrapment, including specific mechanical tests, dimensions for rails and barriers, and force/stability provisions
• Machine washable criteria and cleaning symbology for infection control
• Graphic marking requirements, informing users of compatibility and device limits

Facilities including pediatric hospitals, rehabilitation centers, and home care must ensure compliance when beds are used for children and patients with exceptional body sizes. The document introduces enhanced mechanical protection requirements, new graphic symbols, and updated procedures for periodic inspection and maintenance.

Key highlights:

• Entrapment protection through precise dimensioning and force testing
• Graphic symbols for safety, cleaning, and patient positioning
• Explicit exclusion of adult-only, specialty, and transport devices

Access the full standard:View IEC 80601-2-89:2025 (ISO) on iTeh Standards

IEC 80601-2-89:2025 (ISO Edition, Duplicate Publication) – Medical Beds for Children

Medical electrical equipment – Part 2-89: Particular requirements for the basic safety and essential performance of medical beds for children

This edition mirrors the previous publication, issued simultaneously by ISO within the joint IEC/ISO harmonization approach. The technical content, implementation targets, and compliance obligations are identical—guiding manufacturers, hospitals, and procurement agencies toward a single, unified safety framework for pediatric and non-standard medical beds.

Key highlights:

• Redundant but authoritative dual publication for global harmonization
• Ensures seamless international recognition and legal compliance
• No substantive changes beyond organizational issuance

Access the full standard:View IEC 80601-2-89:2025 (ISO) on iTeh Standards

IEC 80601-2-89:2025 (IEC Edition) – Pediatric and Atypical-Size Medical Beds

Medical electrical equipment – Part 2-89: Particular requirements for the basic safety and essential performance of medical beds for children

This direct IEC publication provides full technical guidelines for manufacturers and care providers sourcing or producing medical beds for children and individuals with dimensions outside the adult norm. Like the ISO version, it addresses electrical and manual beds, specifying:

• Internal length/height dimensions for patient safety
• Entrapment risks associated with rails, gaps, and hinges
• Mechanical stability, including dynamic impact and load testing
• Electromagnetic compatibility
• Markings and documentation to support user understanding
• Exclusions for products not intended for pediatric care

Special attention is given to risk assessment protocols, periodic inspection requirements, and compatibility between mattresses and beds, which must be visibly marked.

Key highlights:

• Electric and non-electric medical beds both covered
• Focus on child-sized barriers, rail heights, and gap controls
• Rigorous periodic inspection recommendations to reduce long-term risks

Access the full standard:View IEC 80601-2-89:2025 (IEC) on iTeh Standards

IEC 80601-2-89:2025 (IEC Edition, Duplicate Publication) – Pediatric Medical Bed Safety

Medical electrical equipment – Part 2-89: Particular requirements for the basic safety and essential performance of medical beds for children

This duplicate IEC publication exists to ensure that all systemic, organizational, and legal channels applying IEC standards have direct, up-to-date access to the most recent pediatric medical bed requirements. Like the ISO track, this standard is necessary for compliance in regulated healthcare markets, government tenders, and cross-jurisdictional device design.

Key highlights:

• Guarantees up-to-date worldwide adoption of pediatric safety requirements
• Identical technical content, providing legal certainty for buyers and manufacturers
• Supports broad, harmonized global market access

Access the full standard:View IEC 80601-2-89:2025 (IEC) on iTeh Standards

EN ISO 80601-2-70:2025 – Basic Safety and 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 (ISO 80601-2-70:2025)

This European-international harmonized standard is vital for ventilatory medical devices used in the management of obstructive sleep apnoea (OSA). It sets out detailed safety, performance, and usability criteria for devices that deliver therapeutic pressure to relieve apnoea, addressing both home and professional healthcare settings.

Critical requirements include:

• Design, testing, and functional connection criteria
• Operating modes and device classifications (e.g., CPAP, BiPAP)
• Stability of airway pressure (long/short-term)
• Marking, instructions, routine cleaning, and accessory integration
• Distinction between device usage for non-ventilator-dependent patients vs. those requiring full ventilatory support
• Exclusions (devices for neonates, critical care, anaesthetics, emergency use, etc.)

Manufacturers and providers supplying sleep apnoea therapy equipment to sleep labs, hospitals, and home care markets must update documentation, training, and procurement criteria to match these new requirements.

Key highlights:

• Comprehensive guidance for home and clinical sleep apnoea treatment devices
• Explicit inclusion/exclusion of device types and patient populations
• Demanding accuracy, bio-compatibility, and failure protection performance

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

Industry Impact & Compliance

Adoption and compliance with the December 2025 standards are crucial for:

• Medical device manufacturers
• Healthcare procurement departments
• Clinical engineering and biomedical maintenance teams
• Quality assurance, safety, and regulatory affairs professionals

Key compliance considerations:

• Most standards are immediately effective for new equipment; transition timelines may apply for previously certified devices
• Documentation and marking must be updated to reflect new graphic symbols, warnings, and operational criteria
• Hospital procurement and tendering processes must reference updated requirements

Benefits of adopting the new standards:

• Minimized risk of adverse events (e.g., entrapment, falls, equipment malfunction)
• Streamlined international market access and legal compliance
• Improved user and patient satisfaction through clearer instructions and enhanced device reliability

Risks of non-compliance:

• Regulatory action or exclusion from procurement processes
• Increased liability and potential safety incidents
• Loss of certification or product recall events

Technical Insights

Common requirements and best practices across these December 2025 standards include:

• Mechanical safety: Entrapment testing, load tolerance, and stability for medical furniture
• Electrical safety: Comprehensive protection against leakage and fault conditions
• Performance reliability: Long-term and short-term accuracy for sleep therapy pressures
• Usability: Placement of operational symbols, clear cleaning guidelines, and instructions for use
• Testing & certification: All new devices should undergo rigorous bench and simulated-use testing per the outlined procedures, ideally under third-party assessment for market confidence

Implementation tips:

1. Conduct a gap analysis comparing current products with new requirements
2. Update technical files, product labels, and user documentation
3. Revise and retrain staff using updated, standards-aligned protocols
4. Engage with notified bodies or national regulators early

Conclusion / Next Steps

The December 2025 health care technology standards round-up brings an essential leap in the safe design, procurement, and use of both pediatric medical beds and modern sleep apnoea therapy equipment.

Organizations are strongly advised to:

• Review and integrate these specifications into product development, purchasing, and facility standards
• Update clinical, technical, and procurement teams on new requirements
• Use the direct standard links provided to ensure full, current access via iTeh Standards
• Monitor future updates and plan for ongoing staff training and device audits

Stay at the forefront of clinical safety, compliance, and patient care by embracing these latest international benchmarks—your patients, staff, and institution’s reputation depend on it.