Overview
ISO/TS 5137:2026 establishes the requirements for a comprehensive medical device maintenance management programme specifically for healthcare delivery organizations (HDOs). This technical specification focuses on reusable medical devices that require maintenance under HDO supervision. It clearly defines the responsibilities of healthcare organizations and their biomedical engineering services (BES), ensuring patient safety, optimal device performance, and compliance with relevant regulatory standards.
Designed with flexibility to accommodate various national and local regulations, ISO/TS 5137:2026 does not apply to device manufacturers maintaining their own products or to device modifications. Instead, it provides a robust framework that supports effective planning, documentation, process monitoring, and continual improvement for all phases of medical device maintenance within HDOs.
Key Topics
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Maintenance Programme Structure
- Documented maintenance management programme tailored to organizational needs
- Clear procedure for both scheduled and unscheduled maintenance activities
- Application of manufacturers’ maintenance instructions, safety standards, and best practices
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Management and Documentation
- Defined quality objectives aligned with regulatory requirements
- Thorough documentation including procedures, method statements, records, and risk assessments
- Control processes for documentation and records ensuring accessibility, traceability, and security
- Use of a maintenance management information system (MMIS) for asset tracking and work order management
- Technical library with manuals, guidance, and training materials
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Responsibility and Resources
- Assignment of biomedical engineering services representatives to oversee programme implementation
- Clearly documented responsibilities, authority, and communication structures
- Competence requirements for staff, with structured training and records management
- Adequate provision of infrastructure, maintenance tools, and contamination controls
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Maintenance Service Realization
- Planned maintenance intervals based on risk assessment, manufacturer recommendations, and device history
- Procedures for preventive, predictive, and unscheduled maintenance
- Calibration, routine inspection, and reduction of device downtime
- Comprehensive risk management plan to control hazards throughout the device lifecycle
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Continuous Improvement
- Ongoing measurement and analysis of maintenance processes
- Incident reporting, internal audits, and nonconformity management
- Medical device replacement planning and advisory services
Applications
ISO/TS 5137:2026 is a vital standard for healthcare facilities such as hospitals, clinics, and specialized treatment centers. It helps ensure:
- Enhanced device safety and compliance by structuring maintenance according to recognized best practices and regulatory requirements
- Operational reliability by minimizing unplanned downtime through effective preventive and predictive maintenance strategies
- Improved process efficiency and standardization, supporting resource optimization and cost control
- Streamlined incident and risk management by documenting processes and actions addressing device failures or hazards
- Simplified quality management system integration for HDOs certified or seeking certification in ISO 13485 or ISO 9001
These outcomes facilitate better health outcomes, secure patient environments, and robust regulatory compliance.
Related Standards
For organizations implementing ISO/TS 5137:2026, the following standards are highly relevant:
- ISO 13485: Quality management systems for medical devices
- ISO 9001: Quality management systems – Requirements
- IEC 62353: Medical electrical equipment – Recurrent test and test after repair
- ISO 14971: Application of risk management to medical devices
ISO/TS 5137:2026 can be used alongside these frameworks to build a cohesive, reliable, and safe medical device maintenance programme for healthcare delivery organizations.
Keywords: medical device maintenance, ISO/TS 5137:2026, healthcare delivery organization, HDO, biomedical engineering services, maintenance management, medical device safety, regulatory compliance, healthcare standards, preventive maintenance, quality management system, ISO 13485.