IEC 60601-1
Medical Electrical Equipment Safety
General Requirements for basic safety and essential performance of medical electrical equipment.
ISO 13485
Medical Device
Quality Management System
International standard for establishing
and maintaining an effective quality
management system throughout the
medical device lifecycle.
IEC 62353
Periodic Electrical
Safety Testing
Guidance for routine inspection,
testing and maintenance of medical
electrical equipment after installation
and during service life.
ISO 14971
Medical Device
Risk Management
International framework for identifying,
evaluating, controlling and monitoring
risks throughout the lifecycle of
medical devices.
WHO Practical Checklist
Practical guidance for planning, operating, and maintaining medical equipment programs in healthcare facilities. Includes maintenance workflows, inventory control, safety checks, and lifecycle management recommendations.
QA & PM Checklist
Quality Assurance &
Preventive MaintenanceComprehensive inspection and
maintenance checklist for ensuring
medical equipment performance,
safety, reliability and compliance.
Supplier Evaluation Chicklist
Procurement & Supplier
Qualification Guide
Practical framework for evaluating
refurbished medical equipment
suppliers, quality systems, technical
processes and regulatory compliance.
Medical Equipment Procurement
Priority Framework &
Brand Comparison Matrix
Practical methodology for evaluating,
prioritizing and comparing medical
equipment options before purchase.
NFPA 99
Healthcare Risk & Safety Management
A practical reference for biomedical engineers and hospital managers covering medical gases, electrical safety, emergency systems, and facility risk contr
IEC 60601-1-2
Medical Device EMC Compliance
A practical reference for biomedical engineers covering EMC testing, electromagnetic immunity, emissions evaluation, and regulatory compliance.
ISO 15223-1
Medical Device Labeling & Symbols
A practical reference for biomedical engineers, manufacturers, and distributors covering device symbols, labeling requirements, packaging information, and regulatory compliance.
ISO 10993
Biological Evaluation of Medical Devices
A practical reference for biomedical engineers, manufacturers, and regulatory professionals covering biocompatibility testing, biological risk assessment, material safety, and patient protection.