| Quality Management System | Confirm that the production and quality processes are controlled under a medical-device quality system. | ISO 13485:2016 certification should be current and within the stated scope. | Current certificate, certification scope, issuing body, validity dates, and audit status. | 15% |
| Electrical Safety | Evaluate protection against electric shock, abnormal operation, leakage current, and mechanical hazards. | IEC 60601-1 is the primary general standard for medical electrical equipment. | Test report, declaration of conformity, electrical safety test records, and applicable national approvals. | 15% |
| Surgical Luminaire Compliance | Check whether the design addresses the specific safety and performance requirements for surgical and diagnostic luminaires. | IEC 60601-2-41 is the relevant particular standard for surgical and diagnostic luminaires. | Product-specific compliance report referencing the applicable edition and test configuration. | 15% |
| Photometric Performance | Compare illuminance, color rendering, color temperature, shadow management, and light-field stability. | Request measured values at the specified working distance; do not rely only on marketing descriptions. | Independent photometric report, test distance, measurement method, tolerance, and product configuration. | 15% |
| Color and Tissue Visibility | Assess whether the light supports accurate visual differentiation during procedures. | Ask for CRI and, where relevant, R9 or other color-quality data rather than a single color-temperature value. | Complete color-performance data sheet and sample evaluation under representative operating-room conditions. | 8% |
| Mechanical Structure | Review arm movement, balance, ceiling load, sterilizable handles, brake performance, and positioning repeatability. | The mounting structure must be compatible with the room’s ceiling, reinforcement, and electrical layout. | Installation drawings, ceiling-load requirements, movement test records, and site survey checklist. | 10% |
| Risk Management | Confirm that hazards have been identified and controlled throughout the product life cycle. | ISO 14971:2019 is the recognized framework for medical-device risk management. | Risk-management summary, hazard analysis, residual-risk evaluation, and change-control procedure. | 8% |
| Reliability and Testing | Check durability of LEDs, control systems, suspension arms, fans, switches, and backup functions. | Reliability claims should be supported by defined test conditions, sample sizes, and acceptance criteria. | Factory acceptance test, burn-in records, life-test methodology, failure-rate data, and corrective-action records. | 7% |
| Regulatory Documentation | Ensure the supplied model and configuration match the documents used for market access. | Documentation requirements vary by destination market and device classification. | Technical file index, labeling, instructions for use, certificates, declarations, and registration support documents. | 5% |
| After-Sales Support | Evaluate installation, training, troubleshooting, spare parts, warranty, and response procedures. | Require written service levels, spare-parts availability, and a defined warranty period. | Warranty terms, service contacts, spare-parts list, response-time commitment, and training plan. | 7% |