| 1 | Medical Device Quality System | A documented quality management system aligned with ISO 13485:2016 for the design and manufacture of medical devices. | Current ISO 13485 certificate, certification scope, issuing body, validity dates, and manufacturing-site address. | Critical | Inconsistent production quality, weak traceability, and difficult corrective-action management. |
| 2 | Electrical Safety | Compliance evaluation against IEC 60601-1, which covers basic safety and essential performance of medical electrical equipment. | CB test report, safety test report, leakage-current results, dielectric-strength results, and applicable product certificate. | Critical | Electric shock, overheating, electrical failure, or non-acceptance by the destination market. |
| 3 | Electromagnetic Compatibility | EMC evaluation according to IEC 60601-1-2, including emissions and immunity testing for the intended clinical environment. | EMC test report identifying the exact model, accessories, operating modes, and test configuration. | Critical | Flicker, unexpected shutdown, interference with nearby clinical equipment, or failed regulatory review. |
| 4 | Operating-Light Performance | Confirm measured illuminance, color temperature, color-rendering performance, beam diameter, and light-field uniformity for the complete light head. | Independent photometric report with measurement distance, test conditions, tolerances, and stated measurement uncertainty. | Critical | Poor visibility, inaccurate shade perception, excessive glare, or inadequate illumination of the oral cavity. |
| 5 | Color Rendering and Visual Accuracy | Request declared color-rendering values, such as general color rendering index and relevant special color-rendering metrics, rather than relying only on marketing claims. | Spectroradiometric test data, product datasheet, and sample evaluation under normal clinical settings. | High | Reduced ability to distinguish tissue, tooth, restorative, and material color differences. |
| 6 | Mechanical Reliability | Stable arm movement, secure joints, controlled drift, impact-resistant housing, and documented testing for repeated positioning cycles. | Mechanical test plan, cycle-test results, load specifications, installation drawings, and warranty failure statistics where available. | High | Light-head drift, accidental movement, vibration, difficult positioning, or premature structural failure. |
| 7 | Infection-Control Design | Smooth, sealed, easy-to-clean surfaces with minimal dirt traps and controls suitable for the clinic’s cleaning and disinfection procedures. | Cleaning and disinfection instructions, material compatibility data, ingress-protection information, and surface-finish specifications. | High | Surface damage, microbial-contamination concerns, shortened service life, or non-compliance with clinic protocols. |
| 8 | Thermal and Energy Performance | LED light source with documented power consumption, heat-management design, expected service life, and acceptable temperature around the treatment area. | Power-rating label, thermal test data, LED-life assumptions, driver specifications, and replacement-part information. | Medium | Operator discomfort, premature LED or driver failure, higher operating cost, or unstable light output. |
| 9 | Regulatory and Export Capability | The supplier should identify the product classification, applicable market requirements, authorized representative arrangements, and registration responsibilities. | Declaration of conformity, technical file index, product registration evidence where applicable, labeling samples, and export references. | Critical | Customs delays, prohibited sales, missing documentation, or costly market-entry remediation. |
| 10 | After-Sales Service and Supply Continuity | Clearly defined warranty terms, spare-parts availability, technical response times, installation support, and documented production capacity. | Signed warranty policy, spare-parts list, service-level agreement, installation manual, response-time commitment, and factory audit records. | Critical | Long downtime, unavailable replacement parts, uncertain repair costs, and disruption to clinical operations. |