| Intended Use |
Confirm whether the tool is intended for examination, microsurgery, measurement, tissue manipulation, or another clinical task. |
Intended-purpose statement, instructions for use, risk classification, and compatibility information. |
Reject products whose documented intended use does not match the planned clinical procedure or user group. |
High |
| Supplier Quality System |
Assess whether the supplier controls design, production, complaints, corrective actions, and document changes. |
Current ISO 13485 certificate from an accredited certification body, audit summary, and quality agreement. |
Prefer suppliers with a current certificate covering the relevant medical-device scope and production site. |
High |
| Regulatory Authorization |
Verify that the product can legally be supplied and used in the target market. |
Declaration of conformity, applicable market authorization, device registration details, and authorized representative information where required. |
Check the exact model, legal manufacturer, intended purpose, and market; do not rely only on a generic conformity logo. |
High |
| Risk Management |
Review hazards such as tissue damage, incorrect measurement, breakage, contamination, and loss of function. |
Risk-management summary aligned with ISO 14971, residual-risk information, and documented control measures. |
Residual risks should be acceptable for the clinical application and clearly addressed in labeling or training. |
High |
| Biocompatibility |
Evaluate patient-contacting materials, contact duration, sterilization effects, and possible irritation or sensitization. |
Material specification, biological-evaluation report, and applicable ISO 10993 test or justification records. |
Require evidence appropriate to the type and duration of patient contact; avoid undocumented material substitutions. |
High |
| Sterilization and Reprocessing |
Determine whether the tool is single-use or reusable and whether the facility can process it consistently. |
Validated cleaning, disinfection, and sterilization instructions; maximum reprocessing-cycle data; packaging information. |
For reusable tools, select products with validated instructions compatible with the facility's available equipment and workflow. |
High |
| Material and Corrosion Resistance |
Check resistance to repeated exposure to moisture, cleaning agents, disinfectants, and sterilization temperatures. |
Material grade, surface-finish specification, corrosion testing, and maintenance instructions. |
Inspect joints, coatings, serrations, and cutting edges for corrosion or residue retention after simulated processing. |
High |
| Optical and Mechanical Performance |
Assess visual clarity, magnification accuracy, illumination, alignment, grip, movement, and tip geometry. |
Inspection records, calibration certificates where applicable, dimensional drawings, and performance-test results. |
Verify performance using representative samples under realistic operating conditions, not only catalog specifications. |
High |
| Electrical Safety |
For powered ophthalmic equipment, check electrical, thermal, mechanical, and electromagnetic safety. |
Applicable IEC 60601-1 test evidence, electromagnetic-compatibility documentation, and electrical safety instructions. |
Apply this requirement to powered tools and systems; it is generally not relevant to purely manual instruments. |
High |
| Usability and Human Factors |
Evaluate whether users can operate, clean, identify, and store the tool correctly without avoidable errors. |
Usability-engineering file or summary aligned with IEC 62366-1, user instructions, and training materials. |
Conduct a hands-on evaluation with representative clinicians and reprocessing staff before approval. |
High |
| Traceability |
Confirm that products, batches, serial numbers, accessories, and service records can be traced. |
Unique-device identification details where applicable, lot or serial-number format, certificates of conformity, and delivery records. |
Do not approve products that cannot be linked to a specific supplier, production batch, and quality record. |
High |
| Supplier Performance |
Review delivery reliability, complaint response, change notification, technical support, and replacement capability. |
References from comparable healthcare users, service-level terms, complaint procedure, and business-continuity information. |
Use documented service targets and require advance notification of material, design, manufacturing-site, or labeling changes. |
Medium |
| Sampling and Acceptance Testing |
Define incoming-inspection checks for dimensions, surface condition, function, packaging, and labeling. |
Approved inspection plan, sampling method, acceptance criteria, and nonconformance procedure. |
Use risk-based sampling; apply 100% inspection to critical characteristics when failure could cause serious harm. |
High |
| Training Requirements |
Estimate the training needed for clinicians, technicians, and reprocessing personnel. |
Competency checklist, training records, demonstration videos, and user qualification requirements. |
Prefer tools with clear operation and reprocessing steps when performance is otherwise comparable. |
Medium |
| Purchase Price |
Compare the quoted unit price, included accessories, delivery charges, taxes, and minimum order quantities. |
Itemized quotation with model, quantity, warranty, lead time, accessories, and payment terms. |
Compare equivalent configurations only; a lower unit price may exclude essential accessories or service. |
Medium |
| Total Cost of Ownership |
Include acquisition, installation, training, calibration, maintenance, reprocessing, consumables, downtime, and disposal. |
Five-year cost model, preventive-maintenance schedule, spare-parts list, and expected service life. |
Total cost = purchase price + operating cost + maintenance + reprocessing + downtime + replacement/disposal cost. |
High |
| Warranty and Serviceability |
Check warranty duration, exclusions, repair turnaround, loaner availability, and spare-parts support. |
Written warranty, service manual or service scope, repair process, and availability commitment. |
Set a maximum acceptable repair turnaround and define responsibilities for transport, inspection, and replacement. |
Medium |
| Environmental and Disposal Considerations |
Consider packaging, material composition, energy use for powered devices, and disposal of contaminated or electronic components. |
Packaging specifications, material declarations, disposal instructions, and applicable environmental compliance information. |
Prefer durable reusable designs when clinically appropriate and when reprocessing can be performed safely and consistently. |
Low |
| Final Supplier Score |
Combine safety, compliance, performance, service, and cost into a documented purchasing decision. |
Weighted evaluation matrix, trial results, corrective-action records, and approval signatures. |
Use a weighted score such as: safety and compliance 35%, clinical performance 25%, supplier quality 15%, lifecycle cost 15%, service and delivery 10%. |
High |