| Quality Management |
A documented quality-management system covering design, production, inspection, nonconformity control, and corrective actions. |
ISO 13485:2016 may be applicable when the equipment is regulated as a medical device in the target market. |
Request a current certificate, scope, issuing body, and validity dates. |
Essential |
| Product Compliance |
Complete technical documentation, intended-use information, risk controls, labeling, and market-specific conformity evidence. |
Requirements vary by jurisdiction; electrical medical equipment commonly uses IEC 60601-1 as a safety reference. |
Check declarations, test reports, manuals, and local registration requirements. |
Essential |
| Electrical Safety |
Protection against electric shock, overheating, insulation failure, leakage current, and improper grounding. |
IEC 60601-1 is a widely recognized general standard for basic safety and essential performance of medical electrical equipment. |
Review electrical test reports and require site acceptance testing after installation. |
Essential |
| Animal and Operator Safety |
Guarding of moving parts, stable platforms, rounded or protected edges, emergency controls, safe restraint points, and clear operating instructions. |
Risk-management practices should address foreseeable misuse, cleaning, maintenance, and animal-handling hazards. |
Request a risk assessment and conduct a practical safety review with clinical staff. |
Essential |
| Infection Prevention |
Non-porous, cleanable surfaces; corrosion-resistant materials where appropriate; accessible joints; and documented cleaning compatibility. |
Cleaning and disinfection procedures should be compatible with the equipment materials and the veterinary facility’s infection-control policy. |
Obtain a chemical-compatibility list and evaluate seams, drains, casters, and hard-to-reach areas. |
Essential |
| Radiation Protection |
For X-ray equipment, documented shielding calculations, exposure controls, warning indicators, operator training, and maintenance procedures. |
Local radiation regulations and applicable diagnostic X-ray safety requirements take precedence over general purchasing criteria. |
Require a radiation-safety assessment by a qualified local professional before use. |
Essential |
| Installation Planning |
Pre-installation survey covering room dimensions, floor loading, ventilation, electrical capacity, plumbing, data connections, access routes, and service clearances. |
Building, electrical, fire, plumbing, and occupational-safety codes applicable to the project location. |
Approve a site survey and coordinated installation drawing before shipment. |
Essential |
| Installation Execution |
Qualified technicians, documented installation procedures, calibration or functional checks, debris removal, and handover records. |
Installation must comply with the manufacturer’s instructions and local professional or regulatory requirements. |
Use a signed installation checklist and site acceptance certificate. |
High |
| User Training |
Training for veterinarians, veterinary nurses, technicians, cleaners, and maintenance personnel, including safe operation and emergency procedures. |
Training should reflect the equipment’s intended use, risk controls, cleaning requirements, and maintenance schedule. |
Request attendance records, competency checks, and updated operating manuals. |
High |
| Preventive Maintenance |
A written maintenance schedule, inspection points, calibration intervals where applicable, service procedures, and maintenance logs. |
Maintenance intervals should follow the equipment instructions, usage intensity, environmental conditions, and applicable regulations. |
Evaluate the service plan and confirm availability of trained service personnel. |
High |
| Warranty Terms |
Clearly defined warranty duration, covered components, exclusions, labor coverage, response process, and transport responsibilities. |
Warranty terms should be stated in the contract and should not replace required safety inspections or preventive maintenance. |
Compare the written warranty with the quotation and purchase agreement. |
High |
| Technical Support |
Defined support channels, service hours, escalation procedures, remote troubleshooting, and a documented ticket or case-management process. |
Support commitments should be measurable and included in the service-level agreement where operational downtime is critical. |
Confirm response targets, escalation contacts, and after-hours arrangements in writing. |
High |
| Spare Parts Availability |
Parts identification, expected availability period, replacement procedures, and a process for handling discontinued components. |
Parts support should be assessed over the expected service life and aligned with the equipment’s maintenance requirements. |
Request a parts list, lead-time estimates, and obsolescence policy. |
High |
| Documentation |
User manuals, service manuals where appropriate, cleaning instructions, troubleshooting guidance, wiring information, certificates, and change notices. |
Documentation should be current, version-controlled, understandable to intended users, and available in the required local language. |
Review document versions before acceptance and retain the final handover package. |
High |
| Cybersecurity and Data Protection |
For connected equipment: user access controls, software-update procedures, backup guidance, network requirements, vulnerability reporting, and data-handling information. |
Requirements depend on connectivity, software functions, patient data, and applicable privacy and cybersecurity laws. |
Request a security questionnaire, update policy, and data-flow description. |
Medium–High |
| Total Cost of Ownership |
Transparent pricing for equipment, freight, installation, training, consumables, calibration, preventive maintenance, software, spare parts, and disposal. |
A life-cycle assessment is more informative than purchase price alone, particularly for high-use diagnostic and surgical equipment. |
Compare a multi-year cost model and document all recurring charges. |
High |