| 1. Match the product to its intended use | Confirm whether the item is intended for patient examination, isolation, surgery, wound care, or another specific use. Requirements differ by product and risk. | Product labeling and applicable local medical-device regulations; intended-use and risk documentation. | Check the product description, instructions for use, intended user, and stated limitations before comparing products. |
| 2. Review material safety and skin-contact suitability | Assess the material, dyes, finishes, and any substances that may contact skin or other tissues. Suitability depends on the type and duration of contact. | ISO 10993 series for biological evaluation of medical devices, where applicable to the product and its contact category. | Request relevant biocompatibility evaluation information and confirm that it covers the finished product and its intended contact conditions. |
| 3. Check the required filtration and breathability performance | For medical face masks, compare the applicable bacterial filtration, particulate filtration, differential pressure, and splash-resistance results. These measures are not interchangeable. | EN 14683 for medical face masks in relevant markets; ASTM F2100 for materials used in medical face masks in the United States. | Review test reports for the exact product or material configuration, test method, results, and applicable performance level. |
| 4. Verify barrier performance for gowns and drapes | Choose barrier protection according to the anticipated exposure to fluids and the procedure. Also consider seam construction, coverage, fit, and areas of critical protection. | EN 13795-1 for surgical gowns and drapes in relevant markets; ANSI/AAMI PB70 for liquid-barrier classification of protective apparel in the United States. | Check the stated classification and supporting test results; confirm the chosen level suits the use scenario and local guidance. |
| 5. Assess manufacturing quality controls | Look for controlled production, traceability, inspection procedures, complaint handling, and corrective-action processes that support consistent product quality. | ISO 13485 specifies quality-management-system requirements for organizations involved in medical devices; it does not by itself prove that a specific product meets every performance requirement. | Request current quality-system documentation and ask how production lots, changes, and nonconforming products are controlled. |
| 6. Inspect sterile status and packaging integrity | If a product is supplied sterile, verify the sterilization status, package integrity, shelf life, storage conditions, and instructions for use. Do not assume a disposable item is sterile. | ISO 11607 series addresses packaging for terminally sterilized medical devices. | Check the sterile symbol or label, lot and expiry details, and that packaging is undamaged before use. |
| 7. Confirm regulatory status and document consistency | Verify that the product is supplied and labeled in accordance with the rules that apply in the destination market and product category. Regulatory routes vary by jurisdiction. | Examples include EU Medical Device Regulation (EU) 2017/745 and applicable national requirements. CE marking indicates conformity with applicable EU legislation; it is not a general quality certification. | Compare the product label, declaration or registration documentation, instructions, and test reports. Ensure the documents refer to the same product and intended use. |