| 1 | Intended use and syringe type | Confirm whether the product is intended for injection, irrigation, dispensing, or another use; establish whether it is reusable or single-use. | Check the intended-use statement, instructions for use, and applicable regulatory requirements. Do not assume a standard for disposable plastic syringes applies to a reusable metal syringe. | Request the product specification and confirm that the intended use and reuse status match the planned application. |
| 2 | Capacity and graduations | Compare nominal capacity, graduation interval, scale visibility, and the suitability of the measuring range for the intended task. | Review drawings, tolerances, inspection methods, and any applicable measurement or product-specific requirements. | Ask for a controlled drawing and sample inspection records; verify graduations and capacity on representative samples. |
| 3 | Stainless steel grade and material traceability | Specify the required alloy and the parts made from it. Material suitability depends on the product design, fluid exposure, cleaning, and sterilization conditions. | Review material specifications and certificates. Confirm that the stated grade and applicable material requirements match the purchase specification. | Request traceability records linking material batches to finished products and check that certificates can be verified with the issuing source. |
| 4 | Construction and dimensional fit | Assess barrel and plunger fit, connection type, dimensional compatibility, and ease of assembly and disassembly where applicable. | Review approved drawings, dimensional tolerances, and in-process inspection procedures. | Compare samples with the approved drawing and confirm change-control procedures for design or tooling revisions. |
| 5 | Surface finish and cleanability | Inspect surfaces for burrs, sharp edges, visible defects, and features that could retain residue; evaluate cleanability for the intended reuse process. | Review documented surface-finish specifications and relevant cleaning or reprocessing validation, when applicable. | Examine samples under suitable lighting and request evidence that cleaning and inspection processes are controlled. |
| 6 | Leakage and functional performance | Check smooth plunger movement, connection security, and leakage performance under the product's specified operating conditions. | Request the applicable functional test methods, acceptance criteria, and batch inspection records. Requirements depend on the syringe design and intended use. | Confirm that test equipment is calibrated and that nonconforming products are identified and controlled. |
| 7 | Biological and chemical safety | Consider patient or user contact, contact duration, material composition, residues, and the effects of cleaning or sterilization. | Where applicable, review biological evaluation under the ISO 10993 series and the supporting risk-based rationale; do not treat one test as proof of overall safety. | Request relevant test reports or a biological evaluation summary and verify that they cover the supplied product and its materials. |
| 8 | Sterilization and reprocessing | Determine whether the product is supplied sterile or non-sterile and, if reusable, identify the validated cleaning and sterilization instructions. | For products supplied sterile, review the applicable validated sterilization process and records. ISO 11135 concerns ethylene oxide sterilization; ISO 11137 concerns radiation sterilization, where applicable. | Verify sterilization status, process scope, batch release documentation, and reprocessing instructions against the exact product configuration. |
| 9 | Packaging, labeling, and instructions | Check protection against damage and contamination, legibility of labeling, storage conditions, and clear instructions for use and reprocessing. | For sterile barrier packaging, assess the applicability of ISO 11607. Review relevant labeling and information requirements, including ISO 20417 and ISO 15223-1 where applicable. | Request packaging specifications, shelf-life or packaging validation evidence where relevant, and controlled copies of labels and instructions. |
| 10 | Quality system and supplier due diligence | Evaluate manufacturing controls, complaint handling, corrective actions, product traceability, and the supplier's ability to meet the required market regulations. | Review the scope and validity of any ISO 13485 certificate and applicable risk-management records, including ISO 14971 where relevant. Certification alone does not establish product compliance. | Verify certificates with the issuing body, confirm the legal manufacturer and manufacturing site, audit records as appropriate, and approve samples before production orders. |