(202 days)
The intended use of the BAIXIN Disposable Syringe is to inject fluids into or withdraw fluids from the body.
BAIXIN Disposable Syringe is a device intended for medical purposes, consisting of a calibrated hollow barrel and a movable plunger. At one end of the barrel there is a male Luer Lock connector (nozzle) for attaching the female Luer connector (hub) of a hypodermic single lumen needle, or for attaching other devices with a female Luer.
The provided text describes the acceptance criteria and the summary of testing for the BAIXIN™ Disposable Syringe. It focuses on the device's adherence to ISO 7886-1:1993, a consensus standard for sterile hypodermic syringes.
Here's a breakdown of the requested information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Testing Items | Acceptance Criteria (Code Requirement) | Reported Device Performance |
|---|---|---|
| Syringe Column Sealing (Positive Pressure) | 300 Kpa Positive Pressure - No leakage | Meets criteria (implied by "Data supporting conformance") |
| Syringe Column Sealing (Negative Pressure) | 88 Kpa Negative Pressure - No leakage | Meets criteria (implied by "Data supporting conformance") |
| Volume | ± 4% | Meets criteria (implied by "Data supporting conformance") |
| Tip Sealing Property | No Leakage | Meets criteria (implied by "Data supporting conformance") |
| Indicating Ruler - 0 level line | Within 1/4 range | Meets criteria (implied by "Data supporting conformance") |
| Tip Size | No separation at 25N (This seems to be a strength/connection test for the tip) | Meets criteria (implied by "Data supporting conformance") |
| Draw Strength | Not specified in the table's "Code Requirement" column. | Not explicitly reported numerically, but implied conformance. |
| Residue Contents |
§ 880.5860 Piston syringe.
(a)
Identification. A piston syringe is a device intended for medical purposes that consists of a calibrated hollow barrel and a movable plunger. At one end of the barrel there is a male connector (nozzle) for fitting the female connector (hub) of a hypodermic single lumen needle. The device is used to inject fluids into, or withdraw fluids from, the body.(b)
Classification. Class II (performance standards).