Biological Performance

Sterilization

Sterile

Pyrogen

Pyrogen-free

Chemical Performance

PH Value

Difference of PH Values between extract and control fluid≤1.0

Physical Performance

Out Appearance

Clean and straight needle tube; no impurities or visible plastics injection defect in needle stand; no particles and extraneous matter in cone socket; needlepoint shall be free from burrs and hooks.

Dimension

Needle tube’s external diameter complies with the requirements of ISO9626:1991 table 1, length complies with ISO7864:1993 table 1

Stiffness

Deflection shall not be greater than requirements in ISO9626:1991 Table 2

Resistance to breakage

Tubing shall not break in accordance with ISO9626:1991 annex D

Pinnacle Piercing Force

Sharp in needlepoint, maximum piercing force≤0.70N

Connection Strength

The union of hub and needle tube shall not be broken

by the minimum force of 22N.

Object Inside Tube

Needle tube shall be free from particles & extraneous matter.

Conical socket

In accordance with the requirements of ISO594-1:1986 or ISO594-2:1998.

Lubricant

Lubricant shall not be visible as droplet on surfaces.

Color coding

Straight Connection

The connection of needle stand and needle tube should be straight,without obvious deflection.

Break-off Tension of Sheath

No natural sheath break-off, break-off tension ≤15N.