Quality Control

A strict Quality Control protocol is followed at each stage of manufacture. The tests include:

Sharpness testing
which is done on a specially designed digital sharpnesscomparator where the force required for the needle point to penetrate a diaphragm of polyurethane standardized synthetic material (whose characteristics closely mimic the human skin) is measured.

Stiffness
of the needles is also evaluated with a special digital tester which enables the force-vs.-displacement of the needle to be determined, and which also determines whether the needle re-gains its original shape without any permanent set.

Corrosion Resistance
is tested in accordance with IS 7135-1998 and other international standards

Ductility
is evaluated by bending the needle body through a sharp 90 degree angle,which it should withstand without cracking.

Hardness measurement
is done on a micro-Vickers hardness tester, which measures the dimension of the indentation made with a diamond pyramidal indentor which is applied to the polished surface of the needle with a pre-determined force.

Attaching strength
In case of channel type atraumatic needles, test attaching of needles from each batch is done, and the attaching strength measured with a digital tensilometer to ensure that pull strength conforms to USP standards. This is also done with all suture attached products including sternotomy needles.
A Laboratory test certificate is sent with each lot of needles documenting the actual test results obtained with that batch. This certificate also bears the heat number of the raw material used to ensure traceability.