Date: 10th January 2024
TO WHOMSOEVER IT MAY CONCERN
We, hereby confirm that the medical device “sterile hypodermic safety syringe (Needle retractable)
for single use”, is inherently designed with passive safety features, the feature meets the following
stated requirements of Auto-disable syringe feature mentioned to the international product
standards.
The passive safety feature of the medical device does not require an additional step by the user to
activate the safety mechanism and prevent the medical device from re-use. The physical and
functional characteristics of the product conforms to the international standard ISO 7886-4.
“Auto-disable syringe feature
feature that passively activates upon delivering injection of the nominal fixed dose to prevent
subsequent reuse of the syringe and the needle.
Note 1 to entry: A passive activation is an activation of the reuse prevention feature that does
not require an additional step by the user, separate from any action needed to perform the
primary intended injection function of the device.
Note 2 to entry: An active activation is an activation of the reuse prevention feature that does
require an additional step by the user.”
“Re-use prevention feature
feature that either automatically activates upon or during administration of the intended dose
or is activated by the user to prevent subsequent re-use of the syringe”.
“Auto disable feature
feature that automatically activates, prior to end of injection, to render the syringe unusable by
the delivery of the intended dosage”.
For LIFELONG MEDITECH PRIVATE LIMITED
Authorized Signatory
