REVITAL HEALTHCARE (EPZ) LIMITED.

LR.NO.5025/1239 TAKAUNGU Doc. No.: Z/F/07/210G

Issue Date:
JUSTIFICATION FOR THE TEST ARTICLE
MENTIONED IN THE BIOCOMPATIBILITY Revision No.: 00
TEST.

Conducting biocompatibility tests on medical devices is a critical step in ensuring their safety and
compatibility with biological systems. Biocompatibility testing assesses how a device interacts with living
tissues and systems, helping to identify potential risks and adverse reactions that could occur when the
device is used within the human body.
Biocompatibility testing which was conducted by LIVEON BIOLABS was carried as per ISO 10993-1,
“Biological evaluation of medical device-part 1: Evaluation and testing within risk management process.
The samples provided by Revital Healthcare to the external laboratory was, 0.5ml 3piece AD syringe with
23Gx1’’ needle-(Dose capacity of 0.5ml, classification of the device as per EU MDR/US FDA is Class
IIa/ClassB) which is a finished product. An inner box of 100 pieces (as mentioned in the TIDS) was
submitted to the Liveon Biolabs for the above test to be conducted. The samples submitted were fully
assembled as it contained:
1. The barrel, plunger, gasket, stainless steel clip, needle with cap.
2. The syringes are individually packed in a medical grade blister paper and film.
3. 100 pieces of fully assembled and blister packed syringes are packed in an inner box which is
subjected to ethylene oxide sterilization.
‘3piece AD’, mentioned above defines how many parts will be found in the final product, these include: the
barrel, plunger and the gasket.
An image of a fully assembled syringe attached-biocompatibility final study report (LBPL/G-1922 (TX),
page 51 of 51).

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