What is a Hypodermic Needle?
A hypodermic needle is a hollow needle commonly used with a syringe to remove or inject substances/fluids into the body. Syringe that filled with a substance carries the risk of the extractable compounds presence such as heavy metals, which can migrate under conditions of pressure, strong solvents, high temperature into the filling fluid. (Source: MedicalDesign)
The Danger of Heavy Metals Exposure
In syringe products, potential heavy metals exposed include Pb, Cd, Sn, Fe, Zn and they pose risks such as skin irritation, nausea. In cumulative cases, they can disrupt the circulatory system and thyroid functio.n.
Applicable Regulation
Decree of the Republic of Indonesia Minister of Health No. HK.01.07/MENKES/1126/2022 About the Medical Device Compendium. The use of single-use syringes should not be alternated, making syringes an essential commodity widely used in the medical industries, thus quality and safety need to be observed.
How SIG Helps
As a testing laboratory accredited to SNI ISO 17025 and one of the institutions appointed to carry out laboratory testing for medical devices by the Indonesian Ministry of Health, SIG can carry out tests for Extracted Metals (Pb, Cd, Sn, Fe, and Zn) in Hypodermic Syringes according to reference method SNI ISO 7886-1:2017, SNI ISO 7886-3:2009, and SNI ISO 7886-4:2018
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