The products can be sterilized by applying various methods. However, it should be checked whether these methods actually sterilize the products.
The purpose of the sterility test is to determine the control of the sterility of your products.
It is absolutely necessary to check whether the products that are supplied sterile on the market are sterile.
Medical Device Regulation Annex-1: “Sterile medical devices should be manufactured and sterilized by a suitable and valid method.”
In this respect, sterility tests of medical materials and medical products are carried out in accordance with ISO 11737-2 accredited by TURKAK ISO 17025.
The sterility test is evaluated according to turbidity, precipitation and discoloration after 14 days incubation of the sample to be analyzed, as specified in the ISO 11737-2 method. If there is any turbidity at the end of the analysis, it should be verified whether the turbidity is caused by microorganisms.
All these results prove that the products subjected to sterility testing are sterile.
© 1994 | Saniter Gıda – Çevre Bilimi Gözetim Ve Mühendislik Hiz. Tur. Tic. A.Ş.