Artificial Saliva Solution for Metal Ion Release in Medical Devices

ISO 10993-15 Based Artificial Saliva Test Medium

This artificial saliva solution; It is a simulated oral test medium prepared for use in degradation, corrosion, and metal ion release studies in medical devices, dental implants, and biomaterials containing metal or metal alloys. The product is prepared based on the artificial saliva medium defined within the scope of ISO 10993-15 – Biological evaluation of medical devices – Part 15: Identification and quantification of degradation products from metals and alloys. The ionic conditions of the oral environment are controlled in a laboratory setting. Thanks to its electrolyte structure designed to represent and repeatably, it allows the investigation of the behavior of metallic samples under specific test conditions.

After contacting metal or alloy samples with the solution under specific time and temperature conditions, the elements that pass into the test environment can be determined by ICP-OES, ICP-MS, AAS or other suitable analytical techniques.

Purpose of Use

The product can be used as a suitable test environment especially for the following studies:

• Investigation of metal ion emission from medical devices

• Investigation of the degradation behavior of metals and metal alloys

• Evaluation of dental implants and dental metal alloys

• Investigation of orthodontic wires, brackets, and metal-based dental materials

• Investigation of the stability of metallic surfaces under conditions similar to an oral environment

• Conducting corrosion and metal migration studies

• Analytical determination of metal ions present in the solution after decomposition

• Biological applications of medical devices Supporting research and laboratory studies for its evaluation

Product Features

Simulated Oral Environment:
Controlled environment representing the oral environment; It helps in the examination of metallic materials under laboratory conditions by providing an electrolyte system.

Suitable for Metal Ion Release Studies:
It can be used as an exposure medium that allows metal ions that pass from the sample to the test environment to be determined later by appropriate analytical methods.

Controlled Ionic Composition:
Thanks to the defined electrolyte composition, more controlled studies can be conducted.

and helps to create repeatable experimental conditions.

Ready to Use:
The pre-prepared solution can be used directly as a test medium according to the appropriate test protocol.

Based on ISO 10993-15:
The formulation is based on the artificial saliva medium defined in ISO 10993-15 for the evaluation of degradation products of metals and alloys.

Prepared.

Areas of Use

Dental Implant and Biomaterial Research

It can be used to investigate the behavior of titanium and titanium alloys, stainless steels, cobalt-chromium alloys, and other metallic biomaterials in conditions similar to the oral environment.

Orthodontic Materialler

It can be used as a test environment in studies aimed at investigating the release of metal ions that may occur from orthodontic wires, brackets, and other metal-based dental components.

Medical Device Research

It can be used in laboratory studies aimed at characterizing the degradation products of medical devices and components containing metal or metal alloys.

Corrosion and Surface Research

Controlled metal surfaces; It can be used to investigate the behavior of electrolyte media, surface changes, and metal ions formed in the solution.

R&D and Quality Control Laboratories

It can be used for new material development, material comparison, evaluation of process changes, and comparative studies for research purposes.

Relevant Standard

ISO 10993-15
Biological evaluation of medical devices – Part 15: Identification and quantification of degradation products from metals and alloys

ISO 10993-15 covers the general approach to identifying and quantifying degradation products from metals and alloys used in medical devices.

Usage

The sample to be tested is brought into contact with the artificial saliva solution in accordance with the sample/solution ratio determined in the test protocol to be applied.

Exposure time, temperature, and other experimental conditions should be determined according to the purpose of the study and the method to be applied. At the end of the test period, the solution is taken and the target metal ions are determined by the appropriate analytical method.

To reduce the risk of contamination, it is recommended to use laboratory materials suitable for metal ion analysis during sample preparation, storage, and analysis stages.

Storage

The product should be stored in its sealed packaging and protected from direct sunlight. Care should be taken to prevent contamination of the solution with foreign ions or particles during use.

The exact storage temperature and shelf life should be determined in accordance with product stability studies carried out by the manufacturer.

Important Information

This product is a test solution that allows the metallic sample to be exposed in a controlled environment.

Identification and quantification of metal ions are carried out after exposure using appropriate analytical devices and methods.

This product is for laboratory, research and testing purposes only. It is not intended for human consumption or direct clinical use.