Your needs: ensuring the completeness of the extraction method used by the laboratory to validate your cleaning processes according to ISO 10993-12
What is an analysis according to ISO 10993-12 and what is its purpose?
An ISO 10993-12 analysis is a risk assessment process that must be carried out before a product is placed on the market. This analysis is specifically related to medical devices and aims to identify the potential hazards associated with the use of these products. It involves a systematic assessment of all materials that come into contact with the human body during use of the medical device, as well as the processes used to manufacture these materials. The ultimate goal is to ensure that medical devices are safe for patients and that the risks associated with their use are clearly identified and managed.
Our solutions: providing you with our expertise in method validation according to ISO 10993-12
Why choose FILAB for your ISO 10993-12 analysis?
For over 30 years, our FILAB laboratory has had the experience and the specialized analytical equipment needed to support companies in the medical sector. This support notably includes the analysis and validation of the completeness of extraction methods on their samples.
As an independent laboratory with a team of experienced doctors and engineers, FILAB guarantees the reliability of its results, provides rapid processing of requests and offers personalized support to its clients.
FILAB laboratory offers a comprehensive range of analysis services and method validation services for Medical Devices.
our analysis services
Validation of the completeness of the extraction method according to ISO 10993-12
FILAB also supports you with the following services:
Problem solving: non-compliance, breakage, adhesion, corrosion...
FAQ
ISO 10993-12 analysis involves the use of certain reference materials recommended to ensure the accuracy and reliability of the results. These include cellulose, polyurethane and silicone, among others. These materials are used to simulate interactions between the medical device and the surrounding tissues, making it possible to assess potential risks to patients. It is important to follow the recommendations of ISO 10993-12 analysis to ensure the safety and effectiveness of medical devices.
ISO 10993-12 analysis covers a range of aspects, from chemical analysis to the assessment of potential biological effects such as inflammation. The requirements and guidelines defined in ISO 10993-12 are essential for ensuring the safety and effectiveness of medical devices. However, this analysis can be complex and requires expertise in materials and biology to be fully understood and accurately interpreted. In this regard, it is important to consult experts in this field to obtain an accurate assessment of the potential biological effects of medical implants on surrounding tissues, in accordance with ISO 10993-12.
The ISO 10993-12 analysis is crucial for ensuring the biocompatibility of a medical device. It is used to measure the cytotoxicity of these devices. In fact, this analysis determines whether or not cells are damaged by the device. To do so, tests are carried out on cell cultures to verify that the chemicals present in the medical device are not harmful to cells. This method therefore makes it possible to assess the safety of using these devices for patients. The analysis is thus a key element in guaranteeing the quality and safety of medical devices before they are placed on the market.
What does the ISO 19227 standard (Surgical implants -- Cleanliness of orthopedic implants -- General requirements) specify?
This standard specifies that methods for analyzing cleaning residues must be validated. This applies in particular to TOC and TCH analysis, as well as analysis of detergent products (by ICP) and acids (by IC).
Why validate the completeness of an extraction method on a sample? Since the completeness of extraction methods must be demonstrated, particularly by referring to the conditions set out in ISO 10993-12. It is also recommended for chemical characterization in accordance with the ISO 10993-18 standard.
