ISO 10993 Lab Report
4.2.2 Parameters according to DIN EN ISO 10993
ISO 10993:
For assessment of biocompatibility of medical device, the ISO 10993 plays a critical role. Depending on the intended device, a number of test has to be undertaken. These standard describes the experimentation mainly on toxicity, viability, haemocompatibility and carcinogenicity etc. Among these some are in-vitro test whereas the others require extensive animal experiments.
In this standard mainly three categories of contact with human being are differentiated:-
• Surface device- Where the contact is made with skin, intact mucosal membrane and breached or compromised surface, example electrodes.
• External communicating device- Where indirect contact is made with blood, bone and tissue, …show more content…
• Disinfection of medical devices.
• Providing information for medical purposes by means of in vitro examination of specimens derived from the human body.
The first part of the ISO 10993 standard, “Biological Evaluation of Medical Devices: Part 1: Evaluation and Testing” is probably the most relevant to finding a place to start determining which tests methods should be used to assess a material’s biocompatibility. The rest of the sections mostly deal with appropriate methods to conduct the biological tests suggested in Part 1.
ISO 10993 uses matrices to break medical devices down into three categories: Surface, External Communicating, and Implant and further breaks these categories into subcategories based on exposure time (limited, prolonged, and permanent). Once we identify the device category and exposure time, we can then use the ISO 10993 standard to select a recommended biologic testing protocol. ISO 10993-1 is not a formal checklist, but a guide that should be used to provide the information to get you pointed in the right direction and design a testing program.
ISO Part 5:
There are numerous methods used and the end points measured in cytotoxicity can be grouped into the following …show more content…
In case the cell line has to be stored it should be at -80 C or below. Te cell lines that should be used for the test should be free from mycoplasma before use the stock culture should be tested for the absence of mycoplasma. The pH of the culture medium should be maintained in the range of 7.2-7.4.
The qualitative and quantitative assessment of cytotoxicity has to be tested. The test should be performed on a sub-confluent mono layer or on freshly suspended cells. The qualitative and quantitative tests are cell morphology, cell count, cell viability and cell death evaluation. Cytotoxicity data should be assessed in relation to other biocompatibility data and the intended use of the product.
ISO Part 12:
This part of ISO 10993 specifies methods of sample preparation and the selection of reference materials in the biological evaluation of medical devices. Sample preparation method should be appropriate for both the biological evaluation and the material being evaluated. Each biological test method requires the selection of materials, extraction solvent and condition. This part of ISO 10993 address:
• test maerial selection
• selection of representative portions from a device
• test sample
ISO 10993:
For assessment of biocompatibility of medical device, the ISO 10993 plays a critical role. Depending on the intended device, a number of test has to be undertaken. These standard describes the experimentation mainly on toxicity, viability, haemocompatibility and carcinogenicity etc. Among these some are in-vitro test whereas the others require extensive animal experiments.
In this standard mainly three categories of contact with human being are differentiated:-
• Surface device- Where the contact is made with skin, intact mucosal membrane and breached or compromised surface, example electrodes.
• External communicating device- Where indirect contact is made with blood, bone and tissue, …show more content…
• Disinfection of medical devices.
• Providing information for medical purposes by means of in vitro examination of specimens derived from the human body.
The first part of the ISO 10993 standard, “Biological Evaluation of Medical Devices: Part 1: Evaluation and Testing” is probably the most relevant to finding a place to start determining which tests methods should be used to assess a material’s biocompatibility. The rest of the sections mostly deal with appropriate methods to conduct the biological tests suggested in Part 1.
ISO 10993 uses matrices to break medical devices down into three categories: Surface, External Communicating, and Implant and further breaks these categories into subcategories based on exposure time (limited, prolonged, and permanent). Once we identify the device category and exposure time, we can then use the ISO 10993 standard to select a recommended biologic testing protocol. ISO 10993-1 is not a formal checklist, but a guide that should be used to provide the information to get you pointed in the right direction and design a testing program.
ISO Part 5:
There are numerous methods used and the end points measured in cytotoxicity can be grouped into the following …show more content…
In case the cell line has to be stored it should be at -80 C or below. Te cell lines that should be used for the test should be free from mycoplasma before use the stock culture should be tested for the absence of mycoplasma. The pH of the culture medium should be maintained in the range of 7.2-7.4.
The qualitative and quantitative assessment of cytotoxicity has to be tested. The test should be performed on a sub-confluent mono layer or on freshly suspended cells. The qualitative and quantitative tests are cell morphology, cell count, cell viability and cell death evaluation. Cytotoxicity data should be assessed in relation to other biocompatibility data and the intended use of the product.
ISO Part 12:
This part of ISO 10993 specifies methods of sample preparation and the selection of reference materials in the biological evaluation of medical devices. Sample preparation method should be appropriate for both the biological evaluation and the material being evaluated. Each biological test method requires the selection of materials, extraction solvent and condition. This part of ISO 10993 address:
• test maerial selection
• selection of representative portions from a device
• test sample