This part of GB/T 16886 describes test methods to assess the in vitro cytotoxicity of medical devices.
These methods specify the incubation of cultured cells in contact with a device and/or extracts of a device either directly or through diffusion.
These methods are designed to determine the biological response of mammalian cells in vitro using appropriate biological parameters.
2 Normative References
The following referenced documents are indispensable for the application of this document. For dated references, only the edition cited applies. For undated references, the latest edition of the referenced document (including any amendments) applies.
ISO 10993-1 Biological Evaluation of Medical Devices - Part 1: Evaluation and Testing within a Risk Management Process
ISO 10993-12 Biological Evaluation of Medical Devices - Part 12: Sample Preparation and Reference Materials
3 Terms and Definitions
For the purposes of this document, the terms and definitions given in ISO 10993-1 and the following apply.
3.1
culture vessels
vessels appropriate for cell culture including glass petri dishes, plastic culture flasks or plastic multiwells and microtitre plates
Note: these can be used interchangeably in these methods provided that they meet the requirements of tissue culture grade and are suitable for use with mammalian cells.
3.2
positive control material
material which, when tested in accordance with this part, provides a reproducible cytotoxic response
Note: The purpose of the positive control is to demonstrate an appropriate test system response. For example, an organotin-stabilized polyurethane has been used as positive control for solid materials and extracts. Dilutions of phenol, for example, have been used as a positive control for extracts. In addition to a material, pure chemicals can also be used to demonstrate the performance of the test system.
3.3
blank
extraction vehicle not containing the test sample, retained in a vessel identical to that which holds the test sample and subjected to conditions identical to those to which the test sample is subjected during its extraction
Note: The purpose of the blank is to evaluate the possible confounding effects due to the extraction vessel, vehicle and extraction process.
3.4
negative control material
material which, when tested in accordance with this part, does not produce a cytotoxic response
Note: The purpose of the negative control is to demonstrate background response of the cells. For example, high-density polyethylene for synthetic polymers, and aluminum oxide ceramic rods for dental material have been used as negative controls.
3.5
test sample
material, device, device portion, component, extract or portion thereof that is subjected to biological or chemical testing or evaluation
3.6
subconfluency
approximately 80% confluency, i.e. the end of the logarithmic phase of growth
4 Sample and Control Preparation
GB/T 16886.5-2017 The following standards are cited：
GB/T 16886.5-2017 Cited by the following standards：
