This part of GB/T 16886 specifies requirements and gives guidance on the procedures to be followed in the preparation of samples and the selection of reference materials for medical device testing in biological systems in accordance with one or more parts of GB/T 16886.
This part of GB/T 16886addresses the following:
—— test sample selection;
—— selection of representative portions from a device;
———test sample preparation;
——experimental controls;
—— selection of, and requirements, for reference materials;
—— preparation of extracts.
This part of GB/T 16886 is not applicable to live cells, but can be relevant to the material or device components of combination products containing live cells.
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(All parts) Biological Evaluation of Medical Devices
ISO 14971 Medical devices—Application of Risk Management to Medical Devices
3 Terms and Definitions
For the purposes of this document, the following terms and definitions apply.
3.1
accelerated extraction
extraction that provides a measure of the leachable or extractable materials of the device or material, using conditions that shorten the time for leaching of the substances into the extraction vehicle but do not result in a chemical change of the substances being extracted
EXAMPLE:Elevated temperature, agitation, changing of the extraction vehicle.
3.2
blank
extraction vehicle not containing the test material, which is retained in a vessel identical to that holding the test sample and subjected to conditions identical to the ones the test sample is subjected to during its extraction
NOTE: The purpose of the blank is to evaluate possible confounding effects due to the extraction vessel, extraction vehicle and extraction process.
3.3
CRM
certified reference material; CRM
reference material, accompanied by a certificate, one or more of whose property values are certified by a procedure which establishes its traceability to an accurate realization of the unit in which the property values are expressed, and for which each certified value is accompanied by an uncertainty at a stated level of confidence
[ISO Guide 30:1992, definition 2.2]
3.4
exaggerated extraction
extraction that is intended to result in a greater amount of a chemical constituent being released as compared to the amount generated under the simulated conditions of use
NOTE: It is important to ensure that the exaggerated extraction does not result in a chemical change of the material.
GB/T 16886.12-2017 The following standards are cited：
GB/T 16886.12-2017 Cited by the following standards：
