ISO 25539-2:2012 pdf free download – Cardiovascular implants – Endovascular devices – Part 2: Vascular stents Part 2: Vascular stent.
This part of ISO 25539 has been prepared in order to provide minimum requirements for endovascular devices and the methods of test that will enable their evaluation. It is the second part ofa three-part standard. ISO 25539-1 addresses endovascular prostheses and ISO 25539-3 addresses vena cava filters. ISO/TS 15539, from which this part of ISO 25539 is derived, serves as a rationale for the requirements of this part of ISO 25539. The Technical Specification ISO/TS 15539 was developed by first identifying the design requirements for these devices and listing the potential device and clinical failure modes. Tests were then identified to address each of the failure modes. The requirements provided in this part of ISO 25539 are based on that assessment.
iii) for drug-eluting stents, the level of drug in blood, if required by the protocol; 4) any major deviation from protocol;
e) termination data:
1) date of death;
2) reason for early termination or death, if applicable;
3) assessments specified in the protocol (e.g. observation of integrity, tunctionaflty, patency and position of implant);
4) gross observation of the explanted stent and surrounding tissue;
5) pathological assessment of appropriate tissues and/or organs, if required per the protocol;
6) for drug-eluting stents, the level of drug in tissue, if required by the protocol.
8.7.5 Test report and additional information
Results of all animals enrolled in the protocol shall be recorded and reported even if excluded from the final analysis. The test report shall include the following:
a) study protocol;
b) rationale for selection of the following:
1) animal species;
2) implantation site;
3) implantation durations;
4) methods of assessment;
5) type and intervals of interim assessments;
6) sample size (i.e. number of animals and implants);
7) control, if applicable;
c) rationale for not using a control group, if applicable;
d) results:
1) animal accountability, including rationale for exclusion of data;
2) summary of adverse events;
3) summary of early deaths or sacrifices for cause;
4): significant and/or relevant deviations from protocol;
5): summary of results, discussion and conclusions for each specific aim of the study;
6) pathological assessment of appropriate tissues and/or organs, including representative gross photographs and micrographs, if required per the protocol;
7) summary of quality assurance and data auditing procedures, including a statement relative to compliance with appropriate standards.
8.8 Clinical evaluation
8.8.1 Purpose
The purpose of clinical evaluation is to provide reasonable assurance of the safety and effectiveness of the stent system. A clinical investigation shall be carried out for any stent system incorporating design characteristics for which the safety and effectiveness has not been previously demonstrated. The investigation shall be carried out using ISO 14155, taking account of the specific aspects of vascular stents listed below in the following subclauses. The stent shall have satisfied appropriate preclinical testing requirements of this part of ISO 25539 before starting the clinical investigation.
NOTE ISO 14155 provides requirements regarding clinical investigations. The following subclauses provide specific details regarding the clinical investigation of vascular stents.
8.8.2 Specific aims
The specific aims of the study shall be stated and can include the following, as appropriate:
a) evaluate the ability to access the target location with the delivery system;
b) evaluate the handling and visualization of the delivery system and visualization of the stent;
c) verify the accuracy and efficacy of deployment;
d) characterize the ability to withdraw the delivery system;
e) evaluate the appropriateness of stent sizing;
f) evaluate the acute and chronic position, structural integrity and effectiveness of the stent;
g) monitor lesion characteristics and stent positioning (over time).