ANSI AAMI ISO 25539-2 pdf free download

ANSI AAMI ISO 25539-2 pdf free download.Cardiovascular implants Endovascular devices一Part 2: Vascular stents.
It is impossible to take into consideration all future and emerging technologies. The stent systems based on these new technologies will need to be evaluated following the basic requirements of this part of ISO 25539. Testing beyond the scope of this part of ISO 25539 might also be necessary in order to characterize these stent systems. Consideration shall be given to the failure modes of the stent systems and their effects on the performance of the implant in identifying the appropriate testing.
Whenever changes are made in materials, construction, configuration, application or processing methods, an appropriate analysis of the potential impact of the change on the failure modes and performance of the stent system shall be performed. Appropriate testing shall be conducted as deemed necessary.
The use of a control device for comparison should be considered in the evaluation of certain design attributes.
If overlapping of stents can be anticipated in clinical use (e.g. superficial femoral artery, coronary), integrity of the stent under study in overlapping configurations should be evaluated, unless justification can be provided for testing of individual stents. If overlapping with a different device is specifically indicated, testing should include evaluation with the indicated device.
Testing to establish the labeled shelf-life shall be conducted by repeating appropriate tests. Justification for the selection of tests shall be provided. For drug-eluting stents, real time and accelerated testing conditions should be used to define drug attributes for product shelf life.
NOTE 2 Additional guidance for stability testing of drug products can be found in ICH1 Q1A1 (R2), ICH Q1BL35I, and ICH Qi D361.
8.2 Sampling
A sampling plan shall be utilized which will ensure that adequate representation of the data has been obtained for each parameter measured. The design characteristics of the stent (including any drugs and/or coatings), delivery system and stent system shall be verified to be representative of the devices to be released for distribution, including all sizes, configurations and components.
The sampling shall fully represent the range of device designs and might not necessarily require the testing of each size. The stent sizes selected for testing shall represent the worst case combination(s) of diameter and length for each test. A rationale shall be provided for sample selection. It might be necessary to conduct an assessment to identity the size(s) of the device with the greatest potential for failure.
Sampling shall ensure adequate representation of the expected variability in the manufacture of devices. For those tests with specified confidence and reliability parameters, the sample size shall have a statistical basis. For all tests, the number of samples shall be justified.
8.4 Reporting For the purposes of this part of ISO 25539, reporting relates to requests from a national regulatory authority or from a body responsible for assessing conformity. The test report for the preclinical in vitro testing shall include an executive summary of all testing. This summary should include identification of tests, with the rationale for the omission of any tests identified in Annex B or the selection of alternative tests. The information provided in each test report should be based upon a prospectively defined test protocol. A summary of results, with acceptance criteria and any potential clinical significance of the results, should be included and can be in tabular form. Consideration shall be given to the anatomical, physiological, and morphological conditions of the intended use in establishing the acceptance criteria. Justification and clinical applicability of acceptance criteria for each test shall be provided. A table of contents should be provided and pages should be numbered sequentially.ANSI AAMI ISO 25539-2 pdf download.