ANSI AAMI ISO 7198 pdf free download
ANSI AAMI ISO 7198 pdf free download.Cardiovascular implants and extracorporeal systems—Vascular prostheses—Tubular vascular grafts and vascular patches.
7 Materials
The requirements of ISO 14630:201 2, Clause 6 shall apply. Additional testing specific to certain materials should be performed to determine the appropriateness of the material for use in the design. For example, polyurethanes and materials of biologic origin should be subjected to testing in order to assess biostability.
8 Design evaluation
8.1 General
The requirements of ISO 14630:201 2, Clause 7 shall apply. A risk assessment shall be carried out in accordance with the requirements of ISO 14971.
Not all requirements are applicable to all vascular prosthesis designs or intended clinical uses. For a tubular vascular graft or vascular patch, justification shall be provided for any design characteristics that are not evaluated from the list below.
Tubular vascular grafts or vascular patches incorporating new or emerging technologies (e.g. absorbable materials) should be evaluated following this International Standard, as appropriate. Testing beyond the scope of this International Standard might also be necessary to characterize these vascular prostheses. Consideration shall be given to the potential failure modes of the vascular prostheses and their effects on the performance of the implant in identifying the appropriate testing.
For compound prostheses, although it may be appropriate to conduct some of the testing described in this International Standard on components of the prosthesis, testing of the device as a whole is also required. In addition, if the compound prosthesis is partially constructed of an absorbable component, the non-absorbable portion of the device shall be characterized, as well as the device as a whole.
Each segment of a composite prosthesis shall be tested. In addition, any factory manufactured anatomises shall satisfy the requirements of this International Standard relating to leakage and factory anastomotic strength. Whenever changes are made in materials, construction, configuration, implantation site, or processing methods, an appropriate analysis of the possible impact of the change on the potential failure modes and performance of the vascular prosthesis shall be completed. Appropriate testing shall be conducted as deemed necessary based on this analysis.
The use of a control device for comparison may be considered in the evaluation of certain design attributes, particularly for design iterations.
Testing to establish the labelled shelf-life shall be conducted by repeating appropriate tests. Justification for the selection of tests shall be provided.
8.2 Sampling
A sampling plan shall be utilized which will ensure that adequate representation (e.g. multiple sizes) has been
obtained for each characteristic measured. The test samples shall be representative, with respect to the design
attribute under evaluation, of the devices to be released for distribution.
Sampling should ensure adequate representation of the potential variability (e.g. a minimum of three samples from a
minimum of three lots) in device characteristics.
A rationale should be provided for sample selection. For all tests, the number of samples shall be justified.
8.3 Conditioning of test samples
All samples should be subjected to sterilization, including multiple sterilizations if appropriate, unless justification is provided for use of nonsterilized products for the evaluation of specific attributes.
Samples should be subjected to conditions that are normally encountered during clinical use that might affect the test results, including preparation as stated in the instructions for use (IFU), where appropriate.
ANSI AAMI ISO 7198 pdf download.
