Purchase your copy of BS EN ISO as a PDF download or hard copy directly from the official BSI Shop. All BSI British Standards. DIN EN ISO Cardiovascular implants – Endovascular devices – Part 2: Vascular stents (ISO ); German version EN ISO ISO _临床医学_医药卫生_专业资料。INTERNATIONAL STANDARD ISO Second edition Cardiovascular.
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Vascular stent Implants cardiovasculaires? ISO All rights reserved. ISO copyright office Case postale 56? CH Geneva 20 Tel. A informative Attributes of endovascular devices — Vascular stents — Technical and clinical consideration B informative Bench and analytical tests C informative Definitions of reportable clinical events D informative Test methods E informative Supplement to fatigue durability izo analytical approach The work of preparing International Standards is normally carried out through ISO isl committees.
Each member body interested in a subject for which a technical committee has been established has the right to be represented on that committee.
International organizations, governmental and non-governmental, in liaison with ISO, also take part in the work. The main task of technical committees is to prepare International Standards. Draft International Standards adopted by the technical committees are circulated to the member bodies for voting. Publication as an International Standard requires approval by at least 75? Attention is drawn to the possibility that some of the elements of this document may be the subject of 25539-22 rights.
ISO shall not be held responsible for identifying any or all such patent rights. This second edition cancels and iao the first edition Kso This uso revision updates the normative references and provides minor editorial changes to Clause? Endovascular prostheses — Part? Vascular stents — Part? It is the second part of a three-part standard. Tests were then identified to address each of the failure modes. The requirements provided in this part of ISO?
Vascular stents 1 Scope 1. With regard to safety, it gives requirements for intended performance, design attributes, materials, design evaluation, manufacturing, sterilization, packaging and information supplied by the manufacturer. It should be considered as a supplement to ISO?
As further scientific and clinical data become available, appropriate revision of this part of ISO will be necessary. Stents covered with materials that significantly modify the permeability of the uncovered stent are within is scope of ISO? The stent design might dictate the need to address functional requirements identified in both ISO? For dated references, only the edition cited applies.
For undated references, the latest edition of the referenced document including 52539-2 amendments applies. ISO Biological evaluation of medical devices — Part 1: Evaluation and testing within a risk management process ISO?
Requirements for development, validation and routine control of a sterilization process for medical devices ISO?
Requirements for development, validation and routine isp of a sterilization process for medical devices ISOPackaging for terminally sterilized medical devices — Part 25359-2 Requirements for materials, sterile barrier systems and packaging systems?
Validation requirements for forming, sealing and assembly processes ISO? Requirements for the development, validation and routine control of a sterilization process for medical devices 3 Terms and definitions For the purposes of this document, the terms and definitions in ISO? Reportable clinical events are defined in Annex?
Examples of delivery systems include balloon catheters or mechanically activated systems. These events might not have clinical significance and might not be attributable to the device. The following stent types are within the scope of this part of ISO? The stent design might dictate the need to address functional requirements identified in both ISO and this part of ISO? In addition, the following shall be taken into account: The design attributes for vascular stents with or without delivery system are listed in Table?
It is recognized that not all tests identified in a? Additional testing specific to certain materials e. For example, Nitinol materials dependent on shape memory properties shall be subjected to testing in order to assess transformation properties.
In addition, for drug-eluting stents drug identity testing shall be performed, including the identification of impurities and degradants. Electro-chemical potentials of differing metals stents, guidewires, other accessory devices might require additional types of testing. A risk assessment shall be carried out and the requirements of ISO? Justification shall be provided for the properties not measured. 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? Testing beyond the scope of this part of ISO? 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.
ISO – Cardiovascular implants — Endovascular devices — Part 2: Vascular stents
iwo 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. If overlapping with a different device is specifically indicated, testing should include evaluation with the indicated device. 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. 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 identify the size s of the device with the greatest potential for failure. Sampling shall ensure adequate representation of the expected variability in the 225539-2 of devices.
255392 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. Samples shall be subjected to kso that are normally encountered which might affect the test results.
Conditioning might include loading the stent on or inside the delivery catheter, preconditioning of the stent system as recommended in the instructions for use IFUsingle or multiple passes through an anatomical model, and deployment of the stent. A simulated physiological environment e. The test 255392 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 isp given to the anatomical, physiological, and morphological conditions of ios 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. Individual test reports should include the following information: For estimating risks, the hazards to be considered include, but are not limited to, the following: These hazards might result in reportable clinical events, including but not limited to the following: Testing shall include the following items listed in 8.
All bonds shall remain intact under recommended conditions of use. The results shall be evaluated in relation to the force s necessary to 255539-2 the intended location. All components shall be dimensionally compatible. The need for contrast to be able to pass through the lumen of the guide catheter or introducer with the stent system in place should be considered. The results shall be evaluated in relation to the torque necessary to access the system.
Evaluate the potential for displacement of the guidewire from its intended position during the advancement of the stent system, as appropriate for the intended use of the stent e. The use of other technologies for visualization shall be justified. These hazards might result in reportable clinical events, including, but not limited to, the following: The results shall be evaluated in relation to the force s necessary to deploy the stent.
The stent system should be used for this test if the stent is intended to be mounted on the balloon during inflation. Designate the maximum recommended inflation pressure. This pressure should not exceed the RBP. Designate the maximum recommended number of inflation cycles.