Reference number. ISO (E). This is a preview of “ISO “. Click here to purchase the full version from the ANSI store. Buy I.S. EN ISO CARDIOVASCULAR IMPLANTS – ENDOVASCULAR DEVICES – PART 1: ENDOVASCULAR PROSTHESES. Buy AAMI ISO Cardiovascular Implants – Endovascular Devices – Part 1: Endovascular Prostheses from SAI Global.
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BS EN ISO – Cardiovascular Implants. Endovascular devices. Endovascular prostheses
Final text received or FDIS registered for formal approval. This document can be considered as a supplement to ISOwhich specifies general requirements for the performance sio non-active surgical implants.
Although uses of endovascular systems other than treatment of arterial aneurysms or stenoses e. Vis ikke denne igen. Certified by ISO To find similar documents by classification: Similarly, specific prosthesis configurations e.
The valve component of valved conduits constructed with an endovascular prosthesis component and the combination of the valved component and the endovascular prosthesis component are excluded from the scope of this document. Du abonnerer allerede dette emne. The requirements for, and the evaluation of, degradation and other time-dependant aspects of absorbable materials used in the construction of endovascular prostheses are not addressed in this document.
The requirements for, and the evaluation of, degradation and other time-dependant aspects of absorbable materials used in the construction of endovascular prostheses are not addressed in this document. First Balkan IT Conference for business platform for standardization This document can be helpful in identifying the appropriate evaluation of the endovascular prosthesis component of a valved conduit, but specific requirements and testing are not described for these devices.
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Dauerhaftigkeitsprüfung an endovaskulären Prothesen nach ISO
iwo Balloons used to achieve adequate apposition of the prosthesis with the vessel wall or overlapping components are within the scope of this document, even if they are not integral to the endovascular system.
Although isk of endovascular systems other than treatment of arterial aneurysms or stenoses e. Similarly, specific prosthesis configurations e. This document can be helpful in identifying the appropriate evaluation of the endovascular prosthesis component of a valved conduit, but specific requirements and testing are not described for these devices. Vena cava filters ISO Pharmacological aspects of drug eluting or drug coated endovascular prostheses are not addressed in this document.
Although contra-lateral iliac artery occluders when used as an integral part of aorto-uni-iliac endovascular prosthesis are within the scope of this document, specific requirements and testing are not described for these devices. The requirements for, and the evaluation of, degradation and other time-dependant aspects of absorbable materials used in the construction of endovascular prostheses are not addressed in this document. This document can be considered as a supplement to ISOwhich specifies general requirements for the performance of non-active surgical implants.
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Vascular stents ISO Balloons used to achieve adequate apposition of the prosthesis with the izo wall or overlapping components are within the scope of this document, even if they are not integral to jso endovascular system. Pharmacological aspects of drug eluting or drug coated endovascular prostheses are not addressed in this document. The valve component of valved conduits constructed with an endovascular prosthesis component and the combination of the valved component and the endovascular prosthesis component are excluded from the scope of this document.
Some of the requirements are specific to endovascular treatment of arterial aneurysms or stenoses.
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Although contra-lateral iliac artery occluders when used as an integral part of aorto-uni-iliac endovascular prosthesis are within the scope of this document, specific requirements and testing are not described for these devices. Proof sent to secretariat or FDIS ballot initiated: The valve component of valved isl constructed with an endovascular prosthesis component and the combination of the valved component and the endovascular prosthesis component are excluded from the scope of this document.
This document can be helpful in identifying the appropriate evaluation of the endovascular prosthesis component of a valved conduit, but specific requirements and testing are not described for these devices. Cardiovascular implants – Endovascular devices – Part 3: Guidance for the development of in vitro test methods is included in an informative annex to this document.
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