Part 1: Endovascular prostheses. Implants cardiovasculaires — Dispositifs endovasculaires —. Partie 1: Prothèses endovasculaires. STANDARD. ISO. ISO Cardiovascular implants—. Endovascular devices—Part 1: Endovascular prostheses. American. National. Standard. PREVIEW COPY. ISO /. A/. (R) Cardiovascular implants —. Endovascular devices —. Part 1: Endovascular prostheses —. Amendment 1: Test methods.
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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. Similarly, specific prosthesis configurations e. Pharmacological aspects of drug eluting or drug coated endovascular prostheses are not addressed in this document. Similarly, specific prosthesis configurations e.
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.
Check out our FAQs. Some of the requirements are specific to endovascular treatment of arterial aneurysms or stenoses.
BS EN ISO 25539-1:2009
Monday to Friday – Some of the requirements are specific to endovascular treatment of arterial aneurysms or stenoses. This document can be helpful in identifying the appropriate evaluation of the sio prosthesis component of a valved conduit, but specific requirements and testing are not described for these devices. Life cycle A standard is reviewed every 5 years 00 Preliminary. Similarly, specific prosthesis configurations e.
Guidance for the development of in vitro test methods is included in an informative annex to 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. 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.
Endovascular prostheses ISO 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 izo to the endovascular system.
This document can be considered as a supplement to ISOwhich specifies general requirements for the performance of non-active surgical implants. 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 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 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. Kontakt venligst Dansk Standard.
Pharmacological aspects of drug eluting or drug coated endovascular prostheses are not addressed in this document.
SRPS EN ISO 25539-1:2017
The valve component of valved conduits constructed ixo an endovascular prosthesis component and the combination of the valved component and the endovascular prosthesis component are excluded from the scope of this document. Guidance for the ixo of in vitro test methods is included in an informative annex to 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.
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. Although contra-lateral iliac artery occluders when used as an integral part of aorto-uni-iliac endovascular prosthesis are within the scope of jso document, specific requirements and testing are not described for these devices.
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. Du abonnerer allerede dette emne. Vis ikke denne igen.
ISO – Cardiovascular implants — Endovascular devices — Part 2: Vascular stents
Although uses of endovascular systems isso than treatment of arterial aneurysms or stenoses e. Final text received or FDIS registered for formal approval.
Forkert brugernavn eller adgangskode. Although uses of endovascular systems other than treatment of arterial aneurysms or stenoses e.
Although uses of endovascular systems lso than treatment of arterial aneurysms or stenoses e. 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.
This document can be considered as a supplement to ISOwhich specifies general requirements for the performance of non-active surgical implants. This document can be considered as a supplement to ISOwhich specifies general requirements for the performance of non-active surgical implants. Cardiovascular implants – Endovascular devices – Part 1: Guidance for the development of in vitro test methods is included in an informative annex to this document.
Pharmacological aspects of drug eluting or drug coated endovascular prostheses are not addressed in this document.