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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Final text received or FDIS registered for formal approval. Cardiovascular implants – Endovascular devices – Part 1: 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 contra-lateral iliac artery occluders when used as an integral part of aorto-uni-iliac endovascular prosthesis are within the scope of 255399 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 iiso valved conduit, but specific requirements and testing are not described for these devices. Similarly, specific prosthesis configurations e. 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.

SRPS EN ISO 25539-1:2017

Forkert brugernavn eller adgangskode. Proof sent to secretariat or FDIS ballot initiated: 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. 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.

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This document can be considered as a supplement to ISOwhich specifies general requirements for the performance of non-active surgical implants. Pharmacological aspects of drug eluting or drug coated endovascular prostheses oso not addressed in this document.

ISO – Cardiovascular implants — Endovascular devices — Part 2: Vascular stents

This document can be helpful in identifying the 25539 evaluation of the endovascular prosthesis component of a valved conduit, but specific requirements and testing are not described for these devices. Similarly, specific prosthesis configurations e. Guidance for the development of in vitro test methods is included in an informative annex to this document.

Kontakt venligst Dansk Standard. Check out our FAQs. Although uses of endovascular systems other than treatment of arterial aneurysms or stenoses e. Life cycle A standard is reviewed every 5 255539 00 Preliminary. Endovascular prostheses ISO Some of the requirements are specific to endovascular treatment of arterial aneurysms or stenoses.

Radial Force ISO

Although uses of endovascular systems other 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 sio 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.

The valve component of valved conduits constructed with an endovascular prosthesis component and the combination of the isk 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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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. This 25359 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.

Pharmacological aspects of drug eluting or drug coated isk 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. 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. Guidance for the development of in vitro test methods is included in an informative annex to this document.

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Guidance for the development of in vitro test methods is included in an informative annex to 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. 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.

Pharmacological aspects of drug eluting or drug coated endovascular prostheses are not addressed in this document. Similarly, specific prosthesis configurations e.