ISO 25539 PDF

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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Life cycle A standard is reviewed every 5 years 00 Preliminary. Final text received or FDIS registered for formal approval. Although uses of endovascular systems other than treatment of arterial aneurysms or stenoses e. The valve component of valved conduits constructed with an endovascular prosthesis component iao 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. 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.

This document can be ixo 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 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 document can be considered as a supplement to ISOwhich specifies general requirements for the performance of non-active surgical implants.

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.

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Lso uses of endovascular systems other than treatment of arterial aneurysms or stenoses e. This document can be considered as a supplement to ISOwhich specifies general requirements for the performance of non-active surgical implants. 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. Balloons used to achieve adequate apposition of the prosthesis with the vessel wall or overlapping components are within the scope iwo this document, even if they are not integral to the endovascular system. Although contra-lateral iliac artery occluders when used as an iao part of aorto-uni-iliac endovascular prosthesis are within the scope of this document, specific requirements and testing are not described for these devices.

Guidance for the development of in vitro test methods is included in an informative 2539 to this document. Pharmacological aspects of drug eluting or drug coated endovascular prostheses are not addressed in this document.

Radial Force ISO

Guidance for the development of in vitro test methods is included in an informative annex to this document. Similarly, specific prosthesis configurations isp. Guidance for the development of in vitro test methods is included in an ido annex to this document. Kontakt venligst Dansk Standard. Du abonnerer allerede dette emne. Cardiovascular implants – Endovascular devices – Part 1: Forkert brugernavn eller adgangskode.

Vis ikke denne igen. Pharmacological aspects of drug eluting or drug coated endovascular prostheses are not addressed in this document.

Some ieo the requirements are specific to endovascular treatment of arterial aneurysms or stenoses. 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.

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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. isoo

Monday to Friday – Similarly, specific prosthesis configurations e. Endovascular prostheses ISO 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.

Some of the requirements are specific to endovascular treatment of arterial aneurysms or stenoses. This document can be helpful in identifying is appropriate evaluation of the isp prosthesis component of a valved conduit, but specific requirements and testing are not described for these devices. 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 endovascular prosthesis component of a valved conduit, but specific requirements and testing are not described for these devices.

Although uses of endovascular systems other than treatment of arterial aneurysms or stenoses e.

BS EN ISO 25539-1:2009

This document can be considered as a supplement to ISOwhich specifies general requirements for the performance of non-active surgical implants. The izo 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.