Posted on February 28, 2019

ISO 25539-1 PDF

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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Document Number ISO Similarly, specific prosthesis configurations e.

ISO 25539-1:2017

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 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.

Some of the requirements are specific to endovascular treatment of arterial aneurysms or stenoses. Guidance for the development of in vitro test methods is included in an informative annex to this document. Similarly, specific prosthesis configurations e.

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BS EN ISO – Cardiovascular Implants. Endovascular devices. Endovascular prostheses

Some of the requirements are specific to 2553-1 treatment of arterial aneurysms or stenoses. Balloons used to achieve adequate apposition of the prosthesis with the vessel wall or overlapping components are 255339-1 the scope of this document, even if they are not integral to the endovascular system. 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.

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 this document, specific requirements and testing are not described for these devices.

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Although contra-lateral iliac artery occluders when used as an integral part of aorto-uni-iliac endovascular prosthesis are within 255399-1 scope of this document, specific requirements and testing are not described for these devices. Life cycle A standard is reviewed every 5 years 00 Preliminary. Forkert brugernavn eller adgangskode. Certified by ISO This document can be considered as a supplement to ISOwhich specifies general requirements for the performance of non-active surgical ixo.

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 isoo these devices.

Endovascular prostheses ISO Vis ikke denne igen.

Cardiovascular implants – Endovascular devices – Part 1: Although uses of endovascular systems other than treatment of arterial aneurysms or stenoses e. Please contact the ISRM info center. This document can be considered as lso supplement to ISOwhich specifies general requirements for the performance of non-active surgical implants.

Du abonnerer allerede dette emne. Guidance for the development of in vitro test methods is included in an informative annex to this document. Some of the requirements are specific to endovascular treatment of arterial aneurysms or stenoses.

Guidance for the development of in vitro test methods is included in an informative annex to this document. Similarly, specific prosthesis configurations e.

Balloons used to achieve adequate apposition of the prosthesis with the vessel wall 255399-1 overlapping components are within the scope of this document, even if they are not integral to the endovascular system. 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 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 ido of this document.

Vascular stents ISO 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. Although uses of endovascular systems other than treatment of arterial aneurysms or stenoses e. Final text received or FDIS registered for formal approval.

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

Dauerhaftigkeitsprüfung an endovaskulären Prothesen nach ISO

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.

Similarly, specific prosthesis configurations e. Kontakt venligst Dansk Standard. 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.

Although 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 255539-1 performance of non-active surgical implants.

This document can be helpful in identifying the appropriate evaluation of the endovascular prosthesis component of a valved conduit, but specific requirements and testing isl not described for these devices.

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Pharmacological aspects of drug eluting or drug coated endovascular prostheses are not addressed in this document. To find similar documents 2553-91 classification: The following bibliographic material is provided to assist you with your purchasing decision: Pharmacological aspects of drug eluting or drug coated endovascular prostheses are not addressed in this document.

Cardiovascular implants – Endovascular devices – Part 2: