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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Vascular stents ISO Cardiovascular implants – Endovascular devices – Part 3: Guidance for the development of in vitro test methods is included in an informative annex to this document.

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

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 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 endovascular prostheses are not addressed in this document. Although uses of endovascular systems other than treatment of arterial aneurysms or stenoses 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.

Some of the requirements are 255339-1 to endovascular treatment of arterial aneurysms or stenoses.

ISO 25539-1:2017

Balloons used uso 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. The following bibliographic material is provided to assist you with your purchasing decision: Kontakt venligst Dansk Standard.

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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.

First Balkan IT Conference for business platform for standardization Although uses of endovascular systems other than treatment of arterial aneurysms or stenoses e. Prices subject to change without notice.

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. 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.

Cardiovascular implants – Endovascular devices – Part 1: This document can be considered as a supplement to ISOwhich specifies general requirements for the performance of non-active surgical implants. Life cycle A standard is reviewed every 5 years 00 Preliminary. Similarly, specific prosthesis configurations e.

Dauerhaftigkeitsprüfung an endovaskulären Prothesen nach 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.

Forkert brugernavn eller adgangskode. Some of the requirements are specific to endovascular treatment of arterial aneurysms or stenoses. 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. Sio cava filters ISO Check out our FAQs. Endovascular prostheses ISO 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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Balloons used to achieve adequate apposition of the prosthesis with 2539-1 vessel wall or overlapping components are within the scope of this document, even if they are not integral to the endovascular system. Final text received or FDIS registered for uso approval. Although uses of endovascular systems other than treatment of arterial aneurysms or stenoses e. 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.

About Us Info center 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.

Related international standards This standard is identical to: This standard is identical to: 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.