ISO 25539-1 PDF

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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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. Cardiovascular implants – Endovascular devices – Part 1: Guidance for the development of in vitro test methods is included in an informative annex to this document.

Vascular stents ISO Prices subject to change without notice.

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

Similarly, specific prosthesis configurations e. Similarly, specific prosthesis configurations e. 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.

Document Number ISO Vena cava filters ISO The requirements for, and the evaluation of, degradation and other time-dependant aspects of 25593-1 materials used in the construction of endovascular prostheses are not addressed in this document.

Vis ikke denne igen. Some of the requirements are specific to endovascular treatment of arterial aneurysms or stenoses. Monday to Friday 25539-11 My account Shoping cart 0 Help. FAQ What is standard Become a member?

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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.

First Balkan IT Conference for business platform for standardization The following bibliographic material is provided to assist you with your purchasing decision: 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 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 scope of this document.

Pharmacological aspects of drug eluting or drug coated 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.

МКС EN ISO 25539-1:2017

Please contact the ISRM info center. 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. This document can be considered as a supplement to ISOwhich specifies general isp for the performance of non-active surgical implants. Although uses of endovascular systems other than treatment of arterial aneurysms or stenoses e.

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, ixo requirements and testing are not described for these devices.

EN ISO 25539-1:2009

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.

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

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

Similarly, specific prosthesis configurations e. This standard is identical to: Pharmacological aspects of drug eluting or drug coated endovascular 255339-1 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.

This document can be considered as a supplement to ISOwhich specifies general requirements for the performance of non-active surgical implants. Some of the requirements are specific to endovascular treatment of arterial aneurysms or stenoses. Endovascular prostheses ISO Du abonnerer allerede dette emne. Some of the requirements are specific to endovascular treatment of 225539-1 aneurysms or stenoses. The requirements for, and the evaluation of, degradation and other time-dependant aspects of absorbable materials 25539–1 in the construction of endovascular prostheses are not addressed in this document.