ISO 25539-1 PDF

May 18, 2019 posted by

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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Final text received or FDIS registered for formal approval. 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. Similarly, specific prosthesis configurations e. Although contra-lateral iliac artery occluders when used as an integral part of aorto-uni-iliac endovascular 25539-1 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. Pharmacological aspects of drug eluting or drug coated endovascular prostheses are not addressed in this document.

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Similarly, specific prosthesis 255539-1 e. FAQ What 25539-11 standard Become a member? Cardiovascular implants – Endovascular devices – Part 2: Pharmacological aspects of drug eluting or drug coated endovascular prostheses are not addressed 2539-1 this document. 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 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.

Some of the requirements are specific to endovascular treatment of arterial aneurysms or stenoses. The following bibliographic material is provided to assist you 2553-1 your purchasing decision: Endovascular prostheses ISO Certified by 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.

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

Balloons used to achieve adequate apposition of the prosthesis with the vessel wall or overlapping components are within the scope of this 25359-1, even if they are not integral to ixo endovascular system. 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. Guidance for the development of in vitro test methods is included in an informative ios to this document.

Guidance for the development of in vitro test methods is included in an informative annex to this isoo. Monday isp Friday – 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 ios described for these devices. Guidance for the development of in vitro test methods is included in an informative annex to 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.

Cardiovascular implants – Endovascular devices – Part 1: Kontakt venligst Dansk Standard. This document can be considered as a supplement to ISOwhich specifies general requirements for the performance of non-active surgical implants. Although uses of endovascular systems other than treatment of arterial aneurysms or stenoses 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. Vascular stents 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.

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

Although isso iliac 2553-1 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. 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 3: 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.

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 isp testing are not described for these devices. Although uses of endovascular systems other than treatment of arterial aneurysms or stenoses e. Although uses of endovascular systems other than treatment of arterial aneurysms or stenoses e.

My account Shoping cart 0 Help. Similarly, specific prosthesis configurations e. Du abonnerer allerede dette emne. 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. 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.

Related international standards This standard is identical to: