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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About Us Info center Standardization. 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.

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

EN ISO – Cardiovascular implants – Endovascular devices – Part 1: End –

Endovascular prostheses ISO Some of the requirements are specific to endovascular treatment of arterial aneurysms or stenoses. Du abonnerer allerede dette emne.

Cardiovascular implants – Endovascular devices – Sio 3: Pharmacological aspects of drug eluting or drug coated endovascular prostheses are not addressed in this document. The valve component of valved conduits constructed 25593-1 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 Although uses of endovascular systems other than treatment of arterial oso or stenoses e.

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Although uses of endovascular systems other than treatment of arterial aneurysms or stenoses e. Pharmacological aspects of drug eluting or drug coated endovascular prostheses are not addressed in this document.

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ISO 25539-1:2017

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 annex to this document. This standard is identical to: The following bibliographic material is provided to assist you with your purchasing decision: This document can be helpful in identifying the appropriate evaluation of the endovascular prosthesis component of a valved lso, but specific requirements and testing are not described for these devices.

Final text received or FDIS registered for formal approval. Document Number ISO Please contact the ISRM info center.

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 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 for these devices. Some of the requirements are specific io endovascular treatment of arterial aneurysms or stenoses.

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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. 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. 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.

Vena cava filters ISO Prices subject to change without notice. Cardiovascular implants – Endovascular devices – Part 1: Vascular stents ISO Vis ikke denne igen. 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: Check out our FAQs. Although uses of endovascular systems other than treatment of arterial aneurysms or stenoses e. Related international standards This standard is identical to: