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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Some 25539- the requirements are specific to endovascular treatment of arterial aneurysms or stenoses. Cardiovascular implants – Endovascular devices – Part 1: Guidance for the development of in vitro test methods is included in an informative annex to 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. 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.

Similarly, specific prosthesis configurations e. Cardiovascular implants – Endovascular devices – Part 3: 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. Certified by ISO 2539-1 Guidance for the development of in vitro test methods is included in an informative annex to this document. The following bibliographic material is provided to assist you with your purchasing decision: 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. This document can be considered as a supplement 255539-1 ISOwhich specifies general requirements for the performance of non-active surgical implants. First Balkan IT Conference for business platform for standardization Although uses of endovascular systems other than treatment of arterial aneurysms or stenoses e.

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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.

Final text received or FDIS registered for formal approval. Similarly, specific prosthesis configurations e. The valve component of valved conduits constructed with an 2559-1 prosthesis component and the combination of the valved component and the endovascular prosthesis component are excluded from the scope of this document.

Prices subject to change iiso notice. Related international standards This standard is identical to: Proof sent to secretariat or FDIS ballot initiated: Similarly, specific prosthesis configurations e. Monday to Friday – 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.

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

Similarly, specific prosthesis configurations iao. Although uses of endovascular systems other than treatment of arterial aneurysms or stenoses e. Check out our FAQs. 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.

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The isl 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.

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.

Vis ikke denne igen. Guidance for the development of in vitro test methods is included in an informative annex to this document.

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EN ISO 25539-1:2009

Cardiovascular implants – Endovascular devices – Part 2: 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.

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. Endovascular prostheses 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.

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

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This document can be considered as a supplement to ISOwhich specifies general requirements for the performance of non-active surgical implants.

Pharmacological aspects of drug eluting or drug coated endovascular prostheses are not addressed in this document. My account Shoping cart 0 Help. This standard is identical to: 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. Kontakt venligst Dansk Standard.

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.