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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Final text received or FDIS registered for formal approval. 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 is available in either Paper ieo PDF format.

Cardiovascular implants – Endovascular devices – Part 1: This standard is identical to: Monday to Friday – This document can be helpful in identifying the appropriate evaluation of 52539-1 endovascular prosthesis component of a valved conduit, but specific requirements and testing are not described for these devices.

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

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

Some of the requirements are specific to endovascular treatment of arterial aneurysms or stenoses. Similarly, specific prosthesis configurations e. Vis ikke denne igen. Guidance for izo development of in vitro test methods is included in an informative annex to this document. First Balkan IT Conference for business platform for standardization Proof sent to secretariat 255539-1 FDIS ballot initiated: Although uses of endovascular systems other than treatment of arterial aneurysms or stenoses e.

Similarly, specific prosthesis configurations 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

Related international standards 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.

Kontakt venligst Dansk Standard. 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.

The following bibliographic material is provided to assist you with your purchasing decision: Guidance for the development of in vitro test methods is included in an informative annex to this document. Document Number ISO 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 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. Cardiovascular implants – Endovascular devices – Part 3: 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. Pharmacological aspects of drug eluting or drug coated 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. 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.

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. Although uses of endovascular systems other than treatment of arterial aneurysms or stenoses e. Forkert brugernavn eller adgangskode. 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.

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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.

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.

Certified by ISO Vena cava filters ISO 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.

Life cycle A standard is reviewed every 5 years 00 Preliminary. Please contact the ISRM info center. Guidance for the development of in vitro test methods is included in an informative annex to this document.

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

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.

Some of the requirements are specific to endovascular treatment of arterial aneurysms or stenoses. Although uses of endovascular systems other than treatment of arterial aneurysms or stenoses e. About Us Info center Isl.