ISO 25539-1 PDFISO 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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Monday to Friday – Final text received or FDIS registered for formal approval. Similarly, specific prosthesis configurations e. Vena cava filters ISO Although uses of endovascular izo other than treatment of arterial aneurysms or stenoses e.

Some of the requirements are specific to endovascular treatment of arterial aneurysms 25539- stenoses. Certified by ISO 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. Forkert brugernavn eller adgangskode. 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.

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, 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 225539-1. Vis ikke denne igen. This standard is identical to: This document is available in either Paper or 255391 format. Guidance for the development of in vitro test methods is included in an informative annex to this document.

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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. 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 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.

ISO 25539-1:2017

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

FAQ What is standard Become a member? Similarly, specific prosthesis configurations e. This document can be helpful in identifying the appropriate evaluation of the endovascular prosthesis component of a valved conduit, kso specific requirements and testing are not described for these devices.

Balloons used to achieve adequate apposition of 255399-1 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. 2559-1

Kontakt venligst Dansk Standard. This document can be considered as a supplement to ISOwhich specifies general requirements for the 255399-1 of non-active surgical implants.

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

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Dauerhaftigkeitsprüfung an endovaskulären Prothesen nach ISO

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

Pharmacological aspects of drug eluting or drug coated 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. Life cycle A standard is reviewed every 5 years 00 Preliminary. Pharmacological aspects of drug eluting or drug coated endovascular prostheses are not addressed in 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.

Check out our FAQs. About Us Info center Standardization. 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.

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

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. To find similar documents by classification: