Norm

ISO/DIS 25539-1:2015 en

Cardiovasculaire implantaten - Endovasculaire hulpmiddelen - Deel 1: Endovasculaire protheses

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Over deze norm

Status Ontwerp
Aantal pagina's 107
Commissie Chirurgische implantaten
Gepubliceerd op 30-04-2015
Taal Engels
Part 1 of ISO 25539 specifies requirements for the evaluation of endovascular systems (prostheses and delivery systems) and requirements with respect to nomenclature, design attributes and information supplied by the manufacturer, based upon current medical knowledge. Guidance for the development of in vitro test methods is included in an informative annex to this standard. This standard should be considered as a supplement to ISO 14630, which specifies general requirements for the performance of non-active surgical implants. This part of ISO 25539 is applicable to endovascular systems used to treat aneurysms, stenoses, or other vascular anomalies or pathologies, or to create shunts between vessels (e.g., creation of transjugular intrahepatic portosystemic shunting (TIPS)). Some of the requirements are specific to endovascular treatment of arterial aneurysms or stenoses. Although the other uses of endovascular systems are within the scope of this standard, the specific requirements and testing are not described. Similarly, specific prosthesis configurations (e.g., fenestrated, branched) are within the scope, but specific requirements and testing are not described for these devices. This part of ISO 25539 is not applicable to vascular occluders, with the exception of contra-lateral iliac artery occluders when used as an integral part of an aorto-uni-iliac endovascular prosthesis. Although contralateral iliac artery occluders, when used as an integral part of an aorto-uni-iliac endovascular prosthesis, are within the scope of this standard, 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 standard, even if they are not integral to the endovascular system. This part of ISO 25539 provides requirements beyond the requirements of ISO 10555-4 Intravascular catheters - Sterile and single-use catheters, specific to the use of balloons with endovascular prostheses. This part of ISO 25539 is not applicable to procedures and devices used prior to the introduction of the endovascular system, such as balloon angioplasty 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 standard. This standard 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. Pharmacological aspects of drug eluting or drug coated endovascular prostheses are not addressed in this standard. This standard does not address the requirements for, and the evaluation of, viable tissues and nonviable biologic materials used in the construction of 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 standard.

Details

ICS-code 11.040.40
Nederlandse titel Cardiovasculaire implantaten - Endovasculaire hulpmiddelen - Deel 1: Endovasculaire protheses
Engelse titel Cardiovascular implants - Endovascular devices - Part 1: Endovascular prostheses
Normatieve verwijzingen
  • 93/42/EEG, Medische hulpmiddelen

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