ISO 25539-1 Cardiovascular implants - Endovascular devices - Part 1: Endovascular prostheses - Second Edition
Данный раздел/документ содержится в продуктах:
- Техэксперт: Машиностроительный комплекс
- Картотека зарубежных и международных стандартов
- CEN EN 13855-1 Manufactured articles solely filled with feathers and down - Measurement of thickness and compressibility of cushions - Part 1: Test method by rotation
- 59
- CEN EN 13855-1 Manufactured articles solely filled with feathers and down - Measurement of thickness and compressibility of cushions - Part 1: Test method by rotation
- 59.040
- CEN EN 13855-1 Manufactured articles solely filled with feathers and down - Measurement of thickness and compressibility of cushions - Part 1: Test method by rotation
- CEN EN 13855-2 Manufactured articles solely filled with feathers and down - Measurement of thickness and compressibility of cushions - Part 2: Test method by oscillation
- 97
- CEN EN 13855-1 Manufactured articles solely filled with feathers and down - Measurement of thickness and compressibility of cushions - Part 1: Test method by rotation
- 97.140
- CEN EN 13855-1 Manufactured articles solely filled with feathers and down - Measurement of thickness and compressibility of cushions - Part 1: Test method by rotation
- CEN EN 13855-2 Manufactured articles solely filled with feathers and down - Measurement of thickness and compressibility of cushions - Part 2: Test method by oscillation
- CEI EN 61496-2 Safety of machinery - Electro-sensitive protective equipment Part 2: Particular requirements for equipment using active opto-electronic protective devices (AOPDs)
- ISO 16142-1 Medical devices - Recognized essential principles of safety and performance of medical devices - Part 1: General essential principles and additional specific essential principles for all non?IVD medical devices and guidance on the selection of standards - First Edition
- Картотека зарубежных и международных стандартов
International Organization for Standardization
Cardiovascular implants - Endovascular devices - Part 1: Endovascular prostheses - Second Edition
N 25539-1
Annotation
This document 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 document. This document can be considered as a supplement to ISO 14630, which specifies general requirements for the performance of non-active surgical implants.
This document is applicable to endovascular systems used to treat aneurysms, stenoses or other vascular anomalies or pathologies (e.g. dissections, transections) 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 uses of endovascular systems other than treatment of arterial aneurysms or stenoses (e.g. dissections, transections, shunts) are within the scope of this document, 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 document is not applicable to vascular occluders, with the exception of contra-lateral iliac artery occluders when used as an integral part of aorto-uni-iliac endovascular prosthesis. Although contralateral 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. This document provides requirements beyond the requirements of ISO 10555-4, specific to the use of balloons with endovascular prostheses.
