ANSI AAMI ISO 25539-1 pdf free download

ANSI AAMI ISO 25539-1 pdf free download.Cardiovascular implants— Endovascular devices—Part 1: Endovascular prostheses.
4 General requirements for endovascular system The following requirements shall apply to all endovascular systems. 4.1 Type of endovascular prosthesis The type of endovascular prosthesis shall be designated by balloon-expandable, self-expanding or other.4.2 Materials and construction for endovascular system Materials of the endovascular system (e.g. graft material, wire, stent, mechanical support, imaging markers, coatings, drugs) shall be described by their generic or chemical names. 4.3 Configuration and size designation for endovascular prosthesis The configuration of endovascular prosthesis shall be designated by its geometry (e.g. straight, bifurcated, branched, fenestrated, tapered, flared). The size of an endovascular system shall be designated by the outer diameter of the delivery system and the appropriate nominal relaxed diameters of each component of the endovascular prosthesis (e.g. main body, branches, extenders, cuffs) and the appropriate lengths.Anatomical indications (e.g. vessel diameter ranges for treatment of occlusive disease, range of landing zone diameters and lengths for the treatment of aneurysms, maximum angulation) shall be specified. For branched or fenestrated devices, the additional vessels to be treated shall be specified. For endovascular prostheses intended to be used in conjunction with adjunctive procedures (e.g. percutaneous transluminal angioplasty), the adjunctive procedure shall be specified. If an endovascular prostheses may be used in a secondary procedure (e.g. treatment of in-stent restenosis, secondary repair of previously placed endovascular prosthesis with inadequate seal or fixation), the conditions of use shall be specified. 4.5 Balloon designation Balloons integral to the endovascular system and balloons intended to achieve adequate apposition of the prosthesis shall be designated by the nominal diameter(s) as a function of the inflation pressure(s) or volume(s), the maximum recommended inflation pressure or volume and the rated burst pressure (RBP). If a commercially available balloon is recommended for use in the instructions for use (IFU), the balloon shall be designated by the balloon type [e.g. percutaneous transluminal angioplasty (PTA), moulding, low-pressure aortic, compliant]. 5 Intended performance The requirements of ISO 1 4630:2012, Clause 4 shall apply. 6 Design attributes 6.1 General The requirements of ISO 14630:201 2, Clause 5 shall apply. General design attributes for endovascular systems are listed in Tables A.3 and A.4 with reference to the nonclinical testing necessary for the evaluation of the design. It is recognised that not all tests identified in a category will be necessary or practical for any given endovascular prosthesis and/or system. The rationale for the selection of tests shall be documented.6.2 Endovascular system In addition to the general requirements, the design attributes of the endovascular system shall at least take into account the following: a) ability to consistently, accurately and safely access the intended location; b) ability to consistently, accurately and safely deploy the endovascular prosthesis; c) ability to safely withdraw the delivery system; d) ability to minimize blood loss (haemostasis). 6.3 Endovascular prosthesis In addition to the general requirements, the design attributes of the endovascular prosthesis shall at least take into account the following: a) ability of the endovascular prosthesis to ensure effective fixation within the vasculature; b) ability of the endovascular prosthesis to maintain adequate integrity; c) ability of the endovascular prosthesis to isolate the lesion as appropriate to its intended use (e.g. provide seal between the endovascular prosthesis and aneurysm, prevent blood from flowing through the implant wall); Changes in wall permeability after implantation shall be considered when establishing an appropriate in vitro specification for permeability.ANSI AAMI ISO 25539-1 pdf download.