{"id":198143,"date":"2024-10-19T12:36:50","date_gmt":"2024-10-19T12:36:50","guid":{"rendered":"https:\/\/pdfstandards.shop\/product\/uncategorized\/aami-25539-1-2017\/"},"modified":"2024-10-25T05:10:02","modified_gmt":"2024-10-25T05:10:02","slug":"aami-25539-1-2017","status":"publish","type":"product","link":"https:\/\/pdfstandards.shop\/product\/publishers\/aami\/aami-25539-1-2017\/","title":{"rendered":"AAMI 25539 1 2017"},"content":{"rendered":"

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.<\/p>\n

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1<\/td>\nANSI\/AAMI\/ISO 25539-1:2017; Cardiovascular implants\u2014Endovascular devices\u2014Part 1: Endovascular prostheses <\/td>\n<\/tr>\n
2<\/td>\nObjectives and uses of AAMI standards andrecommended practices <\/td>\n<\/tr>\n
3<\/td>\nTitle page <\/td>\n<\/tr>\n
4<\/td>\nAAMI Standard
Copyright information <\/td>\n<\/tr>\n
5<\/td>\nContents <\/td>\n<\/tr>\n
6<\/td>\nGlossary of equivalent standards <\/td>\n<\/tr>\n
7<\/td>\nCommittee representation <\/td>\n<\/tr>\n
8<\/td>\nBackground of AAMI adoption of ISO 25539-1:2017 <\/td>\n<\/tr>\n
9<\/td>\nForeword <\/td>\n<\/tr>\n
10<\/td>\nIntroduction <\/td>\n<\/tr>\n
13<\/td>\n1 Scope <\/td>\n<\/tr>\n
14<\/td>\n2 Normative references
3 Terms and definitions <\/td>\n<\/tr>\n
16<\/td>\n4 General requirements for endovascular system
4.1 Type of endovascular prosthesis <\/td>\n<\/tr>\n
17<\/td>\n4.2 Materials and construction for endovascular system
4.3 Configuration and size designation for endovascular prosthesis
4.4 Intended clinical use for endovascular system <\/td>\n<\/tr>\n
18<\/td>\n4.5 Balloon designation
5 Intended performance
6 Design attributes
6.1 General <\/td>\n<\/tr>\n
19<\/td>\n6.2 Endovascular system
6.3 Endovascular prosthesis
6.4 Endovascular system and endovascular prosthesis
7 Materials <\/td>\n<\/tr>\n
20<\/td>\n8 Design evaluation
8.1 General <\/td>\n<\/tr>\n
21<\/td>\n8.2 Sampling
8.3 Conditioning of test samples
8.4 Reporting <\/td>\n<\/tr>\n
22<\/td>\n8.5 Bench and analytical tests
8.5.1 Endovascular system and delivery system
8.5.1.1 Balloon testing <\/td>\n<\/tr>\n
23<\/td>\n8.5.1.1.1 Balloon burst pressure for non-compliant balloons
8.5.1.1.2 Balloon deflation times
8.5.1.1.3 Balloon rated fatigue
8.5.1.1.4 Balloon volume to burst for compliant balloons
8.5.1.2 Dimensional verification of the endovascular system
8.5.1.3 Dislodgement force (pre-mounted, balloon-expandable endovascular prosthesis)
8.5.1.4 Force to deploy for self-expanding endovascular prostheses
8.5.1.5 Simulated use
8.5.1.6 Tensile bond strength <\/td>\n<\/tr>\n
24<\/td>\n8.5.1.7 Torsional bond strength
8.5.1.8 Haemostasis
8.5.1.9 Biocompatibility
8.5.1.10 Sterilization assurance
8.5.1.11 Visibility
8.5.2 Endovascular prosthesis
8.5.2.1 Corrosion
8.5.2.2 Fatigue and durability\u2014Computational analyses
8.5.2.3 Fatigue and durability\u2014in vitro testing <\/td>\n<\/tr>\n
25<\/td>\n8.5.2.3.1 General considerations
8.5.2.3.2 Radial fatigue and durability
8.5.2.3.3 Active fixation fatigue and durability
8.5.2.3.4 Axial fatigue and durability
8.5.2.3.5 Bending fatigue and durability
8.5.2.3.6 Torsional fatigue and durability <\/td>\n<\/tr>\n
26<\/td>\n8.5.2.4 Fixation and seal
8.5.2.4.1 Leakage at seal zone
8.5.2.4.2 Migration resistance
8.5.2.4.3 Separation force for overlapping endovascular prostheses
8.5.2.5 Patency-related tests <\/td>\n<\/tr>\n
27<\/td>\nTable 1\u2014Rationale for crush and compression resistance and radial force requirements <\/td>\n<\/tr>\n
28<\/td>\n8.5.2.5.1 Compression resistance to perpendicularly applied load (self-expanding, non-aortic endovascular prostheses)
8.5.2.5.2 Crush resistance with perpendicularly applied load (balloon-expandable, non-aortic endovascular prostheses)
8.5.2.5.3 Crush resistance with radially applied load (balloon-expandable endovascular prostheses)
8.5.2.5.4 Radial force (self-expanding endovascular prostheses)
8.5.2.5.5 Resistance to kinking (flexibility)
8.5.2.6 Permeability
8.5.2.6.1 Integral water leakage
8.5.2.6.2 Porosity (non-textile materials) <\/td>\n<\/tr>\n
29<\/td>\n8.5.2.6.3 Water entry pressure (non-textile materials)
8.5.2.6.4 Water permeability (textile materials)
8.5.2.7 Sizing-related testing
8.5.2.7.1 Dimensional verification of the endovascular prosthesis
8.5.2.7.2 Implant diameter to balloon inflation pressure (balloon-expandable endovascular prostheses)
8.5.2.7.3 Implant length to diameter relationship (endovascular prostheses that have clinically relevant length changes with diameter changes)
8.5.2.7.4 Recoil (balloon-expandable endovascular prostheses)
8.5.2.8 Strength
8.5.2.8.1 Burst strength
8.5.2.8.2 Factory seam strength (endovascular prostheses with seams in the graft material)
8.5.2.8.3 Longitudinal tensile strength <\/td>\n<\/tr>\n
30<\/td>\n8.5.2.8.4 Strength after repeated puncture (endovascular prostheses for vascular access)
8.5.2.8.5 Strength of the connection(s) between the graft material and a discrete fixation system(s)
8.5.2.9 Magnetic resonance imaging (MRI) safety
8.6 Preclinical in vivo evaluation
8.6.1 Purpose <\/td>\n<\/tr>\n
31<\/td>\n8.6.2 Specific aims
8.6.3 Protocol considerations
8.6.4 Data acquisition <\/td>\n<\/tr>\n
33<\/td>\n8.6.5 Test report and additional information <\/td>\n<\/tr>\n
34<\/td>\n8.7 Clinical evaluation
8.7.1 Purpose
8.7.2 Specific aims <\/td>\n<\/tr>\n
35<\/td>\n8.7.3 Protocol considerations <\/td>\n<\/tr>\n
36<\/td>\n8.7.4 Data acquisition <\/td>\n<\/tr>\n
39<\/td>\n8.7.5 Final report <\/td>\n<\/tr>\n
40<\/td>\n9 Post-market surveillance
10 Manufacturing
11 Sterilization
11.1 Products supplied sterile <\/td>\n<\/tr>\n
41<\/td>\n11.2 Sterilization residuals
12 Packaging
12.1 Protection from damage in storage and transport
12.1.1 General
12.1.2 Unit container
12.1.3 Outer container
12.1.4 Shipping container
12.1.5 Maintenance of sterility in transit
12.2 Labelling
12.2.1 Container label <\/td>\n<\/tr>\n
42<\/td>\n12.2.2 Record label
12.3 Instructions for use
12.3.1 General
12.3.2 Information and instructions for use for endovascular systems <\/td>\n<\/tr>\n
44<\/td>\nAnnex A (informative) Relationship between testing requirements and device attributes and potential failure modes <\/td>\n<\/tr>\n
46<\/td>\nTable A.1\u2014Table headings and explanations for Tables A.3 and A.4 and for a device-specific DESa <\/td>\n<\/tr>\n
47<\/td>\nTable A.2\u2014Legend for grouped associated clinical effects of failure <\/td>\n<\/tr>\n
48<\/td>\nTable A.3\u2014Device evaluation strategy for the endovascular system <\/td>\n<\/tr>\n
53<\/td>\nTable A.4\u2014Device evaluation strategy for endovascular prosthesis <\/td>\n<\/tr>\n
60<\/td>\nTable A.5\u2014Design comparison between a previously evaluated device and the modified device <\/td>\n<\/tr>\n
61<\/td>\nTable A.6\u2014Indication for use comparison of a previously evaluated device and the study devicea <\/td>\n<\/tr>\n
62<\/td>\nTable A.7\u2014Device evaluation strategy for device design modifications and\/or changes in intended use <\/td>\n<\/tr>\n
63<\/td>\nAnnex B (informative) Description of clinical and device effects of failure
Table B.1\u2014Description of clinical effects of failure <\/td>\n<\/tr>\n
65<\/td>\nTable B.2\u2014Description of device effects of failure <\/td>\n<\/tr>\n
67<\/td>\nAnnex C (informative) Bench and analytical tests
Table C.1\u2014Bench and analytical tests <\/td>\n<\/tr>\n
74<\/td>\nAnnex D (informative) Test methods <\/td>\n<\/tr>\n
76<\/td>\nTable D.1\u2014Index of test methods <\/td>\n<\/tr>\n
123<\/td>\nFigure D.1\u2014Determination of outward force <\/td>\n<\/tr>\n
139<\/td>\nBibliography <\/td>\n<\/tr>\n<\/table>\n","protected":false},"excerpt":{"rendered":"

ANSI\/AAMI\/ISO 25539-1:2017 – Cardiovascular implants- Endovascular devices-Part 1: Endovascular prostheses<\/b><\/p>\n\n\n\n\n
Published By<\/td>\nPublication Date<\/td>\nNumber of Pages<\/td>\n<\/tr>\n
AAMI<\/b><\/a><\/td>\n2017<\/td>\n140<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n","protected":false},"featured_media":198149,"template":"","meta":{"rank_math_lock_modified_date":false,"ep_exclude_from_search":false},"product_cat":[2654],"product_tag":[],"class_list":{"0":"post-198143","1":"product","2":"type-product","3":"status-publish","4":"has-post-thumbnail","6":"product_cat-aami","8":"first","9":"instock","10":"sold-individually","11":"shipping-taxable","12":"purchasable","13":"product-type-simple"},"_links":{"self":[{"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/product\/198143","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/product"}],"about":[{"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/types\/product"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/media\/198149"}],"wp:attachment":[{"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/media?parent=198143"}],"wp:term":[{"taxonomy":"product_cat","embeddable":true,"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/product_cat?post=198143"},{"taxonomy":"product_tag","embeddable":true,"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/product_tag?post=198143"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}