{"id":198259,"date":"2024-10-19T12:37:15","date_gmt":"2024-10-19T12:37:15","guid":{"rendered":"https:\/\/pdfstandards.shop\/product\/uncategorized\/aami-7198-2016\/"},"modified":"2024-10-25T05:10:23","modified_gmt":"2024-10-25T05:10:23","slug":"aami-7198-2016","status":"publish","type":"product","link":"https:\/\/pdfstandards.shop\/product\/publishers\/aami\/aami-7198-2016\/","title":{"rendered":"AAMI 7198 2016"},"content":{"rendered":"

Specifies requirements for the evaluation of vascular prostheses 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 International Standard.<\/p>\n

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1<\/td>\nANSI\/AAMI\/ISO 7198:2016; Cardiovascular implants and extracorporeal systems\u2014Vascular prostheses\u2014Tubular vascular grafts and vascular patches <\/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
Untitled <\/td>\n<\/tr>\n
5<\/td>\nContents Page <\/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 7198:2016 <\/td>\n<\/tr>\n
9<\/td>\nForeword <\/td>\n<\/tr>\n
10<\/td>\nIntroduction <\/td>\n<\/tr>\n
11<\/td>\n1 Scope <\/td>\n<\/tr>\n
12<\/td>\n2 Normative references
3 Terms and definitions <\/td>\n<\/tr>\n
17<\/td>\n4 General requirements
4.1 Configuration designation for tubular vascular grafts
4.2 Size designation
4.2.1 Uniform straight tubular vascular grafts
4.2.2 Uniform bifurcated tubular vascular grafts
4.2.3 Tapered tubular vascular grafts <\/td>\n<\/tr>\n
18<\/td>\n4.2.4 Other configurations of tubular vascular grafts
4.2.5 Vascular patches
4.3 Materials
4.3.1 General
4.3.2 Classification of tubular vascular grafts and vascular patches
4.3.3 Nomenclature
4.3.3.1 General
4.3.3.2 Synthetic materials
4.3.3.3 Biological materials <\/td>\n<\/tr>\n
19<\/td>\n4.3.3.4 Coatings
4.3.3.5 Storage fluids
4.4 Intended clinical use designation
5 Intended performance
6 Design attributes
6.1 General <\/td>\n<\/tr>\n
20<\/td>\n6.2 Tubular vascular grafts
6.3 Vascular patches
6.4 Coatings
6.5 Drug coatings and drug-eluting coatings <\/td>\n<\/tr>\n
21<\/td>\n7 Materials
8 Design evaluation
8.1 General
8.2 Sampling
8.3 Conditioning of test samples <\/td>\n<\/tr>\n
22<\/td>\n8.4 Reporting <\/td>\n<\/tr>\n
23<\/td>\n8.5 Biocompatibility
8.5.1 Residual chemicals
8.5.2 Biocompatibility
8.6 Biostability
8.7 Bench and analytical tests
8.7.1 General <\/td>\n<\/tr>\n
24<\/td>\n8.7.2 Tubular vascular grafts
8.7.2.1 Permeability
8.7.2.1.1 General
8.7.2.1.2 Integral water permeability\/leakage
8.7.2.1.3 Porosity (non-textile materials)
8.7.2.1.4 Water entry pressure (non-textile materials)
8.7.2.1.5 Water permeability (textile materials)
8.7.2.2 Strength
8.7.2.2.1 General
8.7.2.2.2 Circumferential tensile strength
8.7.2.2.3 Diaphragm pressurized burst strength
8.7.2.2.4 Longitudinal tensile strength <\/td>\n<\/tr>\n
25<\/td>\n8.7.2.2.5 Pressurized burst strength
8.7.2.2.6 Probe burst strength
8.7.2.2.7 Strength after repeated puncture
8.7.2.3 Length
8.7.2.4 Relaxed internal diameter
8.7.2.5 Pressurized internal diameter
8.7.2.6 Wall thickness
8.7.2.7 Suture retention strength
8.7.2.8 Kink diameter\/radius <\/td>\n<\/tr>\n
26<\/td>\n8.7.2.9 Dynamic radial compliance
8.7.3 Vascular patches
8.7.3.1 Permeability
8.7.3.1.1 General
8.7.3.1.2 Porosity
8.7.3.1.3 Water entry pressure
8.7.3.1.4 Water permeability
8.7.3.2 Strength
8.7.3.2.1 General
8.7.3.2.2 Diaphragm pressurized burst strength
8.7.3.2.3 Longitudinal tensile strength
8.7.3.2.4 Probe burst strength
8.7.3.3 Length and width
8.7.3.4 Wall thickness <\/td>\n<\/tr>\n
27<\/td>\n8.7.3.5 Suture retention strength
9 Preclinical in vivo evaluation test methods for vascular prostheses
9.1 Preclinical in vivo evaluation
9.1.1 Purpose
9.1.2 Specific aims
9.1.3 Protocol considerations <\/td>\n<\/tr>\n
28<\/td>\n9.1.4 Data acquisition <\/td>\n<\/tr>\n
29<\/td>\n9.1.5 Test report and additional information <\/td>\n<\/tr>\n
30<\/td>\n10 Clinical investigation methods for vascular prostheses
10.1 Clinical investigation
10.1.1 Purpose
10.1.2 Specific aims
10.1.3 Protocol considerations <\/td>\n<\/tr>\n
31<\/td>\n10.1.4 Data acquisition <\/td>\n<\/tr>\n
34<\/td>\n10.1.5 Final report <\/td>\n<\/tr>\n
35<\/td>\n10.2 Post market surveillance
11 Manufacturing
12 Sterility <\/td>\n<\/tr>\n
36<\/td>\n13 Packaging and labelling
13.1 General
13.2 Unit container
13.3 Outer container
13.4 Shipping container
13.5 Maintenance of sterility in transit
13.6 Marking
13.6.1 Container label <\/td>\n<\/tr>\n
37<\/td>\n13.6.2 Record label
13.6.3 General information and instructions for use <\/td>\n<\/tr>\n
38<\/td>\nAnnex A (informative) Test methods
A.1 General
A.2 Sampling
A.3 Conditioning of test samples <\/td>\n<\/tr>\n
39<\/td>\nA.4 Reporting <\/td>\n<\/tr>\n
40<\/td>\nA.5 Test methods
Table A.1 \u2014 Index of test methods <\/td>\n<\/tr>\n
41<\/td>\nA.5.1 Permeability
A.5.1.1 Porosity (N) <\/td>\n<\/tr>\n
42<\/td>\nA.5.1.1.1 Planimetric porosity
A.5.1.1.1.1 Purpose
A.5.1.1.1.2 Materials
A.5.1.1.1.3 Sampling
A.5.1.1.1.4 Test procedure
A.5.1.1.1.5 Expression of results
A.5.1.1.1.6 Test report and additional information
A.5.1.1.2 Gravimetric porosity <\/td>\n<\/tr>\n
43<\/td>\nA.5.1.1.2.1 Purpose
A.5.1.1.2.2 Materials
A.5.1.1.2.3 Sampling
A.5.1.1.2.4 Test procedure
A.5.1.1.2.5 Expression of results
A.5.1.1.2.6 Test report and additional information
A.5.1.1.3 Microscopic porosity (inter-nodal distance)
A.5.1.1.3.1 Purpose <\/td>\n<\/tr>\n
44<\/td>\nA.5.1.1.3.2 Materials
A.5.1.1.3.3 Sampling
A.5.1.1.3.4 Test procedure
A.5.1.1.3.5 Expression of results
A.5.1.1.3.6 Test report and additional information
A.5.1.2 Water permeability (B, T, C)
A.5.1.2.1 Purpose
A.5.1.2.2 Materials <\/td>\n<\/tr>\n
45<\/td>\nA.5.1.2.3 Sampling
A.5.1.2.4 Test procedure
A.5.1.2.5 Expression of results <\/td>\n<\/tr>\n
46<\/td>\nA.5.1.2.6 Test report
A.5.1.3 Integral water permeability\/leakage (A)
A.5.1.3.1 Purpose
A.5.1.3.2 Materials
A.5.1.3.3 Sampling
A.5.1.3.4 Test procedure <\/td>\n<\/tr>\n
47<\/td>\nA.5.1.3.5 Expression of results
A.5.1.3.6 Test report and additional information
A.5.1.4 Water entry pressure (N)
A.5.1.4.1 Purpose
A.5.1.4.2 Materials
A.5.1.4.3 Sampling
A.5.1.4.4 Test procedure
A.5.1.4.5 Expression of results
A.5.1.4.6 Test report and additional information <\/td>\n<\/tr>\n
48<\/td>\nA.5.2 Strength
A.5.2.1 General
A.5.2.2 Pressurized burst strength (A)
A.5.2.2.1 Purpose
A.5.2.2.2 Materials
A.5.2.2.3 Sampling
A.5.2.2.4 Procedure <\/td>\n<\/tr>\n
49<\/td>\nA.5.2.3 Longitudinal tensile strength (A)
A.5.2.3.1 Purpose
A.5.2.3.2 Materials
A.5.2.3.3 Sampling
A.5.2.3.4 Test procedure
A.5.2.3.5 Expression of results
A.5.2.2.5 Expression of results
A.5.2.2.6 Test report and additional information <\/td>\n<\/tr>\n
50<\/td>\nA.5.2.3.6 Test report and additional information
A.5.2.4 Circumferential tensile strength \u2013 tubular vascular graft only (A)
A.5.2.4.1 Purpose
A.5.2.4.2 Materials <\/td>\n<\/tr>\n
51<\/td>\nFigure A.1\u2014Split bar tester <\/td>\n<\/tr>\n
52<\/td>\nA.5.2.4.3 Sampling
A.5.2.4.4 Test procedure
A.5.2.4.5 Expression of results
A.5.2.4.6 Test report and additional information
A.5.2.5 Diaphragm pressurized burst strength (A)
A.5.2.5.1 Purpose
A.5.2.5.2 Materials <\/td>\n<\/tr>\n
53<\/td>\nA.5.2.5.3 Sampling
A.5.2.5.4 Test procedure
A.5.2.5.5 Expression of results
A.5.2.5.6 Test report and additional information
A.5.2.6 Probe burst strength (A)
A.5.2.6.1 Purpose
A.5.2.6.2 Materials <\/td>\n<\/tr>\n
54<\/td>\nFigure A.2\u2014Example of a probe burst tester
A.5.2.6.3 Sampling
A.5.2.6.4 Test procedure
A.5.2.6.5 Expression of results <\/td>\n<\/tr>\n
55<\/td>\nA.5.2.6.6 Test report and additional information
A.5.2.7 Strength after repeated puncture \u2014 tubular prosthesis only (A)
A.5.2.7.1 Purpose
A.5.2.7.2 Materials
A.5.2.7.3 Sampling
A.5.2.7.4 Test procedure
A.5.2.7.5 Expression of results
A.5.2.7.6 Test report and additional information
A.5.3 Length (including width for vascular patches) (A)
A.5.3.1 Purpose <\/td>\n<\/tr>\n
56<\/td>\nA.5.3.2 Materials
A.5.3.3 Sampling
A.5.3.4 Test procedure
A.5.3.5 Expression of results
A.5.3.6 Test report and additional information
A.5.4 Relaxed internal diameter \u2014 tubular prosthesis only (A)
A.5.4.1 Purpose
A.5.4.2 Materials <\/td>\n<\/tr>\n
57<\/td>\nFigure A.3 \u2014 Example of a conical gauge for relaxed internal diameter
A.5.4.3 Sampling
A.5.4.4 Test procedure
A.5.4.5 Expression of results <\/td>\n<\/tr>\n
58<\/td>\nA.5.4.6 Test report and additional information
A.5.5 Pressurized internal diameter \u2014 tubular prosthesis only (A) (if appropriate, see 8.7.2.5)
A.5.5.1 Purpose
A.5.5.2 Materials
A.5.5.3 Sampling
A.5.5.4 Test procedure <\/td>\n<\/tr>\n
59<\/td>\nA.5.5.5 Expression of results
A.5.5.6 Test report and additional information
A.5.6 Wall thickness (A)
A.5.6.1 Purpose
A.5.6.2 Materials
A.5.6.3 Sampling
A.5.6.4 Test procedure
A.5.6.4.1 Non-contact determination of wall thickness <\/td>\n<\/tr>\n
60<\/td>\nA.5.6.4.2 Constant-load gauge determination of wall thickness
A.5.6.5 Expression of results
A.5.6.6 Test report and additional information
A.5.7 Suture retention strength (A)
A.5.7.1 Purpose
A.5.7.2 Materials
Figure A.4 \u2014 Example of suture retention strength test \u2014 Side view <\/td>\n<\/tr>\n
61<\/td>\nA.5.7.3 Sampling
A.5.7.4 Test procedure
A.5.7.4.1 Straight-across procedure (longitudinally oriented suture)
A.5.7.4.2 Oblique procedure
A.5.7.4.3 Longitudinal procedure (transverse oriented suture)
A.5.7.5 Expression of results
A.5.7.6 Test report and additional information
A.5.8 Kink diameter\/radius \u2014 tubular vascular grafts only (A)
A.5.8.1 Purpose
A.5.8.2 Materials <\/td>\n<\/tr>\n
62<\/td>\nA.5.8.3 Sampling
A.5.8.4 Test procedure
A.5.8.5 Expression of results
A.5.8.6 Test report and additional information
A.5.9 Dynamic radial compliance \u2014 tubular vascular grafts only (A)
A.5.9.1 Purpose
A.5.9.2 Materials <\/td>\n<\/tr>\n
63<\/td>\nA.5.9.3 Sampling
A.5.9.4 Test procedure <\/td>\n<\/tr>\n
64<\/td>\nA.5.9.5 Expression of results
A.5.9.6 Test report and additional information <\/td>\n<\/tr>\n
65<\/td>\nBibliography <\/td>\n<\/tr>\n<\/table>\n","protected":false},"excerpt":{"rendered":"

ANSI\/AAMI\/ISO 7198:2016 – Cardiovascular implants-Tubular vascular 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>\n2016<\/td>\n65<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n","protected":false},"featured_media":198260,"template":"","meta":{"rank_math_lock_modified_date":false,"ep_exclude_from_search":false},"product_cat":[2654],"product_tag":[],"class_list":{"0":"post-198259","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\/198259","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\/198260"}],"wp:attachment":[{"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/media?parent=198259"}],"wp:term":[{"taxonomy":"product_cat","embeddable":true,"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/product_cat?post=198259"},{"taxonomy":"product_tag","embeddable":true,"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/product_tag?post=198259"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}