{"id":198073,"date":"2024-10-19T12:36:36","date_gmt":"2024-10-19T12:36:36","guid":{"rendered":"https:\/\/pdfstandards.shop\/product\/uncategorized\/aami-tir17137-2014\/"},"modified":"2024-10-25T05:09:50","modified_gmt":"2024-10-25T05:09:50","slug":"aami-tir17137-2014","status":"publish","type":"product","link":"https:\/\/pdfstandards.shop\/product\/publishers\/aami\/aami-tir17137-2014\/","title":{"rendered":"AAMI TIR17137 2014"},"content":{"rendered":"

Outlines design verification and validation considerations for absorbable cardiovascular implants. Applies to implants in direct contact with the cardiovascular system, where the intended action is upon the circulatory system.<\/p>\n

PDF Catalog<\/h4>\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n
PDF Pages<\/th>\nPDF Title<\/th>\n<\/tr>\n
1<\/td>\nANSI\/AAMI\/ISO TIR17137:2014, Cardiovascular implants and extracorporeal systems \u2013 Cardiovascular absorbable <\/td>\n<\/tr>\n
3<\/td>\nTitle page <\/td>\n<\/tr>\n
4<\/td>\nCopyright information <\/td>\n<\/tr>\n
5<\/td>\nAAMI Technical Information Report
ANSI Technical Report <\/td>\n<\/tr>\n
6<\/td>\nContents <\/td>\n<\/tr>\n
7<\/td>\nGlossary of equivalent standards <\/td>\n<\/tr>\n
8<\/td>\nCommittee representation <\/td>\n<\/tr>\n
9<\/td>\nBackground on ANSI\/AAMI adoption of ISO\/TS 17137:2014 <\/td>\n<\/tr>\n
10<\/td>\nForeword <\/td>\n<\/tr>\n
11<\/td>\nIntroduction <\/td>\n<\/tr>\n
13<\/td>\n1 Scope
2 Normative references <\/td>\n<\/tr>\n
14<\/td>\n3 Terms and definitions <\/td>\n<\/tr>\n
15<\/td>\n4 Implant considerations
4.1 Classification
4.2 Intended clinical performance
4.3 Intended clinical use <\/td>\n<\/tr>\n
16<\/td>\n4.4 Materials
4.5 Packaging, labelling, and sterilization
4.5.1 Packaging
4.5.1.1 General
4.5.1.2 Considerations for absorbable product
4.5.2 Labelling
4.5.2.1 Label(s) <\/td>\n<\/tr>\n
17<\/td>\n4.5.2.2 Instructions for use (IFU) <\/td>\n<\/tr>\n
18<\/td>\n4.5.3 Sterilization
4.5.3.1 General
4.5.3.2 Radiation sterilization
4.5.3.3 Ethylene oxide sterilization
4.5.3.4 Steam sterilization
4.5.3.5 Alternative sterilization <\/td>\n<\/tr>\n
19<\/td>\n4.6 Risk management
4.6.1 General
4.6.2 Failure modes
4.6.3 Risk mitigation
4.6.4 Specific aspects for absorbable implants <\/td>\n<\/tr>\n
20<\/td>\nFigure 1 \u2014 Life cycle of one single device\/implant
5 Design verification and validation \u2014 Testing and analysis
5.1 Overview <\/td>\n<\/tr>\n
21<\/td>\nFigure 2 \u2014 Schematic representation of stages in the degradation of an absorbable implant
5.2 Considerations in the characterization and assessment of material and implant properties
5.2.1 General considerations <\/td>\n<\/tr>\n
23<\/td>\n5.2.2 Drug-substrate Interaction considerations
5.2.3 Summary of in vitro evaluation steps <\/td>\n<\/tr>\n
24<\/td>\n5.3 in vitro procedural assessment
5.3.1 Conditioning of test samples
5.3.2 Assessment of delivery and placement <\/td>\n<\/tr>\n
25<\/td>\n5.3.3 Assessment of initial function post-deployment
5.4 in vitro degradation assessment (post procedure)
5.4.1 General <\/td>\n<\/tr>\n
26<\/td>\n5.4.2 Implant integrity
5.4.2.1 Mechanical evaluation
5.4.2.2 Cyclic fatigue durability
5.4.2.3 Physical characterization of degradation\/corrosion <\/td>\n<\/tr>\n
27<\/td>\n5.4.2.4 Material composition assessment
5.4.2.5 Other property assessments
5.4.2.5.1 Corrosion\/degradation
5.4.2.5.2 Evaluate clinically using relevant imaging modalities <\/td>\n<\/tr>\n
28<\/td>\n5.4.2.5.3 Radiopacity
5.4.2.5.4 MRI compatibility
5.5 in vitro-in vivo correlation (IVIVC)
5.6 Biocompatibility
5.6.1 General considerations <\/td>\n<\/tr>\n
29<\/td>\n5.6.2 Sterilization considerations
5.6.3 Drug-device combination product considerations
5.7 Pre-clinical in vivo evaluation
5.7.1 Purpose <\/td>\n<\/tr>\n
30<\/td>\n5.7.2 Specific aims
5.7.3 Protocol <\/td>\n<\/tr>\n
32<\/td>\n5.7.4 Data acquisition
5.7.5 Test report and additional information
5.8 Clinical considerations specific to absorbable implants
5.8.1 Purpose
5.8.2 Specific aims
5.8.3 Clinical-investigation plan <\/td>\n<\/tr>\n
33<\/td>\n5.8.4 Data acquisition
5.8.5 Final report
5.8.6 Post market surveillance
5.9 Shelf life considerations
5.9.1 General information <\/td>\n<\/tr>\n
34<\/td>\n5.9.2 Real time aging
5.9.3 Accelerated aging <\/td>\n<\/tr>\n
35<\/td>\nAnnex A: Nomenclature of absorb, degrade and related terms <\/td>\n<\/tr>\n
36<\/td>\nBibliography <\/td>\n<\/tr>\n<\/table>\n","protected":false},"excerpt":{"rendered":"

AAMI\/ISO TIR17137:2014 – Cardiovascular implants and extracorporeal systems-Cardiovascular absorbable implants<\/b><\/p>\n\n\n\n\n
Published By<\/td>\nPublication Date<\/td>\nNumber of Pages<\/td>\n<\/tr>\n
AAMI<\/b><\/a><\/td>\n2014<\/td>\n38<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n","protected":false},"featured_media":198077,"template":"","meta":{"rank_math_lock_modified_date":false,"ep_exclude_from_search":false},"product_cat":[2654],"product_tag":[],"class_list":{"0":"post-198073","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\/198073","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\/198077"}],"wp:attachment":[{"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/media?parent=198073"}],"wp:term":[{"taxonomy":"product_cat","embeddable":true,"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/product_cat?post=198073"},{"taxonomy":"product_tag","embeddable":true,"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/product_tag?post=198073"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}