{"id":374166,"date":"2024-10-20T02:37:18","date_gmt":"2024-10-20T02:37:18","guid":{"rendered":"https:\/\/pdfstandards.shop\/product\/uncategorized\/aami-10993-15-2019\/"},"modified":"2024-10-26T04:34:56","modified_gmt":"2024-10-26T04:34:56","slug":"aami-10993-15-2019","status":"publish","type":"product","link":"https:\/\/pdfstandards.shop\/product\/publishers\/aami\/aami-10993-15-2019\/","title":{"rendered":"AAMI 10993 15 2019"},"content":{"rendered":"

This standard provides guidance on general requirements for the design of tests for identifying and quantifying degradation products from finished metallic medical devices or corresponding material samples finished as ready for clinical use.<\/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
PDF Pages<\/th>\nPDF Title<\/th>\n<\/tr>\n
1<\/td>\nANSI\/AAMI\/ISO 10993-15:2019; Biological evaluation of medical devices\u2014Part 15:
\nIdentification and quantification of degradation products from metals and alloys <\/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 Page <\/td>\n<\/tr>\n
6<\/td>\nCommittee representation <\/td>\n<\/tr>\n
8<\/td>\nBackground of ANSI\/AAMI adoption of ISO 10993-15:2019 <\/td>\n<\/tr>\n
9<\/td>\nForeword <\/td>\n<\/tr>\n
10<\/td>\nIntroduction <\/td>\n<\/tr>\n
11<\/td>\n1 Scope
2 Normative references <\/td>\n<\/tr>\n
12<\/td>\n3 Terms and definitions <\/td>\n<\/tr>\n
13<\/td>\n4 Degradation test methods
4.1 General
4.2 Prerequisites <\/td>\n<\/tr>\n
14<\/td>\n5 Reagent and sample preparation
5.1 Sample documentation
5.2 Test solution (electrolyte)
5.3 Preparation of test samples
5.3.1 Test samples
5.3.2 Sampling
5.3.3 Sample shape <\/td>\n<\/tr>\n
15<\/td>\n5.3.4 Sample surface condition
6 Electrochemical tests
6.1 Apparatus
6.2 Sample preparation
6.3 Test conditions
6.4 Potentiodynamic measurements <\/td>\n<\/tr>\n
16<\/td>\nFigure 1\uf8e7Plot of current density versus potential, showing the start of corrosion current at Ea and breakdown potential, Ep <\/td>\n<\/tr>\n
17<\/td>\nFigure 2\u2014Log current density versus potential plot showing the breakdown potential, Ep, at the inflection point of the curve
6.5 Potentiostatic measurements <\/td>\n<\/tr>\n
18<\/td>\n7 Immersion test
7.1 Apparatus
7.2 Sample preparation
7.3 Immersion test procedure <\/td>\n<\/tr>\n
19<\/td>\n8 Analysis
9 Test report <\/td>\n<\/tr>\n
21<\/td>\nAnnex A (informative) Electrolytes for the electrochemical tests
A.1 General
A.2 Isotonic aqueous solution of 0,9 % sodium chloride
A.3 Artificial saliva[2]
A.4 Artificial plasma[2]
A.5 Phosphate Buffered Saline (PBS) (sterile filtered tissue culture grade) <\/td>\n<\/tr>\n
22<\/td>\nAnnex B (informative) Schematic diagram of the electrochemical measuring circuit
Figure B.1\u2014Schematic diagram of the electrochemical measuring circuit <\/td>\n<\/tr>\n
23<\/td>\nAnnex C (informative) Schematic drawing of an electrolytic cell
Figure C.1\u2014Schematic drawing of an electrolytic cell <\/td>\n<\/tr>\n
24<\/td>\nBibliography <\/td>\n<\/tr>\n<\/table>\n","protected":false},"excerpt":{"rendered":"

ANSI\/AAMI\/ISO 10993-15:2019 Biological evaluation of medical devices-Part 15: Identification and quantification of degradation products from metals and alloys<\/b><\/p>\n\n\n\n\n
Published By<\/td>\nPublication Date<\/td>\nNumber of Pages<\/td>\n<\/tr>\n
AAMI<\/b><\/a><\/td>\n2019<\/td>\n24<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n","protected":false},"featured_media":374169,"template":"","meta":{"rank_math_lock_modified_date":false,"ep_exclude_from_search":false},"product_cat":[2654],"product_tag":[],"class_list":{"0":"post-374166","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\/374166","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\/374169"}],"wp:attachment":[{"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/media?parent=374166"}],"wp:term":[{"taxonomy":"product_cat","embeddable":true,"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/product_cat?post=374166"},{"taxonomy":"product_tag","embeddable":true,"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/product_tag?post=374166"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}