{"id":197967,"date":"2024-10-19T12:36:15","date_gmt":"2024-10-19T12:36:15","guid":{"rendered":"https:\/\/pdfstandards.shop\/product\/uncategorized\/aami-10993-15-2000-ra-2011\/"},"modified":"2024-10-25T05:09:31","modified_gmt":"2024-10-25T05:09:31","slug":"aami-10993-15-2000-ra-2011","status":"publish","type":"product","link":"https:\/\/pdfstandards.shop\/product\/publishers\/aami\/aami-10993-15-2000-ra-2011\/","title":{"rendered":"AAMI 10993 15 2000 RA 2011"},"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
PDF Pages<\/th>\nPDF Title<\/th>\n<\/tr>\n
1<\/td>\nANSI\/AAMI\/ISO 10993-15:200\/(R)2011, Biological evaluation of medical devices\u2014Part 15: Identification and quantification of degradation products from metals and a <\/td>\n<\/tr>\n
2<\/td>\nThe Objectives and Uses of AAMI Standards and Recommended Practices <\/td>\n<\/tr>\n
3<\/td>\nANSI\/AAMI\/ISO 10993-15:2000 Approved 16 October 2000 <\/td>\n<\/tr>\n
4<\/td>\nCopyright page <\/td>\n<\/tr>\n
5<\/td>\nContents <\/td>\n<\/tr>\n
7<\/td>\nGlossary of equivalent standards <\/td>\n<\/tr>\n
9<\/td>\nCommittee representation <\/td>\n<\/tr>\n
10<\/td>\nBackground of AAMI adoption of ISO 10993-15:2000 <\/td>\n<\/tr>\n
11<\/td>\nForeword <\/td>\n<\/tr>\n
12<\/td>\nIntroduction <\/td>\n<\/tr>\n
13<\/td>\n1\tScope
2\tNormative references <\/td>\n<\/tr>\n
14<\/td>\n3\tTerms and definitions
4\tDegradation test methods
4.1\tGeneral
4.2\tPrerequisites
5\tReagent and sample preparation
5.1\tSample documentation
5.2\tTest solution (electrolyte) <\/td>\n<\/tr>\n
15<\/td>\n5.3\tPreparation of test samples
5.3.1\tTest samples
5.3.2\tSampling
5.3.3\tSample shape
5.3.4\tSample surface condition
6\tElectrochemical tests
6.1\tApparatus
6.2\tSample preparation <\/td>\n<\/tr>\n
16<\/td>\n6.3\tTest conditions
6.4\tPotentiodynamic measurements
6.5\tPotentiostatic measurements
7\tImmersion test
7.1\tApparatus
7.2\tSample preparation
7.3\tImmersion test procedure <\/td>\n<\/tr>\n
18<\/td>\n8\tAnalysis
9\tTest report <\/td>\n<\/tr>\n
19<\/td>\nAnnex A, Schematic diagram of the electrochemical measuring circuit <\/td>\n<\/tr>\n
20<\/td>\nAnnex B, Schematic drawing of an electrolytic cell <\/td>\n<\/tr>\n
21<\/td>\nAnnex C, Electrolytes for the electrochemical tests <\/td>\n<\/tr>\n
22<\/td>\nBibliography <\/td>\n<\/tr>\n<\/table>\n","protected":false},"excerpt":{"rendered":"

ANSI\/AAMI\/ISO 10993-15:2000\/(R)2011 – 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>\n2000<\/td>\n22<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n","protected":false},"featured_media":197971,"template":"","meta":{"rank_math_lock_modified_date":false,"ep_exclude_from_search":false},"product_cat":[2654],"product_tag":[],"class_list":{"0":"post-197967","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\/197967","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\/197971"}],"wp:attachment":[{"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/media?parent=197967"}],"wp:term":[{"taxonomy":"product_cat","embeddable":true,"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/product_cat?post=197967"},{"taxonomy":"product_tag","embeddable":true,"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/product_tag?post=197967"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}