{"id":197963,"date":"2024-10-19T12:36:14","date_gmt":"2024-10-19T12:36:14","guid":{"rendered":"https:\/\/pdfstandards.shop\/product\/uncategorized\/aami-10993-3-2014\/"},"modified":"2024-10-25T05:09:31","modified_gmt":"2024-10-25T05:09:31","slug":"aami-10993-3-2014","status":"publish","type":"product","link":"https:\/\/pdfstandards.shop\/product\/publishers\/aami\/aami-10993-3-2014\/","title":{"rendered":"AAMI 10993 3 2014"},"content":{"rendered":"

Specifies strategies for hazard identification and tests on medical devices for genotoxicity, carcinogenicity, and reproductive and developmental toxicity. Applicable when the need to evaluate a medical device for potential genotoxicity, carcinogenicity, or reproductive toxicity has been established<\/p>\n

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1<\/td>\nANSI\/AAMI\/ISO 10993-3:2014, Biological evaluation of medical devices\u2014Part 3: Tests for genotoxicity, carcinogenicity, and reproductive toxicity <\/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
7<\/td>\nGlossary of equivalent standards <\/td>\n<\/tr>\n
8<\/td>\nCommittee representation <\/td>\n<\/tr>\n
10<\/td>\nBackground of ANSI\/AAMI adoption of ISO 10993-3:2014 <\/td>\n<\/tr>\n
11<\/td>\nForeword <\/td>\n<\/tr>\n
13<\/td>\nIntroduction
Introduction <\/td>\n<\/tr>\n
15<\/td>\n1 Scope
2 Normative references <\/td>\n<\/tr>\n
16<\/td>\n3 Terms and definitions
4 Requirements for test strategies
4.1 General <\/td>\n<\/tr>\n
17<\/td>\n4.2 Additional requirements for carcinogenicity testing
4.3 Additional requirements for reproductive toxicity testing <\/td>\n<\/tr>\n
18<\/td>\n5 Genotoxicity tests
5.1 General
5.2 Test strategy
5.2.1 General
5.2.2 Test battery <\/td>\n<\/tr>\n
19<\/td>\n5.2.3 Follow-up evaluation <\/td>\n<\/tr>\n
20<\/td>\n5.3 Sample preparation <\/td>\n<\/tr>\n
21<\/td>\n6 Carcinogenicity tests
6.1 General
6.2 Evaluation strategy <\/td>\n<\/tr>\n
22<\/td>\n6.3 Sample preparation
6.4 Test methods <\/td>\n<\/tr>\n
23<\/td>\n7 Reproductive and developmental toxicity tests
7.1 General
7.2 Test strategy <\/td>\n<\/tr>\n
24<\/td>\n7.3 Sample preparation
7.4 Test methods
8 Test report <\/td>\n<\/tr>\n
26<\/td>\nAnnex A: Guidance on selecting an appropriate sample preparation procedure in genotoxicity testing
A.1 General <\/td>\n<\/tr>\n
27<\/td>\nA.2 Device materials
A.2.1 Low Molecular Weight Chemicals (LMWC)
A.2.2 Polymers (including naturally occurring polymers)
A.2.2.1 LMWC contained in polymers
A.2.2.2 Oligomers <\/td>\n<\/tr>\n
28<\/td>\nA.2.2.3 Biodegradable polymers
A.2.3 Inorganic materials: Wear debris from metals, alloys and ceramics
A.3 Sample Preparation Methods
A.3.1 General <\/td>\n<\/tr>\n
29<\/td>\nFigure A.1 \u2014 Structured approach to select a sample preparation procedure <\/td>\n<\/tr>\n
30<\/td>\nTable A.1 \u2014 Common extraction solvents
A.3.2 Method A
A.3.3 Method B
A.3.3.1 General <\/td>\n<\/tr>\n
31<\/td>\nA.3.3.2 Test sample preparation
A.3.3.3 Procedure <\/td>\n<\/tr>\n
32<\/td>\nA.3.3.4 Expression of results
A.3.4 Method C
A.3.4.1 General
A.3.4.2 Procedure <\/td>\n<\/tr>\n
33<\/td>\nA.4 Additional guidance on special sample preparation procedures
A.4.1 Biodegradable polymers
A.4.2 Inorganic materials: Wear debris from metals, alloys and ceramics
A.4.3 LMWC <\/td>\n<\/tr>\n
34<\/td>\nAnnex B: Flowchart for follow-up evaluation
Figure B.1 \u2014 Flowchart for follow-up evaluation <\/td>\n<\/tr>\n
35<\/td>\nAnnex C: Rationale of test systems
C.1 Genotoxicity tests <\/td>\n<\/tr>\n
36<\/td>\nC.2 Carcinogenicity tests
C.3 Reproductive\/developmental toxicity tests <\/td>\n<\/tr>\n
37<\/td>\nAnnex D: Cell transformation test systems <\/td>\n<\/tr>\n
38<\/td>\nAnnex E: Considerations for carcinogenicity studies performed as implantation studies
E.1 Foreign body carcinogenesis
E.2 Animal welfare considerations <\/td>\n<\/tr>\n
39<\/td>\nAnnex F: In vitro tests for embryo toxicity
Table F.1 \u2014 Criteria defined by the management team of the study to evaluate test performance <\/td>\n<\/tr>\n
40<\/td>\nTable F.2 \u2014 Summary of the classification results (all data[88]) <\/td>\n<\/tr>\n
41<\/td>\nAnnex ZA: Relationship between this European Standard and the Essential Requirements of EU Directive 93\/42 EEC on medical devices
Table ZA.1 \u2014 Correspondence between this European Standard and Directive 93\/42\/EEC on medical devices <\/td>\n<\/tr>\n
43<\/td>\nAnnex ZB: Relationship between this European Standard and the Essential Requirements of EU Directive 90\/385\/EEC on active implantable medical devices
Table ZB.1 \u2014 Correspondence between this European Standard and Directive 90\/385\/EEC on active implantable medical devices <\/td>\n<\/tr>\n
44<\/td>\nBibliography <\/td>\n<\/tr>\n<\/table>\n","protected":false},"excerpt":{"rendered":"

ANSI\/AAMI\/ISO 10993-3:2014 – Biological evaluation of medical devices-Part 3: Tests for genotoxicity, carcinogenicity, and reproductive toxicity<\/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>\n50<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n","protected":false},"featured_media":197965,"template":"","meta":{"rank_math_lock_modified_date":false,"ep_exclude_from_search":false},"product_cat":[2654],"product_tag":[],"class_list":{"0":"post-197963","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\/197963","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\/197965"}],"wp:attachment":[{"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/media?parent=197963"}],"wp:term":[{"taxonomy":"product_cat","embeddable":true,"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/product_cat?post=197963"},{"taxonomy":"product_tag","embeddable":true,"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/product_tag?post=197963"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}