{"id":198051,"date":"2024-10-19T12:36:32","date_gmt":"2024-10-19T12:36:32","guid":{"rendered":"https:\/\/pdfstandards.shop\/product\/uncategorized\/aami-10993-6-2016\/"},"modified":"2024-10-25T05:09:46","modified_gmt":"2024-10-25T05:09:46","slug":"aami-10993-6-2016","status":"publish","type":"product","link":"https:\/\/pdfstandards.shop\/product\/publishers\/aami\/aami-10993-6-2016\/","title":{"rendered":"AAMI 10993 6 2016"},"content":{"rendered":"

Specifies test methods for the assessment of the local effects after implantation of biomaterials intended for use in medical devices.<\/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\n\n
PDF Pages<\/th>\nPDF Title<\/th>\n<\/tr>\n
1<\/td>\nANSI\/AAMI\/ISO 10993-6:2016;
\nBiological evaluation of medical devices\u2014Part 6: Tests for local effects after implantation <\/td>\n<\/tr>\n
2<\/td>\nObjectives and uses of AAMI standards and recommended practices <\/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
6<\/td>\nGlossary of equivalent standards <\/td>\n<\/tr>\n
7<\/td>\nCommittee representation <\/td>\n<\/tr>\n
9<\/td>\nBackground of AAMI adoption of ISO 10993-6:2016 <\/td>\n<\/tr>\n
10<\/td>\nForeword <\/td>\n<\/tr>\n
13<\/td>\n1 Scope
2 Normative references <\/td>\n<\/tr>\n
14<\/td>\n3 Terms and definitions
4 Common provisions for implantation test methods
4.1 General <\/td>\n<\/tr>\n
15<\/td>\n4.2 Preparation of samples for implantation
4.3 Study design
5 Test methods, general aspects
5.1 Tissue and implantation site <\/td>\n<\/tr>\n
16<\/td>\n5.2 Animals
5.3 Test periods <\/td>\n<\/tr>\n
18<\/td>\nTable 1\u2014Possible test periods for long-term implantation of biomaterials
5.4 Surgery and testing conditions <\/td>\n<\/tr>\n
19<\/td>\n5.5 Evaluation <\/td>\n<\/tr>\n
21<\/td>\n6 Test report
6.1 General
6.2 Test laboratory
6.3 Implant samples
6.4 Animals and implantation <\/td>\n<\/tr>\n
22<\/td>\n6.5 Retrieval and histological procedure
6.6 Macroscopic and microscopic evaluation
6.7 Final evaluation <\/td>\n<\/tr>\n
23<\/td>\nAnnex A (normative) Test methods for implantation in subcutaneous tissue
A.1 Field of application
A.2 Principle
A.3 Test samples
A.4 Test animals and implant sites <\/td>\n<\/tr>\n
24<\/td>\nA.5 Implantation procedure
A.6 Implantation period
A.7 Evaluation of biological response
A.8 Test report <\/td>\n<\/tr>\n
25<\/td>\nAnnex B (normative) Test method for implantation in muscle
B.1 Field of application
B.2 Principle
B.3 Test samples
B.4 Test animals and implant sites <\/td>\n<\/tr>\n
26<\/td>\nB.5 Implantation procedure
B.6 Implantation period
B.7 Evaluation of biological response
B.8 Format of test report <\/td>\n<\/tr>\n
27<\/td>\nAnnex C(normative)Test method for implantation in bone
C.1 Field of application
C.2 Principle
C.3 Test samples <\/td>\n<\/tr>\n
28<\/td>\nC.4 Test animals and implant sites
C.5 Implantation procedure <\/td>\n<\/tr>\n
29<\/td>\nC.6 Implantation period
C.7 Evaluation of biological response
C.8 Test report <\/td>\n<\/tr>\n
30<\/td>\nAnnex D(normative)Test method for implantation in brain tissue
D.1 Field of application
D.2 Principle
D.3 Test samples <\/td>\n<\/tr>\n
31<\/td>\nD.4 Test animals and implant sites
D.5 Implantation procedure <\/td>\n<\/tr>\n
32<\/td>\nD.6 Implantation period
D.7 Post-implantation observation
D.8 Evaluation of biological response <\/td>\n<\/tr>\n
33<\/td>\nTable D.1\u2014Examples brain biomarkers and stains <\/td>\n<\/tr>\n
34<\/td>\nD.9 Test report <\/td>\n<\/tr>\n
35<\/td>\nAnnex E (informative) Examples of evaluation of local biological effects after implantation
E.1 General
Table E.1\u2014An example of a histological evaluation system\u2014Cell type\/response <\/td>\n<\/tr>\n
36<\/td>\nTable E.2\u2014An example of a histological evaluation system\u2014Tissue responseResponseScore <\/td>\n<\/tr>\n
37<\/td>\nTable E.3\u2014Example of semiquantitative scoring scheme <\/td>\n<\/tr>\n
38<\/td>\nE.2 Conclusion
E.3 Comments
Table E.4\u2014An example of a histological evaluation system\u2014Neural tissue response <\/td>\n<\/tr>\n
39<\/td>\nBibliography <\/td>\n<\/tr>\n<\/table>\n","protected":false},"excerpt":{"rendered":"

ANSI\/AAMI\/ISO 10993-6:2016 – Biological evaluation of medical devices-Part 6: Tests for local effects after implantation<\/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>\n41<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n","protected":false},"featured_media":198056,"template":"","meta":{"rank_math_lock_modified_date":false,"ep_exclude_from_search":false},"product_cat":[2654],"product_tag":[],"class_list":{"0":"post-198051","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\/198051","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\/198056"}],"wp:attachment":[{"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/media?parent=198051"}],"wp:term":[{"taxonomy":"product_cat","embeddable":true,"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/product_cat?post=198051"},{"taxonomy":"product_tag","embeddable":true,"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/product_tag?post=198051"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}