{"id":198053,"date":"2024-10-19T12:36:32","date_gmt":"2024-10-19T12:36:32","guid":{"rendered":"https:\/\/pdfstandards.shop\/product\/uncategorized\/aami-10993-5-2009-ra-2014\/"},"modified":"2024-10-25T05:09:46","modified_gmt":"2024-10-25T05:09:46","slug":"aami-10993-5-2009-ra-2014","status":"publish","type":"product","link":"https:\/\/pdfstandards.shop\/product\/publishers\/aami\/aami-10993-5-2009-ra-2014\/","title":{"rendered":"AAMI 10993 5 2009 RA 2014"},"content":{"rendered":"

AAMI\/AAMI\/ISO 10993-5 describes test methods to assess the in vitro cytotoxicity of devices. These methods specify the incubation of cultured cells either directly or through diffusion with extracts of the device, and\/or in contact with a device. These methods are designed to determine the biological response of mammalian cells in vitro using appropriate biological parameters.<\/p>\n

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PDF Pages<\/th>\nPDF Title<\/th>\n<\/tr>\n
1<\/td>\nANSI\/AAMI\/ISO 10993-5:2009\/(R)2014, Biological evaluation of medical devices \u2014Part 5: Tests for in vitro cytotoxicity <\/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
8<\/td>\nCommittee representation <\/td>\n<\/tr>\n
9<\/td>\nBackground of AAMI adoption of ISO 10993-5:2009 <\/td>\n<\/tr>\n
10<\/td>\nForeword <\/td>\n<\/tr>\n
12<\/td>\nIntroduction <\/td>\n<\/tr>\n
13<\/td>\n1 Scope
2 Normative references
3 Terms and definitions <\/td>\n<\/tr>\n
14<\/td>\n4 Sample and control preparation
4.1 General <\/td>\n<\/tr>\n
15<\/td>\n4.2 Preparation of liquid extracts of material
4.2.1 Principles of extraction
4.2.2 Extraction vehicle
4.2.3 Extraction conditions <\/td>\n<\/tr>\n
16<\/td>\n4.3 Preparation of material for direct-contact tests
4.3.1 Form of test samples
4.3.2 Sterility of test samples <\/td>\n<\/tr>\n
17<\/td>\n4.3.3 Liquid test samples
4.3.4 Absorbent test samples
4.4 Preparation of controls
5 Cell lines <\/td>\n<\/tr>\n
18<\/td>\n6 Culture medium
7 Preparation of cell stock culture
8 Test procedures
8.1 Number of replicates
8.2 Test on extracts <\/td>\n<\/tr>\n
19<\/td>\n8.3 Test by direct contact <\/td>\n<\/tr>\n
20<\/td>\n8.4 Test by indirect contact
8.4.1 Agar diffusion <\/td>\n<\/tr>\n
21<\/td>\n8.4.2 Filter diffusion
8.5 Determination of cytotoxicity <\/td>\n<\/tr>\n
23<\/td>\n9 Test report
10 Assessment of results <\/td>\n<\/tr>\n
25<\/td>\nAnnex A Neutral red uptake (NRU) cytotoxicity test
A.1 General
A.2 Experimental procedure
A.2.1 Basic procedure
A.2.2 Material
A.2.2.1 Cell line
A.2.2.2 Technical equipment <\/td>\n<\/tr>\n
26<\/td>\nA.2.2.3 Chemicals, media and sera <\/td>\n<\/tr>\n
27<\/td>\nA.2.2.4 Preparations
A.2.2.4.1 General
A.2.2.4.2 Media
A.2.2.4.3 Neutral red (NR) stock solution <\/td>\n<\/tr>\n
28<\/td>\nA.2.2.4.4 Neutral red (NR) medium
A.2.2.4.5 Ethanol\/acetic acid solution (NRdesorb)
A.2.2.4.6 Preparation of sample extract
A.2.3 Methods
A.2.3.1 General
A.2.3.2 Quality check of assay (I); positive control (PC) <\/td>\n<\/tr>\n
29<\/td>\nA.2.3.3 Quality check of assay (II); blank
A.2.3.4 Quality check of concentration-response
A.2.3.5 Concentrations of test sample extracts
A.2.3.5.1 Range finder experiment
A.2.3.5.2 Main experiment
A.2.3.6 Test procedure <\/td>\n<\/tr>\n
31<\/td>\nA.2.4 Data analysis <\/td>\n<\/tr>\n
33<\/td>\nAnnex B Colony formation cytotoxicity test
B.1 General
B.2 Experimental procedure
B.2.1 Basic procedure
B.2.2 Material
B.2.2.1 Cell Line
B.2.2.2 Technical equipment <\/td>\n<\/tr>\n
34<\/td>\nB.2.2.3 Chemicals, media and sera
B.2.2.4 Preparations
B.2.2.4.1 General <\/td>\n<\/tr>\n
35<\/td>\nB.2.2.4.2 Media
B.2.2.4.3 5% Giemsa solution
B.2.2.4.4 Preparation of sample extract <\/td>\n<\/tr>\n
36<\/td>\nB.2.3 Methods
B.2.3.1 General
B.2.3.2 Quality check of assay (I); positive control (PC) and negative control (NC)
B.2.3.3 Quality check of assay (II); blank
B.2.3.4 Quality check of concentration-response
B.2.3.5 Concentrations of test sample extracts
B.2.3.5.1 Range finder experiment
B.2.3.5.2 Main experiment
B.2.3.6 Test procedure <\/td>\n<\/tr>\n
37<\/td>\nB.2.3.7 Presentation of results
B.2.4 Test report <\/td>\n<\/tr>\n
38<\/td>\nAnnex C MTT cytotoxicity test
C.1 General
C.2 Experimental procedure
C.2.1 Basic procedure
C.2.2 Material
C.2.2.1 Cell line
C.2.2.2 Technical equipment <\/td>\n<\/tr>\n
39<\/td>\nC.2.2.3 Chemicals, media and sera
C.2.2.4 Preparations
C.2.2.4.1 General
C.2.2.4.2 Media <\/td>\n<\/tr>\n
40<\/td>\nC.2.2.4.3 MTT Solution
C.2.2.4.4 Preparation of sample extract
C.2.3 Methods
C.2.3.1 General
C.2.3.2 Quality check of assay (I); positive control (PC) and negative control (NC)
C.2.3.3 Quality check of assay (II); blank <\/td>\n<\/tr>\n
41<\/td>\nC.2.3.4 Test procedure <\/td>\n<\/tr>\n
42<\/td>\nC.2.4 Data recording
C.2.5 Data analysis <\/td>\n<\/tr>\n
44<\/td>\nAnnex D XTT cytotoxicity test
D.1 General
D.2 Experimental procedure
D.2.1 Basic procedure
D.2.2 Material
D.2.2.1 Cell line
D.2.2.2 Technical equipment <\/td>\n<\/tr>\n
45<\/td>\nD.2.2.3 Chemicals, media and sera
D.2.2.4 Preparations
D.2.2.4.1 General
D.2.2.4.2 Media <\/td>\n<\/tr>\n
46<\/td>\nD.2.2.4.3 XTT\/PMS solution
D.2.2.4.4 Preparation of sample extract
D.2.3 Methods
D.2.3.1 General
D.2.3.2 Quality check of assay (I); positive control (PC) and negative control (NC)
D.2.3.3 Quality check of assay (II); blank <\/td>\n<\/tr>\n
47<\/td>\nD.2.3.4 Test procedure <\/td>\n<\/tr>\n
48<\/td>\nD.2.4 Data recording
D.2.5 Data analysis <\/td>\n<\/tr>\n
49<\/td>\nBibliography <\/td>\n<\/tr>\n<\/table>\n","protected":false},"excerpt":{"rendered":"

ANSI\/AAMI\/ISO 10993-5:2009\/(R)2014 – Biological evaluation of medical devices-Part 5: Tests for in vitro cytotoxicity<\/b><\/p>\n\n\n\n\n
Published By<\/td>\nPublication Date<\/td>\nNumber of Pages<\/td>\n<\/tr>\n
AAMI<\/b><\/a><\/td>\n2009<\/td>\n49<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n","protected":false},"featured_media":198057,"template":"","meta":{"rank_math_lock_modified_date":false,"ep_exclude_from_search":false},"product_cat":[2654],"product_tag":[],"class_list":{"0":"post-198053","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\/198053","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\/198057"}],"wp:attachment":[{"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/media?parent=198053"}],"wp:term":[{"taxonomy":"product_cat","embeddable":true,"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/product_cat?post=198053"},{"taxonomy":"product_tag","embeddable":true,"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/product_tag?post=198053"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}