{"id":198213,"date":"2024-10-19T12:37:04","date_gmt":"2024-10-19T12:37:04","guid":{"rendered":"https:\/\/pdfstandards.shop\/product\/uncategorized\/aami-10993-10-2010-ra-2014\/"},"modified":"2024-10-25T05:10:14","modified_gmt":"2024-10-25T05:10:14","slug":"aami-10993-10-2010-ra-2014","status":"publish","type":"product","link":"https:\/\/pdfstandards.shop\/product\/publishers\/aami\/aami-10993-10-2010-ra-2014\/","title":{"rendered":"AAMI 10993 10 2010 RA 2014"},"content":{"rendered":"

Describes the procedure for the assessment of medical devices and their constituent materials with regard to their potential to produce irritation and skin sensitization. Includes: a) pretest considerations for irritation, including in silico and in vitro methods for dermal exposure; b) details of in vivo (irritation and sensitization) test procedures, and; c) key factors for the interpretation of the results. Instructions are given in Annex A for the preparation of materials specifically in relation to the above tests. In Annex B several special irritation tests are described for application of medical devices in areas other than skin.<\/p>\n

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1<\/td>\nANSI\/AAMI\/ISO 10993-10:2010\/(R)2014, Biological evaluation of medical devices \u2014 Part 10: Tests for irritation and skin sensitization <\/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
10<\/td>\nBackground of ANSI\/AAMI adoption of ISO 10993-10:2010 <\/td>\n<\/tr>\n
11<\/td>\nForeword <\/td>\n<\/tr>\n
13<\/td>\nIntroduction <\/td>\n<\/tr>\n
15<\/td>\n1 Scope
2 Normative references <\/td>\n<\/tr>\n
16<\/td>\n3 Terms and definitions <\/td>\n<\/tr>\n
18<\/td>\n4 General principles\u00a0\u2014 Step-wise approach <\/td>\n<\/tr>\n
19<\/td>\n5 Pretest considerations
5.1 General
5.2 Types of material
5.2.1 Initial considerations
5.2.2 Ceramics, metals and alloys <\/td>\n<\/tr>\n
20<\/td>\n5.2.3 Polymers
5.2.4 Biologically derived materials
5.3 Information on chemical composition
5.3.1 General
5.3.2 Existing data sources <\/td>\n<\/tr>\n
21<\/td>\n6 Irritation tests
6.1 In\u00a0vitro irritation tests
6.2 In\u00a0vivo irritation tests\u00a0\u2014 Factors to be considered in design and selection of in\u00a0vivo tests <\/td>\n<\/tr>\n
22<\/td>\n6.3 Animal irritation test
6.3.1 Principle
6.3.2 Test material
6.3.3 Animals and husbandry <\/td>\n<\/tr>\n
23<\/td>\n6.3.4 Test procedure
6.3.4.1 Preparation of animals
6.3.4.2 Application of test sample
6.3.4.2.1 Application of powder or liquid sample <\/td>\n<\/tr>\n
24<\/td>\n6.3.4.2.2 Application of extracts and extract vehicle
6.3.4.2.3 Application of solid sample <\/td>\n<\/tr>\n
25<\/td>\n6.3.5 Observation of animals
6.3.5.1 General
6.3.5.2 Single-exposure test
6.3.5.3 Repeated-exposure test
6.3.6 Evaluation of results <\/td>\n<\/tr>\n
26<\/td>\n6.3.7 Test report
6.4 Animal intracutaneous (intradermal) reactivity test
6.4.1 Introduction <\/td>\n<\/tr>\n
27<\/td>\n6.4.2 Exclusion from test
6.4.3 Test sample
6.4.4 Animals and husbandry
6.4.5 Test procedure <\/td>\n<\/tr>\n
28<\/td>\n6.4.6 Observation of animals <\/td>\n<\/tr>\n
29<\/td>\n6.4.7 Evaluation of results
6.4.8 Test report <\/td>\n<\/tr>\n
30<\/td>\n6.5 Human skin irritation test
6.5.1 Introduction
6.5.2 Initial considerations <\/td>\n<\/tr>\n
31<\/td>\n7 Skin sensitization tests
7.1 Choice of test methods
7.2 Murine Local Lymph Node Assay (LLNA)
7.2.1 Principle
7.2.2 Test sample preparation <\/td>\n<\/tr>\n
32<\/td>\n7.2.3 Animals and husbandry
7.2.4 Test procedure <\/td>\n<\/tr>\n
33<\/td>\n7.2.5 Treatment groups
7.2.6 Determination of cellular proliferation and tissue preparation <\/td>\n<\/tr>\n
34<\/td>\n7.2.7 Results and interpretation
7.2.8 Test report <\/td>\n<\/tr>\n
35<\/td>\n7.3 Guinea pig assays for the detection of skin sensitization
7.3.1 Principle
7.3.2 Choice of test sample concentrations
7.3.3 Induction
7.3.4 Challenge
7.4 Important factors affecting the outcome of the test <\/td>\n<\/tr>\n
36<\/td>\n7.5 Guinea pig maximization test (GPMT)
7.5.1 Principle
7.5.2 Test sample preparation
7.5.3 Animals and husbandry <\/td>\n<\/tr>\n
37<\/td>\n7.5.4 Test procedure
7.5.4.1 Preparation
7.5.4.2 Preliminary tests <\/td>\n<\/tr>\n
38<\/td>\n7.5.4.3 Main test
7.5.4.3.1 Intradermal induction phase
7.5.4.3.2 Topical induction phase <\/td>\n<\/tr>\n
39<\/td>\n7.5.4.3.3 Challenge phase
7.5.5 Observation of animals
7.5.6 Evaluation of results
7.5.7 Test report <\/td>\n<\/tr>\n
40<\/td>\n7.6 Closed-patch test (Buehler test)
7.6.1 Principle
7.6.2 Test sample preparation
7.6.3 Animals and husbandry
7.6.4 Test procedure
7.6.4.1 Preparation
7.6.4.2 Preliminary tests <\/td>\n<\/tr>\n
41<\/td>\n7.6.4.3 Main test
7.6.4.3.1 Induction phase
7.6.4.3.2 Challenge phase
7.6.5 Observation of animals <\/td>\n<\/tr>\n
42<\/td>\n7.6.6 Evaluation of results
7.6.7 Test report
8 Key factors in interpretation of test results <\/td>\n<\/tr>\n
44<\/td>\nAnnex A Preparation of materials for irritation\/sensitization testing
A.1 General
A.2 Materials for direct-contact exposure
A.2.1 Solid test materials
A.2.2 Liquid test materials
A.3 Extracts of test materials <\/td>\n<\/tr>\n
45<\/td>\nA.4 Solvents
A.5 Sterile test materials <\/td>\n<\/tr>\n
46<\/td>\nAnnex B Special irritation tests
B.1 General
B.2 Ocular irritation test
B.2.1 General
B.2.2 Principle
B.2.3 Exclusion from test
B.2.4 Test material <\/td>\n<\/tr>\n
47<\/td>\nB.2.5 Animals and husbandry
B.2.6 Test procedure
B.2.7 Observation of animals <\/td>\n<\/tr>\n
50<\/td>\nB.2.8 Evaluation of results <\/td>\n<\/tr>\n
51<\/td>\nB.2.9 Test report
B.3 Oral mucosa irritation test
B.3.1 General
B.3.2 Principle
B.3.3 Exclusion from test
B.3.4 Test material
B.3.5 Animals and husbandry <\/td>\n<\/tr>\n
52<\/td>\nB.3.6 Test procedure
B.3.7 Observation of animals <\/td>\n<\/tr>\n
53<\/td>\nB.3.8 Assessment of results
B.3.8.1 Macroscopic evaluation
B.3.8.2 Histological evaluation <\/td>\n<\/tr>\n
54<\/td>\nB.3.9Test report <\/td>\n<\/tr>\n
56<\/td>\nB.4 Penile irritation test
B.4.1 General
B.4.2 Principle
B.4.3 Exclusion from test
B.4.4 Test sample
B.4.5 Animals and husbandry
B.4.6 Test procedure <\/td>\n<\/tr>\n
57<\/td>\nB.4.7 Observation of animals
B.4.8 Assessment of results
B.4.8.1 Macroscopic evaluation
B.4.8.2 Histological evaluation <\/td>\n<\/tr>\n
58<\/td>\nB.4.9 Test report
B.5 Rectal irritation test
B.5.1 General
B.5.2 Principle
B.5.3 Exclusion from test
B.5.4 Test material
B.5.5 Animals and husbandry <\/td>\n<\/tr>\n
59<\/td>\nB.5.6 Test procedure
B.5.7 Observation of animals
B.5.8 Evaluation of results
B.5.8.1 Macroscopic evaluation <\/td>\n<\/tr>\n
60<\/td>\nB.5.8.2 Histological evaluation
B.5.9 Test report
B.6 Vaginal irritation test
B.6.1 General <\/td>\n<\/tr>\n
61<\/td>\nB.6.2 Principle
B.6.3 Exclusion from test
B.6.4 Test material
B.6.5 Animals and husbandry
B.6.6 Test procedure <\/td>\n<\/tr>\n
62<\/td>\nB.6.7 Observation of animals
B.6.8 Evaluation of results
B.6.8.1 Macroscopic evaluation
B.6.8.2 Histological evaluation
B.6.9 Test report <\/td>\n<\/tr>\n
64<\/td>\nAnnex C Human skin irritation test
C.1 General
C.2 Principle
C.3 Description of the method
C.3.1 Selection of human volunteers
C.3.2 Preparation of doses <\/td>\n<\/tr>\n
65<\/td>\nC.3.3 Procedure
C.3.3.1 Number of volunteers
C.3.3.2 Application of the test material
C.3.3.3 Duration of exposure
C.3.3.4 Limited exposure
C.3.3.5 Clinical observation and grading of skin reactions <\/td>\n<\/tr>\n
66<\/td>\nC.3.3.6 Rationale for and selection of a concurrent positive control substance
C.4 Data and reporting
C.4.1 Data
C.4.2 Data evaluation\/interpretation <\/td>\n<\/tr>\n
67<\/td>\nC.4.3 Test report <\/td>\n<\/tr>\n
68<\/td>\nAnnex D In vitro tests for skin irritation
D.1 Background information <\/td>\n<\/tr>\n
69<\/td>\nD.2 Principle of the in vitro skin irritation tests
D.2.1 General
D.2.2 General model characteristics
D.2.3 Functional model requirements
D.2.3.1 General
D.2.3.2 Viability <\/td>\n<\/tr>\n
70<\/td>\nD.2.3.3 Barrier function
D.2.3.4 Morphology
D.2.3.5 Reproducibility
D.2.3.6 Quality controls (QC) of the model
D.3 Test material <\/td>\n<\/tr>\n
71<\/td>\nD.4 Test procedures <\/td>\n<\/tr>\n
72<\/td>\nD.5 Results and interpretation <\/td>\n<\/tr>\n
73<\/td>\nD.6 Test report <\/td>\n<\/tr>\n
74<\/td>\nAnnex E Method for the preparation of extracts from polymeric test materials
E.1 General
E.2 Preparation method
E.2.1 Preliminary extraction
E.2.2 Final extraction
E.2.2.1 General <\/td>\n<\/tr>\n
75<\/td>\nE.2.2.2 Test sample preparation according to Method 1
E.2.2.3 Test sample preparation according to Method 2 <\/td>\n<\/tr>\n
76<\/td>\nE.3 Guinea pig maximization test (GPMT)
E.3.1 General
E.3.2 Challenge phase <\/td>\n<\/tr>\n
77<\/td>\nAnnex F Background information
F.1 Irritation tests <\/td>\n<\/tr>\n
78<\/td>\nF.2 Sensitization tests for skin sensitization <\/td>\n<\/tr>\n
81<\/td>\nBibliography <\/td>\n<\/tr>\n<\/table>\n","protected":false},"excerpt":{"rendered":"

ANSI\/AAMI\/ISO 10993-10:2010\/(R)2014 – Biological evaluation of medical devices-Part 10: Tests for irritation and skin sensitization<\/b><\/p>\n\n\n\n\n
Published By<\/td>\nPublication Date<\/td>\nNumber of Pages<\/td>\n<\/tr>\n
AAMI<\/b><\/a><\/td>\n2010<\/td>\n88<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n","protected":false},"featured_media":198216,"template":"","meta":{"rank_math_lock_modified_date":false,"ep_exclude_from_search":false},"product_cat":[2654],"product_tag":[],"class_list":{"0":"post-198213","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\/198213","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\/198216"}],"wp:attachment":[{"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/media?parent=198213"}],"wp:term":[{"taxonomy":"product_cat","embeddable":true,"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/product_cat?post=198213"},{"taxonomy":"product_tag","embeddable":true,"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/product_tag?post=198213"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}