AAMI 10993 10 2010 RA 2014
$140.32
ANSI/AAMI/ISO 10993-10:2010/(R)2014 – Biological evaluation of medical devices-Part 10: Tests for irritation and skin sensitization
| Published By | Publication Date | Number of Pages |
| AAMI | 2010 | 88 |
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.
PDF Catalog
| PDF Pages | PDF Title |
|---|---|
| 1 | ANSI/AAMI/ISO 10993-10:2010/(R)2014, Biological evaluation of medical devices — Part 10: Tests for irritation and skin sensitization |
| 2 | Objectives and uses of AAMI standards and recommended practices |
| 3 | Title page |
| 4 | AAMI Standard Copyright information |
| 5 | Contents |
| 6 | Glossary of equivalent standards |
| 8 | Committee representation |
| 10 | Background of ANSI/AAMI adoption of ISO 10993-10:2010 |
| 11 | Foreword |
| 13 | Introduction |
| 15 | 1 Scope 2 Normative references |
| 16 | 3 Terms and definitions |
| 18 | 4 General principles — Step-wise approach |
| 19 | 5 Pretest considerations 5.1 General 5.2 Types of material 5.2.1 Initial considerations 5.2.2 Ceramics, metals and alloys |
| 20 | 5.2.3 Polymers 5.2.4 Biologically derived materials 5.3 Information on chemical composition 5.3.1 General 5.3.2 Existing data sources |
| 21 | 6 Irritation tests 6.1 In vitro irritation tests 6.2 In vivo irritation tests — Factors to be considered in design and selection of in vivo tests |
| 22 | 6.3 Animal irritation test 6.3.1 Principle 6.3.2 Test material 6.3.3 Animals and husbandry |
| 23 | 6.3.4 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 |
| 24 | 6.3.4.2.2 Application of extracts and extract vehicle 6.3.4.2.3 Application of solid sample |
| 25 | 6.3.5 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 |
| 26 | 6.3.7 Test report 6.4 Animal intracutaneous (intradermal) reactivity test 6.4.1 Introduction |
| 27 | 6.4.2 Exclusion from test 6.4.3 Test sample 6.4.4 Animals and husbandry 6.4.5 Test procedure |
| 28 | 6.4.6 Observation of animals |
| 29 | 6.4.7 Evaluation of results 6.4.8 Test report |
| 30 | 6.5 Human skin irritation test 6.5.1 Introduction 6.5.2 Initial considerations |
| 31 | 7 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 |
| 32 | 7.2.3 Animals and husbandry 7.2.4 Test procedure |
| 33 | 7.2.5 Treatment groups 7.2.6 Determination of cellular proliferation and tissue preparation |
| 34 | 7.2.7 Results and interpretation 7.2.8 Test report |
| 35 | 7.3 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 |
| 36 | 7.5 Guinea pig maximization test (GPMT) 7.5.1 Principle 7.5.2 Test sample preparation 7.5.3 Animals and husbandry |
| 37 | 7.5.4 Test procedure 7.5.4.1 Preparation 7.5.4.2 Preliminary tests |
| 38 | 7.5.4.3 Main test 7.5.4.3.1 Intradermal induction phase 7.5.4.3.2 Topical induction phase |
| 39 | 7.5.4.3.3 Challenge phase 7.5.5 Observation of animals 7.5.6 Evaluation of results 7.5.7 Test report |
| 40 | 7.6 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 |
| 41 | 7.6.4.3 Main test 7.6.4.3.1 Induction phase 7.6.4.3.2 Challenge phase 7.6.5 Observation of animals |
| 42 | 7.6.6 Evaluation of results 7.6.7 Test report 8 Key factors in interpretation of test results |
| 44 | Annex 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 |
| 45 | A.4 Solvents A.5 Sterile test materials |
| 46 | Annex 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 |
| 47 | B.2.5 Animals and husbandry B.2.6 Test procedure B.2.7 Observation of animals |
| 50 | B.2.8 Evaluation of results |
| 51 | B.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 |
| 52 | B.3.6 Test procedure B.3.7 Observation of animals |
| 53 | B.3.8 Assessment of results B.3.8.1 Macroscopic evaluation B.3.8.2 Histological evaluation |
| 54 | B.3.9Test report |
| 56 | B.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 |
| 57 | B.4.7 Observation of animals B.4.8 Assessment of results B.4.8.1 Macroscopic evaluation B.4.8.2 Histological evaluation |
| 58 | B.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 |
| 59 | B.5.6 Test procedure B.5.7 Observation of animals B.5.8 Evaluation of results B.5.8.1 Macroscopic evaluation |
| 60 | B.5.8.2 Histological evaluation B.5.9 Test report B.6 Vaginal irritation test B.6.1 General |
| 61 | B.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 |
| 62 | B.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 |
| 64 | Annex 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 |
| 65 | C.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 |
| 66 | C.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 |
| 67 | C.4.3 Test report |
| 68 | Annex D In vitro tests for skin irritation D.1 Background information |
| 69 | D.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 |
| 70 | D.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 |
| 71 | D.4 Test procedures |
| 72 | D.5 Results and interpretation |
| 73 | D.6 Test report |
| 74 | Annex 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 |
| 75 | E.2.2.2 Test sample preparation according to Method 1 E.2.2.3 Test sample preparation according to Method 2 |
| 76 | E.3 Guinea pig maximization test (GPMT) E.3.1 General E.3.2 Challenge phase |
| 77 | Annex F Background information F.1 Irritation tests |
| 78 | F.2 Sensitization tests for skin sensitization |
| 81 | Bibliography |
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