BS EN ISO 10993-10:2010:2012 Edition
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Biological evaluation of medical devices – Tests for irritation and skin sensitization
| Published By | Publication Date | Number of Pages |
| BSI | 2012 | 76 |
This part of ISO 10993 describes the procedure for the assessment of medical devices and their constituent materials with regard to their potential to produce irritation and skin sensitization.
This part of ISO 10993 includes:
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pretest considerations for irritation, including in silico and in vitro methods for dermal exposure;
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details of in vivo (irritation and sensitization) test procedures;
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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 |
|---|---|
| 8 | Scope Normative references Scope Normative references |
| 9 | Terms and definitions Terms and definitions |
| 11 | General principles — Step-wise approach Pretest considerations General General principles — Step-wise approach Pretest considerations General |
| 12 | Types of material Initial considerations Ceramics, metals and alloys Polymers Biologically derived materials Information on chemical composition General Existing data sources Types of material Initial considerations Ceramics, metals and alloys Polymers Biologically derived materials Information on chemical composition General Existing data sources |
| 13 | Irritation tests In vitro irritation tests In vivo irritation tests — Factors to be considered in desig Irritation tests In vitro irritation tests In vivo irritation tests — Factors to be considered in desig |
| 14 | Animal irritation test Principle Test material Animals and husbandry Animal irritation test Principle Test material Animals and husbandry |
| 15 | Test procedure Preparation of animals Application of test sample Application of powder or liquid sample Test procedure Preparation of animals Application of test sample Application of powder or liquid sample |
| 16 | Application of extracts and extract vehicle Application of solid sample Application of extracts and extract vehicle Application of solid sample |
| 17 | Observation of animals General Single-exposure test Repeated-exposure test Evaluation of results Observation of animals General Single-exposure test Repeated-exposure test Evaluation of results |
| 18 | Test report Animal intracutaneous (intradermal) reactivity test Introduction Exclusion from test Test sample Test report Animal intracutaneous (intradermal) reactivity test Introduction Exclusion from test Test sample |
| 19 | Animals and husbandry Test procedure Animals and husbandry Test procedure |
| 20 | Observation of animals Evaluation of results Observation of animals Evaluation of results |
| 21 | Test report Human skin irritation test Introduction Initial considerations Test report Human skin irritation test Introduction Initial considerations |
| 22 | Skin sensitization tests Choice of test methods Murine Local Lymph Node Assay (LLNA) Principle Skin sensitization tests Choice of test methods Murine Local Lymph Node Assay (LLNA) Principle |
| 23 | Test sample preparation Animals and husbandry Test procedure Test sample preparation Animals and husbandry Test procedure |
| 24 | Treatment groups Determination of cellular proliferation and tissue preparati Treatment groups Determination of cellular proliferation and tissue preparati |
| 25 | Results and interpretation Test report Guinea pig assays for the detection of skin sensitization Principle Results and interpretation Test report Guinea pig assays for the detection of skin sensitization Principle |
| 26 | Choice of test sample concentrations Induction Challenge Important factors affecting the outcome of the test Choice of test sample concentrations Induction Challenge Important factors affecting the outcome of the test |
| 27 | Guinea pig maximization test (GPMT) Principle Test sample preparation Animals and husbandry Test procedure Preparation Guinea pig maximization test (GPMT) Principle Test sample preparation Animals and husbandry Test procedure Preparation |
| 28 | Preliminary tests Main test Intradermal induction phase Preliminary tests Main test Intradermal induction phase |
| 29 | Topical induction phase Challenge phase Observation of animals Topical induction phase Challenge phase Observation of animals |
| 30 | Evaluation of results Test report Closed-patch test (Buehler test) Principle Test sample preparation Animals and husbandry Evaluation of results Test report Closed-patch test (Buehler test) Principle Test sample preparation Animals and husbandry |
| 31 | Test procedure Preparation Preliminary tests Main test Induction phase Challenge phase Test procedure Preparation Preliminary tests Main test Induction phase Challenge phase |
| 32 | Observation of animals Evaluation of results Test report Observation of animals Evaluation of results Test report |
| 33 | Key factors in interpretation of test results Key factors in interpretation of test results |
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