BS EN ISO 10993-10:2013:2014 Edition
$215.11
Biological evaluation of medical devices – Tests for irritation and skin sensitization
| Published By | Publication Date | Number of Pages |
| BSI | 2014 | 80 |
PDF Catalog
| PDF Pages | PDF Title |
|---|---|
| 5 | Annex ZA (informative) Relationship between this European Standard and the Essential Requirements of EU Directive 93/42/EEC on Medical Devices |
| 6 | Annex ZB (informative) Relationship between this European Standard and the Essential Requirements of EU Directive 90/385/EEC on Active Implantable Medical Devices |
| 11 | Scope Normative references |
| 12 | Terms and definitions |
| 14 | General principles — Step-wise approach Pretest considerations General |
| 15 | Types of material Initial considerations Ceramics, metals and alloys Polymers Biologically derived materials Information on chemical composition General Existing data sources |
| 16 | Irritation tests In vitro irritation tests In vivo irritation tests — Factors to be considered in desig |
| 17 | Animal irritation test Principle Test material Animals and husbandry |
| 18 | Test procedure Preparation of animals Application of test sample Application of powder or liquid sample |
| 19 | Application of extracts and extract vehicle Application of solid sample |
| 20 | Observation of animals General Single-exposure test Repeated-exposure test Evaluation of results |
| 21 | Test report Animal intracutaneous (intradermal) reactivity test Introduction Exclusion from test Test sample |
| 22 | Animals and husbandry Test procedure |
| 23 | Observation of animals Evaluation of results |
| 24 | Test report Human skin irritation test Introduction Initial considerations |
| 25 | Skin sensitization tests Choice of test methods Murine Local Lymph Node Assay (LLNA) Principle |
| 26 | Test sample preparation Animals and husbandry Test procedure |
| 27 | Treatment groups Determination of cellular proliferation and tissue preparati |
| 28 | Results and interpretation Test report Guinea pig assays for the detection of skin sensitization Principle |
| 29 | Choice of test sample concentrations Induction Challenge Important factors affecting the outcome of the test |
| 30 | Guinea pig maximization test (GPMT) Principle Test sample preparation Animals and husbandry Test procedure Preparation |
| 31 | Preliminary tests Main test Intradermal induction phase |
| 32 | Topical induction phase Challenge phase Observation of animals |
| 33 | Evaluation of results Test report Closed-patch test (Buehler test) Principle Test sample preparation Animals and husbandry |
| 34 | Test procedure Preparation Preliminary tests Main test Induction phase Challenge phase |
| 35 | Observation of animals Evaluation of results Test report |
| 36 | Key factors in interpretation of test results |
