AAMI 10993 5 2009 RA 2014
$93.55
ANSI/AAMI/ISO 10993-5:2009/(R)2014 – Biological evaluation of medical devices-Part 5: Tests for in vitro cytotoxicity
| Published By | Publication Date | Number of Pages |
| AAMI | 2009 | 49 |
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.
PDF Catalog
| PDF Pages | PDF Title |
|---|---|
| 1 | ANSI/AAMI/ISO 10993-5:2009/(R)2014, Biological evaluation of medical devices —Part 5: Tests for in vitro cytotoxicity |
| 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 |
| 9 | Background of AAMI adoption of ISO 10993-5:2009 |
| 10 | Foreword |
| 12 | Introduction |
| 13 | 1 Scope 2 Normative references 3 Terms and definitions |
| 14 | 4 Sample and control preparation 4.1 General |
| 15 | 4.2 Preparation of liquid extracts of material 4.2.1 Principles of extraction 4.2.2 Extraction vehicle 4.2.3 Extraction conditions |
| 16 | 4.3 Preparation of material for direct-contact tests 4.3.1 Form of test samples 4.3.2 Sterility of test samples |
| 17 | 4.3.3 Liquid test samples 4.3.4 Absorbent test samples 4.4 Preparation of controls 5 Cell lines |
| 18 | 6 Culture medium 7 Preparation of cell stock culture 8 Test procedures 8.1 Number of replicates 8.2 Test on extracts |
| 19 | 8.3 Test by direct contact |
| 20 | 8.4 Test by indirect contact 8.4.1 Agar diffusion |
| 21 | 8.4.2 Filter diffusion 8.5 Determination of cytotoxicity |
| 23 | 9 Test report 10 Assessment of results |
| 25 | Annex 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 |
| 26 | A.2.2.3 Chemicals, media and sera |
| 27 | A.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 |
| 28 | A.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) |
| 29 | A.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 |
| 31 | A.2.4 Data analysis |
| 33 | Annex 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 |
| 34 | B.2.2.3 Chemicals, media and sera B.2.2.4 Preparations B.2.2.4.1 General |
| 35 | B.2.2.4.2 Media B.2.2.4.3 5% Giemsa solution B.2.2.4.4 Preparation of sample extract |
| 36 | B.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 |
| 37 | B.2.3.7 Presentation of results B.2.4 Test report |
| 38 | Annex 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 |
| 39 | C.2.2.3 Chemicals, media and sera C.2.2.4 Preparations C.2.2.4.1 General C.2.2.4.2 Media |
| 40 | C.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 |
| 41 | C.2.3.4 Test procedure |
| 42 | C.2.4 Data recording C.2.5 Data analysis |
| 44 | Annex 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 |
| 45 | D.2.2.3 Chemicals, media and sera D.2.2.4 Preparations D.2.2.4.1 General D.2.2.4.2 Media |
| 46 | D.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 |
| 47 | D.2.3.4 Test procedure |
| 48 | D.2.4 Data recording D.2.5 Data analysis |
| 49 | Bibliography |
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