BSI PD ISO/TR 10993-55:2023
$142.49
Biological evaluation of medical devices – Interlaboratory study on cytotoxicity
| Published By | Publication Date | Number of Pages |
| BSI | 2023 | 32 |
PDF Catalog
| PDF Pages | PDF Title |
|---|---|
| 2 | National foreword |
| 6 | Foreword |
| 7 | Introduction |
| 9 | 1 Scope 2 Normative references 3 Terms and definitions 4 Participants 5 Materials and sample preparation |
| 10 | 6 Test procedures 7 Results 7.1 Neutral red uptake 7.1.1 General 7.1.2 Sodium lauryl sulfate as positive control |
| 11 | 7.1.3 Test samples |
| 12 | 7.2 Colony formation assay 7.2.1 General |
| 13 | 7.2.2 Negative reference material 7.2.3 Positive reference materials |
| 15 | 8 Assessment of results |
| 17 | Annex A (informative) Interlaboratory study protocol for the neutral red uptake cytotoxicity test |
| 25 | Annex B (informative) Interlaboratory study protocol for the colony formation cytotoxicity test |
| 31 | Bibliography |
