BSI PD ISO/TR 21582:2021
$142.49
Pyrogenicity. Principles and methods for pyrogen testing of medical devices
| Published By | Publication Date | Number of Pages |
| BSI | 2021 | 26 |
This document specifies the principles and methods for pyrogen testing of medical devices and their materials.
PDF Catalog
| PDF Pages | PDF Title |
|---|---|
| 2 | National foreword |
| 6 | Foreword |
| 7 | Introduction |
| 9 | 1 Scope 2 Normative references 3 Terms and definitions |
| 10 | 4 Abbreviated terms |
| 11 | 5 Characterization of pyrogen 5.1 General 5.2 Bacterial endotoxin 5.3 Microbial components other than endotoxin |
| 12 | 5.4 Pro-inflammatory cytokines 5.5 Chemical agents and other pyrogens |
| 13 | 5.6 Principle of febrile reaction 6 Assessment of pyrogenicity 6.1 General 6.2 Bacterial endotoxin test (BET) 6.2.1 General |
| 14 | 6.2.2 Principle of LAL reaction 6.2.3 General procedure of BET 6.2.4 Properties of the BET |
| 15 | 6.3 Rabbit pyrogen test 6.3.1 General 6.3.2 Principle of the rabbit test 6.3.3 Procedure of the rabbit test 6.3.4 Characteristic of the rabbit test |
| 16 | 6.4 Human cell-based pyrogen test (HCPT) 6.4.1 General 6.4.2 Principle of the HCPT 6.4.3 Selection of human cells |
| 17 | 6.4.4 Selection of marker cytokine 6.4.5 Procedure of HCPT |
| 18 | 6.4.6 Characteristic of the HCPT |
| 19 | 6.4.7 Validation study 7 Conclusion |
| 20 | Bibliography |
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