AAMI TIR22442 4 2011 RA 2016
$93.55
AAMI/ISO TIR22442-4:2011/(R)2016 – Medical devices utilizing animal tissues and their derivatives-Part 4: Principles for elimination and/or inactivation of transmissible spongiform encephalopathy (TSE) agents and validation assays for those processes
| Published By | Publication Date | Number of Pages |
| AAMI | 2011 | 30 |
Adresses methods of elimination and inactivation of transmissible spongiform encephalopathies (TSE agents) from animal tissues to be used in medical devices. The methods addressed will include those designed for: [1] inactivating infectivity (preferred method to reduce opportunities for cross-contamination); and [2] physically removing TSE agents (without complete inactivation). Includes inactivation and elimination methods to be used in the product manufacturing process and in facilities and equipment designed for utilizing animal tissue products.
PDF Catalog
| PDF Pages | PDF Title |
|---|---|
| 3 | Title page |
| 4 | Copyright information |
| 5 | AAMI Technical Information Report ANSI Technical Report |
| 6 | Contents |
| 7 | Glossary of equivalent standards |
| 9 | Committee representation |
| 11 | Background of AAMI Adoption of ISO/TR 22442-4:2010 |
| 12 | Foreword |
| 13 | Introduction |
| 15 | 1 Scope 2 Normative references |
| 16 | 3 Terms and definitions 4 Elimination of TSE agents: basic considerations 4.1 General 4.1.1 TSEs of concern 4.1.2 Animal tissues of concern |
| 17 | 4.1.3 Tissues infected with TSE agents 5 Potential methods to eliminate TSE agents 5.1 Methods for inactivating infectivity 5.1.1 General 5.1.2 Physical methods for inactivating TSE infectivity 5.1.2.1 Heat |
| 18 | 5.1.2.2 Radiation 5.1.3 Chemical methods for inactivating TSE infectivity 5.1.3.1 Alkaline hydrolysis treatments |
| 19 | 5.1.3.2 Acid treatments 5.1.3.3 Halide and other oxidizing agent treatments 5.1.3.4 Treatments with phenolic disinfectants 5.1.3.5 Protease treatments 5.1.3.6 Guanidine and other chaotropic chemical treatments 5.1.3.7 Combined treatments |
| 20 | 5.1.3.8 Potential processes to remove TSE agents from non-viable tissue-derived medical devices that have been investigated 5.1.3.9 Ineffective treatments 5.2 Methods for removing TSE infectivity without inactivating infectivity 6 Experimental validation of methods for eliminating TSE agents from medical devices utilizing non-viable animal tissues 6.1 General 6.2 Defining of product families for purposes of designing TSE process validation studies |
| 21 | 6.3 Selection and testing of product for establishing and verifying the infecting dose of TSE agent 6.4 TSE agent spiking materials 6.5 Availability of bioassay animals (conventional and transgenic mice, other rodents, farm animals) |
| 22 | 6.6 Potential development of cell culture assays for infectivity 6.7 Correlations between PrPTSE and infectivity assays |
| 23 | 6.8 Reductions in infectivity compared with failure to detect at limits of detection 6.9 Determining numbers of replicate validations needed to support inferences of reduction in infectivity rather than variations in assay performance 6.10 Requirements for step-wise reductions in PrPTSE and infectivity verses whole-process validation |
| 24 | Bibliography |
