AAMI TIR17 2017
$149.56
AAMI TIR17:2017 – Compatibility of materials subject to sterilization
| Published By | Publication Date | Number of Pages |
| AAMI | 2017 | 123 |
This technical information report provides guidance for health care product manufacturers in the qualification of polymeric materials, ceramics, and metals for use in health care products that are sterilized by the following modalities: a) radiation (gamma, electron beam, or x-ray); b) ethylene oxide; c) moist heat (steam); d) dry heat; e) hydrogen peroxide; f) nitrogen dioxide, g) peracetic acid vapor, h) liquid peracetic acid, and i) hydrogen peroxide–ozone. Annexes address the specific sterilization modality concerns.
PDF Catalog
| PDF Pages | PDF Title |
|---|---|
| 1 | AAMI TIR17:2017; Compatibility of materials subject to sterilization |
| 3 | Title page |
| 4 | AAMI Technical Information Report Copyright information |
| 5 | Contents |
| 6 | Committee representation |
| 9 | Foreword |
| 11 | 1 Scope |
| 12 | 2 Definitions, symbols, and abbreviations |
| 14 | 3 Selection of materials 3.1 General considerations 3.2 Guidance specific to different sterilization modalities 3.2.1 Radiation sterilization (gamma, electron beam, x-ray) 3.2.1.1 Background 3.2.1.2 Typical use |
| 15 | 3.2.1.3 Process parameters and variability 3.2.1.4 General material compatibility |
| 19 | 3.2.1.5 Pharmaceuticals and biologics 3.2.1.6 Packaging 3.2.2 Ethylene oxide (EO) sterilization 3.2.2.1 Background |
| 20 | 3.2.2.2 Typical uses 3.2.2.3 Process parameters and variability |
| 21 | 3.2.2.4 General material compatibility 3.2.2.5 Pharmaceuticals and biologics |
| 22 | 3.2.2.6 Packaging |
| 23 | 3.2.3 Moist heat (steam) sterilization 3.2.3.1 Background 3.2.3.2 Typical uses 3.2.3.3 Process parameters and variability |
| 24 | 3.2.3.4 General material compatibility |
| 25 | 3.2.3.5 Pharmaceuticals and biologics 3.2.3.6 Packaging |
| 26 | 3.2.4 Dry heat sterilization 3.2.4.1 Background 3.2.4.2 Typical uses 3.2.4.3 Process parameters and variability |
| 27 | 3.2.4.4 General material compatibility |
| 28 | 3.2.4.5 Pharmaceuticals and biologics 3.2.4.6 Packaging |
| 29 | 3.2.5 Hydrogen peroxide sterilization 3.2.5.1 Background 3.2.5.2 Typical uses 3.2.5.3 Process parameters and variability |
| 30 | 3.2.5.4 General material compatibility |
| 31 | 3.2.5.5 Pharmaceuticals and biologics |
| 32 | 3.2.5.6 Packaging 3.2.6 Nitrogen dioxide sterilization 3.2.6.1 Background |
| 33 | 3.2.6.2 Typical uses 3.2.6.3 Process parameters and variability 3.2.6.4 General material compatibility |
| 34 | 3.2.6.5 Pharmaceuticals and biologics |
| 35 | 3.2.6.6 Packaging 3.2.7 Peracetic acid vapor sterilization 3.2.7.1 Background 3.2.7.2 Typical uses 3.2.7.3 Process parameters and variability |
| 36 | 3.2.7.4 General material compatibility |
| 37 | 3.2.7.5 Pharmaceuticals and biologics |
| 38 | 3.2.7.6 Packaging 3.2.8 Liquid peracetic acid sterilization 3.2.8.1 Background 3.2.8.2 Typical uses 3.2.8.3 Process parameters and variability |
| 39 | 3.2.8.4 General material compatibility |
| 40 | 3.2.8.5 Pharmaceuticals and biologics 3.2.8.6 Packaging 3.2.9 Hydrogen peroxide–ozone sterilization 3.2.9.1 Background 3.2.9.2 Typical uses 3.2.9.3 Process parameters and variability |
| 41 | 3.2.9.4 General material compatibility |
| 42 | 3.2.9.5 Pharmaceuticals and biologics 3.2.9.6 Packaging |
| 43 | 4 Manufacturing process and design considerations 4.1 General considerations 4.2 Impact of manufacturing processing vs. impact of sterilization |
| 44 | 4.2.1 Manufacturing processing considerations for injection molding |
| 45 | 4.3 Product design considerations |
| 46 | 5 Material testing 5.1 General considerations 5.2 Definition of requirements for product functionality 5.3 Definition of worst-case sterilization processing conditions 5.3.1 General considerations 5.3.2 Considerations for processing conditions unique to radiation sterilization |
| 48 | 5.4 Product functionality testing |
| 49 | 5.5 Material biocompatibility 5.5.1 General considerations |
| 50 | 5.5.2 Biocompatibility concerns regarding sterilant residuals 5.6 Packaging considerations |
| 52 | 6 Accelerated aging programs 6.1 Background 6.2 New guidance |
| 53 | Annex A (informative) Radiation sterilization—Material compatibility fundamentals |
| 59 | Annex B (informative) Ethylene oxide sterilization—Material compatibility fundamentals |
| 65 | Annex C (informative) Moist heat sterilization—Material compatibility fundamentals |
| 74 | Annex D (informative) Dry heat sterilization—Material compatibility fundamentals |
| 82 | Annex E (informative) Hydrogen peroxide sterilization—Material qualification fundamentals |
| 87 | Annex F (informative) Nitrogen dioxide sterilization—Material qualification fundamentals |
| 92 | Annex G (informative) Peracetic acid (PA) vapor sterilization—Material compatibility fundamentals |
| 97 | Annex H (informative) Liquid peracetic acid sterilization—Material compatibility fundamentals |
| 101 | Annex I (informative) Hydrogen peroxide–ozone sterilization—Material compatibility fundamentals |
| 105 | Annex J (informative) Accelerated aging programs |
| 111 | Annex K (informative) Example of a device evaluation process |
| 113 | Annex L (informative) Material abbreviations |
| 114 | Bibliography |
