AAMI TIR37137 2014
$75.64
ANSI/AAMI/ISO TIR37137:2014 – Cardiovascular biological evaluation of medical devices-Guidance for absorbable implants
| Published By | Publication Date | Number of Pages |
| AAMI | 2014 | 27 |
Provides interim part-by-part guidance on potential adjustments to various test methods within the 10993 series to account for the intentional release of soluble components or degradation products from absorbable medical devices.
PDF Catalog
| PDF Pages | PDF Title |
|---|---|
| 1 | ANSI/AAMI/ISO TIR37137:2014, Cardiovascular biological evaluation of medical devices — Guidance for absorbable implants |
| 3 | Title report |
| 4 | Copyright information |
| 5 | AAMI Technical Information Report ANSI Technical Report |
| 6 | Contents |
| 7 | Glossary of equivalent standards |
| 8 | Committee representation |
| 10 | Background of AAMI adoption of ISO/TR 37137:2014 |
| 11 | Foreword |
| 13 | 1 Scope 2 Terms and definitions 3 General considerations |
| 14 | 4 Sterilization considerations |
| 15 | 5 Drug-device combination product considerations 6 Part listing and description of absorbable related issues in addition to the relevant parts of ISO 10993 series “Biological evaluation of medical devices” 6.1 ISO 10993-1:2009, Evaluation and testing within a risk management process |
| 16 | 6.2 ISO 10993-2:2006, Animal welfare requirements 6.3 ISO 10993-3:2003, Tests for genotoxicity, carcinogenicity and reproductive toxicity 6.4 ISO 10993-4:2002, Selection of tests for interactions with blood |
| 17 | 6.5 ISO 10993-5:2009, Tests for in vitro cytotoxicity |
| 18 | 6.6 ISO 10993-6:2007, Tests for local effects after implantation |
| 19 | 6.7 ISO 10993-7:2008, Ethylene oxide sterilization residuals |
| 20 | 6.8 ISO 10993-9:2009, Framework for identification and quantification of potential degradation products 6.9 ISO 10993-10:2010, Tests for irritation and delayed-type hypersensitivity 6.10 ISO 10993-11:2006, Biological evaluation of medical devices — Part 11: Tests for systemic toxicity |
| 21 | 6.11 ISO 10993-12:2012, Sample preparation and reference materials |
| 24 | 6.12 ISO 10993-13:2010, Identification and quantification of degradation products from polymeric medical devices 6.13 ISO 10993-14:2001, Identification and quantification of degradation products from ceramics 6.14 ISO 10993-15:2000, Identification and quantification of degradation products from metals and alloys 6.15 ISO 10993-16:2010, Toxicokinetic study design for degradation products and leachables 6.16 ISO 10993-17:2002, Establishment of allowable limits for leachable substances 6.17 ISO 10993-18:2005, Chemical characterization of materials |
| 25 | 6.18 ISO/TS 10993-19:2006, Physico-chemical, morphological and topographical characterization of materials 6.19 ISO/TS 10993-20:2006, Principles and methods for immunotoxicology testing of medical devices |
| 26 | Annex A: Nomenclature of absorb, degrade and related terms0F |
| 27 | Bibliography |
