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PD ISO/TS 37137-1:2021 Biological evaluation of absorbable medical devices - General requirements, 2021
- National foreword
- Foreword
- Introduction
- 1 Scope
- 2 Normative references
- 3 Terms and definitions
- 4 General considerations
- 5 Test article considerations
- 6 Sterilization considerations
- 7 Drug-device combination product considerations
- 8 Evaluation of absorbable medical devices in the context of the ISO 10993 series [Go to Page]
- 8.1 General
- 8.2 ISO 10993‑1, evaluation and testing within a risk management process
- 8.3 ISO 10993‑2, animal welfare requirements
- 8.4 ISO 10993‑3, tests for genotoxicity, carcinogenicity, and reproductive toxicity
- 8.5 ISO 10993‑4, selection of tests for interactions with blood
- 8.6 ISO 10993‑5, tests for in vitro cytotoxicity
- 8.7 ISO 10993‑6, Tests for local effects after implantation
- 8.8 ISO 10993‑7, ethylene oxide sterilization residuals
- 8.9 ISO 10993‑9, framework for identification and quantification of potential degradation products
- 8.10 ISO 10993‑10, tests for skin sensitization
- 8.11 ISO 10993‑11, tests for systemic toxicity
- 8.12 ISO 10993‑12, sample preparation and reference materials
- 8.13 ISO 10993‑13, identification and quantification of degradation products from polymeric medical devices
- 8.14 ISO 10993‑14, identification and quantification of degradation products from ceramics
- 8.15 ISO 10993‑15, identification and quantification of degradation products from metals and alloys
- 8.16 ISO 10993‑16, toxicokinetic study design for degradation products and leachables
- 8.17 ISO 10993‑17, establishment of allowable limits for leachable substances
- 8.18 ISO 10993‑18, chemical characterization of materials
- 8.19 ISO/TS 10993‑19, physico-chemical, morphological and topographical characterization of materials
- 8.20 ISO/TS 10993‑20, principles and methods for immunotoxicology testing of medical devices
- 8.21 ISO/TR 10993‑22, guidance on nanomaterials
- 8.22 ISO 10993‑23, tests for irritation [Go to Page]
- 8.22.1 General
- 8.22.2 Tests for irritation
- Annex A (informative) Nomenclature of absorb, degrade and related terms
- Bibliography [Go to Page]
