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PD ISO/TR 37137:2014 Cardiovascular biological evaluation of medical devices. Guidance for absorbable implants, 2014
- Section sec_1
- Section sec_2
- Section sec_2.1
- Section sec_2.2
- Section sec_2.3
- Section sec_2.4
- Section sec_3
- Section sec_4
- Section sec_5
- Section sec_6
- Section sec_6.1
- Section sec_6.2
- Section sec_6.3
- Section sec_6.4
- Section sec_6.5
- Section sec_6.6
- Section sec_6.7
- Section sec_6.8
- Section sec_6.9
- Section sec_6.10
- Section sec_6.11
- Section sec_6.12
- Section sec_6.13
- Section sec_6.14
- Section sec_6.15
- Section sec_6.16
- Section sec_6.17
- Section sec_6.18
- Section sec_6.19
- Annex sec_A
- Reference ref_1
- Reference ref_2
- Reference ref_3
- Reference ref_4
- Reference ref_5
- Reference ref_6
- Reference ref_7
- Reference ref_8
- Reference ref_9
- Reference ref_10
- Reference ref_11
- Reference ref_12
- Reference ref_13
- Reference ref_14
- Reference ref_15
- Reference ref_16
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- Foreword
- 1 Scope
- 2 Terms and definitions
- 3 General considerations
- 4 Sterilization considerations
- 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
- 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
- 6.5 ISO 10993‑5:2009, Tests for in vitro cytotoxicity
- 6.6 ISO 10993‑6:2007, Tests for local effects after implantation
- 6.7 ISO 10993‑7:2008, Ethylene oxide sterilization residuals
- 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
- 6.11 ISO 10993‑12:2012, Sample preparation and reference materials
- 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
- 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
- Annex A
(informative)
Nomenclature of absorb, degrade and related terms
- Bibliography [Go to Page]