ISO/TR 15499:2016
Biological evaluation of medical devices - Guidance on the conduct of biological evaluation within a risk management process

Standard No.

ISO/TR 15499:2016

Release Date

2016

Published By

International Organization for Standardization (ISO)

Latest

ISO/TR 15499:2016

ISO/TR 15499:2016 Referenced Document

• ISO 10993-11:2006 Biological evaluation of medical devices - Part 11: Tests for systemic toxicity
• ISO 10993-12:2012 Biological evaluation of medical devices - Part 12: Sample preparation and reference materials
• ISO 10993-13:2010 Biological evaluation of medical devices - Part 13: Identification and quantification of degradation products from polymeric medical devices
• ISO 10993-14:2001 Biological evaluation of medical devices - Part 14: Identification and quantification of degradation products from ceramics
• ISO 10993-15:2000 Biological evaluation of medical devices - Part 15: Identification and quantification of degradation products from metals and alloys
• ISO 10993-16:2010 Biological evaluation of medical devices - Part 16: Toxicokinetic study design for degradation products and leachables
• ISO 10993-17:2002 Biological evaluation of medical devices - Part 17: Establishment of allowable limits for leachable substances
• ISO 10993-18:2005 Biological evaluation of medical devices - Part 18: Chemical characterization of materials
• ISO 10993-1:2009 Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process
• ISO 10993-7:2008 Biological evaluation of medical devices - Part 7: Ethylene oxide sterilization residuals
• ISO 10993-9:2009 Biological evaluation of medical devices - Part 9: Framework for identification and quantification of potential degradation products
• ISO 13485:2016 Medical devices - Quality management systems - Requirements for regulatory purposes
• ISO 14971:2007 Medical devices - Application of risk management to medical devices
• ISO/IEC 17025:2005 General requirements for the competence of testing and calibration laboratories
• ISO/TS 10993-19:2006 Biological evaluation of medical devices - Part 19: Physico-chemical, morphological and topographical characterization of materials

ISO/TR 15499:2016 history

• 2016 ISO/TR 15499:2016 Biological evaluation of medical devices - Guidance on the conduct of biological evaluation within a risk management process
• 2012 ISO/TR 15499:2012 Biological evaluation of medical devices - Guidance on the conduct of biological evaluation within a risk management process