ISO 10993-4:2017
Biological evaluation of medical devices - Part 4: Selection of tests for interactions with blood

Standard No.

ISO 10993-4:2017

Release Date

2017

Published By

International Organization for Standardization (ISO)

Latest

ISO 10993-4:2017

ISO 10993-4:2017 Referenced Document

• ASTM F1830-97 Standard Practice for Selection of Blood for In Vitro Evaluation of Blood Pumps
• ASTM F1841-97 Standard Practice for Assessment of Hemolysis in Continuous Flow Blood Pumps
• ASTM F1984-99 Standard Practice for Testing for Whole Complement Activation in Serum by Solid Materials
• ASTM F2888-13 Standard Test Method for Platelet Leukocyte Count—An In-Vitro Measure for Hemocompatibility Assessment of Cardiovascular Materials
• ASTM F756-13 Standard Practice for Assessment of Hemolytic Properties of Materials*， 2023-12-23 Update
• GB/T 16175-2008 Biological evaluation test methods for medical organic silicon materials
• ISO 10993-10:2010 Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitization
• ISO 10993-11:2006 Biological evaluation of medical devices - Part 11: Tests for systemic toxicity
• ISO 10993-1:2009 Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process
• ISO 10993-2:2006 Biological evaluation of medical devices - Part 2: Animal welfare requirements
• ISO 10993-3:2014 Biological evaluation of medical devices - Part 3: Tests for genotoxicity, carcinogenicity and reproductive toxicity
• ISO 10993-4:2002 Biological evaluation of medical devices - Part 4: Selection of test for interactions with blood
• ISO 10993-5:2009 Biological evaluation of medical devices — Part 5: Tests for cytotoxicity: in vitro methods
• ISO 10993-6:2016 Biological evaluation of medical devices - Part 6: Tests for local effects after implantation
• 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 3826-3:2006 Plastics collapsible containers for human blood and blood components - Part 3: Blood bag systems with integrated features
• ISO 5840-1:2015 Cardiovascular implants - Cardiac valve prostheses - Part 1: General requirements
• ISO 5840-2:2015 Cardiovascular implants - Cardiac valve prostheses - Part 2: Surgically implanted heart valve substitutes
• ISO 5840-3:2013 Cardiovascular implants - Cardiac valve prostheses - Part 3: Heart valve substitutes implanted by transcatheter techniques
• ISO 5841-3:2013 Implants for surgery - Cardiac pacemakers - Part 3: Low-profile connectors (IS-1) for implantable pacemakers
• ISO 7198:2016 Cardiovascular implants and extracorporeal systems - Vascular prostheses - Tubular vascular grafts and vascular patches
• ISO 7199:2016 Cardiovascular implants and artificial organs - Blood-gas exchangers (oxygenators)
• ISO 8637:2010 Cardiovascular implants and extracorporeal systems - Haemodialysers, haemodiafilters, haemofilters and haemoconcentrators

ISO 10993-4:2017 history

• 2017 ISO 10993-4:2017 Biological evaluation of medical devices - Part 4: Selection of tests for interactions with blood
• 2006 ISO 10993-4:2002/Amd 1:2006 Biological evaluation of medical devices - Part 4: Selection of tests for interactions with blood
• 2002 ISO 10993-4:2002 Biological evaluation of medical devices - Part 4: Selection of test for interactions with blood
• 1992 ISO 10993-4:1992 Biological evaluation of medical devices — Part 4: Selection of tests for interactions with blood