DIN EN ISO 10993-4:2017
Biological evaluation of medical devices - Part 4: Selection of tests for interactions with blood (ISO 10993-4:2017); German version EN ISO 10993-4:2017

Standard No.

DIN EN ISO 10993-4:2017

Release Date

2017

Published By

German Institute for Standardization

Status

Be replaced

Replace By

DIN EN ISO 10993-4:2017-12

Latest

DIN EN ISO 10993-4/A1:2024-04

Replace

DIN EN ISO 10993-4:2009 DIN EN ISO 10993-4:2016

Scope

This document provides general requirements for evaluating the interactions of medical devices with blood. It describes: a) a classification of medical devices that are intended for use in contact with blood, based on the intended use and duration of contact as defined in ISO 10993-1; b) the fundamental principles governing the evaluation of the interaction of devices with blood; c) the rationale for structured selection of tests according to specific categories, together with the principles and scientific basis of these tests. Detailed requirements for testing cannot be specified because of the limitations in knowledge and precision of tests for interactions of devices with blood. Further, this part of ISO 10993 describes biological evaluation in general terms and may not necessarily provide sufficient guidance for test methods for a specific device.

DIN EN ISO 10993-4:2017 Referenced Document

• DIN EN ISO 10993-10:2014 Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitization (ISO 10993-10:2010); German version EN ISO 10993-10:2013
• DIN EN ISO 10993-11:2009 Biological evaluation of medical devices - Part 11: Tests for systemic toxicity (ISO 10993-11:2006); English version of DIN ENISO 10993-11:2009-08
• DIN EN ISO 10993-12:2012 Biological evaluation of medical devices - Part 12: Sample preparation and reference materials (ISO 10993-12:2012); German version EN ISO 10993-12:2012
• DIN EN ISO 10993-13:2010 Biological evaluation of medical devices - Part 13: Identification and quantification of degradation products from polymeric medical devices (ISO 10993-13:2010); German version EN ISO 10993-13:2010
• DIN EN ISO 10993-14:2009 Biological evaluation of medical devices - Part 14: Identification and quantification of degradation products from ceramics (ISO 10993-14:2001)
• DIN EN ISO 10993-1:2010 Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management system (ISO 10993-1:2009); German version EN ISO 10993-1:2009
• DIN EN ISO 10993-2:2006 Biological evaluation of medical devices - Part 2: Animal welfare requirements (ISO 10993-2:2006); English version of DIN EN ISO 10993-2:2006-10
• DIN EN ISO 10993-3:2015 Biological evaluation of medical devices - Part 3: Tests for genotoxicity, carcinogenicity and reproductive toxicity (ISO 10993-3:2014); German version EN ISO 10993-3:2014
• DIN EN ISO 10993-4:2009 Biological evaluation of medical devices - Part 4: Selection of tests for interactions with blood (ISO 10993-4:2002, including Amd 1:2006); English version of DIN EN ISO 10993-4:2009-10
• DIN EN ISO 10993-5:2009 Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity (ISO 10993-5:2009); English version of DIN EN ISO 10993-5:2009-10
• DIN EN ISO 10993-6:2017 Biological evaluation of medical devices - Part 6: Tests for local effects after implantation (ISO 10993-6:2016); German version EN ISO 10993-6:2016
• DIN EN ISO 10993-7 Berichtigung 1:2011 
• DIN EN ISO 10993-7:2009 Biological evaluation of medical devices - Part 7: Ethylene oxide sterilization residuals (ISO 10993-7:2008); English version of DIN EN ISO 10993-7:2009-02
• DIN EN ISO 10993-9:2010 Biological evaluation of medical devices - Part 9: Framework for identification and quantification of potential degradation products (ISO 10993-9:2009)
• DIN EN ISO 3826-3:2008 Plastics collapsible containers for human blood and blood components - Part 3: Blood bag systems with integrated features (ISO 3826-3:2006); English version of DIN EN ISO 3826-3:2008-03
• DIN EN ISO 5840-1:2015 Cardiovascular implants - Cardiac valve prostheses - Part 1: General requirements (ISO 5840-1:2015); German version EN ISO 5840-1:2015
• DIN EN ISO 5840-2:2016 Cardiovascular implants - Cardiac valve prostheses - Part 2: Surgically implanted heart valve substitutes (ISO 5840-2:2015); German version EN ISO 5840-2:2015
• DIN EN ISO 5840-3:2013 Cardiovascular implants - Cardiac valve prostheses - Part 3: Heart valve substitutes implanted by transcatheter techniques (ISO 5840-3:2013); German version EN ISO 5840-3:2013
• DIN EN ISO 7199:2017 Cardiovascular implants and artificial organs - Blood-gas exchangers (oxygenators) (ISO 7199:2016); German version EN ISO 7199:2017
• DIN EN ISO 8637:2014 Cardiovascular implants and extracorporeal systems - Haemodialysers, haemodiafilters, haemofilters and haemoconcentrators (ISO 8637:2010, including Amendment 1:2013-04-01); German version EN ISO 8637:2014

DIN EN ISO 10993-4:2017 history

• 2024 DIN EN ISO 10993-4/A1:2024-04 Biological evaluation of medical devices - Part 4: Selection of tests for interactions with blood - Amendment 1 (ISO 10993-4:2017/DAM 1:2024); German and English version EN ISO 10993-4:2017/prA1:2024
• 2017 DIN EN ISO 10993-4:2017-12 Biological evaluation of medical devices - Part 4: Selection of tests for interactions with blood (ISO 10993-4:2017); German version EN ISO 10993-4:2017
• 2017 DIN EN ISO 10993-4:2017 Biological evaluation of medical devices - Part 4: Selection of tests for interactions with blood (ISO 10993-4:2017); German version EN ISO 10993-4:2017
• 2009 DIN EN ISO 10993-4:2009 Biological evaluation of medical devices - Part 4: Selection of tests for interactions with blood (ISO 10993-4:2002, including Amd 1:2006); English version of DIN EN ISO 10993-4:2009-10
• 2007 DIN EN ISO 10993-4:2007 Biological evaluation of medical devices - Part 4: Selection of tests for interactions with blood (ISO 10993-4:2002+Amd.1:2006); German version EN ISO 10993-4:2002+A1:2006