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

Available format(s)

Hardcopy , PDF

Language(s)

Spanish, Castilian, English

Published date

01-24-2018

Publisher

Asociacion Espanola de Normalizacion

This document specifies general requirements for evaluating the interactions of medical devices with blood.

Committee	CTN 111
DevelopmentNote	Supersedes UNE EN 30993-4. (02/2007)
DocumentType	Standard
Pages	101
PublisherName	Asociacion Espanola de Normalizacion
Status	Current
Supersedes	UNE-EN ISO 10993-4:2017

Standards	Relationship
DIN EN ISO 10993-4:2009-10	Identical
EN ISO 10993-4:2017	Identical
ISO 10993-4:2017	Identical
NS EN ISO 10993-4 : 2017	Identical
NF EN ISO 10993-4 : 2017	Identical
BS EN ISO 10993-4:2017	Identical
NBN EN ISO 10993-4 : 2009	Identical
DIN EN ISO 10993-4:2016-02 (Draft)	Identical
I.S. EN ISO 10993-4:2017	Identical
NEN EN ISO 10993-4 : OCT 2017	Identical
UNI EN ISO 10993-4 : 2009	Identical

ISO/IEC 17025:2005	General requirements for the competence of testing and calibration laboratories
ASTM F 756 : 2017 : REDLINE	Standard Practice for Assessment of Hemolytic Properties of Materials
ISO 7198:2016	Cardiovascular implants and extracorporeal systems — Vascular prostheses — Tubular vascular grafts and vascular patches
ISO 8637:2010	Cardiovascular implants and extracorporeal systems Haemodialysers, haemodiafilters, haemofilters and haemoconcentrators
ISO 14708-5:2010	Implants for surgery Active implantable medical devices Part 5: Circulatory support devices
ISO 3826-3:2006	Plastics collapsible containers for human blood and blood components — Part 3: Blood bag systems with integrated features
ISO 15675:2016	Cardiovascular implants and artificial organs — Cardiopulmonary bypass systems — Arterial blood line filters
ISO 14708-2:2012	Implants for surgery Active implantable medical devices Part 2: Cardiac pacemakers
AAMI RD16 : 2007	CARDIOVASCULAR IMPLANTS AND ARTIFICIAL ORGANS - HEMODIALYZERS, HEMODIAFILTERS, HEMOFILTERS AND HEMOCONCENTRATORS
ISO 7199:2016	Cardiovascular implants and artificial organs Blood-gas exchangers (oxygenators)
ISO 10993-12:2012	Biological evaluation of medical devices Part 12: Sample preparation and reference materials
ISO 5841-3:2013	Implants for surgery — Cardiac pacemakers — Part 3: Low-profile connectors (IS-1) for implantable pacemakers
ISO 15674:2016	Cardiovascular implants and artificial organs — Hard-shell cardiotomy/venous reservoir systems (with/without filter) and soft venous reservoir bags
ISO 10993-1:2009	Biological evaluation of medical devices Part 1: Evaluation and testing within a risk management process
CFR 21(PTS1-99) : 0	FOOD AND DRUGS - FOOD AND DRUG ADMINISTRATION, CHAPTER 1 DEPARTMENT OF HEALTH AND HUMAN SERVICES - PARTS 1-99
SAC GB/T 16175 : 1996	BIOLOGICAL EVALUATION TEST METHODS FOR MEDICAL ORGANIC SILICON MATERIALS
ISO 12891-1:2015	Retrieval and analysis of surgical implants Part 1: Retrieval and handling
ASTM F 2888 : 2013	Standard Test Method for Platelet Leukocyte Count—An <emph type="bdit">In-Vitro</emph > Measure for Hemocompatibility Assessment of Cardiovascular Materials