I.S. EN ISO 10993-4:2017
Current
The latest, up-to-date edition.
BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 4: SELECTION OF TESTS FOR INTERACTIONS WITH BLOOD (ISO 10993-4:2017)
Hardcopy , PDF
English
28-05-2017
For Harmonized Standards, check the EU site to confirm that the Standard is cited in the Official Journal.
Only cited Standards give presumption of conformance to New Approach Directives/Regulations.
Important note : All end users must be registered with an Account prior to user licenses being assigned.
National Foreword
European foreword
Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 Abbreviated terms
5 Types of devices in contact with blood (as
categorized in ISO 10993-1)
6 Characterization of blood interactions
Annex A (informative) - Preclinical evaluation
of cardiovascular devices and prostheses
Annex B (informative) - Recommended laboratory
tests - Principles, scientific basis and
interpretation
Annex C (informative) - Thrombosis - Methods
for in vivo testing
Annex D (informative) - Haematology/haemolysis - Methods
for testing - Evaluation of haemolytic properties
of medical devices and medical device materials
Annex E (informative) - Complement - Methods for testing
Annex F (informative) - Less common laboratory tests
Annex G (informative) - Tests which are not recommended
Bibliography
Annex ZA (informative) - Relationship between
this European Standard and the essential
requirements of Directive 93/42/EEC
[OJ L 169] aimed to be covered
Annex ZB (informative) - Relationship between this
European Standard and the essential requirements
of Directive 90/385/EEC [OJ L 189] aimed to be covered
Defines general requirements for evaluating the interactions of medical devices with blood.
| DevelopmentNote |
Supersedes I.S. EN 30993-4 (02/2003)
|
| DocumentType |
Standard
|
| Pages |
90
|
| PublisherName |
National Standards Authority of Ireland
|
| Status |
Current
|
| Supersedes |
| Standards | Relationship |
| EN ISO 10993-4:2017 | Identical |
| ISO 10993-4:2017 | Identical |
| UNE-EN ISO 10993-4:2009 | 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 |
| NEN EN ISO 10993-4 : OCT 2017 | Identical |
| UNI EN ISO 10993-4 : 2009 | Identical |
| DIN EN ISO 10993-4:2009-10 | Identical |
| SN EN ISO 10993-4:2018 | Identical |
| ONORM EN ISO 10993-4 : 2018 | Identical |
| UNE-EN ISO 10993-4:2018 | 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 |
Access your standards online with a subscription
Features
-
Simple online access to standards, technical information and regulations.
-
Critical updates of standards and customisable alerts and notifications.
-
Multi-user online standards collection: secure, flexible and cost effective.