I.S. EN ISO 10993-4:2017
Current
The latest, up-to-date edition.
Hardcopy , PDF
English
05-28-2017
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.
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
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