BS EN ISO 10993-4:2017

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

Describes general requirements for evaluating the interactions of medical devices with blood.

This document specifies general requirements for evaluating the interactions of medical devices with blood. It describes 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 ISO10993‑1, the fundamental principles governing the evaluation of the interaction of devices with blood, 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 limitations in the knowledge and precision of tests for evaluating interactions of devices with blood. This document describes biological evaluation in general terms and may not necessarily provide sufficient guidance for test methods for a specific device. The changes in this document do not indicate that testing conducted according to prior versions of this document is invalid. For marketed devices with a history of safe clinical use, additional testing according to this revision is not recommended.