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BS EN ISO 10993-4:2017

BS EN ISO 10993-4:2017

Current

Current

The latest, up-to-date edition.

Biological evaluation of medical devices Selection of tests for interactions with blood

Available format(s)

Hardcopy , PDF

Language(s)

English

Published date

25-05-2017

Publisher

British Standards Institution

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.

Committee
CH/194
DevelopmentNote
Supersedes BS EN 30993-4 and 00/560454 DC (11/2002) Supersedes 15/30290736 DC. (05/2017)
DocumentType
Standard
Pages
82
PublisherName
British Standards Institution
Status
Current
Supersedes

ISO/IEC 17025:2005 General requirements for the competence of testing and calibration laboratories
CFR 29(PTS1900-1910) : 0 LABOR - OCCUPATIONAL SAFETY AND HEALTH ADMINISTRATION, DEPARTMENT OF LABOR
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)
CLSI H44 A : 1997 METHODS FOR RETICULOCYTE COUNTING (FLOW CYTOMETRY AND SUPRAVITAL DYES)
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

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