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ISO 10993-4

Biological evaluation of medical devices — Part 4: Selection of tests for interactions with blood AMENDMENT 1

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Organization: ISO
Publication Date: 15 July 2006
Status: inactive
Page Count: 52
ICS Code (Biological evaluation of medical devices): 11.100.20
scope:

Foreword

ISO (the International Organization for Standardization) is a worldwide federation of national standards bodies (ISO member bodies). The work of preparing International Standards is normally carried out through ISO technical committees. Each member body interested in a subject for which a technical committee has been established has the right to be represented on that committee. International organizations, governmental and non-governmental, in liaison with ISO, also take part in the work. ISO collaborates closely with the International Electrotechnical Commission (IEC) on all matters of electrotechnical standardization.

International Standards are drafted in accordance with the rules given in the ISO/IEC Directives, Part 2.

The main task of technical committees is to prepare International Standards. Draft International Standards adopted by the technical committees are circulated to the member bodies for voting. Publication as an International Standard requires approval by at least 75 % of the member bodies casting a vote.

Attention is drawn to the possibility that some of the elements of this document may be the subject of patent rights. ISO shall not be held responsible for identifying any or all such patent rights.

Amendment 1 to ISO 10993-4:2002 was prepared by Technical Committee ISO/TC 194, Biological evaluation of medical devices.

Document History

April 1, 2017
Biological evaluation of medical devices - Part 4: Selection of tests for interactions with blood
This document specifies general requirements for evaluating the interactions of medical devices with blood. It describes a) a classification of medical devices that are intended for use in contact...
ISO 10993-4
July 15, 2006
Biological evaluation of medical devices — Part 4: Selection of tests for interactions with blood AMENDMENT 1
Foreword ISO (the International Organization for Standardization) is a worldwide federation of national standards bodies (ISO member bodies). The work of preparing International Standards is...
October 15, 2002
Biological Evaluation of Medical Devices - Part 4: Selection of Tests for Interactions with Blood
This part of ISO 10993 provides general requirements for evaluating the interactions of medical devices with blood. It describes a) a classification of medical and dental devices that are intended...
January 1, 1992
Biological Evaluation of Medical Devices - Part 4: Selection of Tests for Interactions with Blood; (CEN EN 30993-4: 1993)
A description is not available for this item.

References

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