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SSH EN ISO 10993-4:2009

Biological evaluation of medical devices - Part 4: Selection of tests for interactions with blood (ISO 10993-4:2002, including Amd 1:2006)

Nov 24, 2009
95.99 Withdrawal of Standard   Oct 23, 2017

General information

95.99     Oct 23, 2017

DPS

DPS/KT 206

European Norm

11.100.20  

English  

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Scope

ISO 10993-4:2002 provides general requirements for evaluating the interactions of medical devices with blood.
It describes
a classification of medical and dental devices that are intended for use in contact with blood, based on the intended use and duration of contact as defined in ISO 10993-1,
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 interactions of devices with blood. ISO 10993-4:2002 describes biological evaluation in general terms and may not necessarily provide sufficient guidance for test methods for a specific device.

Related directives

Directives related to this standards.

93/42/EEC

Medical devices

Harmonized
90/385/EEC

Active implantable medical devices

Harmonized
2007/47/EC

Directive 2007/47/EC of the European Parliament and of the council of 5 September 2007 amending Council Directive 90/385/EEC on the approximation of the laws of the Member States relating to active implantable medical devices, Council Directive 93/42/EEC concerning medical devices and Directive 98/8/EC concerning the placing of biocidal products on the market

Life cycle

NOW

WITHDRAWN
SSH EN ISO 10993-4:2009
95.99 Withdrawal of Standard
Oct 23, 2017

REVISED BY

WITHDRAWN
SSH EN ISO 10993-4:2004

PUBLISHED
SSH EN ISO 10993-4:2017

Related project

Adopted from EN ISO 10993-4:2009