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EVS-EN ISO 10993-4 V2:2017

Meditsiiniseadmete bioloogiline hindamine. Osa 4: Vastasmõjude hindamiseks läbiviidavad valikkatsed verega

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Kehtiv alates 01.11.2017
Alusdokumendid
EN ISO 10993-4:2017; ISO 10993-4:2017
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01.11.2017
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02.06.2017
Põhitekst
ISO 10993-4:2017 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 with blood, based on the intended use and duration of contact as defined in ISO 10993-1, b) the fundamental principles governing the evaluation of the interaction of devices with blood, c) 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.
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EVS-EN ISO 10993-6:2016

Meditsiiniseadmete bioloogiline hindamine. Osa 6: Katsed implantatsioonijärgsete paiksete toimete hindamiseks
Uusim versioon Kehtiv alates 03.01.2017
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EVS-EN ISO 10993-5:2009

Meditsiinivahendite bioloogiline hindamine. Osa 5: Katsed tsütotoksilisuse hindamiseks - in vitro meetodid
Uusim versioon Kehtiv alates 07.08.2009
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EVS-EN ISO 10993-10:2013

Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitization (ISO 10993-10:2010)
Uusim versioon Kehtiv alates 07.10.2013
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EVS-EN 62366-1:2015

Meditsiiniseadmed. Osa 1: Kasutatavusprojekteerimise rakendamine meditsiiniseadmetele
Kehtiv alates 07.05.2015