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SSH EN ISO 10993-4:2017

Vlerësimi biologjik i pajisjeve mjekësore - Pjesa 4: Përzgjedhja e testeve për ndërveprime me gjakun (ISO 10993-4:2017)

Biological evaluation of medical devices - Part 4: Selection of tests for interactions with blood (ISO 10993-4:2017)
23 tet 2017

General information

60.60     17 korr 2017

DPS

DPS/KT 206

European Norm

11.100.20  

anglisht  

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Scope

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.

Related directives

Directives related to this standards.

93/42/EEC

Pajisje Mjekësore

90/385/EEC

Pajisjet mjekësore aktive transplatuese

2007/47/EC

Direktiva 2007/47/EC e Parlamentit Europian dhe e Këshillit të 5 shtator 2007 amendon Direktivën e Këshillit 90/385/EEC mbi përafrimin e ligjeve të Shteteve Anëtare në lidhje me pajisje medicinale aktive transplatuese, Direktiva e Këshillit 93/42/EEC në lidhje me pajisjet mjekësore dhe Direktivën 98/8/EC në lidhje me vendosjen e produkteve biocide në treg

Life cycle

PREVIOUSLY

WITHDRAWN
SSH EN ISO 10993-4:2009

NOW

PUBLISHED
SSH EN ISO 10993-4:2017
60.60 Standard published
17 korr 2017

Related project

Adopted from EN ISO 10993-4:2017