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SSH EN ISO 10993-6:2009

Vlerësimi biologjik i pajisjeve mjekësore - Pjesa 6: Provat për efektet locale pas implantimit (ISO 10993-6:2007)

Biological evaluation of medical devices - Part 6: Tests for local effects after implantation (ISO 10993-6:2007)
24 nën 2009
95.99 Withdrawal of Standard   23 tet 2017

General information

95.99     23 tet 2017

DPS

DPS/KT 206

European Norm

11.100.20  

anglisht  

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Scope

ISO 10993-6:2007 specifies test methods for the assessment of the local effects after implantation of biomaterials intended for use in medical devices.
ISO 10993-6:2007 applies to materials that are:
solid and non-biodegradable;
degradable and/or resorbable;
non-solid, such as porous materials, liquids, pastes and particulates.
ISO 10993-6:2007 may also be applied to medical devices that are intended to be used topically in clinical indications where the surface or lining may have been breached, in order to evaluate local tissue responses.
This part of ISO 10993 does not deal with systemic toxicity, carcinogenicity, teratogenicity or mutagenicity. However, the long-term implantation studies intended for evaluation of local biological effects may provide insight into some of these properties. Systemic toxicity studies conducted by implantation may satisfy the requirements of ISO 10993-6:2007.

Related directives

Directives related to this standards.

93/42/EEC

Pajisje Mjekësore

Të harmonizuara
90/385/EEC

Pajisjet mjekësore aktive transplatuese

Të harmonizuara
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

NOW

WITHDRAWN
SSH EN ISO 10993-6:2009
95.99 Withdrawal of Standard
23 tet 2017

REVISED BY

WITHDRAWN
SSH EN 30993-6:2000

PUBLISHED
SSH EN ISO 10993-6:2016

Related project

Adopted from EN ISO 10993-6:2009