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SSH EN ISO 10993-10:2010

Vlerësimi biologjik i pajisjeve mjekësore - Pjesa 10: Provat për irritimin dhe ndjeshmërinë e lëkurës (ISO 10993-10:2010)

Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitization (ISO 10993-10:2010)
26 mar 2012
95.99 Withdrawal of Standard   30 mar 2015

General information

95.99     30 mar 2015

DPS

DPS/KT 206

European Norm

11.100.20  

anglisht  

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Scope

ISO 10993-10:2010 describes the procedure for the assessment of medical devices and their constituent materials with regard to their potential to produce irritation and skin sensitization.
ISO 10993-10:2010 includes:
pretest considerations for irritation, including in silico and in vitro methods for dermal exposure;
details of in vivo (irritation and sensitization) test procedures;
key factors for the interpretation of the results.
Instructions are given for the preparation of materials specifically in relation to the above tests and several special irritation tests are described for application of medical devices in areas other than skin.

Related directives

Directives related to this standards.

90/385/EEC

Pajisjet mjekësore aktive transplatuese

93/42/EEC

Pajisje Mjekësore

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WITHDRAWN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 10993-10:2010
95.99 Withdrawal of Standard
30 mar 2015

REVISED BY

WITHDRAWN
SSH EN ISO 10993-10:2013

Related project

Adopted from EN ISO 10993-10:2010