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SSH EN 12006-3:1998+A1:2009

Implantet kirurgjikale joaktive - Kërkesa të veçanta për implantet kardio-vaskulare - Kërkesa të veçanta për implantet kardiake dhe vaskulare - Pjesa 3 Pajisje endovaskulare

Non active surgical implants - Particular requirements for cardiac and vascular implants - Part 3: Endovascular devices
1 jan 2009
95.99 Withdrawal of Standard   13 maj 2015

General information

95.99     13 maj 2015

DPS

DPS/KT 205

European Norm

11.040.40  

anglisht  

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Scope

This European Standard specifies particular requirements for endovascular devices.
With regard to safety, this standard gives in addition to EN ISO 14630, requirements for intended performance, design attributes, materials, design evaluation, manufacturing, sterilization, packaging and information supplied by the manufacturer.
NOTE 1 Vascular occluders are not addressed in this standard. For the time being the requirements as stated in EN ISO 14630:1997 apply for these products.
NOTE 2 Due to the variations in the design of the implants covered by this standard and in some cases due to the relatively recent development of some of these implants, acceptable standardized in vitro tests and long term results of clinical trials are not always available.
Where no test method is described in this standard a complete description of the validated test method and sample preparation procedure used should be documented by the manufacturer. With regard to design evaluation, where a specific standardized test is not described, guidance is given by referring to current scientific literature (see Annex A). This standard aims to ensure that manufacturers will address all aspects of design evaluation that relate to the safety of the product. As further scientific and clinical data become available, appropriate revision of the standard will be necessary.

Related directives

Directives related to this standards.

93/42/EEC

Pajisje Mjekësore

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WITHDRAWN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 12006-3:1998+A1:2009
95.99 Withdrawal of Standard
13 maj 2015

Related project

Adopted from EN 12006-3:1998+A1:2009