Publikuar
This European Standard specifies general requirements and test methods for assistive products for persons with a disability, which are medical devices according to the definition laid down in the EU Directive 93/42/EEC.
This European Standard does not apply to assistive products which achieve their intended purpose by administering pharmaceutical substances to the user.
Where other European Standards exist for particular types of assistive products then those standards apply. However, some of the requirements of this standard may still apply and may be considered in addition to those in other European standards.
NOTE Not all the items listed in EN ISO 9999 are medical devices. Contracting parties may wish to consider if this standard or parts of this standard can be used for assistive products which are not medical devices as defined in the EU Directive 93/42/EEC.
Directives related to this standards.
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
Replaces
SSH EN 12182:1999
PUBLISHED
SSH EN 12182:2012
60.60
Standard published
17 dhj 2012
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