Publikuar
IEC 60601-1:2005+A1:2012, 1.1 is replaced by:
ISO 11197:2016 applies to the basic safety and essential performance of medical supply units, hereafter also referred to as me equipment.
ISO 11197:2016 applies to medical supply units manufactured within a factory or assembled on site, including cabinetry and other enclosures, which incorporate patient care services.
NOTE 1 A party that assembles on site various components intended for patient care services into an enclosure is considered the manufacturer of the medical supply unit.
Hazards inherent in the intended function of me equipment or me systems within the scope of this International Standard are not covered by specific requirements in this standard except in 7.2.13 and 8.4.1 of IEC 60601-1:2005+A1:2012 (see 201.1.4).
NOTE 2 See also IEC 60601-1:2005+A1:2012, 4.2.
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
WITHDRAWN
SSH EN ISO 11197:2009
PUBLISHED
SSH EN ISO 11197:2016
60.60
Standard published
27 tet 2016
English