BAS EN 60601-1-11:2011

Medicinska električna oprema - dio 1-11: Opći zahtjevi za osnovnu sigurnost i esencijalne radne karakteristike - Prateći standard: zahtjevi za medicinsku električnu opremu i medicinske električne sisteme koji se koriste za zdravstvenu brigu u kućnom okruženju


Опште информације
Статус: Повучен
Број страна: 127
Језик: Енглески, Француски
Издање: 1.
Метода усвајања: Proglašavanje
Датум објаве: 06.12.2011
Технички комитет:
Директива:
93/42/EEC, Медицинска средства;
...

Апстракт
IEC 60601-1-11:2010 applies to the basic safety and essential performance of medical electrical equipment and medical electrical systems which are intended by their manufacturer for use in the home healthcare environment, regardless of whether the medical electrical equipment or medical electrical system is intended for use by a lay operator or by trained healthcare personnel. The object of IEC 60601-1-11:2010 is to specify general requirements that are in addition to those of the general standard IEC 60601-1:2005 and to serve as the basis for particular standards. It is the recommendation of the committee that the content of this publication be adopted for implementation nationally not earlier than 3 years from the date of publication.

Животни циклус
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Изворни документ и степен усаглашености
  • EN 60601-1-11:2010, идентичан
  • IEC 60601-1-11:2010, идентичан

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