BAS EN ISO 11140-1:2010

Sterilizacija proizvoda za zdravstvenu njegu – Hemijski indikatori – dio 1: opći zahtjevi


Opšte informacije
Status: Povučen
Broj strana: 38
Jezik: Engleski
Izdanje: 2.
Metoda usvajanja: Proglašavanje
Datum objave: 29.06.2010
Direktiva:
90/385/EEC, Aktivna ugradiva medicinska sredstva
93/42/EEC, Medicinska sredstva;
...

Apstrakt
ISO 11140-1:2005 specifies general requirements and test methods for indicators that show exposure to sterilization processes by means of physical and/or chemical change of substances, and which are used to monitor the attainment of one or more of the variables required for a sterilization process. They are not dependent for their action on the presence or absence of a living organism. The requirements and test methods of ISO 11140-1:2005 apply to all indicators specified in subsequent parts of ISO 11140, unless the requirement is modified or added to by a subsequent part, in which case the requirement of that particular part will apply.

Životni ciklus
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Izvorni dokument i stepen usklađenosti
  • EN ISO 11140-1:2009, identičan
  • ISO 11140-1:2005, identičan