ČSN P CEN ISO/TS 13004 (855258)

Sterilizace výrobků pro zdravotní péči - Sterilizace zářením - Potvrzení sterilizační dávky: Metoda VDmaxSD

Objednat
Cena: 590 Kč
včetně 15 % DPH
ks
skladem
tisk na počkání

Anotace obsahu normy

1.1 - Inclusions
This Technical Specification describes a method for substantiating a selected sterilization dose of 17,5, 20, 22,5, 27,5, 30, 32,5 or 35 kGy that achieves a sterility assurance level (SAL) of 10-6 or less for radiation sterilization of health care products. This Technical Specification also specifies a method of sterilization dose audit used to demonstrate the continued effectiveness of the substantiated sterilization dose.
NOTE - Selection and substantiation of the sterilization dose is used to meet the requirements for establishing the sterilization dose within process definition in ISO 11137-1.
1.2 - Exclusions
This method is for the substantiation of a selected sterilization dose of 17,5, 20, 22,5, 27,5, 30, 32,5,
or 35 kGy only and is not used to substantiate other sterilization doses. The method is not used for
the substantiation of a selected sterilization dose if the average bioburden of the entire product item
exceeds the limit specified for the selected sterilization dose (see Table 3).
NOTE - The methods for substantiation of selected sterilization doses of 25 kGy and 15 kGy are not included in this Technical Specification; they are described in ISO 11137-2.
1.3 - Application
If the decision is made to use this method of sterilization dose establishment, the method is to be followed according to the requirements (shall) and guidance (should) stipulated herein.

Označení ČSN P CEN ISO/TS 13004 (855258)
Katalogové číslo 95723
Cena 590 Kč590
Datum schválení 1. 10. 2014
Datum účinnosti 1. 11. 2014
Jazyk angličtina (obsahuje pouze anglický originál)
Počet stran 72 stran formátu A4
EAN kód 8590963957234
Dostupnost skladem (tisk na počkání)