DS/CEN ISO/TS 13004:2014

Sterilisation af sundhedsplejeprodukter - Bestråling - Dokumentation af udvalgte sterilisationsdoser: Metode VDmaxSD


Status:
Gældende
Type:
Standard
Sprog:
Engelsk
Kategori:
Pris fra:
kr. 847,00

Beskrivelse

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.

Antal sider: 72

Udgivet: 2014-07-03

Godkendelsesdato: 2014-06-18

Internationale relationer : CEN ISO/TS 13004:2014 IDT ISO/TS 13004:2013 IDT

ICS: 11.080.01 - Sterilisation og desinfektion. Generelt

Varenummer: M284363


Udvalg og komiteer

Komite

  • CEN/TC 204
  • ISO/TC 198

Dansk udvalg

DS/S-259