Standard

DS/EN ISO 11138-4:2017

Sterilisation af sundhedsplejeprodukter – Biologiske indikatorer – Del 4: Biologiske indikatorer for sterilisationsprocesser med tør varme

Status
Gældende Checkmark
Type
Standard
Varenummer
M300721
Udgivelsesdato
2017-04-05
Komite

CEN/TC 102

ISO/TC 198

International arbejdsgruppe WG

CEN/TC 102

ISO/TC 198

Internationale relationer
Tooltip
ISO 11138-4:2017 IDT, EN ISO 11138-4:2017 IDT
Dansk udvalg
Antal sider
22

Scope

This part of ISO 11138 provides specific requirements for test organisms, suspensions, inoculated carriers, biological indicators, and test methods intended for use in assessing the performance of sterilization processes employing dry heat as the sterilizing agent at sterilizing temperatures within the range of 120 °C to 180 °C. NOTE 1 – Requirements for validation and control of dry heat sterilization processes are provided by ISO 14937. NOTE 2 – Requirements for work place safety may be provided by national or regional regulations.