Standard

DS/EN ISO 11138-5:2017

Sterilisation af sundhedsplejeprodukter – Biologiske indikatorer – Del 5: Biologiske indikatorer for sterilisationsprocesser med lavtemperaturdamp og formaldehyd

Status
Gældende Checkmark
Type
Standard
Varenummer
M300714
Udgivelsesdato
2017-04-05
Komite

CEN/TC 102

ISO/TC 198

International arbejdsgruppe WG

CEN/TC 102

ISO/TC 198

Internationale relationer
Tooltip
ISO 11138-5:2017 IDT, EN ISO 11138-5:2017 IDT
Dansk udvalg
Antal sider
20

Scope

ISO 11138-5:2017 specifies requirements for test organisms, suspensions, inoculated carriers, biological indicators and test methods intended for use in assessing the performance of sterilization processes employing low-temperature steam and formaldehyde as the sterilizing agent. NOTE 1 – Requirements for validation and control of low-temperature steam and formaldehyde sterilization processes are provided by ISO 14937. NOTE 2 – Requirements for work place safety can be provided by national or regional regulations.