Sterilization of health care products - Biological indicators - Part 5: Biological indicators for low-temperature steam and formaldehyde sterilization processes
STANDARD published on 1.10.2017
Designation standards: ČSN EN ISO 11138-5
Classification mark: 847111
Catalog number: 502941
Publication date standards: 1.10.2017
The number of pages: 20
Approximate weight : 60 g (0.13 lbs)
Country: Czech technical standard
Category: Technical standards ČSN
This document 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