ISO 11138-5:2006
Sterilization of health care products - Biological indicators - Part 5: Biological indicators for low-temperature steam and formaldehyde sterilization processes

Standard No.

ISO 11138-5:2006

Release Date

2006

Published By

International Organization for Standardization (ISO)

Status

Be replaced

Replace By

ISO 11138-5:2017

Latest

ISO 11138-5:2017

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 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 may be provided by national or regional regulations.

ISO 11138-5:2006 Referenced Document

• ISO 11138-1:2006 Sterilization of health care products - Biological indicators - Part 1: General requirements

ISO 11138-5:2006 history

• 2017 ISO 11138-5:2017 Sterilization of health care products - Biological indicators - Part 5: Biological indicators for low-temperature steam and formaldehyde sterilization processes
• 2006 ISO 11138-5:2006 Sterilization of health care products - Biological indicators - Part 5: Biological indicators for low-temperature steam and formaldehyde sterilization processes