Most recent

ANSI/AAMI/ISO 11138-1:2017 (R2024)

Sterilization of health care products—Biological indicators—Part 1: General requirements

This document specifies general requirements for production, labelling, test methods and performance characteristics of biological indicators, including inoculated carriers and suspensions, and their components, to be used in the validation and routine monitoring of sterilization processes. This document specifies basic and common requirements that are applicable to all parts of ISO 11138. Requirements for biological indicators for particular specified processes are provided in the relevant parts of ISO 11138. If no specific subsequent part is provided, this document applies.

CONTENT PROVIDER
Association for the Advancement of Medical Instrumentation [aami]

Others Also Bought
Sterilization of health care products—Biological indicators—Part 2: Biological indicators for ethylene oxide sterilization ...
Biological evaluation of medical devices Selection of tests for interactions with blood (British Standard)
Small-bore connectors for liquids and gases in healthcare applications Common test methods (British Standard)
Included in Packages
This standard is not included in any packages.
Document History
Amendments & Corrections
We have no amendments or corrections for this standard.