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AAMI/ISO 11138-1:2017

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AAMI/ISO 11138-1:2017

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

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Provides 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.

Author ANSI/AAMI/ISO
Editor AAMI
Document type Standard
Format File
Confirmation date 2017-08-01
ICS 11.080.01 : Sterilization and disinfection in general
11.080.20 : Disinfectants and antiseptics
Replace ANSI/AAMI/ISO 11138-1 (2006)
Cross references ISO 11138-1 (2017-03), IDT
Year 2017
Document history ANSI/AAMI/ISO 11138-1 (2017)
Country USA
Keyword ANSI 11138;ANSI/AAMI/ISO 11138;11138;ANSI/AAMI/ISO 11138-1-2017