BS EN ISO 11138-1:2006
Sterilization of health care products - Biological indicators - General requirements

Standard No.

BS EN ISO 11138-1:2006

Release Date

2006

Published By

British Standards Institution (BSI)

Status

Be replaced 2017-04

Replace By

BS EN ISO 11138-1:2017

Latest

BS EN ISO 11138-1:2017

Replace

04/30078095 DC:2004 BS EN 866-1:1997

Scope

ISO 11138-1:2006 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.ISO 11138-1:2006 specifies basic and common requirements that are applicable to all subsequent parts of ISO 11138. Requirements for biological indicators for particular specified processes are provided in the subsequent parts of ISO 11138. If no specific subsequent part is provided, this part applies.

BS EN ISO 11138-1:2006 history

• 2017 BS EN ISO 11138-1:2017 Sterilization of health care products. Biological indicators. General requirements
• 2006 BS EN ISO 11138-1:2006 Sterilization of health care products - Biological indicators - General requirements

BS EN ISO 11138-1:2006 Sterilization of health care products - Biological indicators - General requirements has been changed from BS EN 866-1:1997 Biological systems for testing sterilizers and sterilization processes Part 1. General requirements.