1.1.1 BS EN 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.

1.1.2 BS EN 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.

NOTE National or regional regulations may apply.

1.2 BS EN ISO 11138-1:2006 does not apply to microbiological test systems for processes that rely on physical removal of microorganisms, e.g. filtration processes or processes that combine physical and/or mechanical removal with microbiological inactivation, such as use of washer disinfectors or flushing and steaming of pipelines. This part of ISO 11138, however, could contain elements relevant to such microbiological test systems.

Cross References:
ISO 8601
ISO 11135:1994
ISO 11137-1
ISO 11137-2
ISO 11137-3 ISO 11607-1
ISO 11607-2 ISO 11737-1
ISO 13485
ISO 15223
ISO 17665-1
ISO 18472
ISO 31
ISO 690:1987
ISO 1000:1992
ISO 1000:1992/AMD 1:1998
ISO 10241:1992
ISO/TS 11139
ISO 14161:2000
ISO 14937:2000
IEC 60027