SSH EN ISO 11138-1:2006

Sterilizimi i produkteve të kujdesit të shëndetit -Treguesit biologjikë - Pjesa 1: Kërkesa të përgjitshme (ISO 11138-1:2006)

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

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.

Related directives

Directives related to this standards.