Sterilization of health care products. Biological indicators - General requirements Ingestion-build-190310 Text amended in NA

Text amended in NA

For double specification limits

it is important that all stakeholders are able to understand and interact within the local systems

This part of ISO 3534 defines applied statistics terms

Sterilization of health care products. Biological indicators - General requirements Ingestion-build-190310 Text amended in NABS EN ISO 11138 1: 2006 specifies general requirements for production, labelling, test methods and performance requirements for the manufacture of biological indicators including inoculated carriers and suspensions intended for use in validation and monitoring of sterilization processes. Subsequent parts of ISO 11138 provide additional specific requirements for biological indicators for defined sterilization processes. This part of BS EN ISO 11138