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ISO 11138-1:1994

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

Specifies general production, labelling and performance requirements for the manufacture of biological indicators and suspensions intended for use in the validation and monitoring of sterilization cycles. Does not contain requirements for product directly inoculated with test organisms, or recovery procedures for such inoculated product.

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International Organization for Standardization [iso]

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