GB/T 18281.4-2024 Sterilization of health care products—Biological indicators—Part 4:Biological indicators for dry heat sterilization processes

Scope

This document specifies the requirements and test methods for test microorganisms, bacterial suspensions, contaminated carriers, and biological indicators to be used in evaluating the performance of sterilizers and sterilization processes. The sterilizer and sterilization process use dry heat air, with a sterilization temperature range of 120°C to 180°C.
Note 1: The validation of the dry heat sterilization process and its routine control are in accordance with ISO 20857.
Note 2: Workplace safety should refer to the relevant regulations of the country or region.

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