GB/T 18282.1-2025 Sterilization of health care products—Chemical indicators—Part 1:General requirements

Scope

This document specifies the general requirements and test methods for indicators, which indicate their exposure to the sterilization process through physical and/or chemical changes and are used to monitor whether specific single or multiple process parameters are met during the sterilization process. Their response is not directly related to the presence or absence of microorganisms.
Note 1: Biological testing systems rely on demonstrating the viability of organisms for testing. Such testing systems are covered in ISO 11138 for biological indicators (BIs).
This document applies to all indicators specified in other parts of GB/T 18282, except for the requirements modified or added in other parts, in which case the requirements of the specific parts will apply. If other parts modify or add requirements, then the modified or added content requirements will also apply.
Related testing equipment is described in ISO 18472.
Note 2: Additional requirements for specific test indicators/indicator systems (Category II) are given in ISO 11140-3, ISO 11140-4, and ISO 11140-5.

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