GB/T 24628-2025 Sterilization of health care products—Biological and chemical indicators—Test equipment

Scope

This document is applicable to testing equipment for the following purposes:
—— Detection of biological indicators meeting the requirements of GB/T 18281 (all parts), such as steam, ethylene oxide gas, and dry heat;
—— Detection of chemical indicators meeting the requirements of GB/T 18282.1–2025, such as steam, ethylene oxide gas, dry heat, and vaporized hydrogen peroxide.
This document also provides informative methodological information, which helps to determine the performance characteristics of biological and chemical indicators for their intended use, and can also be used for routine quality control testing of indicators.
GB/T 18281.2–2024, GB/T 18281.3–2024, GB/T 18281.4–2024, and GB/T 18282.1–2025 all require the use of resistance testers specified in this document, which are used in conjunction with the test methods specified in GB/T 18281 (all parts) and ISO 11140 (all parts).
This document is not applicable to testing equipment for chemical and biological indicators specifically used for monitoring isolators and indoor biological purification under atmospheric pressure.
This document is not applicable to resistance testers for formaldehyde indicators. The steam-formaldehyde testing method using laboratory instruments is included in GB/T 18281.5–2024.
ISO 11140-3:2007, ISO 11140-4:2007, and ISO 11140-5:2007 specify testing equipment for testing Class 2 (e.g., B-D tests) chemical indicators.

Development Information

Replace the following standards

Referenced Standards

Adopt standards

Related Standards