GB/T 18282.6-2026 Sterilization of health care products—Chemical indicators—Part 6:Type 2 indicators and process challenge devices for use in performance testing of small steam sterilizers

Scope

This document specifies the performance indicators for cavity devices and porous devices used in small-scale steam sterilizers, as well as the corresponding chemical and biological indicators. It also describes the corresponding testing methods, with the aim of detecting the steam penetration performance of Type B cycles and certain Type S cycles in small-scale steam sterilizers that comply with YY/T0646.
Note: The cavity and porous devices described in this document cannot be used as substitutes for cavity and porous devices in medical institutions.
The chemical indicators specified in this document for use with porous devices are intended to demonstrate sufficient steam penetration in porous devices in small-scale steam sterilizers (see YY/T0646).
This document stipulates the following requirements.
—— Reference porous devices (RPD) as reference devices for alternative porous indicator systems (APIS), which can demonstrate the equivalence of their performance according to this document. For example, using a temperature measuring device to determine the steam penetration degree of a textile test package.
—— A porous chemical indicator system with the same performance as the reference porous device. For example, an alternative porous indicator system APIS commonly designed and manufactured commercially.
The chemical indicators specified in this document for use with cavity loading devices are intended to demonstrate sufficient steam penetration in small-scale steam sterilizers (see YY/T0646).
This document stipulates the following requirements.
—— Reference cavity devices (RHD) specified in this document as reference devices. For example, a cavity device with a chamber, which can be used to determine its steam penetration performance by observing the survival or killing of specific biological indicators placed in it.
—— An alternative cavity device:
• Adopting the same specific test loads as

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