GB/T 32309-2015 in English

《GB/T 32309-2015过氧化氢低温等离子体灭菌器》由TC200（全国消毒技术与设备标准化技术委员会）归口，主管部门为国家药品监督管理局。
本标准规定了过氧化氢低温等离子体灭菌器(以下简称灭菌器)的术语和定义、要求、试验方法、检验规则和标志、包装、使用说明书、运输和储存。
本标准适用于仅以过氧化氢为灭菌介质,能够产生等离子体的低温灭菌器。
本标准未规定涉及使用风险范围的安全要求,未规定低温过氧化氢等离子体的确认和常规控制的要求。
注:本标准所指低温灭菌器,其灭菌室内温度不大于60℃。

Scope

This standard specifies the terms and definitions, requirements, test methods, inspection rules, as well as marking, packaging, instructions for use, transportation and storage of hydrogen peroxide low-temperature plasma sterilizers (hereinafter referred to as sterilizers). This standard applies to low-temperature sterilizers that use only hydrogen peroxide as a sterilization medium and can produce plasma. This standard does not specify safety requirements involving the scope of risk of use, nor does it specify the requirements for confirmation and routine control of low-temperature hydrogen peroxide plasma. Note: The low-temperature sterilizer referred to in this standard has a sterilization chamber temperature of no more than 60°C.