GB27955-2020

Hygienic requirements for low-temperature hydrogen peroxide gas plasma sterilizer

过氧化氢气体等离子体低温灭菌器卫生要求

GB 27955-2020 は現行の中国強制国家規格です：Hygienic requirements for low-temperature hydrogen peroxide gas plasma sterilizer。業界：食品。テーマ：製品安全。施行日：2020年11月1日。

適用可否は製品範囲、認証ルート、所管当局の通知、移行規定によって異なります。コンプライアンス判断に使う前に、翻訳をご依頼いただくか公式情報源をご確認ください。

コンプライアンス概要

この概要は現在英語のみで提供しています。

適用範囲

This standard specifies the technical requirements and hygienic rules for low-temperature hydrogen peroxide gas plasma sterilizers. It applies to the sterilization of medical devices, instruments, and items that are not moisture-resistant and not high-temperature resistant. The standard explicitly prohibits the use of these sterilizers for liquids, powders, implants, and items with blind lumens. It references GB/T 1616 for industrial hydrogen peroxide quality.

技術要求

The standard outlines the mandatory requirements for the sterilization process, which must include conditioning, sterilization, and ventilation stages. The sterilant used must be hydrogen peroxide with a concentration maintained between 53% and 60%. Manufacturers must ensure that the sterilizer displays and records critical parameters such as chamber temperature, pressure, and plasma input power. For sterilization efficacy, the standard requires a half-cycle full load test with no bacterial growth. Safety requirements cover environmental exposure limits, where the time-weighted average concentration of hydrogen peroxide must not exceed 1.5mg/m³. Additionally, the standard mandates biological compatibility and material compatibility to ensure no corrosion or adverse effects on sterilized items, referencing the GB/T 16886 series for biological evaluation.

試験方法

Testing involves verifying the sterilization program parameters, including chamber pressure (≤80Pa), wall temperature (≤60°C), and plasma input power. Sterilization efficacy is evaluated using biological indicators, specifically Geobacillus stearothermophilus spores, placed in stainless steel and polytetrafluoroethylene (PTFE) lumens. Material compatibility is assessed by subjecting metal and non-metal samples to at least 100 sterilization cycles and evaluating corrosion rates. Environmental exposure testing follows GBZ/T 300.48.

よくある質問

What products are regulated under GB 27955-2020?

It regulates low-temperature hydrogen peroxide gas plasma sterilizers used for heat- and moisture-sensitive medical devices.

What items cannot be sterilized under this standard?

The standard prohibits sterilizing liquids, powders, implants, items with blind lumens, and cellulose-based materials.

What is the required concentration of the hydrogen peroxide sterilant?

The hydrogen peroxide sterilant must have a concentration between 53% and 60%, complying with GB/T 1616.

The summary above provides a high-level overview of GB 27955-2020. To ensure complete compliance for your products entering the Chinese market, a precise and professional translation of the full technical specifications is essential. Purchase our high-quality English translation of GB 27955-2020 today to access all detailed parameters, tables, and testing procedures.

適用のヒント

種別: 製品
CCS: C50
ICS: 11.080
所管部門: National Disease Control and Prevention Administration
技術委員会: National Disease Control and Prevention Administration