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 é uma norma nacional chinesa obrigatória vigente: Hygienic requirements for low-temperature hydrogen peroxide gas plasma sterilizer. Setor: Alimentos. Foco: Segurança de produtos. Entrada em vigor: 1 de nov. de 2020.

A aplicabilidade depende do escopo do produto, da via de certificação, dos avisos da autoridade competente e das regras de transição. Solicite uma tradução ou verifique a fonte antes de usar este registro em uma decisão de conformidade.

Visão geral de conformidade

Esta visão geral está disponível por enquanto apenas em inglês.

Escopo e aplicabilidade

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.

Requisitos técnicos

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.

Métodos de ensaio

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.

Perguntas frequentes

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.

Indicações de aplicabilidade

Tipo: Produto
CCS: C50
ICS: 11.080
Órgão competente: National Disease Control and Prevention Administration
Comitê técnico: National Disease Control and Prevention Administration

Relações

Substitui:GB 27955-2011