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 es una norma nacional china obligatoria vigente: Hygienic requirements for low-temperature hydrogen peroxide gas plasma sterilizer. Sector: Alimentos. Enfoque: Seguridad de productos. Entrada en vigor: 1 nov 2020.

La aplicabilidad depende del alcance del producto, la vía de certificación, los avisos de la autoridad competente y las reglas de transición. Solicite una traducción o verifique la fuente antes de usar esta ficha en una decisión de cumplimiento.

Resumen de cumplimiento

Este resumen está disponible por ahora solo en inglés.

Alcance y aplicabilidad

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 ensayo

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.

Preguntas frecuentes

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.

Indicaciones de aplicabilidad

Tipo: Producto
CCS: C50
ICS: 11.080
Organismo competente: National Disease Control and Prevention Administration
Comité técnico: National Disease Control and Prevention Administration

Relaciones

Sustituye a:GB 27955-2011