GB8599-2023

Technical requirements for large steam sterilizers

大型压力蒸汽灭菌器技术要求

GB 8599-2023 ist eine kommende verbindliche chinesische Nationalnorm: Technical requirements for large steam sterilizers. Branchencluster: Lebensmittel. Schwerpunkt: Produktsicherheit. Inkrafttreten: 1. Okt. 2026.

Die Anwendbarkeit hängt vom Produktumfang, dem Zertifizierungsweg, Bekanntmachungen der Behörden und Übergangsregeln ab. Fordern Sie eine Übersetzung an oder prüfen Sie die Quelle, bevor Sie diesen Eintrag für Compliance-Entscheidungen nutzen.

Compliance-Überblick

Dieser Überblick ist derzeit nur auf Englisch verfügbar.

Geltungsbereich und Anwendbarkeit

This standard applies to large steam sterilizers with a side-opening sterilization chamber capable of loading at least one sterilization unit or having a volume of no less than 60L, equipped with vacuum functionality. It is primarily intended for the sterilization of healthcare products and their accessories, explicitly excluding liquids, flammable/explosive items, biological waste, and human tissues. Manufacturers of large medical autoclaves must comply with these mandatory technical requirements.

Technische Anforderungen

The standard specifies comprehensive safety and structural requirements for large steam sterilizers. It mandates strict guidelines for pressure vessels, including door sealing, interlocking mechanisms for double-door sterilizers, and test connectors. Electrical safety and electromagnetic compatibility must align with the referenced GB 4793 and GB/T 18268 standards. Performance criteria are rigorously defined, focusing on steam penetration (Bowie and Dick test), biological indicator inactivation, and precise temperature parameters under both small and full load conditions. The equipment must maintain specific equilibration times and temperature tolerances during the sterilization plateau. Additionally, it sets limits for vacuum leakage rates, load drying effectiveness, and noise levels. The standard also details requirements for measurement, display, and recording systems. Sterilizers must be equipped with independent temperature and pressure sensors, absolute pressure measurement systems, and robust control systems with fault detection capabilities. Appendix D provides normative specifications for the testing instruments and materials required to validate these parameters.

Prüfverfahren

- BD Test (Bowie and Dick Test): Evaluates the sterilizer's ability to successfully remove air and allow steam penetration. - Hollow Load Test: Assesses air dilution and steam penetration into lumen devices using a Process Challenge Device (PCD). - Temperature Performance Tests: Verifies temperature distribution and equilibration times under small and full load conditions using standard test packs. - Vacuum Leakage Test: Measures the pressure rise rate to ensure system integrity under vacuum. - Load Drying Effect Test: Determines moisture absorption in fabric and metal loads post-sterilization. - Noise and Pressure Change Rate Tests: Ensures operational noise and pressure fluctuations remain within safe limits.

Häufige Fragen

What products are regulated under GB 8599-2023?

It regulates large steam sterilizers with a volume of at least 60L or capable of holding one sterilization unit, specifically those with vacuum functions used for healthcare products.

Are there any updates from the previous version of GB 8599?

Yes, the 2023 version replaces GB 8599-2008, featuring updated requirements for double-door sterilizers, measurement systems, BD test criteria, and the inclusion of wireless temperature sensor allowances.

How does GB 8599-2023 address environmental considerations?

Appendix A provides informative guidelines on environmental impacts throughout the sterilizer's lifecycle, including material selection, energy consumption, and waste disposal.

The summary above provides a high-level overview of GB 8599-2023. 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 8599-2023 today to access all detailed parameters, tables, and testing procedures.

Hinweise zur Anwendbarkeit

Normtyp: Produkt
CCS: C47
ICS: 11.080.10
Zuständige Behörde: National Medical Products Administration
Technisches Komitee: National Technical Committee on Disinfection Technology and Equipment of Standardization Administration of China

Normbeziehungen

Ersetzt:GB 8599-2008 (Gültig)