GB8599-2023

Technical requirements for large steam sterilizers

大型压力蒸汽灭菌器技术要求

GB 8599-2023 é uma norma nacional chinesa obrigatória que entrará em vigor: Technical requirements for large steam sterilizers. Setor: Alimentos. Foco: Segurança de produtos. Entrada em vigor: 1 de out. de 2026.

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 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.

Requisitos técnicos

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.

Métodos de ensaio

- 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.

Perguntas frequentes

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.

Indicações de aplicabilidade

Tipo: Produto
CCS: C47
ICS: 11.080.10
Órgão competente: National Medical Products Administration
Comitê técnico: National Technical Committee on Disinfection Technology and Equipment of Standardization Administration of China

Relações

Substitui:GB 8599-2008 (Vigente)