GB 8599-2008
Technical requirements for large steam sterilizers.Automatic type (English Version)

Standard No.

GB 8599-2008

Language

Chinese, Available in English version

Release Date

2008

Published By

General Administration of Quality Supervision, Inspection and Quarantine of the People‘s Republic of China

Status

Be replaced 2026-10

Replace By

GB 8599-2023

Latest

GB 8599-2023

Replace

GB 8599-1988 GB/T 8600-1988

Scope

This standard specifies the technical requirements for large-scale steam sterilizers—terms and definitions, types and basic parameters, requirements and test methods of automatic control type. This standard applies to large steam sterilizers (hereinafter referred to as sterilizers) that can be loaded with one or more sterilization units and whose volume is greater than 60 L. This sterilizer is mainly used for the sterilization of healthcare products and their accessories. The sterilizer designed and produced according to this standard shall consider the impact of environmental factors in the product life cycle. See Appendix A for environmental factors. This standard does not specify the requirements for the quality assurance system used to control the various stages of sterilizer manufacturing and production. This standard does not apply to manually controlled large-scale steam sterilizers.

GB 8599-2008 Referenced Document

• GB 150 Pressure Vessels (Bound Edition)*， 2024-04-19 Update
• GB 18281.1-2000 Sterilization of health care products--Biological indicators--Part 1: General
• GB 18281.3-2000 Sterilization of health care products--Biological indicators--Part 3: Biological indicators for moist heat sterilization
• GB 18282.1-2000 Sterilization of health care products--Chemical indicators--Part 1: General requirements
• GB 4793.1 Safety requirements for electrical equipment for measurement,control,and laboratory use.Part 1:General requirements
• GB 4793.4 Safety requirements for electrical equipment for measurement,control and laboratory use—Part 4: Particular requirements for sterilizers and washer-disinfectors used to treat medical materials*， 2019-12-17 Update
• GB/T 16839.2-1997 Thermocouples--Part 2: Tolerances
• GB/T 18268-2000 Electrical equipment for measurement,control and laboratory use--EMC requirements
• GB/T 19633 Packaging for terminally sterilized medical devices
• GB/T 19971-2005 Sterilization of health care products.Vocabulary
• ISO 11140-3:2000 Sterilization of health care products - Chemical indicators- Part 3: Class 2 indicators for steam penetration test sheets
• JB/T 8622-1997 Technical specification and reference table for industrial platinum thermal resistance

GB 8599-2008 history

• 2023 GB 8599-2023 Technical requirements for large pressure steam sterilizers
• 2008 GB 8599-2008 Technical requirements for large steam sterilizers.Automatic type
• 1988 GB 8599-1988 Specifications for automated autoclave sterilizer

GB 8599-2008 Technical requirements for large steam sterilizers.Automatic type has been changed from GB/T 8600-1988 Inspecting method for sterilizing effect of automated autoclave sterilizer.