GB 8599-2008 Active National standards force_standard

GB 8599-2008 Technical requirements for large steam sterilizers—Automatic type

Publish Date: 2008-12-12 Implement Date: 2009-12-31 For services related to genuine standard inquiry, procurement, translation, and other related services in China, please Contact Us

Basic Information

Standard Code: GB 8599-2008

Standard Type: National standards

Standard Status: Active

is_force_gb: yes

CCS Name: Public medical equipment

ICS Name: Disinfection equipment

Publish Date: 2008-12-12

Implement Date: 2009-12-31

Pages: 37 pages

Scope

This standard specifies the technical requirements for large-scale steam sterilizers - the terms and definitions, types and basic parameters, requirements, and test methods of automatic control models.
This standard applies to large-scale steam sterilizers (hereinafter referred to as sterilizers) that can load one or more sterilization units and have a volume greater than 60L. These sterilizers are mainly used for the sterilization of medical and healthcare products and their accessories.
Sterilizers designed and manufactured in accordance with this standard should take into account the impact of environmental factors during the product life cycle. Environmental factors are described in Appendix A.
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.