GB/T 32309-2015Hydrogen peroxide low temperature plasma sterilizer (English PDF)

1 Scope

This standard specifies the hydrogen peroxide low temperature plasma sterilizer (hereinafter referred to as sterilization) terms and definitions, requirements, test methods, inspection

Inspection rules and signs, packaging, manual, transport and storage.

This standard applies only to hydrogen peroxide sterilization media, capable of producing low-temperature plasma sterilizer.

This standard does not specify the scope of the risks involved in the use of security requirements, low-temperature hydrogen peroxide plasma, validation and routine control unspecified

Claim.

Note. This standard refers to the low temperature sterilization, the sterilizing chamber temperature of not more than 60 °C.

2 Normative references

The following documents for the application of this document is essential. For dated references, only the dated version suitable for use herein

Member. For undated references, the latest edition (including any amendments) applies to this document.

GB/T 191 Packaging - Pictorial signs

GB/T 1616 Industrial hydrogen peroxide

GB 4793.1 measurement, control and laboratory safety requirements for electrical equipment - Part 1. General requirements

GB/T 4982 Vacuum technology - Quick release couplings - Dimensions - Part 1. Clamping Type

GB/T 14710-2009 medical electrical environmental requirements and test methods

EMC requirements for electrical equipment GB/T 18268 (all parts) measurement, control and laboratory use

GB 19192-2003 contact lens care solution hygiene requirements

GB Z159-2004 workplace air sampling regulate hazardous substances monitoring

Spectrophotometric method WS/T 132-1999 Workplace air hydrogen peroxide

Symbol YY0466 medical equipment used with medical device labels, labeling and information provided

Disinfection Technical Specification (Version 2002) People's Republic of China Ministry of Health

3 Terms and Definitions

The following terms and definitions apply to this document.