GB/T 24628-2009 (English Version) PDF

Standard No.: GB/T 24628-2009
Language: Chinese, Available in English version
Release Date: 2009
Published By: General Administration of Quality Supervision, Inspection and Quarantine of the People‘s Republic of China
Latest: GB/T 24628-2009

Scope: This standard specifies the requirements for the test equipment, which is used to test whether the biological and chemical indicators in the sterilization process of steam, ethylene oxide, dry heat and vaporized hydrogen peroxide comply with GB 18282.1 for chemical indicators or GB 18282 series for Requirements for biological indicators. This standard also provides informative method information to help determine the performance characteristics of biological and chemical indicators for their intended use, and can also be used for routine quality control testing of indicators.

GB/T 24628-2009 Referenced Document

GB 18281.2-2000 Sterilization of health care products--Biological indicators--Part 2: Biological indicators for ethylene oxide sterilization
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 18282.4-2009 Sterilization of health care products-Chemical indicators-Part 4:Class 2 indicators as an alternative to the Bowie and Dick-type test for detection of steam penetration
IEC 60584-1:1995 Thermocouples - Part 1: Reference tables
IEC 60584-2:1982 Thermocouples Part 2: Tolerances (Edition 1.0)
IEC 60584-3:2007 Thermocouples - Part 3: Extension and compensating cables - Tolerances and identification systems
IEC 60751:2008 Industrial platinium resistance thermometer and platinum temperature sensors
ISO 11138-4:2006 Sterilization of health care products - Biological indicators - Part 4: Biological indicators for dry heat sterilization processes
ISO 17665-1:2006 Sterilization of health care products - Moist heat - Part 1: Requirements for the development, validation and routine control of a sterilization process for medical devices

2009 GB/T 24628-2009 Sterilization of health care products.Biological and chemical indicators.Test equipment