GB/T 19972-2005 (English Version) PDF

Standard No.: GB/T 19972-2005
Language: Chinese, Available in English version
Release Date: 2005
Published By: General Administration of Quality Supervision, Inspection and Quarantine of the People‘s Republic of China
Status: Be replaced 2018-10
Replace By: GB/T 19972-2018
Latest: GB/T 19972-2018

Scope: When using biological indicators to set up, confirm and routinely monitor the sterilization process, this standard provides guidelines for the selection, use and judgment of test results of biological indicators. This standard is applicable to various biological indicators that have existing national standards. This standard does not consider those processes that rely solely on physical methods to remove microorganisms, such as filtration. This standard does not apply to the use of various combined processes, such as washer-disinfectors or flushing and steaming of pipelines. This standard also does not apply to processes using liquid sterilization.

GB/T 19972-2005 Referenced Document

GB 18278-2000 Sterilization of health care products--Requirements for validation and routine control--Industrial moist heat sterilization
GB 18279-2000 Medical devices--Validation and routine control of ethylene oxide sterilization
GB 18281.1-2000 Sterilization of health care products--Biological indicators--Part 1: General
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

2018 GB/T 19972-2018 Sterilization of health care products—Biological indicators—Guidance for the selection, use and interpretation of results
2005 GB/T 19972-2005 Sterilization of health care products.Biological indicators.Guidance for the selection, use and interpretation of results