GB 18282.1-2015 (English Version) PDF

Standard No.: GB 18282.1-2015
Language: Chinese, Available in English version
Release Date: 2017
Published By: General Administration of Quality Supervision, Inspection and Quarantine of the People‘s Republic of China
Latest: GB 18282.1-2015
Replace: GB 18282.1-2000

Scope: 1.1 This part of GB 18282 specifies the general requirements and test methods for indicators. These indicators show their exposure to the sterilization process through physical and/or chemical changes in substances, and are used to monitor the attainment of specified single or multiple sterilization conditions. Process parameters that do not depend on the survival or inactivation response to microorganisms. NOTE: Biological test systems rely on the demonstration of organism viability for testing. About this type of test system should be covered in the ISO11138 series of biological indicators (BIs). 1.2 "The requirements and test methods of this part are applicable to all indicators specified in other parts of GB18282. Except for the requirements modified or added in other parts, the requirements of this specific part will apply. The relevant test equipment is described in ISO18472 Note: The additional requirements for specific test indicators (Class II) are given in GB18282.3, GB18282.4 and GB18282.5.

GB 18282.1-2015 Referenced Document

ISO 11607 Packaging for terminally sterilized medical devices
ISO 18472 Sterilization of health care products - Biological and chemical indicators - Test equipment*， 2018-07-31 Update
ISO 8601 Data elements and interchange formats - Information interchange - Representation of dates and times

2017 GB 18282.1-2015 Chemical indicators for sterilization of healthcare products - part 1: general rules
2000 GB 18282.1-2000 Sterilization of health care products--Chemical indicators--Part 1: General requirements