GB 18282.1-2015 Replaced National standards force_standard

GB 18282.1-2015 Sterilization of health care products—Chemical indicator—Part 1:General requirements

Publish Date: 2015-12-10 Implement Date: 2017-01-01 For services related to genuine standard inquiry, procurement, translation, and other related services in China, please Contact Us

Basic Information

Standard Code: GB 18282.1-2015

Standard Type: National standards

Standard Status: Replaced

is_force_gb: yes

CCS Name: Public medical equipment

ICS Name: Integrated disinfection and sterilization

Publish Date: 2015-12-10

Implement Date: 2017-01-01

Pages: 28 pages

Scope

1.1 This part of GB 18282 specifies the general requirements and test methods for indicators that display their exposure to sterilization processes through physical and/or chemical changes, and are used to monitor the achievement of specified single or multiple sterilization process parameters. They do not rely on the survival or inactivation response of microorganisms.
Note: Biological testing systems rely on demonstrating the viability of organisms to conduct tests. Information on such testing systems should be referred to the biological indicators (BIs) in the ISO 11138 series.
1.2 The requirements and test methods in this part apply to all indicators specified in other parts of GB 18282, except for requirements modified or added in other parts, in which case the requirements of the specific parts will apply.
Related testing equipment is described in ISO 18472.
Note: Additional requirements for specific test indicators (Class II) are given in GB 18282.3, GB 18282.4, and GB 18282.5.