YY/T 1793-2021 Active Industry standards-Medicine

YY/T 1793-2021 Bacterial endotoxin detection kit

Publish Date: 2021-09-06 Implement Date: 2023-03-01 For services related to genuine standard inquiry, procurement, translation, and other related services in China, please Contact Us

Basic Information

Standard Code: YY/T 1793-2021

Standard Type: Industry standards

Standard Status: Active

is_force_gb: no

CCS Name: Medical laboratory equipment

ICS Name: Laboratory medicine

Publish Date: 2021-09-06

Implement Date: 2023-03-01

Pages: 12 pages

Scope

This standard specifies the requirements, test methods, marking, labeling, user manuals, packaging, transportation, and storage of bacterial endotoxin assay kits.
This standard applies to kits that use the luminometer-based limulus amebocyte lysate (LAL) assay to quantitatively detect bacterial endotoxins produced by Gram-negative bacteria in human serum and plasma. Bacterial endotoxins are composed of lipopolysaccharide-protein complexes, and lipopolysaccharide is a component of bacterial endotoxins. Therefore, this standard also applies to kits that use the luminometer-based LAL assay to quantitatively detect lipopolysaccharides from Gram-negative bacteria in human serum and plasma.