Overview of ANSI/AAMI ST72:2019 Regulations and Their Relationship with Lunar Eclipse Bacterial Endotoxicity
Date: 2025-09-18Read: 47
The Association for the Advancement of Medical Instrumentation (AAMI) is the main producer of domestic and international standards for the medical device industry, and is also the primary organization for professionals in the fields of medical technology and disinfection to obtain practical information, support, and guidance.AAMIThe standardization program has obtained certification from the American National Standards Institute (ANSI) for healthcare technology products, processes, and related services.
Specifically,The ANSI/AAMI ST72:2019 bacterial endotoxin standard provides guidance for bacterial endotoxin testing (BET)And it specifies the use ofLimulus amebocyte lysate (LAL)General standard for detecting bacterial endotoxin content on medical devices, components, and raw materials using bacterial endotoxin testing method1.
As stated in USP Chapter<85>2， ANSI/AAMI ST72:2019 also discusses the pharmacopoeial requirements for bacterial endotoxin testing methods and the effectiveness of bacterial endotoxin testing methods under applicable requirements. This includes but is not limited to the following:
Qualification confirmation of horseshoe crab reagent and analyst
linear
standard curvescope
Positive Product Controls (PPC)
Scope of recovery for positive product control
ANSI/AAMI ST72 Requirements
PhotometryThe detection techniques (including dynamic turbidity method and dynamic colorimetric method) require the use of a linear standard curve for the entire endotoxin concentration detection range. The absolute value | r | of the linear requirement correlation coefficient must be greater than or equal to 0.980 within the endotoxin concentration range specified by the Limulus Amebocyte Lysate (LAL) manufacturer. This applies to every test, including qualification confirmation for horseshoe crab reagents and analysts.
Qualification confirmation of horseshoe crab reagent:
At least 3 endotoxin concentrations must be used to generate the standard curve. For each endotoxin concentration, it must be tested 3 times and generate a correlation coefficient value | r | greater than or equal to 0.980.
Analyst Qualification Confirmation:
Similar to the qualification confirmation of horseshoe crab reagents, analysts must run at least three standard curves for endotoxin concentrations. For each endotoxin concentration, it must be tested 3 times and generate a qualified | r |.
Positive Product Control (PPC):
The positive product control must be in at least two copies and have an endotoxin spiked value at or near the middle concentration of the standard curve. The actual endotoxin acceptance standard for positive product control is between 50-200%.
The sample must be in at least two copies.
There are at least 3 concentrations, each with at least 2 repeated values.
At least two copies must be made.
Sievers®Eclipse
Compliance of Lunar Eclipse Bacterial endotoxin Tester
Sievers®Eclipse is a compliant endotoxin detectorSatisfyThe United States Pharmacopeia (USP)The pharmacopoeial requirements specified in the European Pharmacopoeia EP 2.6.14, Japanese Pharmacopoeia JP 4.01, Chinese Pharmacopoeia ChP, and ANSI/AAMI ST72 meet the overall acceptance criteria.
Eclipse comes with standard curves and provides 5 concentrations(Range: 50-0.005 EU/mL, in triplicate),Each sample is accompanied by a positive product controlTherefore, ensure that all regulatory requirements for testing are met.
