ANSI/AAMI ST72:2019 pdf download.Bacterial endotoxins - Test methods, routine monitoring, and alternatives to batch testing.
1.1 This document specifes general criteia to be aplied in the determination of bacterial endotoxins on or in medical devices, components, or raw materials employing bacterial endotoxins test (BET) methods using amebocyte lysate reagents from Limulus polyphemus or Tachypleus tnidentatus.
NOTE Although the scope of this standard is limited to medical devices, it also includes requirements and provides testing guidance that might be aplicable to other health care products, such as, biologics, tssue-based products and combination products.
1.2 This document is not applicable to the evaluation of pyrogens other than bacterial endotoxins.
2Normative references
The following documents contain provisions that, through reference in this text, constitute provisions of this guideline.
At the time of publication, the editions indicated were valid. All standards are subject to revision, and parties to agreements based on this guideline are encouraged to investigate the possbilit of applying the most recent editions of the standards indicated below.
The United States Phamacopoeia (USP) <85>. current edition, United States Pharmacopeial Convention (USP),Rockville MD.
The United States Pharmacopoeia (USP) <161>. current edition, United States Phamacopeial Convention (USP),Rockville MD.
U.S. Food and Drug Administration:1998, Quality System Regulation, 21 CFR, Part 820.
3Definitions
For the purpose of this document, the ollowing definitions apply.
bacterial endotoxins test (BET): Assay for measuring bacterial endotoxins by combining a liquid test sample or test sample extract with Tachypleus or Limulus amebocyte lysate (TAL/LAL) reagent and measuring the resuling proportional reaction via visual, turbidimetric, or chromogenic techniques.
3.2batch: Defined quantity of product intended or purported to be uniform in character and quality produced during a specified cycle of manufacture.
[Source: ISo 11139:2018]
3.3chromogenic technique: BET methodology that quantifes or detects endotoxins on the basis of a measured color-producing reaction proportional to the interaction of LAL and endotoxin.
3.4control standard endotoxin (CSE): Endotoxin standard preparation whose potency has been standardized against the Reference Standard Endotoxin (RSE) for a specific batch of LAL.
3.5depyrogenation: Validated process designed to remove or inactivate endotoxin.
3.6direct contact: Term used for a device or device component that comes into physical contact with body tssue
3.7end product testing: Testing carried out on product samples that have completed the entire manufacturing process.
3.8 endotoxin or bacterial endotoxin: High molecular weight complex associated with the cell wall of Gramnegative bacteria that is pyrogenic in humans and specifically interacts with an endotoxin detection system.ANSI/AAMI ST72 pdf download.