ANSI/AAMI ST 72-2002
Bacterial endotoxins - Test methodologies,routine monitoring,and alternatives to batch testing

Standard No.

ANSI/AAMI ST 72-2002

Release Date

2002

Published By

American National Standards Institute （ANSI)

Latest

ANSI/AAMI ST 72-2002

Scope

Specifies general criteria to be applied in the determination of bacterial endotoxins (pyrogens) on sterilized or sterilizable healthcare products, components or raw materials. Endotoxin methodologies covered include both qualitative (limit) methods and quantitative (end-point) methods. Determination of pyrogens other than bacterial endotoxins is not covered and acceptable levels for bacterial endotoxins are not covered.This standard was listed for public review in the 4/20/2001 issue of Standards Action. It is being resubmitted due to substantive changes to the text.

ANSI/AAMI ST 72-2002 Referenced Document

• ISO 9001:2000 Quality management systems - Requirements

ANSI/AAMI ST 72-2002 history

• 2002 ANSI/AAMI ST 72-2002 Bacterial endotoxins - Test methodologies,routine monitoring,and alternatives to batch testing