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AAMI ANSI/AAMI ST67:2019

Sterilization of health care products—Requirements and guidance for selecting a sterility assurance level (SAL) for products labeled —sterile—
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AAMI ANSI/AAMI ST67:2019

Sterilization of health care products—Requirements and guidance for selecting a sterility assurance level (SAL) for products labeled —sterile—

PUBLISH DATE 2019
AAMI ANSI/AAMI ST67:2019
This standard establishes requirements, guidance and a risk framework for identification of acceptable approach(es) for assurance of sterility and for selection of alternative SAL(s) or aseptic processing for health care product that cannot be terminally sterilized to achieve an SAL value of 10 to the -6.
SDO AAMI: Assoc. for the Advancement of Medical Instrumentation
Document Number ST67
Publication Date Nov. 25, 2019
Language en - English
Page Count
Revision Level
Supercedes
Committee
Publish Date Document Id Type View
Nov. 25, 2019 Revision