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AAMI ST67:2019

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

Pages: 41
Publication date: 2019-07-29
Price: 131 vnd

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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 10-6.
Document identifier
AAMI ST67:2019
Title
Sterilization of health care products - Requirements and guidance for selecting a sterility assurance level (SAL) for products labeled "sterile"
AAMI Category
General and Miscellaneous
Publication date
2019-07-29
Status
Effective
International Relationship
Cross references
Latest version
AAMI ST67:2019
Sterilization of health care products - Requirements and guidance for selecting a sterility assurance level (SAL) for products labeled "sterile"
Document identifier AAMI ST67:2019
Publication date 2019-07-29
Classification
Status Effective
*
History of version
AAMI ST67:2019 * AAMI ST67:2011/(R)2017 * AAMI ST67:2003/(R)2008
Keywords
Classification
Pages
41
Price 131 vnd

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