UNLIMITED FREE ACCESS TO THE WORLD'S BEST IDEAS

close
Already an Engineering360 user? Log in.

This is embarrasing...

An error occurred while processing the form. Please try again in a few minutes.

Customize Your Engineering360 Experience

close
Privacy Policy

This is embarrasing...

An error occurred while processing the form. Please try again in a few minutes.

AAMI - ST67

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

inactive
Organization: AAMI
Publication Date: 1 January 2011
Status: inactive
Page Count: 23
scope:

Inclusions

This standard specifies requirements and provides guidance for selecting an appropriate SAL for a terminally sterilized health care product that is labeled "sterile." The requirements and guidance provided in this standard also apply to the selection of an appropriate SAL for a terminally sterilized health care product that is labeled "Sterile Fluid Path."

Exclusions

This standard does not address health care products that are not labeled "sterile." For example, nonsterile health care products that possess antimicrobial properties or contain preservatives for the control of microbial levels are not addressed.

This standard does not address the sterility of aseptically processed products.

Document History

January 1, 2019
Sterilization of health care products—Requirements and guidance for selecting a sterility assurance level (SAL) for products labeled “sterile”
Inclusions This standard specifies requirements and provides guidance on selecting approaches to establish assurance of sterility for a health care product labelled as “sterile.” Approaches to...
ST67
January 1, 2011
Sterilization of health care products-Requirements and guidance for selecting a sterility assurance level (SAL) for products labeled ‘sterile’
Inclusions This standard specifies requirements and provides guidance for selecting an appropriate SAL for a terminally sterilized health care product that is labeled “sterile.” The requirements and...
January 1, 2011
Sterilization of health care products—Requirements and guidance for selecting a sterility assurance level (SAL) for products labeled “sterile”
Inclusions This standard specifies requirements and provides guidance for selecting an appropriate SAL for a terminally sterilized health care product that is labeled "sterile." The requirements and...
January 1, 2003
Sterilization of health care products—Requirements for products labeled “STERILE”
Inclusions This standard specifies requirements and provides guidance for selecting an appropriate SAL for a terminally sterilized medical device or a maximum contamination rate for an aseptically...
January 1, 2003
Sterilization of health care products—Requirements for products labeled “STERILE”
A description is not available for this item.

References

Advertisement