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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"

standard by Association for the Advancement of Medical Instrumentation , 07/29/2019

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Full Description

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.
 

Product Details

Published:
07/29/2019
ISBN(s):
9781570207273
ANSI:
ANSI Approved
Number of Pages:
41
File Size:
1 file , 680 KB
Note:
This product is unavailable in Russia, Ukraine, Belarus
 

Document History

  1. AAMI ST67:2019

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

    • Most Recent

  2. AAMI ST67:2011/(R)2017


    Sterilization of Health Care Products--Requirements for Products Labeled 'STERILE'

    • Historical Version

  3. AAMI ST67:2003/(R)2008


    Sterilization of Health Care Products--Requirements for Products Labeled "STERILE"

    • Historical Version