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AAMI ST67 pdf free download

AAMI ST67 pdf free download.Sterilization of health care products – Requirements and guidance for selecting a sterility assurance level (SAL) for products labeled“sterile’.
4.2.2 Selection based on intended use of the health care product
NOTE—Examples of products that historically have been terminally sterilized and the SAL5 that historically have been selected for the products are provided in Annex B.
The SAL selected for a terminally sterilized device is related to the risk of patient infection associated with the intended use of the device:
a) a 10.6 SAL shall be used for:
— products intended to come into contact with breached skin or compromised tissue (i.e., tissue that has
lost its natural barrier integrity or is damaged or injured);
— invasive products that enter normally sterile tissue;
— products with claims of sterile fluid pathways; and
— surgically implanted devices.
NOTE—4.2.4 describes instances in which other SALs may be acceptable.
b) a iO SAL, or an SAL providing a greater assurance of sterility (i.e., 1O, iO, etc.), shall be used for:
— products not intended to come into contact with breached skin or compromised tissue,
— topical products that contact intact skin or mucous membranes, or
— products that meet the criteria specified in 4.2.4.
4.2.3 Selection based on sterilization process and/or validation method
NOTE—Examples of products that historically have been terminally sterilized and the SALs that historically have been selected for the products are provided in Annex B.
The extent of treatment with a sterilizing agent that is determined as being required to achieve a particular SAL may be related to the validation method used. For example, in general, a bioburden-based validation method will give a shorter extent of treatment to achieve a particular SAL than a biological indicator—bioburden or “overkill” method. Validation methods for specified sterilization processes are detailed in ANSI/AAMI/ISO 17665-I, ANSI/AAMI/lSO 11135, ANSI/AAMI/ISO 11137, ANSI/AAMI/ISO 14161, ANSI/AAMI/ISO 14937, and ANSI/AAMI ST63.
For those products that require a 106 SAL and are incapable of withstanding the sterilization process chosen, alternative sterilization processes and/or validation methods should be investigated before selecting an alternative SAL (e.g., iO, i04, or 1O) (see also 4.2.4). For example, if the manufacturer has chosen to validate a moist heat sterilization process using an overkill method and the product cannot withstand the process, alternative sterilization processes (e.g., ethylene oxide or radiation) or validation methods (e.g., biological indicator—bioburden or bioburden) should be investigated.
4.2.4 Selection based upon the product’s inability to withstand a terminal sterilization process that achieves a 10.6 SAL
NOTE—Examples of products that historically have been terminally sterilized and the SALs that historically have been selected for the products are provided in Annex B.
If, based on its intended use, a product would be required to possess a 1O SAL, but the product is incapable of withstanding the sterilization process, the selection of an SAL other than 10.6 may be necessary. A risk assessment may be used as an indication of risk and as a rationale for selecting a different SAL when the following conditions apply:
a) the product cannot be des igned to allow a sterilization process that achieves an SAL of 106 without adversely affecting its essential safety and function; and.AAMI ST67 pdf download.

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