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AAMI ST67 2019

AAMI ST67 2019

$75.64

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

Published By Publication Date Number of Pages
AAMI 2019 41
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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.

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PDF Pages PDF Title
1 ANSI/AAMI ST67:2019; Sterilization of health care products—Requirements and guidance for selecting a sterility assurance level (SAL) for products labeled “sterile”
3 Title page
4 AAMI Standard
Copyright information
5 Contents Page
6 Committee representation
9 Foreword
10 Introduction
11 1 Scope
1.1 Inclusions
1.2 Exclusions
2 Normative references
12 3 Definitions
14 4 Determination of approach for assurance of sterility
4.1 General
4.2 Selection of a sterility assurance level, SAL
4.2.1 Intended use
4.2.2 Compatibility with an SAL value of 10-6
15 Figure 1—Numerical values of sterility assurance level (SAL) together with the concept of assurance of sterility
4.2.3 Modification strategies to achieve an SAL value of 10-6
16 4.3 Risk assessment to determine acceptability of an approach to sterility assurance other than an SAL value of 10-6
17 Figure 2—Flowchart for product to achieve an SAL value of 10-6 or alternate SAL (4.2.1)
4.3.1 Risk-based feasibility assessment
18 4.3.2 Consideration of other approaches to assure sterility
5 Approaches to assure sterility other than use of an SAL value of 10-6
5.1 Selection of an alternative SAL
19 5.2 Aseptic Processing
20 Annex A (informative) Background and historical application of sterility assurance
A.1 Introduction
A.2 History of sterility assurance
21 A.3 Explanation of terms SAL and PNSU
Table A.1—Examples of historical SALs for terminally sterilized product*
22 Annex B (informative) Modification strategies to consider in order to achieve terminal sterilization at an SAL value of 10-6
B.1 Materials
23 B.2 Product and package design
B.3 Method of sterilization establishment
24 B.4 Sterilization technology
26 B.5 Bioburden
28 Annex C (informative) Risk management considerations if an SAL value of 10-6 cannot be achieved
C.1 General
C.2 Criteria in determining if a modification is feasible
29 C.3 Selection of method for assurance of sterility
C.4 Risk aspects to consider in determining if a modification is feasible
30 C.5 Risk aspects to consider for an individual patient
31 Table C.1—Risk aspects to consider for an individual patient: Example of severity rankings
Figure C.1—Probability of infection resulting from three potential sources
32 Table C.2—Risk aspects to consider for an individual patient: Example of probability rankings
Table C.3—Risk aspects to consider for an individual patient: Example of overall risk rankings
33 Annex D (informative) Examples of risk management considerations to select an approach to assure sterility
D.1 General
D.2 Examples of microbiological factors that might be associated with a risk analysis
34 D.3 Example 1—Biosynthetic skin dressing
Table D.1—Assessment of product SAL requirements and practicability of 10-6 sterilization for biosynthetic skin dressing
36 D.4 Example 2—Porcine heart valve
Table D.2—Assessment of product SAL requirements and practicability of 10-6 sterilization for porcine heart valve
37 D.5 Example 3—Drug with drug delivery device
Table D.3—Assessment of product SAL requirements and practicability of 10-6 sterilization for drug with drug delivery device
38 D.6 Example 4—Ultrasonic tissue cutting device
Table D.4—Assessment of product SAL requirements and practicability of 10-6 sterilization for ultrasonic cutting device
39 Bibliography

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AAMI ST67 2019
$75.64