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

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

ANSI/AAMI ST67:2019; Sterilization of health care products—Requirements and guidance for selecting a sterility assurance level (SAL) for products labeled “sterile”
Title page
AAMI Standard
Copyright information
Contents Page
Committee representation
Foreword
Introduction
1 Scope [Go to Page]
1.1 Inclusions
1.2 Exclusions
2 Normative references
3 Definitions
4 Determination of approach for assurance of sterility [Go to Page]
4.1 General
4.2 Selection of a sterility assurance level, SAL [Go to Page]
4.2.1 Intended use
4.2.2 Compatibility with an SAL value of 10-6 [Go to Page]
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
4.3 Risk assessment to determine acceptability of an approach to sterility assurance other than an SAL value of 10-6 [Go to Page]
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
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 [Go to Page]
5.1 Selection of an alternative SAL
5.2 Aseptic Processing
Annex A (informative) Background and historical application of sterility assurance [Go to Page]
A.1 Introduction
A.2 History of sterility assurance
A.3 Explanation of terms SAL and PNSU [Go to Page]
Table A.1—Examples of historical SALs for terminally sterilized product*
Annex B (informative) Modification strategies to consider in order to achieve terminal sterilization at an SAL value of 10-6 [Go to Page]
B.1 Materials
B.2 Product and package design
B.3 Method of sterilization establishment
B.4 Sterilization technology
B.5 Bioburden
Annex C (informative) Risk management considerations if an SAL value of 10-6 cannot be achieved [Go to Page]
C.1 General
C.2 Criteria in determining if a modification is feasible
C.3 Selection of method for assurance of sterility
C.4 Risk aspects to consider in determining if a modification is feasible
C.5 Risk aspects to consider for an individual patient [Go to Page]
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
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
Annex D (informative) Examples of risk management considerations to select an approach to assure sterility [Go to Page]
D.1 General
D.2 Examples of microbiological factors that might be associated with a risk analysis
D.3 Example 1—Biosynthetic skin dressing [Go to Page]
Table D.1—Assessment of product SAL requirements and practicability of 10-6 sterilization for biosynthetic skin dressing
D.4 Example 2—Porcine heart valve [Go to Page]
Table D.2—Assessment of product SAL requirements and practicability of 10-6 sterilization for porcine heart valve
D.5 Example 3—Drug with drug delivery device [Go to Page]
Table D.3—Assessment of product SAL requirements and practicability of 10-6 sterilization for drug with drug delivery device
D.6 Example 4—Ultrasonic tissue cutting device [Go to Page]
Table D.4—Assessment of product SAL requirements and practicability of 10-6 sterilization for ultrasonic cutting device
Bibliography [Go to Page]

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