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ANSI/AAMI ST67:2019 - Sterilization of health care products-Requirements and guidance for selecting a sterility assurance level (SAL) for products labeled “sterile” >
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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]
- 2 Normative references
- 3 Definitions
- 4 Determination of approach for assurance of sterility [Go to Page]
- 5 Approaches to assure sterility other than use of an SAL value of 10-6 [Go to Page]
- Annex A (informative) Background and historical application of sterility assurance [Go to Page]
- Annex B (informative) Modification strategies to consider in order to achieve terminal sterilization at an SAL value of 10-6 [Go to Page]
- Annex C (informative) Risk management considerations if an SAL value of 10-6 cannot be achieved [Go to Page]
- Annex D (informative) Examples of risk management considerations to select an approach to assure sterility [Go to Page]
- Bibliography [Go to Page]
