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PD ISO/TS 19930:2017 Guidance on aspects of a risk-based approach to assuring sterility of terminally sterilized, single-use health care product that is unable to withstand processing to achieve maximally a sterility assurance level of 10-6 >
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PD ISO/TS 19930:2017 Guidance on aspects of a risk-based approach to assuring sterility of terminally sterilized, single-use health care product that is unable to withstand processing to achieve maximally a sterility assurance level of 10-6, 2017
- National foreword
- Foreword
- Introduction
- 1 Scope
- 2 Normative references
- 3 Terms and definitions
- 4 Assurance of sterility and sterility assurance level (SAL)
- 5 Management responsibility
- 6 Compatibility of product with a sterilization process [Go to Page]
- 7 Strategies to achieve a maximal SAL of 10−6
- 8 Considerations if a maximal SAL of 10−6 cannot be achieved [Go to Page]
- 9 Label claims
- 10 Establishing the sterilization process
- 11 Specific considerations for validation, routine monitoring and control, and product release from sterilization
- 12 Assessment of change
- Annex A (informative) Illustration of the sequence of activities in selecting and justifying an alternative SAL
- Bibliography [Go to Page]
