PD ISO/TS 19930:2017
Current
The latest, up-to-date edition.
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
Hardcopy , PDF
English
12-01-2017
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
7 Strategies to achieve a maximal SAL of 10-6
8 Considerations if a maximal SAL of 10-6 cannot
be achieved
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
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