CSA Z11135-2 : 2009 : R2014
Withdrawn
A Withdrawn Standard is one, which is removed from sale, and its unique number can no longer be used. The Standard can be withdrawn and not replaced, or it can be withdrawn and replaced by a Standard with a different number.
A Withdrawn Standard is one, which is removed from sale, and its unique number can no longer be used. The Standard can be withdrawn and not replaced, or it can be withdrawn and replaced by a Standard with a different number.
STERILIZATION OF HEALTH CARE PRODUCTS - ETHYLENE OXIDE - PART 2: GUIDANCE ON THE APPLICATION OF ISO 11135-1
Hardcopy , PDF
07-24-2021
English
01-01-2014
Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 Quality management systems
5 Sterilizing agent characterization
6 Process and equipment characterization
7 Product definition
8 Process definition
9 Validation
10 Routine monitoring and control
11 Product release from sterilization
12 Maintaining process effectiveness
Annex A (informative) - Guidance on ISO 11135-1:2007 Annex
A Determination of process lethality - Biological
indicator/bioburden approach
Annex B (informative) - Guidance on ISO 11135-1:2007 Annex
B Conservative determination of lethal rate of the
sterilization process - Overkill approach
Bibliography
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