I.S. EN ISO 11135:2014&A1:2019
Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
Hardcopy , PDF
03-14-2020
English
11-26-2019
For Harmonized Standards, check the EU site to confirm that the Standard is cited in the Official Journal.
Only cited Standards give presumption of conformance to New Approach Directives/Regulations.
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 (normative) Determination of lethal rate of the sterilization process — Biological indicator/bioburden approach
Annex B (normative) Conservative determination of lethal rate of the sterilization process — Overkill approach
Annex C (informative) Temperature sensors, RH sensors and biological indicator numbers
Annex D (informative) Guidance on the application of the normative requirements
Annex E (normative) Single Lot Release
Bibliography
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