ISO 11135:2014
Sterilization of health-care products — Ethylene oxide — Requirements for the development, validation and routine control of a sterilization process for medical devices
ISO 11135:2014 specifies requirements for the development, validation and routine control of an ethylene oxide sterilization process for medical devices in both the industrial and health care facility settings, and it acknowledges the similarities and differences between the two applications.
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Section sec_1
Section sec_1.1
Section sec_1.2
Section sec_1.2.1
Section sec_1.2.2
Section sec_1.2.3
Section sec_1.2.4
Section sec_1.2.5
Section sec_1.2.6
Section sec_2
Section sec_3
Section sec_3.1
Section sec_3.2
Section sec_3.3
Section sec_3.4
Section sec_3.5
Section sec_3.6
Section sec_3.7
Section sec_3.8
Section sec_3.9
Section sec_3.10
Section sec_3.11
Section sec_3.12
Section sec_3.13
Section sec_3.14
Section sec_3.15
Section sec_3.16
Section sec_3.17
Section sec_3.18
Section sec_3.19
Section sec_3.20
Section sec_3.21
Section sec_3.22
Section sec_3.23
Section sec_3.24
Section sec_3.25
Section sec_3.26
Section sec_3.27
Section sec_3.28
Section sec_3.29
Section sec_3.30
Section sec_3.31
Section sec_3.32
Section sec_3.33
Section sec_3.34
Section sec_3.35
Section sec_3.36
Section sec_3.37
Section sec_3.38
Section sec_3.39
Section sec_3.40
Section sec_3.41
Section sec_3.42
Section sec_3.43
Section sec_3.44
Section sec_3.45
Section sec_3.46
Section sec_3.47
Section sec_3.48
Section sec_3.49
Section sec_3.50
Section sec_3.51
Section sec_3.52
Section sec_3.53
Section sec_3.54
Section sec_3.55
Section sec_3.56
Section sec_3.57
Section sec_3.58
Section sec_4
Section sec_4.1
Section sec_4.1.1
Section sec_4.1.2
Section sec_4.2
Section sec_4.2.1
Section sec_4.2.2
Section sec_4.3
Section sec_4.3.1
Section sec_4.3.2
Section sec_4.3.3
Section sec_4.4
Section sec_5
Section sec_5.1
Section sec_5.2
Section sec_5.3
Section sec_5.4
Section sec_5.5
Section sec_5.5.1
Section sec_5.5.2
Section sec_5.5.3
Section sec_6
Section sec_6.1
Section sec_6.1.1
Section sec_6.1.2
Section sec_6.2
Section sec_6.2.1
Section sec_6.2.2
Section sec_6.2.3
Section sec_6.2.4
Section sec_6.2.5
Section sec_6.3
Section sec_6.3.1
Section sec_6.3.2
Section sec_6.3.3
Section sec_6.3.4
Section sec_6.3.5
Section sec_7
Section sec_7.1
Section sec_7.1.1
Section sec_7.1.2
Section sec_7.1.3
Section sec_7.1.4
Section sec_7.1.5
Section sec_7.1.6
Section sec_7.2
Section sec_7.2.1
Section sec_7.2.2
Section sec_7.2.3
Section sec_7.2.4
Section sec_7.3
Section sec_7.3.1
Section sec_7.3.2
Section sec_7.4
Section sec_8
Section sec_8.1
Section sec_8.2
Section sec_8.3
Section sec_8.4
Section sec_8.5
Section sec_8.6
Section sec_8.7
Section sec_8.8
Section sec_8.9
Section sec_9
Section sec_9.1
Section sec_9.1.1
Section sec_9.1.2
Section sec_9.1.3
Section sec_9.1.4
Section sec_9.2
Section sec_9.2.1
Section sec_9.2.1.1
Section sec_9.2.1.2
Section sec_9.2.1.3
Section sec_9.2.2
Section sec_9.2.2.1
Section sec_9.2.2.2
Section sec_9.2.2.3
Section sec_9.2.2.4
Section sec_9.2.2.5
Section sec_9.2.2.6
Section sec_9.3
Section sec_9.3.1
Section sec_9.3.2
Section sec_9.4
Section sec_9.4.1
Section sec_9.4.1.1
Section sec_9.4.1.2
Section sec_9.4.1.3
Section sec_9.4.1.4
Section sec_9.4.1.5
Section sec_9.4.1.6
Section sec_9.4.1.7
Section sec_9.4.1.8
Section sec_9.4.1.9
Section sec_9.4.1.10
Section sec_9.4.2
Section sec_9.4.2.1
Section sec_9.4.2.2
Section sec_9.4.2.3
Section sec_9.4.2.4
Section sec_9.4.2.5
Section sec_9.4.2.6
Section sec_9.4.3
Section sec_9.4.3.1
Section sec_9.4.3.2
Section sec_9.5
Section sec_9.5.1
Section sec_9.5.2
Section sec_9.5.3
Section sec_9.5.4
Section sec_9.5.5
Section sec_9.5.6
Section sec_10
Section sec_10.1
Section sec_10.2
Section sec_10.3
Section sec_10.4
Section sec_10.5
Section sec_11
Section sec_11.1
Section sec_11.2
Section sec_11.3
Section sec_11.4
Section sec_12
Section sec_12.1
Section sec_12.1.1
Section sec_12.1.2
Section sec_12.2
Section sec_12.2.1
Section sec_12.2.2
Section sec_12.2.3
Section sec_12.2.4
Section sec_12.3
Section sec_12.3.1
Section sec_12.3.2
Section sec_12.3.3
Section sec_12.3.4
Section sec_12.4
Section sec_12.4.1
Section sec_12.4.2
Section sec_12.4.3
Section sec_12.4.4
Section sec_12.4.5
Section sec_12.4.6
Section sec_12.5
Section sec_12.5.1
Section sec_12.5.2
Annex sec_A
Annex sec_A.1
Annex sec_A.1.1
Annex sec_A.1.2
Annex sec_A.1.3
Annex sec_A.2
Annex sec_B
Annex sec_B.1
Annex sec_B.1.1
Annex sec_B.1.2
Annex sec_B.1.3
Annex sec_B.1.4
Annex sec_B.2
Annex sec_B.2.1
Annex sec_B.2.2
Annex sec_B.2.3
Annex sec_B.2.4
Annex sec_B.2.5
Annex sec_C
Annex sec_C.1
Table tab_C.1
Annex sec_C.2
Table tab_C.2
Annex sec_C.3
Table tab_C.3
Annex sec_D
Annex sec_D.1
Annex sec_D.2
Annex sec_D.3
Annex sec_D.4
Annex sec_D.4.1
Annex sec_D.4.2
Annex sec_D.4.2.1
Annex sec_D.4.2.2
Annex sec_D.4.3
Annex sec_D.4.3.1
Annex sec_D.4.3.2
Annex sec_D.4.3.3
Annex sec_D.4.4
Annex sec_D.5
Annex sec_D.5.1
Annex sec_D.5.2
Annex sec_D.5.3
Annex sec_D.5.4
Annex sec_D.5.5
Annex sec_D.5.5.1
Annex sec_D.5.5.2
Annex sec_D.5.5.3
Annex sec_D.6
Annex sec_D.6.1
Annex sec_D.6.2
Annex sec_D.6.2.1
Annex sec_D.6.2.2
Annex sec_D.6.2.3
Annex sec_D.6.2.4
Annex sec_D.6.2.5
Annex sec_D.6.3
Annex sec_D.6.3.1
Annex sec_D.6.3.2
Annex sec_D.6.3.3
Annex sec_D.6.3.4
Annex sec_D.6.3.5
Annex sec_D.7
Annex sec_D.7.1
Annex sec_D.7.1.1
Annex sec_D.7.1.2
Annex sec_D.7.1.3
Annex sec_D.7.1.4
Annex sec_D.7.1.5
Annex sec_D.7.1.6
Annex sec_D.7.2
Annex sec_D.7.2.1
Annex sec_D.7.2.2
Annex sec_D.7.2.3
Annex sec_D.7.2.4
Annex sec_D.7.3
Annex sec_D.7.3.1
Annex sec_D.7.3.2
Annex sec_D.7.4
Annex sec_D.8
Annex sec_D.8.1
Annex sec_D.8.2
Annex sec_D.8.3
Annex sec_D.8.4
Annex sec_D.8.5
Annex sec_D.8.6
Annex sec_D.8.7
Annex sec_D.8.8
Annex sec_D.8.9
Annex sec_D.9
Annex sec_D.9.1
Annex sec_D.9.1.1
Annex sec_D.9.1.2
Annex sec_D.9.1.3
Annex sec_D.9.1.4
Annex sec_D.9.2
Annex sec_D.9.2.1
Annex sec_D.9.2.1.1
Annex sec_D.9.2.1.2
Annex sec_D.9.2.1.3
Annex sec_D.9.2.2
Annex sec_D.9.2.2.1
Annex sec_D.9.2.2.2
Annex sec_D.9.2.2.3
Annex sec_D.9.2.2.4
Annex sec_D.9.2.2.5
Annex sec_D.9.2.2.6
Annex sec_D.9.3
Annex sec_D.9.3.1
Annex sec_D.9.3.2
Annex sec_D.9.4
Annex sec_D.9.4.1
Annex sec_D.9.4.1.1
Annex sec_D.9.4.1.2
Annex sec_D.9.4.1.3
Annex sec_D.9.4.1.4
Annex sec_D.9.4.1.5
Annex sec_D.9.4.1.6
Annex sec_D.9.4.1.7
Annex sec_D.9.4.1.8
Annex sec_D.9.4.1.9
Annex sec_D.9.4.1.10
Annex sec_D.9.4.2
Annex sec_D.9.4.2.1
Annex sec_D.9.4.2.2
Annex sec_D.9.4.2.3
Annex sec_D.9.4.2.4
Annex sec_D.9.4.2.5
Annex sec_D.9.4.3
Annex sec_D.9.4.3.1
Annex sec_D.9.4.3.2
Annex sec_D.9.4.4
Annex sec_D.9.5.1
Annex sec_D.9.5.2
Annex sec_D.9.5.3
Annex sec_D.9.5.4
Annex sec_D.9.5.5
Annex sec_D.9.5.6
Annex sec_D.10
Annex sec_D.10.1
Annex sec_D.10.2
Annex sec_D.10.3
Annex sec_D.10.4
Annex sec_D.10.5
Annex sec_D.11
Annex sec_D.11.1
Annex sec_D.11.2
Annex sec_D.11.3
Annex sec_D.11.4
Annex sec_D.11.5
Annex sec_D.12
Annex sec_D.12.1
Annex sec_D.12.1.1
Annex sec_D.12.1.2
Annex sec_D.12.2
Annex sec_D.12.2.1
Annex sec_D.12.2.2
Annex sec_D.12.2.3
Annex sec_D.12.2.4
Annex sec_D.12.3
Annex sec_D.12.3.1
Annex sec_D.12.3.2
Annex sec_D.12.3.3
Figure fig_D.1
Annex sec_D.12.3.4
Annex sec_D.12.3.5
Annex sec_D.12.4
Annex sec_D.12.4.1
Annex sec_D.12.4.2
Annex sec_D.12.4.3
Annex sec_D.12.4.4
Annex sec_D.12.4.5
Annex sec_D.12.4.6
Annex sec_D.12.5
Annex sec_D.12.5.1
Annex sec_D.12.5.2
Annex sec_D.12.5.3
Annex sec_D.12.5.4
Annex sec_D.12.5.5
Annex sec_D.12.5.6
Annex sec_D.12.5.7
Annex sec_D.12.5.8
Annex sec_D.12.5.9
Annex sec_D.12.5.10
Annex sec_D.12.5.11
Annex sec_D.12.5.11.1
Annex sec_D.12.5.11.2
Annex sec_D.12.5.11.3
Annex sec_D.12.5.11.4
Annex sec_D.12.5.11.5
Annex sec_D.12.5.11.6
Annex sec_D.12.5.11.7
Annex sec_D.13
Annex sec_D.13.1
Annex sec_D.13.1.1
Annex sec_D.13.1.2
Annex sec_D.13.1.3
Annex sec_D.13.2
Annex sec_D.14
Annex sec_D.14.1
Annex sec_D.14.1.1
Annex sec_D.14.1.2
Annex sec_D.14.1.3
Annex sec_D.14.1.4
Annex sec_D.14.2
Annex sec_D.14.2.1
Annex sec_D.14.2.2
Annex sec_D.14.2.3
Annex sec_D.14.2.4
Annex sec_D.14.2.5
Annex sec_E
Annex sec_E.1
Annex sec_E.2
Annex sec_E.2.1
Annex sec_E.2.2
Annex sec_E.2.3
Annex sec_E.2.4
Reference ref_1
Reference ref_2
Reference ref_3
Reference ref_4
Reference ref_5
Reference ref_6
Reference ref_7
Reference ref_8
Reference ref_9
Reference ref_10
Reference ref_11
Reference ref_12
Reference ref_13
Reference ref_14
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Reference ref_18
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Reference ref_23
Reference ref_24
Reference ref_25
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Reference ref_31
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Reference ref_33
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Reference ref_35
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Reference ref_43
Foreword
Introduction
1 Scope
1.1 Inclusions
1.2 Exclusions
2 Normative references
3 Terms and definitions
4 Quality management systems
4.1 Documentation
4.2 Management responsibility
4.3 Product realization
4.4 Measurement, analysis and improvement — Control of nonconforming product
5 Sterilizing agent characterization
5.1 General
5.2 Sterilizing agent
5.3 Microbicidal effectiveness
5.4 Material effects
5.5 Safety and the environment
6 Process and equipment characterization
6.1 General
6.2 Process characterization
6.3 Equipment characterization
7 Product definition
7.1 General
7.2 Product safety, quality and performance
7.3 Microbiological quality
7.4 Documentation
8 Process definition
9 Validation
9.1 General
9.2 Installation qualification, IQ
9.3 Operational qualification, OQ
9.4 Performance qualification, PQ
9.5 Review and approval of validation
10 Routine monitoring and control
11 Product release from sterilization
12 Maintaining process effectiveness
12.1 General
12.2 Maintenance of equipment
12.3 Requalification
12.4 Assessment of change
12.5 Assessment of equivalence
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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Section sec_1
Section sec_1.1
Section sec_1.2
Section sec_1.2.1
Section sec_1.2.2
Section sec_1.2.3
Section sec_1.2.4
Section sec_1.2.5
Section sec_1.2.6
Section sec_2
Section sec_3
Section sec_3.1
Section sec_3.2
Section sec_3.3
Section sec_3.4
Section sec_3.5
Section sec_3.6
Section sec_3.7
Section sec_3.8
Section sec_3.9
Section sec_3.10
Section sec_3.11
Section sec_3.12
Section sec_3.13
Section sec_3.14
Section sec_3.15
Section sec_3.16
Section sec_3.17
Section sec_3.18
Section sec_3.19
Section sec_3.20
Section sec_3.21
Section sec_3.22
Section sec_3.23
Section sec_3.24
Section sec_3.25
Section sec_3.26
Section sec_3.27
Section sec_3.28
Section sec_3.29
Section sec_3.30
Section sec_3.31
Section sec_3.32
Section sec_3.33
Section sec_3.34
Section sec_3.35
Section sec_3.36
Section sec_3.37
Section sec_3.38
Section sec_3.39
Section sec_3.40
Section sec_3.41
Section sec_3.42
Section sec_3.43
Section sec_3.44
Section sec_3.45
Section sec_3.46
Section sec_3.47
Section sec_3.48
Section sec_3.49
Section sec_3.50
Section sec_3.51
Section sec_3.52
Section sec_3.53
Section sec_3.54
Section sec_3.55
Section sec_3.56
Section sec_3.57
Section sec_3.58
Section sec_4
Section sec_4.1
Section sec_4.1.1
Section sec_4.1.2
Section sec_4.2
Section sec_4.2.1
Section sec_4.2.2
Section sec_4.3
Section sec_4.3.1
Section sec_4.3.2
Section sec_4.3.3
Section sec_4.4
Section sec_5
Section sec_5.1
Section sec_5.2
Section sec_5.3
Section sec_5.4
Section sec_5.5
Section sec_5.5.1
Section sec_5.5.2
Section sec_5.5.3
Section sec_6
Section sec_6.1
Section sec_6.1.1
Section sec_6.1.2
Section sec_6.2
Section sec_6.2.1
Section sec_6.2.2
Section sec_6.2.3
Section sec_6.2.4
Section sec_6.2.5
Section sec_6.3
Section sec_6.3.1
Section sec_6.3.2
Section sec_6.3.3
Section sec_6.3.4
Section sec_6.3.5
Section sec_7
Section sec_7.1
Section sec_7.1.1
Section sec_7.1.2
Section sec_7.1.3
Section sec_7.1.4
Section sec_7.1.5
Section sec_7.1.6
Section sec_7.2
Section sec_7.2.1
Section sec_7.2.2
Section sec_7.2.3
Section sec_7.2.4
Section sec_7.3
Section sec_7.3.1
Section sec_7.3.2
Section sec_7.4
Section sec_8
Section sec_8.1
Section sec_8.2
Section sec_8.3
Section sec_8.4
Section sec_8.5
Section sec_8.6
Section sec_8.7
Section sec_8.8
Section sec_8.9
Section sec_9
Section sec_9.1
Section sec_9.1.1
Section sec_9.1.2
Section sec_9.1.3
Section sec_9.1.4
Section sec_9.2
Section sec_9.2.1
Section sec_9.2.1.1
Section sec_9.2.1.2
Section sec_9.2.1.3
Section sec_9.2.2
Section sec_9.2.2.1
Section sec_9.2.2.2
Section sec_9.2.2.3
Section sec_9.2.2.4
Section sec_9.2.2.5
Section sec_9.2.2.6
Section sec_9.3
Section sec_9.3.1
Section sec_9.3.2
Section sec_9.4
Section sec_9.4.1
Section sec_9.4.1.1
Section sec_9.4.1.2
Section sec_9.4.1.3
Section sec_9.4.1.4
Section sec_9.4.1.5
Section sec_9.4.1.6
Section sec_9.4.1.7
Section sec_9.4.1.8
Section sec_9.4.1.9
Section sec_9.4.1.10
Section sec_9.4.2
Section sec_9.4.2.1
Section sec_9.4.2.2
Section sec_9.4.2.3
Section sec_9.4.2.4
Section sec_9.4.2.5
Section sec_9.4.2.6
Section sec_9.4.3
Section sec_9.4.3.1
Section sec_9.4.3.2
Section sec_9.5
Section sec_9.5.1
Section sec_9.5.2
Section sec_9.5.3
Section sec_9.5.4
Section sec_9.5.5
Section sec_9.5.6
Section sec_10
Section sec_10.1
Section sec_10.2
Section sec_10.3
Section sec_10.4
Section sec_10.5
Section sec_11
Section sec_11.1
Section sec_11.2
Section sec_11.3
Section sec_11.4
Section sec_12
Section sec_12.1
Section sec_12.1.1
Section sec_12.1.2
Section sec_12.2
Section sec_12.2.1
Section sec_12.2.2
Section sec_12.2.3
Section sec_12.2.4
Section sec_12.3
Section sec_12.3.1
Section sec_12.3.2
Section sec_12.3.3
Section sec_12.3.4
Section sec_12.4
Section sec_12.4.1
Section sec_12.4.2
Section sec_12.4.3
Section sec_12.4.4
Section sec_12.4.5
Section sec_12.4.6
Section sec_12.5
Section sec_12.5.1
Section sec_12.5.2
Annex sec_A
Annex sec_A.1
Annex sec_A.1.1
Annex sec_A.1.2
Annex sec_A.1.3
Annex sec_A.2
Annex sec_B
Annex sec_B.1
Annex sec_B.1.1
Annex sec_B.1.2
Annex sec_B.1.3
Annex sec_B.1.4
Annex sec_B.2
Annex sec_B.2.1
Annex sec_B.2.2
Annex sec_B.2.3
Annex sec_B.2.4
Annex sec_B.2.5
Annex sec_C
Annex sec_C.1
Table tab_C.1
Annex sec_C.2
Table tab_C.2
Annex sec_C.3
Table tab_C.3
Annex sec_D
Annex sec_D.1
Annex sec_D.2
Annex sec_D.3
Annex sec_D.4
Annex sec_D.4.1
Annex sec_D.4.2
Annex sec_D.4.2.1
Annex sec_D.4.2.2
Annex sec_D.4.3
Annex sec_D.4.3.1
Annex sec_D.4.3.2
Annex sec_D.4.3.3
Annex sec_D.4.4
Annex sec_D.5
Annex sec_D.5.1
Annex sec_D.5.2
Annex sec_D.5.3
Annex sec_D.5.4
Annex sec_D.5.5
Annex sec_D.5.5.1
Annex sec_D.5.5.2
Annex sec_D.5.5.3
Annex sec_D.6
Annex sec_D.6.1
Annex sec_D.6.2
Annex sec_D.6.2.1
Annex sec_D.6.2.2
Annex sec_D.6.2.3
Annex sec_D.6.2.4
Annex sec_D.6.2.5
Annex sec_D.6.3
Annex sec_D.6.3.1
Annex sec_D.6.3.2
Annex sec_D.6.3.3
Annex sec_D.6.3.4
Annex sec_D.6.3.5
Annex sec_D.7
Annex sec_D.7.1
Annex sec_D.7.1.1
Annex sec_D.7.1.2
Annex sec_D.7.1.3
Annex sec_D.7.1.4
Annex sec_D.7.1.5
Annex sec_D.7.1.6
Annex sec_D.7.2
Annex sec_D.7.2.1
Annex sec_D.7.2.2
Annex sec_D.7.2.3
Annex sec_D.7.2.4
Annex sec_D.7.3
Annex sec_D.7.3.1
Annex sec_D.7.3.2
Annex sec_D.7.4
Annex sec_D.8
Annex sec_D.8.1
Annex sec_D.8.2
Annex sec_D.8.3
Annex sec_D.8.4
Annex sec_D.8.5
Annex sec_D.8.6
Annex sec_D.8.7
Annex sec_D.8.8
Annex sec_D.8.9
Annex sec_D.9
Annex sec_D.9.1
Annex sec_D.9.1.1
Annex sec_D.9.1.2
Annex sec_D.9.1.3
Annex sec_D.9.1.4
Annex sec_D.9.2
Annex sec_D.9.2.1
Annex sec_D.9.2.1.1
Annex sec_D.9.2.1.2
Annex sec_D.9.2.1.3
Annex sec_D.9.2.2
Annex sec_D.9.2.2.1
Annex sec_D.9.2.2.2
Annex sec_D.9.2.2.3
Annex sec_D.9.2.2.4
Annex sec_D.9.2.2.5
Annex sec_D.9.2.2.6
Annex sec_D.9.3
Annex sec_D.9.3.1
Annex sec_D.9.3.2
Annex sec_D.9.4
Annex sec_D.9.4.1
Annex sec_D.9.4.1.1
Annex sec_D.9.4.1.2
Annex sec_D.9.4.1.3
Annex sec_D.9.4.1.4
Annex sec_D.9.4.1.5
Annex sec_D.9.4.1.6
Annex sec_D.9.4.1.7
Annex sec_D.9.4.1.8
Annex sec_D.9.4.1.9
Annex sec_D.9.4.1.10
Annex sec_D.9.4.2
Annex sec_D.9.4.2.1
Annex sec_D.9.4.2.2
Annex sec_D.9.4.2.3
Annex sec_D.9.4.2.4
Annex sec_D.9.4.2.5
Annex sec_D.9.4.3
Annex sec_D.9.4.3.1
Annex sec_D.9.4.3.2
Annex sec_D.9.4.4
Annex sec_D.9.5.1
Annex sec_D.9.5.2
Annex sec_D.9.5.3
Annex sec_D.9.5.4
Annex sec_D.9.5.5
Annex sec_D.9.5.6
Annex sec_D.10
Annex sec_D.10.1
Annex sec_D.10.2
Annex sec_D.10.3
Annex sec_D.10.4
Annex sec_D.10.5
Annex sec_D.11
Annex sec_D.11.1
Annex sec_D.11.2
Annex sec_D.11.3
Annex sec_D.11.4
Annex sec_D.11.5
Annex sec_D.12
Annex sec_D.12.1
Annex sec_D.12.1.1
Annex sec_D.12.1.2
Annex sec_D.12.2
Annex sec_D.12.2.1
Annex sec_D.12.2.2
Annex sec_D.12.2.3
Annex sec_D.12.2.4
Annex sec_D.12.3
Annex sec_D.12.3.1
Annex sec_D.12.3.2
Annex sec_D.12.3.3
Figure fig_D.1
Annex sec_D.12.3.4
Annex sec_D.12.3.5
Annex sec_D.12.4
Annex sec_D.12.4.1
Annex sec_D.12.4.2
Annex sec_D.12.4.3
Annex sec_D.12.4.4
Annex sec_D.12.4.5
Annex sec_D.12.4.6
Annex sec_D.12.5
Annex sec_D.12.5.1
Annex sec_D.12.5.2
Annex sec_D.12.5.3
Annex sec_D.12.5.4
Annex sec_D.12.5.5
Annex sec_D.12.5.6
Annex sec_D.12.5.7
Annex sec_D.12.5.8
Annex sec_D.12.5.9
Annex sec_D.12.5.10
Annex sec_D.12.5.11
Annex sec_D.12.5.11.1
Annex sec_D.12.5.11.2
Annex sec_D.12.5.11.3
Annex sec_D.12.5.11.4
Annex sec_D.12.5.11.5
Annex sec_D.12.5.11.6
Annex sec_D.12.5.11.7
Annex sec_D.13
Annex sec_D.13.1
Annex sec_D.13.1.1
Annex sec_D.13.1.2
Annex sec_D.13.1.3
Annex sec_D.13.2
Annex sec_D.14
Annex sec_D.14.1
Annex sec_D.14.1.1
Annex sec_D.14.1.2
Annex sec_D.14.1.3
Annex sec_D.14.1.4
Annex sec_D.14.2
Annex sec_D.14.2.1
Annex sec_D.14.2.2
Annex sec_D.14.2.3
Annex sec_D.14.2.4
Annex sec_D.14.2.5
Annex sec_E
Annex sec_E.1
Annex sec_E.2
Annex sec_E.2.1
Annex sec_E.2.2
Annex sec_E.2.3
Annex sec_E.2.4
Reference ref_1
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Foreword
Introduction
1 Scope
1.1 Inclusions
1.2 Exclusions
2 Normative references
3 Terms and definitions
4 Quality management systems
4.1 Documentation
4.2 Management responsibility
4.3 Product realization
4.4 Measurement, analysis and improvement — Control of nonconforming product
5 Sterilizing agent characterization
5.1 General
5.2 Sterilizing agent
5.3 Microbicidal effectiveness
5.4 Material effects
5.5 Safety and the environment
6 Process and equipment characterization
6.1 General
6.2 Process characterization
6.3 Equipment characterization
7 Product definition
7.1 General
7.2 Product safety, quality and performance
7.3 Microbiological quality
7.4 Documentation
8 Process definition
9 Validation
9.1 General
9.2 Installation qualification, IQ
9.3 Operational qualification, OQ
9.4 Performance qualification, PQ
9.5 Review and approval of validation
10 Routine monitoring and control
11 Product release from sterilization
12 Maintaining process effectiveness
12.1 General
12.2 Maintenance of equipment
12.3 Requalification
12.4 Assessment of change
12.5 Assessment of equivalence
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