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BS EN ISO 11135:2014:2015 Edition

BS EN ISO 11135:2014:2015 Edition

$215.11

Sterilization of health-care products. Ethylene oxide. Requirements for the development, validation and routine control of a sterilization process for medical devices

Published By Publication Date Number of Pages
BSI 2015 94
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PDF Catalog

PDF Pages PDF Title
9 Foreword
10 Introduction
13 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
1 Scope
1.1 Inclusions
1.2 Exclusions
14 Section sec_1.2.4
Section sec_1.2.5
Section sec_1.2.6
Section sec_2
2 Normative references
15 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
3 Terms and definitions
16 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
17 Section sec_3.17
Section sec_3.18
Section sec_3.19
Section sec_3.20
Section sec_3.21
Section sec_3.22
18 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
19 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
20 Section sec_3.39
Section sec_3.40
Section sec_3.41
Section sec_3.42
21 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
22 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
23 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
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
24 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
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
25 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
6.3 Equipment characterization
26 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
7 Product definition
7.1 General
27 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
7.2 Product safety, quality and performance
7.3 Microbiological quality
7.4 Documentation
8 Process definition
28 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
9 Validation
9.1 General
29 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
9.2 Installation qualification, IQ
9.3 Operational qualification, OQ
30 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
9.4 Performance qualification, PQ
31 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
32 Section sec_9.5
Section sec_9.5.1
Section sec_9.5.2
Section sec_9.5.3
Section sec_9.5.4
9.5 Review and approval of validation
33 Section sec_9.5.5
Section sec_9.5.6
34 Section sec_10
Section sec_10.1
Section sec_10.2
Section sec_10.3
10 Routine monitoring and control
35 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
11 Product release from sterilization
12 Maintaining process effectiveness
12.1 General
36 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
12.2 Maintenance of equipment
12.3 Requalification
12.4 Assessment of change
37 Section sec_12.4.5
Section sec_12.4.6
Section sec_12.5
Section sec_12.5.1
Section sec_12.5.2
12.5 Assessment of equivalence
38 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 A
(normative)

Determination of lethal rate of the sterilization process — Biological indicator/bioburden approach

39 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 B
(normative)

Conservative determination of lethal rate of the sterilization process — Overkill approach

40 Annex sec_B.2.3
Annex sec_B.2.4
Annex sec_B.2.5
41 Annex sec_C
Annex sec_C.1
Table tab_C.1
Annex sec_C.2
Annex C
(informative)

Temperature sensors, RH sensors and biological indicator numbers

42 Table tab_C.2
Annex sec_C.3
43 Table tab_C.3
44 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 D
(informative)

Guidance on the application of the normative requirements

45 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
46 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
47 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
48 Annex sec_D.6.2.3
Annex sec_D.6.2.4
49 Annex sec_D.6.2.5
Annex sec_D.6.3
Annex sec_D.6.3.1
50 Annex sec_D.6.3.2
51 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
52 Annex sec_D.7.1.2
53 Annex sec_D.7.1.3
Annex sec_D.7.1.4
Annex sec_D.7.1.5
Annex sec_D.7.1.6
54 Annex sec_D.7.2
Annex sec_D.7.2.1
55 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
56 Annex sec_D.8
Annex sec_D.8.1
Annex sec_D.8.2
57 Annex sec_D.8.3
Annex sec_D.8.4
Annex sec_D.8.5
Annex sec_D.8.6
59 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
60 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
61 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
62 Annex sec_D.9.2.2.6
Annex sec_D.9.3
Annex sec_D.9.3.1
Annex sec_D.9.3.2
63 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
64 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
65 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
66 Annex sec_D.9.4.3.1
Annex sec_D.9.4.3.2
67 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
68 Annex sec_D.10
Annex sec_D.10.1
Annex sec_D.10.2
69 Annex sec_D.10.3
Annex sec_D.10.4
Annex sec_D.10.5
70 Annex sec_D.11
Annex sec_D.11.1
Annex sec_D.11.2
Annex sec_D.11.3
71 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
72 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
73 Annex sec_D.12.3.2
Annex sec_D.12.3.3
74 Figure fig_D.1
Annex sec_D.12.3.4
75 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
76 Annex sec_D.12.5.2
Annex sec_D.12.5.3
Annex sec_D.12.5.4
77 Annex sec_D.12.5.5
Annex sec_D.12.5.6
78 Annex sec_D.12.5.7
Annex sec_D.12.5.8
Annex sec_D.12.5.9
Annex sec_D.12.5.10
79 Annex sec_D.12.5.11
Annex sec_D.12.5.11.1
Annex sec_D.12.5.11.2
80 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
81 Annex sec_D.13
Annex sec_D.13.1
Annex sec_D.13.1.1
82 Annex sec_D.13.1.2
Annex sec_D.13.1.3
Annex sec_D.13.2
83 Annex sec_D.14
Annex sec_D.14.1
Annex sec_D.14.1.1
84 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
85 Annex sec_D.14.2.5
86 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 E
(normative)

Single Lot Release

87 Annex sec_E.2.4
88 Reference ref_1
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Bibliography
89 Reference ref_22
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90 Reference ref_40
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