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AAMI 11135 2014

AAMI 11135 2014

$162.84

ANSI/AAMI/ISO 11135:2014 – Sterilization of health care products-Ethylene oxide-Requirements for development, validation and routine control of a sterilization process for medical devices

Published By Publication Date Number of Pages
AAMI 2014 95
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Specifies requirements for the development, validation, and routine control of an ethylene oxide sterilization process for medical devices.

PDF Catalog

PDF Pages PDF Title
1 ANSI/AAMI/ISO 11135:2014, Sterilization of health care products —Ethylene oxide —Requirements for development, validation and routine control of a sterilization process for medical devices
2 Objectives and uses of AAMI standards and recommended practices
3 Title page
4 AAMI Standard
Copyright information
5 Contents
8 Glossary of equivalent standards
9 Committee representation
12 Background of ANSI/AAMI adoption of ISO 11135:2014
13 Foreword
14 Introduction
17 1 Scope
1.1 Inclusions
1.2 Exclusions
18 2 Normative references
19 3 Terms and definitions
27 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
28 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
29 6.2 Process characterization
30 6.3 Equipment characterization
31 7 Product definition
7.1 General
7.2 Product safety, quality and performance
7.3 Microbiological quality
32 7.4 Documentation
8 Process definition
33 9 Validation
9.1 General
9.2 Installation qualification, IQ
9.2.1 Equipment
9.2.2 Installation qualification
34 9.3 Operational qualification, OQ
9.4 Performance qualification, PQ
9.4.1 General
35 9.4.2 Performance qualification — Microbiological
9.4.3 Performance qualification — Physical
36 9.5 Review and approval of validation
38 10 Routine monitoring and control
40 11 Product release from sterilization
12 Maintaining process effectiveness
12.1 General
12.2 Maintenance of equipment
41 12.3 Requalification
12.4 Assessment of change
12.5 Assessment of equivalence
12.5.1 Process equivalence
42 12.5.2 Product
43 Annex A: Determination of lethal rate of the sterilization process — Biological indicator/bioburden approach
A.1 General
A.2 Procedure
44 Annex B: Conservative determination of lethal rate of the sterilization process — Overkill approach
B.1 General
B.2 Procedure
46 Annex C: Temperature sensors, RH sensors and biological indicator numbers
C.1 Temperature sensors
Table C.1 — Minimum recommended number of temperature sensors
47 C.2 Humidity sensors
Table C.2 — Minimum recommended number of humidity sensors
C.3 Biological Indicators
48 Table C.3 — Examples of minimum recommended number of BI/PCDs
49 Annex D: Guidance on the application of the normative requirements
D.1 Scope
D.2 Normative references
D.3 Terms and definitions
D.4 Quality management systems
D.4.1 Documentation
D.4.2 Management responsibility
50 D.4.3 Product realization
D.4.4 Measurement, analysis and improvement — Control of non-conforming product
D.5 Sterilizing agent characterization
D.5.1 General
51 D.5.2 Sterilizing agent
D.5.3 Microbicidal effectiveness
D.5.4 Material effects
D.5.5 Safety and the environment
52 D.6 Process and equipment characterization
D.6.1 General
D.6.2 Process characterization
54 D.6.3 Equipment characterization
56 D.7 Product definition
D.7.1 General
59 D.7.2 Product safety, quality and performance
61 D.7.3 Microbiological quality
D.7.4 Documentation
D.8 Process definition
65 D.9 Validation
D.9.1 General
D.9.2 Installation qualification
D.9.2.1 Equipment
66 D.9.2.2 Installation qualification
67 D.9.3 Operational qualification
69 D.9.4 Performance qualification
D.9.4.1 General
70 D.9.4.2 Performance qualification — Microbiological
71 D.9.4.3 Performance qualification — Physical
72 D.9.4.4 Review and approval of validation
73 D.10 Routine monitoring and control
76 D.11 Product release from sterilization
D.12 Maintaining process effectiveness
D.12.1 General
77 D.12.2 Maintenance of equipment
78 D.12.3 Requalification
80 Figure D.1 — Requalification decision tree
D.12.4 Assessment of change
81 D.12.5 Assessment of equivalence1F**
D.12.5.1 Process equivalence
D.12.5.2 Criteria for process equivalence
82 D.12.5.3 Determination of process equivalence
D.12.5.4 Process analysis and evaluation
D.12.5.5 Evaluation of preconditioning or aeration areas
D.12.5.6 Evaluation of sterilization chamber performance
83 D.12.5.7 Microbiological evaluation
D.12.5.8 Results evaluation
84 D.12.5.9 Maintenance of equivalence
D.12.5.10 Documentation
D.12.5.11 Product
D.12.5.11.1 Product family
85 D.12.5.11.2 Determination of adverse effects to product
D.12.5.11.3 Determination of product design effects
86 D.12.5.11.4 Determination of product material and characteristics effects
D.12.5.11.5 Determination of sterile barrier system effects
D.12.5.11.6 Determination of load configuration effects
D.12.5.11.7 Conclusions of product adoption evaluation
D.13 Guidance on Annex A — Determination of lethal rate of the sterilization process — Biological indicator/bioburden approach
D.13.1 [A.1] General
88 D.13.2 [A.2] Procedure
89 D.14 Guidance on Annex B — Conservative determination of lethal rate of the sterilization process — Overkill approach
D.14.1 [B.1] General
90 D.14.2 [B.2] Procedure
91 Annex E: Single Lot Release
E.1 General
E.2 Procedure
93 Bibliography

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