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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, 2014
- 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
- Objectives and uses of AAMI standards and recommended practices
- Title page
- AAMI Standard
- Copyright information
- Contents
- Glossary of equivalent standards
- Committee representation
- Background of ANSI/AAMI adoption of ISO 11135:2014
- Foreword
- Introduction
- 1 Scope [Go to Page]
- 1.1 Inclusions
- 1.2 Exclusions
- 2 Normative references
- 3 Terms and definitions
- 4 Quality management systems [Go to Page]
- 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 [Go to Page]
- 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 [Go to Page]
- 6.1 General
- 6.2 Process characterization
- 6.3 Equipment characterization
- 7 Product definition [Go to Page]
- 7.1 General
- 7.2 Product safety, quality and performance
- 7.3 Microbiological quality
- 7.4 Documentation
- 8 Process definition
- 9 Validation [Go to Page]
- 9.1 General
- 9.2 Installation qualification, IQ [Go to Page]
- 9.2.1 Equipment
- 9.2.2 Installation qualification
- 9.3 Operational qualification, OQ
- 9.4 Performance qualification, PQ [Go to Page]
- 9.4.1 General
- 9.4.2 Performance qualification — Microbiological
- 9.4.3 Performance qualification — Physical
- 9.5 Review and approval of validation
- 10 Routine monitoring and control
- 11 Product release from sterilization
- 12 Maintaining process effectiveness [Go to Page]
- 12.1 General
- 12.2 Maintenance of equipment
- 12.3 Requalification
- 12.4 Assessment of change
- 12.5 Assessment of equivalence [Go to Page]
- 12.5.1 Process equivalence
- 12.5.2 Product
- Annex A: Determination of lethal rate of the sterilization process — Biological indicator/bioburden approach [Go to Page]
- A.1 General
- A.2 Procedure
- Annex B: Conservative determination of lethal rate of the sterilization process — Overkill approach [Go to Page]
- B.1 General
- B.2 Procedure
- Annex C: Temperature sensors, RH sensors and biological indicator numbers [Go to Page]
- C.1 Temperature sensors [Go to Page]
- Table C.1 — Minimum recommended number of temperature sensors
- C.2 Humidity sensors [Go to Page]
- Table C.2 — Minimum recommended number of humidity sensors
- C.3 Biological Indicators [Go to Page]
- Table C.3 — Examples of minimum recommended number of BI/PCDs
- Annex D: Guidance on the application of the normative requirements [Go to Page]
- D.1 Scope
- D.2 Normative references
- D.3 Terms and definitions
- D.4 Quality management systems [Go to Page]
- D.4.1 Documentation
- D.4.2 Management responsibility
- D.4.3 Product realization
- D.4.4 Measurement, analysis and improvement — Control of non-conforming product
- D.5 Sterilizing agent characterization [Go to Page]
- D.5.1 General
- D.5.2 Sterilizing agent
- D.5.3 Microbicidal effectiveness
- D.5.4 Material effects
- D.5.5 Safety and the environment
- D.6 Process and equipment characterization [Go to Page]
- D.6.1 General
- D.6.2 Process characterization
- D.6.3 Equipment characterization
- D.7 Product definition [Go to Page]
- D.7.1 General
- D.7.2 Product safety, quality and performance
- D.7.3 Microbiological quality
- D.7.4 Documentation
- D.8 Process definition
- D.9 Validation [Go to Page]
- D.9.1 General
- D.9.2 Installation qualification [Go to Page]
- D.9.2.1 Equipment
- D.9.2.2 Installation qualification
- D.9.3 Operational qualification
- D.9.4 Performance qualification [Go to Page]
- D.9.4.1 General
- D.9.4.2 Performance qualification — Microbiological
- D.9.4.3 Performance qualification — Physical
- D.9.4.4 Review and approval of validation
- D.10 Routine monitoring and control
- D.11 Product release from sterilization
- D.12 Maintaining process effectiveness [Go to Page]
- D.12.1 General
- D.12.2 Maintenance of equipment
- D.12.3 Requalification [Go to Page]
- Figure D.1 — Requalification decision tree
- D.12.4 Assessment of change
- D.12.5 Assessment of equivalence1F** [Go to Page]
- D.12.5.1 Process equivalence
- D.12.5.2 Criteria for process equivalence
- 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
- D.12.5.7 Microbiological evaluation
- D.12.5.8 Results evaluation
- D.12.5.9 Maintenance of equivalence
- D.12.5.10 Documentation
- D.12.5.11 Product [Go to Page]
- D.12.5.11.1 Product family
- D.12.5.11.2 Determination of adverse effects to product
- D.12.5.11.3 Determination of product design effects
- 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 [Go to Page]
- D.13.1 [A.1] General
- D.13.2 [A.2] Procedure
- D.14 Guidance on Annex B — Conservative determination of lethal rate of the sterilization process — Overkill approach [Go to Page]
- D.14.1 [B.1] General
- D.14.2 [B.2] Procedure
- Annex E: Single Lot Release [Go to Page]
- E.1 General
- E.2 Procedure
- Bibliography [Go to Page]