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eLibrary > AAMI/ISO TIR21387:2023 - Sterilization of health care products—Guidance on the requirements for the validation and routine processing of ethylene oxide sterilization processes using parametric release >

AAMI/ISO TIR21387:2023 - Sterilization of health care products—Guidance on the requirements for the validation and routine processing of ethylene oxide sterilization processes using parametric release, 2023

AAMI/ISO TIR21387:2023 - Sterilization of health care products—Guidance on the requirements for the validation and routine processing of ethylene oxide sterilization processes using parametric release, 2023

AAMI/ISO TIR21387:2023; Sterilization of health care products—Guidance on the requirements for the validation and routine processing of ethylene oxide sterilization processes using parametric release
Title page
Copyright information
AAMI Technical Information Report
Contents
Committee representation
Background of AAMI adoption of ISO/TS 21387:2020
Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 Quality management systems
5 Sterilization agent characterization
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
8 Process definition
9 Validation [Go to Page]
9.1 General
9.2 Installation qualification [Go to Page]
9.2.1 Equipment
9.2.2 Installation qualification
9.3 Operational qualification
9.4 Performance qualification [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
13 ISO 11135:2014, Annex A
14 ISO 11135:2014, Annex B
Annex A (informative) Establishing specifications for parametric release based on routine processing data [Go to Page]
A.1 General
A.2 Procedure [Go to Page]
A.2.1 General
A.2.2 Number of cycles to review
A.2.3 Data to be collected [Go to Page]
A.2.3.1 Temperature
A.2.3.2 Humidity
A.2.3.3 EO concentration
A.2.4 Establishing parametric release specifications [Go to Page]
A.2.4.1 General
A.2.4.2 Analysis and specification development
A.2.4.3 Temperature
A.2.4.4 Humidity
A.2.4.5 EO concentration
A.2.5 Confirmatory MPQ cycle
Bibliography [Go to Page]

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AAMI/ISO TIR21387:2023 - Sterilization of health care products—Guidance on the requirements for the validation and routine processing of ethylene oxide sterilization processes using parametric release, 2023

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