AAMI TIR20 : 2001

Glossary of equivalent standards
Committee representation
Introduction
1 Scope
2 Cited references
3 Definitions
4 Equipment requirements
  4.1 Preconditioning
  4.2 Sterilization chamber
  4.3 Aeration/degassing
5 Process analysis
  5.1 Overview
  5.2 Frequency of EO analysis
  5.3 EO analysis sampling location(s)
  5.4 EO analysis accuracy
6 Process development
  6.1 Overview
  6.2 Use of biological indicators to develop the
      sterilization process
  6.3 Methods of determining lethality
      6.3.1 Methods overview
      6.3.2 Steps required by both methods
      6.3.3 Method A: Survivor curve construction-Enumeration
            of the BIs
      6.3.4 Method B: Fraction negative
      6.3.5 Sterilization cycle development process
            troubleshooting
  6.4 Sampling considerations for process development studies
  6.5 Performance of Method A or B in a pilot or a production
      chamber
      6.5.1 Four ways that Method A or B may be performed
      6.5.2 Establishing relationship between pilot
            chamber and production chamber
  6.6 Calculation of the sterilization cycle
  6.7 Documentation of the process development
7 Validation
  7.1 Commissioning (IQ/OQ)
  7.2 Performance qualification (PQ)-Microbiological
  7.3 Load configuration
  7.4 Performance qualification-Physical
  7.5 Revalidation
8 Routine processing
9 Product release
  9.1 General
  9.3 Electronic records and signatures
Annexes
A - Gas analysis issues
B - Sensor monitoring tables
C - Factors influencing accuracy and decisions
    regarding the direct analysis of EO concentration

Describes the rationale and approach necessary for the implementation of parametric release for product sterilized by ethylene oxide (EO).